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Minipil
Norgestrel
Minipil
Norgestrel
Indications
Oral contraceptives
Indication detailsView
Norgestrel tablets are indicated for use by females of reproductive potential to prevent pregnancy. This tablet are not for use as emergency contraception.
Therapeutic classView
Oral Contraceptive preparations
PharmacologyView
Progestin-only oral contraceptives such as Norgestrel tablets prevent conception by suppres sing ovulation in approximately half of the cycles in users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state progestin levels and a shorter elimination half-life than concomitant administration with estrogens.
DosageView
To achieve maximum contraceptive effectiveness, Norgestrel Tablets must be taken exactly as directed. The woman should take one tablet every day, at the same time. The administration is continuous, with no interruption between pill packs.
Side effectsView
An increased risk of the following adverse reactions has been reported with the use of progestin-only oral contraceptives: Delayed follicular atresia/ovarian cysts, Menstrual irregularity, changes in menstrual flow; breakthrough bleeding/spotting; amenorrhea, prolonged bleeding. The following adverse reactions were reported in ≥5% of subjects in the Norgestrel Tablet clinical studies:
- Headache
- Dizziness
- Nausea
- Increased appetite
- Abdominal pain, cramps and bloating
- Fatigue
- Vaginal discharge
- Dysmenorrhea
- Nervousness
- Backache
- Breast discomfort
- Acne
ContraindicationsView
Norgestrel tablet is contraindicated for use by women who are known to have the following conditions:
- Known or suspected pregnancy
- Known or suspected carcinoma of the breast, or other progestin-sensitive cancer, now or in the past
- Undiagnosed abnormal uterine bleeding
- Hypersensitivity to any component of this product
- Benign or malignant liver tumors
PrecautionsView
Migraine/Headache: The onset or exacerbation of migraine, or development of headache with a new pattern that is recurrent, persistent, or severe requires evaluation of the cause because women with migraine may be at increased risk of stroke.
Drug Interactions:
Interactions with Laboratory Tests: The following endocrine tests may be affected by Norgestrel Tablets use:
Drug Interactions:
- The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as phenytoin, carbamazepine, barbiturates, rifampin, efavirenz, bosentan and herbal preparations containing St. John’s Wort (hypericum perforatum ). This could result in unintended pregnancy or breakthrough bleeding. During concomitant use of Norgestrel and substances that may affect its efficacy, it is recommended that a nonhormonal back-up method of contraception (such as condom) be used in addition to the regular intake of Norgestrel Tablets. Use of a nonhormonal back-up method is recommeded for 28 days after discontinuation of substances that have led to induction of hepatic microsomal enzymes. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.
- Effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing. If a woman wishes to use Norgestrel Tablets after using ulipristal acetate, she should do so no sooner than 5 days after the intake of ulipristal acetate and she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period.
Interactions with Laboratory Tests: The following endocrine tests may be affected by Norgestrel Tablets use:
- Sex hormone-binding globulin (SHBG) concentrations may be decreased.
- Total thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG). However, free thyroxine level should remain unchanged.
Pregnancy & lactationView
Pregnancy: Norgestrel Tablets are contraindicated for use in pregnant women because there is no need for pregnancy prevention in a woman who is already pregnant. Published studies report no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins in pregnant women. Discontinue Norgestrel Tablets if pregnancy is confirmed.
Nursing Mothers: Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma. No adverse effects have been reported on breastfeeding performance or infant health. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Norgestrel Tablets and any potential adverse effects on the breastfed infant from Norgestrel Tablets or from the underlying maternal condition.
Nursing Mothers: Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma. No adverse effects have been reported on breastfeeding performance or infant health. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Norgestrel Tablets and any potential adverse effects on the breastfed infant from Norgestrel Tablets or from the underlying maternal condition.
Pediatric usageView
Pediatric Use: The safety and efficacy of Norgestrel tablets have been established in women of reproductive age, including adolescents as young as 15 years of age, and almost 30% of subjects in the clinical trials who were under 20 years of age. Use of this product before menarche is not indicated.
Geriatric Use: Norgestrel tablet Tablets have not been studied in postmenopausal women and is not indicated in this population.
Geriatric Use: Norgestrel tablet Tablets have not been studied in postmenopausal women and is not indicated in this population.
Overdose effectsView
Symptoms of oral contraceptive overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence ( drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
StorageView
Store at controlled room temperature between 20° to 25°C.
Minipress XL
Prazosin Hydrochloride
Minipress XL
Prazosin Hydrochloride
Indications
Hypertension
Indication detailsView
Hypertension (Primary and Secondary Hypertension). Raynaud's phenomenon and Raynaud's disease, Congestive heart failure (Prazosin may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides) & Benign prostatic hyperplasia (For the symptomatic treatment of urinary obstruction due to BPH and in patients awaiting prostatic surgery).
Therapeutic classView
Alpha adrenoceptor blocking drugs
PharmacologyView
Prazosin causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. In hypertensive patients, blood pressure is lowered in both the supine and standing positions; this effect is more pronounced on the diastolic blood pressure. Rebound elevation of blood pressure does not occur following abrupt cessation of Prazosin therapy.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
DosageView
Hypertension:
- Recommended starting dose: 0.5 mg (in the evening), twice or thrice daily for 3 to 7 days. This dose should be increased to 1 mg twice or three times daily for a further 3 to 7 days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Prazosin alone of up to 15 mg daily in divided doses.
- Maximum dose: 20 mg in divided doses.
- The dosage of the other drug should be reduced to a maintenance level and Prazosin initiated at 0.5 mg in the evening, then continuing with 0.5 mg twice or three times daily.
- Subsequent dosage increases should be made gradually depending upon the patient's response.
- The recommended starting dose: 0.5 mg two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient's response, based on careful monitoring of cardiopulmonary signs and symptoms.
- Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.
- The recommended starting dosage: 0.5 mg twice daily given for a period of 3 to 7 days and should be adjusted according to the patient's clinical response.
- Usual maintenance dosage: 1 mg or 2 mg twice daily.
- The recommended dosage: 0.5 mg twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response.
- The usual maintenance dosage: 2 mg twice daily.
AdministrationView
May be taken with or without food. Starting dose is best taken within dinner, at least 2-3 hr before retiring. Maintenance doses may be taken with or without meals.
Side effectsView
The most common side effects of Prazosin are allergic reaction, depression, nervousness, insomnia, Hallucinations, dizziness, drowsiness, headache, faintness, syncope, paraesthesia, worsening of pre-existing narcolepsy, blurred vision, eye pain, reddened sclera, vertigo, tinnitus, palpitations etc.
ContraindicationsView
Prazosin is contraindicated in patients with known sensitivity to Prazosin & other quinazolines or any of the excipients.
PrecautionsView
In patients with benign prostatic hyperplasia: Prazosin is not recommended for patients with a history of micturition syncope. It should not normally be administered to patients already receiving another alpha-1-antagonist.
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
InteractionsView
- Use with phosphodiesterase-5 inhibitors (PDE-5 Inhibitors): Concomitant use f PDE-5 inhibitors (e.g. Sildenafil, Tadalafil, Vardenafil) and Prazosin may lead to symptomatic hypotension in some patients.
- Adding Prazosin to beta-adrenergic antagonist or calcium antagonist therapy may produce a substantial reduction in blood pressure.
Pregnancy & lactationView
Pregnancy category C. It should be used only when, in the opinion of the physician, potential benefit outweighs potential risk. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when Prazosin is administered to nursing mothers.
Pediatric usageView
Patients with moderate to severe grades of renal impairment: Evidence to date shows that Prazosin does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of Prazosin, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
StorageView
Keep away from light and moisture, store below 30°C. Keep away from reach out of the children.
Minipress XL
Prazosin Hydrochloride
Minipress XL
Prazosin Hydrochloride
Indications
Hypertension
Indication detailsView
Hypertension (Primary and Secondary Hypertension). Raynaud's phenomenon and Raynaud's disease, Congestive heart failure (Prazosin may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides) & Benign prostatic hyperplasia (For the symptomatic treatment of urinary obstruction due to BPH and in patients awaiting prostatic surgery).
Therapeutic classView
Alpha adrenoceptor blocking drugs
PharmacologyView
Prazosin causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. In hypertensive patients, blood pressure is lowered in both the supine and standing positions; this effect is more pronounced on the diastolic blood pressure. Rebound elevation of blood pressure does not occur following abrupt cessation of Prazosin therapy.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
DosageView
Hypertension:
- Recommended starting dose: 0.5 mg (in the evening), twice or thrice daily for 3 to 7 days. This dose should be increased to 1 mg twice or three times daily for a further 3 to 7 days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Prazosin alone of up to 15 mg daily in divided doses.
- Maximum dose: 20 mg in divided doses.
- The dosage of the other drug should be reduced to a maintenance level and Prazosin initiated at 0.5 mg in the evening, then continuing with 0.5 mg twice or three times daily.
- Subsequent dosage increases should be made gradually depending upon the patient's response.
- The recommended starting dose: 0.5 mg two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient's response, based on careful monitoring of cardiopulmonary signs and symptoms.
- Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.
- The recommended starting dosage: 0.5 mg twice daily given for a period of 3 to 7 days and should be adjusted according to the patient's clinical response.
- Usual maintenance dosage: 1 mg or 2 mg twice daily.
- The recommended dosage: 0.5 mg twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response.
- The usual maintenance dosage: 2 mg twice daily.
AdministrationView
May be taken with or without food. Starting dose is best taken within dinner, at least 2-3 hr before retiring. Maintenance doses may be taken with or without meals.
Side effectsView
The most common side effects of Prazosin are allergic reaction, depression, nervousness, insomnia, Hallucinations, dizziness, drowsiness, headache, faintness, syncope, paraesthesia, worsening of pre-existing narcolepsy, blurred vision, eye pain, reddened sclera, vertigo, tinnitus, palpitations etc.
ContraindicationsView
Prazosin is contraindicated in patients with known sensitivity to Prazosin & other quinazolines or any of the excipients.
PrecautionsView
In patients with benign prostatic hyperplasia: Prazosin is not recommended for patients with a history of micturition syncope. It should not normally be administered to patients already receiving another alpha-1-antagonist.
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
InteractionsView
- Use with phosphodiesterase-5 inhibitors (PDE-5 Inhibitors): Concomitant use f PDE-5 inhibitors (e.g. Sildenafil, Tadalafil, Vardenafil) and Prazosin may lead to symptomatic hypotension in some patients.
- Adding Prazosin to beta-adrenergic antagonist or calcium antagonist therapy may produce a substantial reduction in blood pressure.
Pregnancy & lactationView
Pregnancy category C. It should be used only when, in the opinion of the physician, potential benefit outweighs potential risk. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when Prazosin is administered to nursing mothers.
Pediatric usageView
Patients with moderate to severe grades of renal impairment: Evidence to date shows that Prazosin does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of Prazosin, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
StorageView
Keep away from light and moisture, store below 30°C. Keep away from reach out of the children.
Minirfor
Metformin Hydrochloride
Minirfor
Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
- In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
- Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
- Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
- Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
- Children: Metformin extended release tablet has not been studied in children.
- Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
- Severe renal failure (GFR <30 mL/min).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
- At least annually in patients with normal renal function,
- At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Minirfor
Metformin Hydrochloride
Minirfor
Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
- In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
- Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
- Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
- Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
- Children: Metformin extended release tablet has not been studied in children.
- Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
- Severe renal failure (GFR <30 mL/min).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
- At least annually in patients with normal renal function,
- At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Minirin Melt
Desmopressin Acetate
Minirin Melt
Desmopressin Acetate
Indications
Diabetes insipidus
Indication detailsView
Desmopressin Acetate sublingual tablet is indicated for the treatment of-
- Primary Nocturnal Enuresis
- Nocturia and
- Central Diabetes Insipidus
Therapeutic classView
Synthetic analogue of ADH
PharmacologyView
By mimicking the actions of endogenous ADH, desmopressin acts as a selective agonist of V2 receptors expressed in the renal collecting duct (CD) to increase water re-absorption and reduce urine production. Desmopressin has been shown to be more potent than ADH in increasing plasma levels of factor VIII activity in patients with hemophilia and von Willebrand's disease Type I. Desmopressin demonstrates markedly diminished pressor activity. Desmopressin administered intranasally has an antidiuretic effect about one-tenth that of an equivalent dose administered by injection.
Upon binding of desmopressin to V2 receptors in the basolateral membrane of the cells of the distal tubule and collecting ducts of the nephron, adenylyl cyclase is stimulated. The resulting intracellular cascades in the collecting duct lead to increased rate of insertion of water channels, called aquaporins, into the lumenal membrane and enhanced the permeability of the membrane to water.
Upon binding of desmopressin to V2 receptors in the basolateral membrane of the cells of the distal tubule and collecting ducts of the nephron, adenylyl cyclase is stimulated. The resulting intracellular cascades in the collecting duct lead to increased rate of insertion of water channels, called aquaporins, into the lumenal membrane and enhanced the permeability of the membrane to water.
DosageView
Treatment of diabetes insipidus: Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 micrograms to 720 micrograms. A suitable starting dose in adults and children is 60 micrograms three times daily, administered sublingually. This dosage regimen should then be adjusted in accordance with the patient's response. For the majority of patients, the maintenance dose is 60 micrograms to 120 micrograms sublingually three times daily.
Post-hypophysectomy polyuria/polydipsia: The dose of Desmopressin Acetate Melt should be controlled by measurement of urine osmolality.
Post-hypophysectomy polyuria/polydipsia: The dose of Desmopressin Acetate Melt should be controlled by measurement of urine osmolality.
AdministrationView
Desmopressin Acetate Melt is for sublingual use.
Side effectsView
Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.
ContraindicationsView
Desmopressin Acetate Melt is contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents. Before prescribing Desmopressin Acetate Melt, the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.
PrecautionsView
Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Desmopressin Acetate Melt would be less than normal. Precautions to prevent fluid overload must be taken in:
- conditions characterised by fluid and/or electrolyte imbalance.
- patients at risk for increased intracranial pressure.
InteractionsView
Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia. NSAIDs may induce water retention and/or hyponatraemia. Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. Although not investigated, other drugs slowing intestinal transport might have the same effect. A standardised 27% fat meal significantly decreased the absorption (rate and extent) of a 0.4mg dose of oral desmopressin tablets. Although it did not significantly affect the pharmacodynamic effect (urine production and osmolality), there is the potential for this to occur at lower doses. If a diminution of effect is noted, then the effect of food should be considered before increasing the dose.
Pregnancy & lactationView
Pregnancy: Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.
Lactation: Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Lactation: Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Overdose effectsView
An overdose of Desmopressin Acetate Melt leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia. Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed.
StorageView
Store in the original package in order to protect from moisture and light.
Minirin Melt
Desmopressin Acetate
Minirin Melt
Desmopressin Acetate
Indications
Diabetes insipidus
Indication detailsView
Desmopressin Acetate sublingual tablet is indicated for the treatment of-
- Primary Nocturnal Enuresis
- Nocturia and
- Central Diabetes Insipidus
Therapeutic classView
Synthetic analogue of ADH
PharmacologyView
By mimicking the actions of endogenous ADH, desmopressin acts as a selective agonist of V2 receptors expressed in the renal collecting duct (CD) to increase water re-absorption and reduce urine production. Desmopressin has been shown to be more potent than ADH in increasing plasma levels of factor VIII activity in patients with hemophilia and von Willebrand's disease Type I. Desmopressin demonstrates markedly diminished pressor activity. Desmopressin administered intranasally has an antidiuretic effect about one-tenth that of an equivalent dose administered by injection.
Upon binding of desmopressin to V2 receptors in the basolateral membrane of the cells of the distal tubule and collecting ducts of the nephron, adenylyl cyclase is stimulated. The resulting intracellular cascades in the collecting duct lead to increased rate of insertion of water channels, called aquaporins, into the lumenal membrane and enhanced the permeability of the membrane to water.
Upon binding of desmopressin to V2 receptors in the basolateral membrane of the cells of the distal tubule and collecting ducts of the nephron, adenylyl cyclase is stimulated. The resulting intracellular cascades in the collecting duct lead to increased rate of insertion of water channels, called aquaporins, into the lumenal membrane and enhanced the permeability of the membrane to water.
DosageView
Treatment of diabetes insipidus: Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 micrograms to 720 micrograms. A suitable starting dose in adults and children is 60 micrograms three times daily, administered sublingually. This dosage regimen should then be adjusted in accordance with the patient's response. For the majority of patients, the maintenance dose is 60 micrograms to 120 micrograms sublingually three times daily.
Post-hypophysectomy polyuria/polydipsia: The dose of Desmopressin Acetate Melt should be controlled by measurement of urine osmolality.
Post-hypophysectomy polyuria/polydipsia: The dose of Desmopressin Acetate Melt should be controlled by measurement of urine osmolality.
AdministrationView
Desmopressin Acetate Melt is for sublingual use.
Side effectsView
Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.
ContraindicationsView
Desmopressin Acetate Melt is contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents. Before prescribing Desmopressin Acetate Melt, the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.
PrecautionsView
Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Desmopressin Acetate Melt would be less than normal. Precautions to prevent fluid overload must be taken in:
- conditions characterised by fluid and/or electrolyte imbalance.
- patients at risk for increased intracranial pressure.
InteractionsView
Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia. NSAIDs may induce water retention and/or hyponatraemia. Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. Although not investigated, other drugs slowing intestinal transport might have the same effect. A standardised 27% fat meal significantly decreased the absorption (rate and extent) of a 0.4mg dose of oral desmopressin tablets. Although it did not significantly affect the pharmacodynamic effect (urine production and osmolality), there is the potential for this to occur at lower doses. If a diminution of effect is noted, then the effect of food should be considered before increasing the dose.
Pregnancy & lactationView
Pregnancy: Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.
Lactation: Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Lactation: Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Overdose effectsView
An overdose of Desmopressin Acetate Melt leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia. Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed.
StorageView
Store in the original package in order to protect from moisture and light.
Minista
Rupatadine Fumarate
Minista
Rupatadine Fumarate
Indication detailsView
Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.
DosageView
Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.
Children aged 2 to 11 years:
Children aged 2 to 11 years:
- Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food.
- Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.
Side effectsView
Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.
ContraindicationsView
Hypersensitivity to Rupatadine or to any of the excipients.
PrecautionsView
Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.
InteractionsView
With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.
With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine
With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine
Pregnancy & lactationView
There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.
Pediatric usageView
Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.
Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
Overdose effectsView
The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Minium
Flunarizine
Minium
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
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.
Minium
Flunarizine
Minium
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
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.
Minocin
Minocycline Hydrochloride
Minocin
Minocycline Hydrochloride
Indications
Urinary tract infection
Indication detailsView
Minocycline is indicated for oral administration, for the treatment of infections caused by tetracycline sensitive organisms and some tetracycline resistant strains of staphylococci. Indications include: Acne, skin and soft tissue infections, ophthamological infections, acute and chronic bronchitis, bronchiectasis, lung abscess, ear, nose and throat infections, pelvic inflammatory disease, nocardiosis, urinary tract infections, gonorrhoea, non-gonococcal urethritis and prostatitis. Minocycline may also be used in prophylactic treatment of asymptomatic meningococcal carriers. Also indicated in pre- and post-operative prophylaxis of infection.
Therapeutic classView
Tetracycline group of drugs
DosageView
- Routine antibiotic use: 200 mg daily in divided doses
- Acne: 50 mg twice daily for at least 6 weeks.
- Gonorrhoea: Males: 200 mg initially followed by 100 mg every 12 hours for a minimum of 4 days. Post therapy cultures within 2-3 days. Females: May require a more prolonged therapy.
- Prophylaxis of asymptomatic meningococcal carriers: 100 mg twice daily for 5 days, followed by treatment with rifampicin.
Side effectsView
Reported side effects are oral and anogenital candidiasis, vulvovaginitis, eosinophilia, leucopenia, neutropenia, thrombocytopenia, haemolytic anaemia, pancytopenia, agranulocytosis, anaphylaxis, anaphylactoid reaction, hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, polyarthritisnodosa, abnormal thyroid function, brown-black discolouration of the thyroid, anorexia, dizziness, headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo, Bulging fontanelle, convulsions, sedation, impaired hearing, tinnitus, myocarditis, pericarditis, cough, dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia, pneumonitis, diarrhoea, nausea, stomatitis, discolouration of teeth, vomiting, dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis, increased liver enzymes, hepatitis, autoimmune hepatotoxicity, hepatic cholestatis, hepatic failure, hyperbilirubinemia, jaundice, autoimmune hepatitis, alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of the skin, photosensitivity, pruritis, rash, urticaria, vasculitis, angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson syndrome, toxic epidermal necrolysis, Drug reaction with eosinophilia and systemic symptoms (DRESS), arthralgia, lupus-like syndrome, myalgia, arthritis, bone discolouration, cases of systemic lupus erythematous (SLE), joint stiffness, joint swelling, increased serum urea, acute renal failure, interstitial nephritis, balanitis, fever, etc. In some cases involving these syndromes, death has been reported.
Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, lacrimal secretions and perspiration has been reported. This blue/black/grey or muddy-brown discolouration may be localised or diffuse. The most frequently reported site is in the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. The generalised muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun.
Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, lacrimal secretions and perspiration has been reported. This blue/black/grey or muddy-brown discolouration may be localised or diffuse. The most frequently reported site is in the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. The generalised muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun.
ContraindicationsView
Minocycline is contraindicated in patients with hypersensitivity to tetracyclines, systemic lupus erythematosus, pregnancy, lactation, complete renal failure and children under 12 years.
PrecautionsView
Breathing difficulties: Cases of breathing difficulties including dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia and pneumonitis have been reported with minocycline use. If patients develop breathing difficulties they should seek urgent medical advice and minocycline should be discontinued.
Paediatric population: All tetracyclines form a stable calcium complex in any bone forming tissue. An increase in the fibula growth rate has been observed in premature babies administered oral tetracyclines. Tetracyclines are known to cause a yellow to brown discoloration of the teeth and enamel hypoplasia in the developing child or foetus.
Hepatic impairment: Minocycline should be used with caution in patients with hepatic dysfunction or in conjunction with potentially hepatotoxic drugs, including alcohol.
Auto-immune disorders: Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, minocycline should be discontinued.
Renal impairment: Studies indicate there is no significant drug accumulation in patients with mild to moderate renal impairment when treated with the recommended dosages of minocycline. In cases of severe renal impairment a reduction of dosage and monitoring of renal function may be required.
Cross-sensitivities: Micro-organisms can develop cross resistance to tetracyclines and patients can develop cross sensitivity. Minocycline should be discontinued there are signs/symptoms of overgrowth of resistant organisms.
Intracranial hypertension: As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported. Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported. Treatment should cease if evidence of raised intracranial pressure develops.
Hyperpigmentation: As with other tetracyclines, minocycline may cause hyperpigmentation at various body sites. Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued.
Photosensitivity: Tetracyclines are known to cause photosensitivity reactions. Such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.
Paediatric population: All tetracyclines form a stable calcium complex in any bone forming tissue. An increase in the fibula growth rate has been observed in premature babies administered oral tetracyclines. Tetracyclines are known to cause a yellow to brown discoloration of the teeth and enamel hypoplasia in the developing child or foetus.
Hepatic impairment: Minocycline should be used with caution in patients with hepatic dysfunction or in conjunction with potentially hepatotoxic drugs, including alcohol.
Auto-immune disorders: Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, minocycline should be discontinued.
Renal impairment: Studies indicate there is no significant drug accumulation in patients with mild to moderate renal impairment when treated with the recommended dosages of minocycline. In cases of severe renal impairment a reduction of dosage and monitoring of renal function may be required.
Cross-sensitivities: Micro-organisms can develop cross resistance to tetracyclines and patients can develop cross sensitivity. Minocycline should be discontinued there are signs/symptoms of overgrowth of resistant organisms.
Intracranial hypertension: As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported. Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported. Treatment should cease if evidence of raised intracranial pressure develops.
Hyperpigmentation: As with other tetracyclines, minocycline may cause hyperpigmentation at various body sites. Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued.
Photosensitivity: Tetracyclines are known to cause photosensitivity reactions. Such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.
InteractionsView
Anticoagulants: Plasma prothrombin activity is depressed by tetracyclines. Reduced doses of any concomitant anticoagulants may be necessary.
ACE inhibitors, antacids and adsorbants: Tetracyclines bind to di-/tri-valent cations. Absorption from the gastrointestinal tract is impaired by the concomitant administration of iron, calcium, aluminium, magnesium, bismuth and zinc salt (interactions with specified salts, antacids, kaolin, bismuth containing ulcer-healing drugs, quinapril which contains a magnesium carbonate excipient). Dosages should be maximally separated. Absorption of tetracyclines is not significantly impaired by food, milk and milk products.
Diuretics: Diuretics may aggravate nephrotoxicity by volume depletion.
Antibacterials: Minocycline should not be used with penicillins.
Ergotamine and ergometrine: There is an increased risk of ergotism.
Oral contraceptives: Both can induce hyperpigmentation.
Retinoids: Administration of isotretinoin should be avoided shortly before, during and shortly after minocycline therapy.
ACE inhibitors, antacids and adsorbants: Tetracyclines bind to di-/tri-valent cations. Absorption from the gastrointestinal tract is impaired by the concomitant administration of iron, calcium, aluminium, magnesium, bismuth and zinc salt (interactions with specified salts, antacids, kaolin, bismuth containing ulcer-healing drugs, quinapril which contains a magnesium carbonate excipient). Dosages should be maximally separated. Absorption of tetracyclines is not significantly impaired by food, milk and milk products.
Diuretics: Diuretics may aggravate nephrotoxicity by volume depletion.
Antibacterials: Minocycline should not be used with penicillins.
Ergotamine and ergometrine: There is an increased risk of ergotism.
Oral contraceptives: Both can induce hyperpigmentation.
Retinoids: Administration of isotretinoin should be avoided shortly before, during and shortly after minocycline therapy.
Pregnancy & lactationView
Minocycline use during pregnancy and lactation is contraindicated. Animal studies have indicated that tetracyclines cross the placenta. Tetracyclines have been found in foetal tissues and can have toxic effects on the developing foetus (related to retardation of skeletal development). Studies on animals treated during early pregnancy also indicate embryotoxicity. The use of tetracyclines during the last half of pregnancy, when the teeth are developing, may cause permanent discolouration of teeth (more common with long term or repeated short term use). Enamel hypoplasia has also been reported. Tetracyclines have been detected in the milk of lactating women. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has been reported.
Pediatric usageView
Renal impairment: As adults even in cases of mild to moderate renal impairment. However, caution is advised in patients with severe renal impairment.
Paediatric population: Minocycline is not recommended in children under 12 years. Children over 12 years: 50mg every 12 hours.
Paediatric population: Minocycline is not recommended in children under 12 years. Children over 12 years: 50mg every 12 hours.
Overdose effectsView
Dizziness, nausea and vomiting are the adverse effects most commonly seen in overdose. Gastric lavage plus appropriate supportive treatment. Antacids and calcium salts will reduce absorption of minocycline but there is no specific antidote. Minocycline is not removed in significant quantities by haemodialysis or peritoneal dialysis.
StorageView
Store in a cool and dry place, protected from light, store below 25°C.
Minolac
Ketorolac Tromethamine
Minolac
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Minolac
Ketorolac Tromethamine
Minolac
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Minolac
Ketorolac Tromethamine
Minolac
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Minolac
Ketorolac Tromethamine
Minolac
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Minomal R
Aminophylline
Minomal R
Aminophylline
Indications
Status asthmaticus
Indication detailsView
It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.
Therapeutic classView
Bronchodilator, Methyl xanthine derivatives, Respiratory stimulants: analeptics, Theophylline & related drugs
PharmacologyView
Aminophylline is a combination of theophylline and ethylenediamine. Ethylenediamine is inactive; it increases the solubility of theophylline in water. Theophylline relaxes bronchial smooth muscle. Suggested mechanisms are an increase in intracellular cAMP through inhibition of phosphodiesterase; adenosine receptor antagonism, prostaglandin antagonism and effects on intracellular calcium.
DosageView
Oral:
Chronic bronchospasm:
Acute severe bronchospasm:
Chronic bronchospasm:
- Adult: As hydrate: Initially, 225-450 mg bid, increased if necessary.
- Child: >3 yr: As modified-release hydrate: 12 mg/kg daily increased to 24 mg/kg daily in 2 divided doses after 1 wk.
Acute severe bronchospasm:
- Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.
- Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.
- Elderly: Dose reduction may be necessary.
- Hepatic impairment: Dose reduction may be necessary.
AdministrationView
Tablets should be swallowed whole and not chewed because of the structure of the tablet.
Side effectsView
The most common adverse effects are gastric irritation, nausea, vomiting, diarrhea, hematemesis, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear and reactivation of peptic ulcer, headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability, palpitation, tachycardia, hypotension, circulatory failure, ventricular arrhythmias, and flushing, albuminuria, diuresis and hematuria. Also inappropriate ADH syndrome may occur.
ContraindicationsView
Aminophylline should not be administered to patients with hypersensitivity to xanthines or ehylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions.
PrecautionsView
Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given withcaution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.
Pregnancy & lactationView
Use of aminophylline in pregnant women should be balanced against the risk of uncontrolled disease.
Minomal R
Aminophylline
Minomal R
Aminophylline
Indications
Status asthmaticus
Indication detailsView
It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.
Therapeutic classView
Bronchodilator, Methyl xanthine derivatives, Respiratory stimulants: analeptics, Theophylline & related drugs
PharmacologyView
Aminophylline is a combination of theophylline and ethylenediamine. Ethylenediamine is inactive; it increases the solubility of theophylline in water. Theophylline relaxes bronchial smooth muscle. Suggested mechanisms are an increase in intracellular cAMP through inhibition of phosphodiesterase; adenosine receptor antagonism, prostaglandin antagonism and effects on intracellular calcium.
DosageView
Oral:
Chronic bronchospasm:
Acute severe bronchospasm:
Chronic bronchospasm:
- Adult: As hydrate: Initially, 225-450 mg bid, increased if necessary.
- Child: >3 yr: As modified-release hydrate: 12 mg/kg daily increased to 24 mg/kg daily in 2 divided doses after 1 wk.
Acute severe bronchospasm:
- Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.
- Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.
- Elderly: Dose reduction may be necessary.
- Hepatic impairment: Dose reduction may be necessary.
AdministrationView
Tablets should be swallowed whole and not chewed because of the structure of the tablet.
Side effectsView
The most common adverse effects are gastric irritation, nausea, vomiting, diarrhea, hematemesis, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear and reactivation of peptic ulcer, headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability, palpitation, tachycardia, hypotension, circulatory failure, ventricular arrhythmias, and flushing, albuminuria, diuresis and hematuria. Also inappropriate ADH syndrome may occur.
ContraindicationsView
Aminophylline should not be administered to patients with hypersensitivity to xanthines or ehylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions.
PrecautionsView
Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given withcaution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.
Pregnancy & lactationView
Use of aminophylline in pregnant women should be balanced against the risk of uncontrolled disease.
Minomal SR
Aminophylline
Minomal SR
Aminophylline
Indications
Status asthmaticus
Indication detailsView
It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.
Therapeutic classView
Bronchodilator, Methyl xanthine derivatives, Respiratory stimulants: analeptics, Theophylline & related drugs
PharmacologyView
Aminophylline is a combination of theophylline and ethylenediamine. Ethylenediamine is inactive; it increases the solubility of theophylline in water. Theophylline relaxes bronchial smooth muscle. Suggested mechanisms are an increase in intracellular cAMP through inhibition of phosphodiesterase; adenosine receptor antagonism, prostaglandin antagonism and effects on intracellular calcium.
DosageView
Oral:
Chronic bronchospasm:
Acute severe bronchospasm:
Chronic bronchospasm:
- Adult: As hydrate: Initially, 225-450 mg bid, increased if necessary.
- Child: >3 yr: As modified-release hydrate: 12 mg/kg daily increased to 24 mg/kg daily in 2 divided doses after 1 wk.
Acute severe bronchospasm:
- Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.
- Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.
- Elderly: Dose reduction may be necessary.
- Hepatic impairment: Dose reduction may be necessary.
AdministrationView
Tablets should be swallowed whole and not chewed because of the structure of the tablet.
Side effectsView
The most common adverse effects are gastric irritation, nausea, vomiting, diarrhea, hematemesis, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear and reactivation of peptic ulcer, headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability, palpitation, tachycardia, hypotension, circulatory failure, ventricular arrhythmias, and flushing, albuminuria, diuresis and hematuria. Also inappropriate ADH syndrome may occur.
ContraindicationsView
Aminophylline should not be administered to patients with hypersensitivity to xanthines or ehylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions.
PrecautionsView
Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given withcaution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.
Pregnancy & lactationView
Use of aminophylline in pregnant women should be balanced against the risk of uncontrolled disease.
Minopa
Tolfenamic acid
Minopa
Tolfenamic acid
Indications
Pain
Indication detailsView
Tolfenamic acid is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine
PharmacologyView
Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
DosageView
Adult:
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
- Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
- Mild to moderate pain: 100-200 mg tid
- Renal impairment: Dose adjustments may be needed.
- Severe renal impairment: Avoid.
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
Side effectsView
Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.
ContraindicationsView
Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.
PrecautionsView
Precaution should be needed for patients with asthma bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.
InteractionsView
The rate of absorption of Tolfenamic acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Ciclosporin, Tacrolimus or diuretics
Pregnancy & lactationView
This medicine is not recommended for using during pregnancy unless considered essential by doctor Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations NSAID's should, if possible, be avoided when breastfeeding.
Overdose effectsView
Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.
StorageView
Store in a cool and dry place, away from light Keep out of the reach of children.
Minoxil
Minoxidil
Minoxil
Minoxidil
Indications
Male pattern baldness
Indication detailsView
Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.
Therapeutic classView
Other scalp preparations
PharmacologyView
Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.
Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.
Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.
DosageView
Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.
For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.
Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.
For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.
Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.
Side effectsView
Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.
ContraindicationsView
- Patients with cardiac abnormalities
- Children below 18 years of age
- Patients using occlusive dressings or other medicines on the scalp
- Patients with red, inflamed infection, or irritated or painful scalp (including psoriasis & sunburn)
PrecautionsView
Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.
InteractionsView
Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.
Pregnancy & lactationView
Minoxidil topical solution should not be used during pregnancy and lactation.
Overdose effectsView
Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.
Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
StorageView
Store at a cool and dry place, protected from light. Keep out of the reach of the children.