Medicines
Find Medicines
Search 21,000+ medicines by brand, generic, indication, or drug class
Medogen
Medroxyprogesterone Acetate (Tablet)
Medogen
Medroxyprogesterone Acetate (Tablet)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
Therapeutic classView
Female Sex hormones
PharmacologyView
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
DosageView
Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Side effectsView
The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
- Gastrointestinal: Nausea, cholestatic jaundice.
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
ContraindicationsView
Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected estrogen- or progesterone-dependent neoplasia.
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
- Known liver impairment or disease.
- Known or suspected pregnancy.
PrecautionsView
Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Pregnancy & lactationView
Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
Pediatric usageView
Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Overdose effectsView
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medogen
Medroxyprogesterone Acetate (Injection)
Medogen
Medroxyprogesterone Acetate (Injection)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone Acetate indicated for:
- Ovulation suppression
- The treatment of endometriosis.
- Adjunctive and/or pallivative treatment of recurrent and/or metastatic endometrial or renal carcinoma.
- The treatment of hormonally-dependant recurrent breast cancer in post-menopausal women.
Therapeutic classView
Female Sex hormones
PharmacologyView
Pharmacodynamics: Medroxyprogesterone Acetate injection has prolonged progestational effects when administered by intramuscular injection. This injection suppresses the secretion of pituitary gonadotropins which, in turns, prevents follicular maturation producing long-term anovulation in the reproductive aged women. Medroxyprogesterone Acetate injection suppresses the Leydig cell function in the male. i.e. suppresses endogenous testosterone product.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate is a long acting progestational steroid. The 150 mg/ml formulation reaches half its initial concentration in about 27 days. Its long duration of acting results from its slow absorption from the injection site. The principle metabolite of medroxyprogesterone acetate that has been identified is a 6-alpha-methyl-6 beta 17 alpha, 21 trihydroxy-4-pregnene-3, 20-dione-17 acetate which is excreted in the urine.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate is a long acting progestational steroid. The 150 mg/ml formulation reaches half its initial concentration in about 27 days. Its long duration of acting results from its slow absorption from the injection site. The principle metabolite of medroxyprogesterone acetate that has been identified is a 6-alpha-methyl-6 beta 17 alpha, 21 trihydroxy-4-pregnene-3, 20-dione-17 acetate which is excreted in the urine.
DosageView
Ovulation suppression: Medroxyprogesterone Acetate injectables suspension should be gently shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg/ml of this injectable suspension every three months administered by intramuscular injection in the gluteal or deltoid muscle. The initial injection should be given during the first 5 days after the onset of a menstrual period; within the 5 days post partum if not breast feeding; if exclusively breast-feeding at or after six weeks post partum.
Based on limited experience, some investigators favour the use of a second injection of Medroxyprogesterone Acetate before 90 days to control troublesome bleeding. The third and subsequent injections should be administered at separate 90 days intervals.
If abnormal bleeding persists, appropriate investigations should be instituted to rule out the possibility of organic pathology. Uterine curettage may be required on rare occations.
Based on limited experience, some investigators favour the use of a second injection of Medroxyprogesterone Acetate before 90 days to control troublesome bleeding. The third and subsequent injections should be administered at separate 90 days intervals.
If abnormal bleeding persists, appropriate investigations should be instituted to rule out the possibility of organic pathology. Uterine curettage may be required on rare occations.
Side effectsView
- Weight gain, feeling heaviness and pain in the abdomen, feeling pain, anxiety
- Amenorrhea
- Spotting
- Excessive bleeding
- Infection in the injected site
- Headache, Blurring of vision
- Pain in the back of the leg
- Delay in pregnancy after withdrawing injectable contraceptive.
ContraindicationsView
Known or suspected pregnancy, Undiagnosed vaginal bleeding, Known or suspected malignancy of breast ( when used for ovulation suppression or gynaecology indications), Severe liver dysfunction, Known hypersensitivity to medroxyprogesterone acetate or any component of the drug.
PrecautionsView
Unexpected vaginal bleeding during therapy, patient with a pre-existing medical condition that might be adversely affected by fluid retention, patients with a history of treatment for clinical depression diabetic patient. It may decrease the level of the following endocrine biomarkers: Plasma /urinary steroid (eg: cortisol, oestrogen, pregnanediol , progesterone & testosterone ) Plasma /urinary gonadotrophin (eg: LH & FSH) & sex hormonebinding- globulin (SHBG)
InteractionsView
Aminoglutethimide administered concomitantly with high doses of medroxyprogestrone acetate may significant depress the serum concentration of medroxyprogestrone acetate. User should be warned of the possibility of decreases efficacy with the use of amoniglutethimide.
Pregnancy & lactationView
Not recommended for the first 4 months.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medogen
Medroxyprogesterone Acetate (Tablet)
Medogen
Medroxyprogesterone Acetate (Tablet)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
Therapeutic classView
Female Sex hormones
PharmacologyView
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
DosageView
Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Side effectsView
The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
- Gastrointestinal: Nausea, cholestatic jaundice.
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
ContraindicationsView
Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected estrogen- or progesterone-dependent neoplasia.
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
- Known liver impairment or disease.
- Known or suspected pregnancy.
PrecautionsView
Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Pregnancy & lactationView
Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
Pediatric usageView
Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Overdose effectsView
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medricox
Etoricoxib
Medricox
Etoricoxib
Indications
Rheumatoid arthritis
Indication detailsView
Etoricoxib is indicated for the symptomatic relief of-
- Osteoarthritis (OA)
- Rheumatoid arthritis (RA)
- Ankylosing spondylitis, and
- The pain and signs of inflammation associated with acute gouty arthritis.
- For the short-term treatment of moderate pain associated with dental surgery.
Therapeutic classView
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.
DosageView
Adult and adolescent over 16 years:
- Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
- Rheumatoid arthritis: The recommended dose is 90 mg once daily.
- Ankylosing spondylitis: The recommended dose is 90 mg once daily.
- Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
- Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.
Side effectsView
Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
- Pregnancy and lactation.
- Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score 10).
- Estimated renal creatinine clearance <30 ml/min.
- Children and adolescents under 16 years of age.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA ll-IV).
- Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
- Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
PrecautionsView
- Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and Gl bleeding.
- Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Etoricoxib after careful consideration.
- Administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered.
- Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason.
- Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormalliver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, Etoricoxib should be discontinued.
- Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
- Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering Etoricoxib with warfarin or other oral anticoagulants.
InteractionsView
With medicine:
- Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
- Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
- Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
- Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
- Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Pregnancy & lactationView
The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.
Overdose effectsView
Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Medricox
Etoricoxib
Medricox
Etoricoxib
Indications
Rheumatoid arthritis
Indication detailsView
Etoricoxib is indicated for the symptomatic relief of-
- Osteoarthritis (OA)
- Rheumatoid arthritis (RA)
- Ankylosing spondylitis, and
- The pain and signs of inflammation associated with acute gouty arthritis.
- For the short-term treatment of moderate pain associated with dental surgery.
Therapeutic classView
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.
DosageView
Adult and adolescent over 16 years:
- Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
- Rheumatoid arthritis: The recommended dose is 90 mg once daily.
- Ankylosing spondylitis: The recommended dose is 90 mg once daily.
- Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
- Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.
Side effectsView
Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
- Pregnancy and lactation.
- Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score 10).
- Estimated renal creatinine clearance <30 ml/min.
- Children and adolescents under 16 years of age.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA ll-IV).
- Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
- Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
PrecautionsView
- Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and Gl bleeding.
- Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Etoricoxib after careful consideration.
- Administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered.
- Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason.
- Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormalliver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, Etoricoxib should be discontinued.
- Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
- Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering Etoricoxib with warfarin or other oral anticoagulants.
InteractionsView
With medicine:
- Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
- Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
- Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
- Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
- Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Pregnancy & lactationView
The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.
Overdose effectsView
Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Medrina
Medroxyprogesterone Acetate (Tablet)
Medrina
Medroxyprogesterone Acetate (Tablet)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
Therapeutic classView
Female Sex hormones
PharmacologyView
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
DosageView
Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Side effectsView
The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
- Gastrointestinal: Nausea, cholestatic jaundice.
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
ContraindicationsView
Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected estrogen- or progesterone-dependent neoplasia.
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
- Known liver impairment or disease.
- Known or suspected pregnancy.
PrecautionsView
Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Pregnancy & lactationView
Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
Pediatric usageView
Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Overdose effectsView
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medrogest
Medroxyprogesterone Acetate (Tablet)
Medrogest
Medroxyprogesterone Acetate (Tablet)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
Therapeutic classView
Female Sex hormones
PharmacologyView
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
DosageView
Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Side effectsView
The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
- Gastrointestinal: Nausea, cholestatic jaundice.
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
ContraindicationsView
Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected estrogen- or progesterone-dependent neoplasia.
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
- Known liver impairment or disease.
- Known or suspected pregnancy.
PrecautionsView
Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Pregnancy & lactationView
Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
Pediatric usageView
Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Overdose effectsView
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medrogest
Medroxyprogesterone Acetate (Tablet)
Medrogest
Medroxyprogesterone Acetate (Tablet)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
Therapeutic classView
Female Sex hormones
PharmacologyView
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
DosageView
Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Side effectsView
The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
- Gastrointestinal: Nausea, cholestatic jaundice.
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
ContraindicationsView
Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected estrogen- or progesterone-dependent neoplasia.
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
- Known liver impairment or disease.
- Known or suspected pregnancy.
PrecautionsView
Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Pregnancy & lactationView
Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
Pediatric usageView
Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Overdose effectsView
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medrol
Methylprednisolone
Medrol
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Medrol
Methylprednisolone
Medrol
Methylprednisolone
Indications
Rheumatic disorders
Indication detailsView
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
DosageView
The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
The following should be kept in mind when considering alternate-day therapy:
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
- Day 6: 1 tablet before breakfast
The following should be kept in mind when considering alternate-day therapy:
- Basic principles and indications for corticosteroid therapy should be applied.
- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
Side effectsView
Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
ContraindicationsView
Systemic fungal infections arid known hypersensitivity to components.
PrecautionsView
Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
InteractionsView
Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
Pregnancy & lactationView
Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
Overdose effectsView
Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children.
Medrol
Methylprednisolone Acetate
Medrol
Methylprednisolone Acetate
Indications
Wiskott-Aldrich syndrome
Indication detailsView
Methyl Prednisolone Acetate is indicated in the treatment of asthma, atopic dermatitis, contact dermatitis, bullous dermatitis herpetiformis, mycosis fungoides, pemphigus, severe erythema multiforme, primary or secondary adrenocortical insufficiency, hypercalcemia associated with cancer, nonsuppurative thyroiditis, ulcerative colitis, hematologic disorders, palliative management of leukemias and lymphomas, sympathetic ophthalmia, keratitis, allergic conjunctivitis, Juvenile rheumatoid arthritis, ankylosing spondylitis, symptomatic sarcoidosis, aspiration pneumonitis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Methylprednisolone binds to and activates intracellular glucocorticoid receptors. Activated glucocorticoid receptors bind to promoter regions of DNA (which may activate or suppress transcription). Unbound glucocorticoids cross cell membranes and bind with high affinity to specific cytoplasmic receptors, modifying transcription and protein synthesis. By this mechanism, glucocorticoids can inhibit leukocyte infiltration at the site of inflammation, interfere with mediators of inflammatory response, and suppress humoral immune responses. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
DosageView
1. Administration For Local Effect:
Rheumatoid and Osteoarthritis: The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. The doses in the following table are given as a general guide:
Dermatological Conditions: 20 to 60mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40mg by repeated local injections in the case of large lesions. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.
2. Administration For Systemic Effect: In patients with the adrenogenital syndrome, a single intramuscular injection of 40mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.
3. Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64mg every other day for 1 month have been shown to be effective (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Or, as directed by the registered physician.
Rheumatoid and Osteoarthritis: The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. The doses in the following table are given as a general guide:
- Large Size of joint (Knees, Ankles, Shoulders): 20 to 80 mg
- Medium Size of joint (Elbows, Wrists): 10 to 40 mg
- Small Size of joint (Metacarpophalangeal, Interphalangeal, Sternoclavicular, Acromioclavicular): 4 to 10 mg.
Dermatological Conditions: 20 to 60mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40mg by repeated local injections in the case of large lesions. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.
2. Administration For Systemic Effect: In patients with the adrenogenital syndrome, a single intramuscular injection of 40mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.
3. Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64mg every other day for 1 month have been shown to be effective (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Or, as directed by the registered physician.
Side effectsView
Congestive heart failure in susceptible patients, hypertension, sodium retention, muscle weakness, osteoporosis, peptic ulcer with possible subsequent and hemorrhage, abdominal distention, increased sweating, convulsion, vertigo, headache, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness, increased intraocular pressure, glaucoma, allergic or hypersensitivity reactions, urticaria, hyperpigmentation or hypopigmentation.
ContraindicationsView
Methylprednisolone acetate sterile aqueous suspension is contraindicated for intrathecal administration. It is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
PrecautionsView
Corticosteroids should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
InteractionsView
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Drug that induce hepatic enzymes such as phenobarbital, phenytoin and rifampicin may increase the clearance of methylprednisolone. Drug such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and decrease its clearance. Methylprednisolone may increase the clearance of chronic high dose aspirin. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids.
Pregnancy & lactationView
Pregnancy Category C. Since adequate human reproduction studies have not been done with corticosteroids, the use of these drug in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
StorageView
Store between 20-25° C.
Medrol
Methylprednisolone Acetate
Medrol
Methylprednisolone Acetate
Indications
Wiskott-Aldrich syndrome
Indication detailsView
Methyl Prednisolone Acetate is indicated in the treatment of asthma, atopic dermatitis, contact dermatitis, bullous dermatitis herpetiformis, mycosis fungoides, pemphigus, severe erythema multiforme, primary or secondary adrenocortical insufficiency, hypercalcemia associated with cancer, nonsuppurative thyroiditis, ulcerative colitis, hematologic disorders, palliative management of leukemias and lymphomas, sympathetic ophthalmia, keratitis, allergic conjunctivitis, Juvenile rheumatoid arthritis, ankylosing spondylitis, symptomatic sarcoidosis, aspiration pneumonitis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Methylprednisolone binds to and activates intracellular glucocorticoid receptors. Activated glucocorticoid receptors bind to promoter regions of DNA (which may activate or suppress transcription). Unbound glucocorticoids cross cell membranes and bind with high affinity to specific cytoplasmic receptors, modifying transcription and protein synthesis. By this mechanism, glucocorticoids can inhibit leukocyte infiltration at the site of inflammation, interfere with mediators of inflammatory response, and suppress humoral immune responses. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
DosageView
1. Administration For Local Effect:
Rheumatoid and Osteoarthritis: The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. The doses in the following table are given as a general guide:
Dermatological Conditions: 20 to 60mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40mg by repeated local injections in the case of large lesions. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.
2. Administration For Systemic Effect: In patients with the adrenogenital syndrome, a single intramuscular injection of 40mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.
3. Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64mg every other day for 1 month have been shown to be effective (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Or, as directed by the registered physician.
Rheumatoid and Osteoarthritis: The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. The doses in the following table are given as a general guide:
- Large Size of joint (Knees, Ankles, Shoulders): 20 to 80 mg
- Medium Size of joint (Elbows, Wrists): 10 to 40 mg
- Small Size of joint (Metacarpophalangeal, Interphalangeal, Sternoclavicular, Acromioclavicular): 4 to 10 mg.
Dermatological Conditions: 20 to 60mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40mg by repeated local injections in the case of large lesions. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.
2. Administration For Systemic Effect: In patients with the adrenogenital syndrome, a single intramuscular injection of 40mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.
3. Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64mg every other day for 1 month have been shown to be effective (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Or, as directed by the registered physician.
Side effectsView
Congestive heart failure in susceptible patients, hypertension, sodium retention, muscle weakness, osteoporosis, peptic ulcer with possible subsequent and hemorrhage, abdominal distention, increased sweating, convulsion, vertigo, headache, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness, increased intraocular pressure, glaucoma, allergic or hypersensitivity reactions, urticaria, hyperpigmentation or hypopigmentation.
ContraindicationsView
Methylprednisolone acetate sterile aqueous suspension is contraindicated for intrathecal administration. It is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
PrecautionsView
Corticosteroids should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
InteractionsView
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Drug that induce hepatic enzymes such as phenobarbital, phenytoin and rifampicin may increase the clearance of methylprednisolone. Drug such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and decrease its clearance. Methylprednisolone may increase the clearance of chronic high dose aspirin. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids.
Pregnancy & lactationView
Pregnancy Category C. Since adequate human reproduction studies have not been done with corticosteroids, the use of these drug in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
StorageView
Store between 20-25° C.
Medrolin
Mebhydrolin Napadisylate
Medrolin
Mebhydrolin Napadisylate
Indications
Vasomotor rhinitis
Indication detailsView
Mebhydrolin Napadisylate is indicated in-
- Allergic disease or symptoms such as urticaria
- Pruritus of various origin
- Eczema
- Itching
- Drug rash
- Insect bites
- Allergic conjunctivitis
- Dermatitis of nutritional origin
- Hay fever,
- Vasomotor rhinitis
- Allergic asthma.
Therapeutic classView
Sedating Anti-histamine
PharmacologyView
Mebhydrolin diminishes or abolishes the main actions of histamine in the body by blocking of histamine receptors.
DosageView
Adults and children over 10 years: 2-6 tablets daily
Children-
Children-
- 5-10 years: 2-4 tablets daily
- 2-5 years: 1-3 tablets daily
- Up to 2 years: 1-2 tablets daily
Side effectsView
Lassitude, dizziness, hypotension, muscular weakness, nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision, tinnitus, depression, nightmares, anorexia, dryness of the mouth, tightness of the chest, tingling, sedation, drowsiness etc. may occur.
ContraindicationsView
- Hypersensitivity to any of the ingredients of Mebhydrolin tablet or to mebhydrolin
- Prostatic hypertrophy, narrow-angle glaucoma.
- First trimester of pregnancy.
PrecautionsView
The substance may cause drowsiness, if affected, driving or operating machinery & alcoholic drinks should be avoided.
InteractionsView
The effects of atropine and tricyclic anti-depressants may be enhanced by Mebhydrolin. It may mask the warning symptoms of damage caused by ototoxic drugs.
Pregnancy & lactationView
Safety in pregnancy and lactation has not been established.
Pediatric usageView
Safety in pregnancy and lactation has not been established.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medroxy
Medroxyprogesterone Acetate (Injection)
Medroxy
Medroxyprogesterone Acetate (Injection)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone Acetate indicated for:
- Ovulation suppression
- The treatment of endometriosis.
- Adjunctive and/or pallivative treatment of recurrent and/or metastatic endometrial or renal carcinoma.
- The treatment of hormonally-dependant recurrent breast cancer in post-menopausal women.
Therapeutic classView
Female Sex hormones
PharmacologyView
Pharmacodynamics: Medroxyprogesterone Acetate injection has prolonged progestational effects when administered by intramuscular injection. This injection suppresses the secretion of pituitary gonadotropins which, in turns, prevents follicular maturation producing long-term anovulation in the reproductive aged women. Medroxyprogesterone Acetate injection suppresses the Leydig cell function in the male. i.e. suppresses endogenous testosterone product.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate is a long acting progestational steroid. The 150 mg/ml formulation reaches half its initial concentration in about 27 days. Its long duration of acting results from its slow absorption from the injection site. The principle metabolite of medroxyprogesterone acetate that has been identified is a 6-alpha-methyl-6 beta 17 alpha, 21 trihydroxy-4-pregnene-3, 20-dione-17 acetate which is excreted in the urine.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate is a long acting progestational steroid. The 150 mg/ml formulation reaches half its initial concentration in about 27 days. Its long duration of acting results from its slow absorption from the injection site. The principle metabolite of medroxyprogesterone acetate that has been identified is a 6-alpha-methyl-6 beta 17 alpha, 21 trihydroxy-4-pregnene-3, 20-dione-17 acetate which is excreted in the urine.
DosageView
Ovulation suppression: Medroxyprogesterone Acetate injectables suspension should be gently shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg/ml of this injectable suspension every three months administered by intramuscular injection in the gluteal or deltoid muscle. The initial injection should be given during the first 5 days after the onset of a menstrual period; within the 5 days post partum if not breast feeding; if exclusively breast-feeding at or after six weeks post partum.
Based on limited experience, some investigators favour the use of a second injection of Medroxyprogesterone Acetate before 90 days to control troublesome bleeding. The third and subsequent injections should be administered at separate 90 days intervals.
If abnormal bleeding persists, appropriate investigations should be instituted to rule out the possibility of organic pathology. Uterine curettage may be required on rare occations.
Based on limited experience, some investigators favour the use of a second injection of Medroxyprogesterone Acetate before 90 days to control troublesome bleeding. The third and subsequent injections should be administered at separate 90 days intervals.
If abnormal bleeding persists, appropriate investigations should be instituted to rule out the possibility of organic pathology. Uterine curettage may be required on rare occations.
Side effectsView
- Weight gain, feeling heaviness and pain in the abdomen, feeling pain, anxiety
- Amenorrhea
- Spotting
- Excessive bleeding
- Infection in the injected site
- Headache, Blurring of vision
- Pain in the back of the leg
- Delay in pregnancy after withdrawing injectable contraceptive.
ContraindicationsView
Known or suspected pregnancy, Undiagnosed vaginal bleeding, Known or suspected malignancy of breast ( when used for ovulation suppression or gynaecology indications), Severe liver dysfunction, Known hypersensitivity to medroxyprogesterone acetate or any component of the drug.
PrecautionsView
Unexpected vaginal bleeding during therapy, patient with a pre-existing medical condition that might be adversely affected by fluid retention, patients with a history of treatment for clinical depression diabetic patient. It may decrease the level of the following endocrine biomarkers: Plasma /urinary steroid (eg: cortisol, oestrogen, pregnanediol , progesterone & testosterone ) Plasma /urinary gonadotrophin (eg: LH & FSH) & sex hormonebinding- globulin (SHBG)
InteractionsView
Aminoglutethimide administered concomitantly with high doses of medroxyprogestrone acetate may significant depress the serum concentration of medroxyprogestrone acetate. User should be warned of the possibility of decreases efficacy with the use of amoniglutethimide.
Pregnancy & lactationView
Not recommended for the first 4 months.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medroxy
Medroxyprogesterone Acetate (Tablet)
Medroxy
Medroxyprogesterone Acetate (Tablet)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
Therapeutic classView
Female Sex hormones
PharmacologyView
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
DosageView
Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Side effectsView
The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
- Gastrointestinal: Nausea, cholestatic jaundice.
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
ContraindicationsView
Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected estrogen- or progesterone-dependent neoplasia.
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
- Known liver impairment or disease.
- Known or suspected pregnancy.
PrecautionsView
Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Pregnancy & lactationView
Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
Pediatric usageView
Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Overdose effectsView
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medroxy
Medroxyprogesterone Acetate (Tablet)
Medroxy
Medroxyprogesterone Acetate (Tablet)
Indications
Uterine bleeding
Indication detailsView
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
Therapeutic classView
Female Sex hormones
PharmacologyView
Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
DosageView
Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
Side effectsView
The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
- Gastrointestinal: Nausea, cholestatic jaundice.
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
ContraindicationsView
Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Known or suspected estrogen- or progesterone-dependent neoplasia.
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
- Known liver impairment or disease.
- Known or suspected pregnancy.
PrecautionsView
Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Pregnancy & lactationView
Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
Pediatric usageView
Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
Overdose effectsView
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Medzith
Azithromycin Dihydrate
Medzith
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Meenazole
Metronidazole
Meenazole
Metronidazole
Indications
Vaginal trichomoniasis
Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
- The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
- The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
- In the treatment of urogenital trichomoniasis.
- Bacterial vaginosis (also known as non-specific vaginitis).
- All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
- Giardiasis.
- Acute ulcerative gingivitis.
- Anaerobically infected leg ulcers and pressure sores.
- Acute dental infections due to anaerobic organisms.
- Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView
Tablet and Suspension:
Trichomoniasis (Adults & Children over 10 yrs)-- 200 mg tid or 400 mg bid for 7 days
- 800 mg in the morning and 1-2 gm at night for 2 days
- 2 gm as a single dose for 1 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- Children 7-10 yrs: 1 gm once daily
- Children 3-7 yrs: 600-800 mg once daily
- Children 1-3 yrs: 500 mg once daily
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- Children 1-10 yrs: 7.5 mg/kg tid
Vaginal Gel:
The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.
Suppository:
Anaerobic Infections-- Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
- Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
- Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
- Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.
IV Infusion:
Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.- Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
- Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
- If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
- Metronidazole should be administered with caution to patients with hepatic encephalopathy.
- Patients should be warned that metronidazole may darken urine.
InteractionsView
- Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
- Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
- Lithium: Plasma levels of lithium may be increased by metronidazole.
- Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
- Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
- 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
- Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.
Meera
Butamirate Citrate
Meera
Butamirate Citrate
Indications
Whooping cough
Indication detailsView
Butamirate Citrate is used to relieve dry (non-productive) cough. Dry cough may be caused by a recent viral infection. Butamirate Citrate is also used for pre & post-operative cough sedation in patients who will undergo surgical procedures and bronchoscopy. It can be used in the acute cough of any etiology, whooping cough and cough due to acute lower respiratory tract infections (tracheitis, laryngitis, bronchitis) etc.
Therapeutic classView
Cough suppressant
PharmacologyView
Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.
DosageView
Use in adult:
Butamirate Citrate 50 mg tablet:
- Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
- Butamirate Citrate syrup: 15 ml 4 times daily.
Butamirate Citrate 50 mg tablet:
- Adolescent over 12 years old: 1-2 tablets daily.
- Children (3-6 yrs): 5 ml 3 times daily.
- Children (6-12 yrs): 10 ml 3 times daily.
- Adolescent: 15 ml 3 times daily.
- Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
- Children (1-3 yrs): 0.75 ml 4 times daily.
Side effectsView
Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.
ContraindicationsView
Hypersensitivity to the active ingredient.
PrecautionsView
Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.
InteractionsView
Concomitant use with expectorants should be avoided.
Pregnancy & lactationView
Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.
Overdose effectsView
Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.
StorageView
Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.
Meera SR
Butamirate Citrate
Meera SR
Butamirate Citrate
Indications
Whooping cough
Indication detailsView
Butamirate Citrate is used to relieve dry (non-productive) cough. Dry cough may be caused by a recent viral infection. Butamirate Citrate is also used for pre & post-operative cough sedation in patients who will undergo surgical procedures and bronchoscopy. It can be used in the acute cough of any etiology, whooping cough and cough due to acute lower respiratory tract infections (tracheitis, laryngitis, bronchitis) etc.
Therapeutic classView
Cough suppressant
PharmacologyView
Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.
DosageView
Use in adult:
Butamirate Citrate 50 mg tablet:
- Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
- Butamirate Citrate syrup: 15 ml 4 times daily.
Butamirate Citrate 50 mg tablet:
- Adolescent over 12 years old: 1-2 tablets daily.
- Children (3-6 yrs): 5 ml 3 times daily.
- Children (6-12 yrs): 10 ml 3 times daily.
- Adolescent: 15 ml 3 times daily.
- Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
- Children (1-3 yrs): 0.75 ml 4 times daily.
Side effectsView
Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.
ContraindicationsView
Hypersensitivity to the active ingredient.
PrecautionsView
Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.
InteractionsView
Concomitant use with expectorants should be avoided.
Pregnancy & lactationView
Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.
Overdose effectsView
Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.
StorageView
Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.