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Endamycin
Clindamycin
Endamycin
Clindamycin
Indications
Toxic shock syndrome
Indication detailsView
Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as Streptococci, Staphylococci and Pneumococci; Upper respiratory infections, Lower respiratory infections, Skin and soft tissue infections, Bone and joint infections, Pelvic infections, Intra-abdominal infections, Septicemia and endocarditis, Dental infections. As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciporum infection.
Therapeutic classView
Macrolides
DosageView
Dosage of Clindamycin Capsule:
Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC90 for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.
Dosage of Clindamycin Powder for oral solution:
Dosage of Clindamycin IV/IM Injection:
Adults-
Pediatric patients (1 month of age to 16 years):
- Serious Infections: 150 mg-300 mg every six hours.
- More severe infections: 300 mg-450 mg every six hours.
Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC90 for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.
Dosage of Clindamycin Powder for oral solution:
- Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
- Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
- More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.
Dosage of Clindamycin IV/IM Injection:
Adults-
- Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
- More severe infections: 1200-2700 mg/day in 2-4 equal doses.
- For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
- Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.
Pediatric patients (1 month of age to 16 years):
- 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
- Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
- In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
Side effectsView
The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.
ContraindicationsView
Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.
PrecautionsView
Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
InteractionsView
Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
Pregnancy & lactationView
Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.
Pediatric usageView
Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.
Geriatric use: Dose adjustment of Clindamycin is not necessary.
Geriatric use: Dose adjustment of Clindamycin is not necessary.
Overdose effectsView
Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.
ReconstitutionView
Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.
Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.
Physico-Chemical Stability of diluted solutions of Clindacin Injection-
Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.
- Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
- Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Physico-Chemical Stability of diluted solutions of Clindacin Injection-
- Room temperature: 16 days at 25°C.
- Refrigeration: 32 days at 4°C.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Endemali
Antacid [Unani]
Endemali
Antacid [Unani]
Indications
Peptic ulcer disease
Indication detailsView
This preparation is indicated in-
- Peptic ulcer
- Hyperacidity
- Dysentery
- Constipation
- Gastritis
- Flatulence
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
This preparation is an effective preparation of Psyllium, gum mastic and other herbal ingredients for peptic ulcer and hyperacidity. This preparation acts as prebiotic (due to presence of Psyllium), which stimulates the growth and activity of probiotics (beneficial bacteria) in the intestine. Probiotic helps to combat pathogenic bacteria that help to ensure better health. This preparation is also effective in the treatment of dysentery and constipation.
DosageView
Peptic ulcer & hyperacidity: 1 sachet twice daily before meal with half glass of water.
Dysentery: 1 sachet 4 times daily. Constipation: 1 sachet at bed time with plenty of water.
Gastritis & flatulence: 1 sachet twice daily before meal with water.
Dysentery: 1 sachet 4 times daily or as prescribed by the physician.
Dysentery: 1 sachet 4 times daily. Constipation: 1 sachet at bed time with plenty of water.
Gastritis & flatulence: 1 sachet twice daily before meal with water.
Dysentery: 1 sachet 4 times daily or as prescribed by the physician.
Side effectsView
No significant side effect has been observed in proper dosage.
ContraindicationsView
There is no known contraindication.
PrecautionsView
Keep out of reach of the children.
StorageView
Store at cool and dry place protect from light.
Endofree
Letrozole
Endofree
Letrozole
Indications
Stimulate ovulation
Indication detailsView
Letrozole is indicated for the first-line treatment of advanced/metastatic breast cancer (hormone receptor positive or receptor status unknown) in post-menopausal women.
Therapeutic classView
Hormonal Chemotherapy
PharmacologyView
Mechanism of Action: Letrozole is a potent and highly specific nonsteroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. Letrozole exerts its antitumor effect by depriving estrogen-dependent breast cancer cells of their growth stimulus. In postmenopausal women, estrogens are derived mainly from the action of the aromatase enzyme, which coverts adrenal androgens primarily androstenedione and testosterone-to oestrone (E1) and oestradiol (E2). The suppression of estrogen biosynthesis in the peripheral tissues and the malignant tissues can be achieved by specifically inhibiting the aromatase enzyme.
In healthy postmenopausal women, single doses of 0.1, 0.5 and 2.5mg letrozole suppress serum oestrone and oestradiol by 75-78% and 78% from baseline respectively. Maximum suppression is achieved in 48-78 hours. In post-menopausal patients, with advanced breast cancer, daily doses of 0.1 to 5mg suppress plasma concentration of oestradiol, oestrone, and oestrone sulphate by 78-95% from baseline in all patients treated. Letrozole had no effect on plasma androgen concentrations (androstenedione and testosterone) among healthy postmenopausal women after single doses of 0.1, 0.5 and 2.5mg indicating that the blockade of estrogen biosynthesis does not lead to accumulation of androgenic precursors. Impairment of adrenal steroidogenesis has not been observed.
Pharmacokinetics: Letrozole is rapidly and completely absorbed from the gastrointestinal tract (absolute bioavailability 99.9%). Food slightly decreases the rate of absorption, but the extent of absorption remains unchanged. The minor effect of the absorption rate is not considered to be of clinical relevance and therefore letrozole may be taken after, with or before food. Plasma protein binding of letrozole is approximately 60%, mainly to albumin (55%). The concentration of letrozole in erythrocytes is about 80% of that in plasma. Metabolic clearance to a pharmacologically inactive carbinol metabolite is the major elimination pathway of letrozole but is relatively slow when compared to hepatic blood flow. The cytochrome P450 isoenzymes 3A4 and 2A6 were found to be capable of converting letrozole to this metabolite in vitro but their individual contributions to letrozole metabolism in vivo have not been established. The apparent terminal elimination half-life in plasma is about 2 days. After daily administration of 2.5mg of letrozole, steady-state levels are reached within 2 to 6 weeks.
In healthy postmenopausal women, single doses of 0.1, 0.5 and 2.5mg letrozole suppress serum oestrone and oestradiol by 75-78% and 78% from baseline respectively. Maximum suppression is achieved in 48-78 hours. In post-menopausal patients, with advanced breast cancer, daily doses of 0.1 to 5mg suppress plasma concentration of oestradiol, oestrone, and oestrone sulphate by 78-95% from baseline in all patients treated. Letrozole had no effect on plasma androgen concentrations (androstenedione and testosterone) among healthy postmenopausal women after single doses of 0.1, 0.5 and 2.5mg indicating that the blockade of estrogen biosynthesis does not lead to accumulation of androgenic precursors. Impairment of adrenal steroidogenesis has not been observed.
Pharmacokinetics: Letrozole is rapidly and completely absorbed from the gastrointestinal tract (absolute bioavailability 99.9%). Food slightly decreases the rate of absorption, but the extent of absorption remains unchanged. The minor effect of the absorption rate is not considered to be of clinical relevance and therefore letrozole may be taken after, with or before food. Plasma protein binding of letrozole is approximately 60%, mainly to albumin (55%). The concentration of letrozole in erythrocytes is about 80% of that in plasma. Metabolic clearance to a pharmacologically inactive carbinol metabolite is the major elimination pathway of letrozole but is relatively slow when compared to hepatic blood flow. The cytochrome P450 isoenzymes 3A4 and 2A6 were found to be capable of converting letrozole to this metabolite in vitro but their individual contributions to letrozole metabolism in vivo have not been established. The apparent terminal elimination half-life in plasma is about 2 days. After daily administration of 2.5mg of letrozole, steady-state levels are reached within 2 to 6 weeks.
DosageView
The recommended dose of Letrozole is 2.5 mg once daily. Treatment with Letrozole should continue as long as tumor response is seen. The drug should be discontinued if tumor stops responding as judged by tumor progression. For elderly patients, no modification of the normal adult dosage regimen is necessary. No dosage adjustment is required for patients with mild to moderate hepatic impairment or renal impairment.
Side effectsView
Adverse events associated with letrozole are generally mild to moderate and rarely severe enough to require discontinuation. Many can be attributed to either the underlying disease or the normal pharmacological consequence of oestrogen deprivation (hot flushes, hair thinning). The most frequently reported adverse events are musculoskeletal pain, arthralgia, headache, fatigue, nausea, dyspnoea, peripheral oedema, coughing, constipation, vomiting, chest pain, viral infection, diarrhoea, rash, abdominal pain, dyspepsia and anorexia. Dizziness, weight increase and pruritus are less commonly seen.
ContraindicationsView
Letrozole is contraindicated in known or suspected hypersensitivity to letrozole, other aromatase inhibitors, or to any of their ingredients. It is contraindicated during pregnancy, lactation and in pre-menopausal women. It is also contraindicated in severe hepatic dysfunction.
PrecautionsView
In breast cancer patients with moderate hepatic dysfunction, no dosage adjustment is necessary, but caution is recommended since letrozole elimination depends mainly on intrinsic metabolic clearance. Renal impairment (calculated creatinine clearance: 20 to 50 ml/min) did not affect steady-state plasma letrozole concentration at a dose of 2.5 mg or 5 mg. Hence, no dose adjustment is necessary for such renal function impairment. It is anticipated that letrozole could be removed from blood by dialysis since it is weakly bound to plasma proteins. The potential risks and benefits to such patients should be considered carefully before prescribing letrozole. In some cases, fatigue and dizziness have been observed with the use of letrozole. Patients should therefore, be advised that their physical and/or mental abilities required for operating machinery or driving a car may be impaired.
InteractionsView
Clinical interaction studies with cimetidine and warfarin indicated that the co-administration of letrozole with these drugs does not result in clinically significant drug reactions, even through cimetidine is a known inhibitor of one of the cytochrome P450 isoenzymes capable of metabolising letrozole in vitro.
Pregnancy & lactationView
Oral administration of letrozole in pregnant rats resulted in teratogenicity and maternal toxicity at 0.03 mg/kg. Embryotoxicity and foetotoxicity were seen at doses >0.003 mg/kg and there was an increase in the incidence of foetal malformation among the animals treated. However, there are no adequate and well-controlled studies of letrozole in pregnant women and its use in these patients is not recommended. It is not known whether letrozole is excreted in human milk. Because many drugs are excreted in human milk, letrozole should not be administered to a nursing woman.
Overdose effectsView
There is no clinical experience of overdosage. There is no specific antidote to letrozole. Since letrozole is not highly protein-bound, dialysis may be helpful. Emesis may be induced if the patient is alert. In general, supportive care and frequent monitoring of vital signs is appropriate.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Endosis
Dienogest
Endosis
Dienogest
Indications
Endometriosis
Indication detailsView
Dienoaest is indicated for the treatment of endometriosis. This is the preparation of Dienogest which belongs to the class of medications called progestins. Progestins reduce the effects of estrogen on tissues such as the endometrium (lining of the uterus) and the breast. By reducing the growth effect of estrogen on the endometrium, Dienogest helps to reduce the pelvic pain experienced by women with endometriosis.
Therapeutic classView
Female Sex hormones
PharmacologyView
Dienogest acts as an agonist at the progesterone receptor (PR) with weak affinity that is comparable to that of progesterone but has a very potent progestagenic effect in the endometrium, causing endometrial atrophy after prolonged use. It promotes antiproliferative, immunologic and antiangiogenic effects on endometrial tissue. Dienogest reduces the level of endogenous production of oestradiol and thereby suppressing the trophic effects of oestradiol on both the eutopic and ectopic endometrium. Continous administration of dienogest results in hyperprogestogenic and moderately hypoestrogenic endocrine environment, which causes initial decidualization of endometrial tissue. It is an antagonist at androgen receptors, improve androgenic symptoms such as acne and hirsutism [A16570].
DosageView
Tablet-taking can be started on any day of the menstrual cycle. The dosage of Dienogest is 2 mg daily without any break, taken preferably at the same time each day with some liquid as needed. Tablet must be taken continuously without regard to vaginal bleeding. When a pack is finished, the next one should be started without interruption.
In the event of missed tablet(s), the woman should take 2 mg only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by 2 mg.
In the event of missed tablet(s), the woman should take 2 mg only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by 2 mg.
Side effectsView
Undesirable effects are more common during the 1st months after start of intake of Dienogest, and subside with duration of treatment. The following undesirable effects have been reported in users of Dienogest. The most frequently reported undesirable effects during treatment that were considered at least possibly related to Dienogest were headache (9%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).
- Nervous System Disorders: Headache, migraine.
- Cardiac Disorders: Uncommon: Unspecified circulatory system disorder, palpitations.
- Vascular Disorders: Uncommon: Hypotension.
- Gastrointestinal Disorders: Common: Nausea, abdominal pain, flatulence.
- Metabolism and nutrition disorders: Weight increase (3.6%)
- Psychiatric Disorders: Depressed mood, irritability, nervousness, altered mood.
ContraindicationsView
Hypersensitivity to dienogest or to any of the excipients of Dienogest. Dienogest should not be used in the presence of any of the conditions such as, Active venous thromboembolic disorder; arterial and cardiovascular disease, (e.g, myocardial infarction, cerebrovascular accident, ischemic heart disease); diabetes mellitus with vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal; presence or history of liver tumors (benign or malignant); known or suspected sex hormone-dependent malignancies and undiagnosed vaginal bleeding.
PrecautionsView
Before starting Dienogest treatment, pregnancy must be excluded. During treatment, patients are advised to use nonhormonal methods of contraception (e.g, barrier method) if contraception is required.
As Dienogest is a progestogen-only preparation, it can be assumed that special warnings and special precautions for use of other progestogen-only preparations are also valid for the use of Dienogest .
As Dienogest is a progestogen-only preparation, it can be assumed that special warnings and special precautions for use of other progestogen-only preparations are also valid for the use of Dienogest .
- Changes in Bleeding Pattern: Dienogest treatment affects the menstrual bleeding pattern in the majority of women.
- Hepatic Impairment: Dienogest is contraindicated in patients with present or past severe hepatic disease.
- Impairment of Fertility: Based on available data, ovulation is inhibited in the majority of patients during treatment with Dienogest. However, Dienogest is not a contraceptive. If contraception is required, a nonhormonal method should be used.
InteractionsView
Progestogens including Dienogest are metabolized mainly by the cytochrome P450 3A4 system . Therefore, inducers or inhibitors of CYP3A4 may affect the progestogen drug metabolism. Known CYP3A4 inhibitors like azole antifungals (e.g, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (e.g, erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (e.g, ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (e.g, nefazodone, fluvoxamine, fluoxetine) may increase plasma levels of progestogens and result in adverse reactions.
Pregnancy & lactationView
There are limited data from the use of Dienogest in pregnant women. Animal studies and data from women exposed to Dienogest during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans. However, Dienogest should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Treatment with Dienogest during lactation is not recommended. Physiochemical properties and animal data indicate excretion of Dienogest in breast milk. A decision must be made whether to discontinue breastfeeding or to abstain from Dienogest therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Treatment with Dienogest during lactation is not recommended. Physiochemical properties and animal data indicate excretion of Dienogest in breast milk. A decision must be made whether to discontinue breastfeeding or to abstain from Dienogest therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Pediatric usageView
Use in Children: Dienogest is not indicated in children prior to menarche. The safety and efficacy of Dienogest in adolescents (menarche to 18 years) has not yet been established.
Use in the Elderly: There is no relevant indication for the use of Dienogest in the geriatric population.
Use in the Elderly: There is no relevant indication for the use of Dienogest in the geriatric population.
Overdose effectsView
Acute toxicity studies performed with Dienogest did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose. There is no specific antidote. Dienogest 20-30 mg/day (10-15 times higher dose than in Dienogest) over 24 weeks of use were very well tolerated.
StorageView
Keep in a cool and dry place. Protect from light. Keep out of the reach of children.
Endoxan
Cyclophosphamide
Endoxan
Cyclophosphamide
Indications
Vasculitis
Indication detailsView
Malignant Diseases:
Cyclophosphamide is indicated for the treatment of:- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
- Multiple myeloma
- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast
Minimal Change Nephrotic Syndrome in Pediatric Patients:
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.
DosageView
Intravenous (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly as a single dose;
- Moderate dose regimen: 10-15 mg/kg wkly as a single dose;
- High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.
- 80-300 mg/m2 daily as a single dose, or
- 300-600 mg/m2 wkly as a single dose, or
- 600-1,500 mg/m2 as a single dose or
- Short infusion at 10- to 20-day intervals.
Oral (Child)-
Nephrotic syndrome:- 2 mg/kg daily for 8-12 wk.
- Max cumulative dose: 168 mg/kg.
- Max duration: 90 days.
Oral (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly in divided dose.
- Alternatively, 100-300 mg daily in divided doses, or
- 50-250 mg/m2 daily or 80-300 mg/m2 daily in divided doses.
AdministrationView
Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
Side effectsView
Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.
ContraindicationsView
Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.
PrecautionsView
Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.
InteractionsView
Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
ReconstitutionView
Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.
StorageView
Store at or below 25°C.
Endoxan
Cyclophosphamide
Endoxan
Cyclophosphamide
Indications
Vasculitis
Indication detailsView
Malignant Diseases:
Cyclophosphamide is indicated for the treatment of:- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
- Multiple myeloma
- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast
Minimal Change Nephrotic Syndrome in Pediatric Patients:
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.
DosageView
Intravenous (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly as a single dose;
- Moderate dose regimen: 10-15 mg/kg wkly as a single dose;
- High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.
- 80-300 mg/m2 daily as a single dose, or
- 300-600 mg/m2 wkly as a single dose, or
- 600-1,500 mg/m2 as a single dose or
- Short infusion at 10- to 20-day intervals.
Oral (Child)-
Nephrotic syndrome:- 2 mg/kg daily for 8-12 wk.
- Max cumulative dose: 168 mg/kg.
- Max duration: 90 days.
Oral (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly in divided dose.
- Alternatively, 100-300 mg daily in divided doses, or
- 50-250 mg/m2 daily or 80-300 mg/m2 daily in divided doses.
AdministrationView
Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
Side effectsView
Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.
ContraindicationsView
Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.
PrecautionsView
Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.
InteractionsView
Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
ReconstitutionView
Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.
StorageView
Store at or below 25°C.
Endoxan
Cyclophosphamide
Endoxan
Cyclophosphamide
Indications
Vasculitis
Indication detailsView
Malignant Diseases:
Cyclophosphamide is indicated for the treatment of:- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
- Multiple myeloma
- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast
Minimal Change Nephrotic Syndrome in Pediatric Patients:
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.
DosageView
Intravenous (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly as a single dose;
- Moderate dose regimen: 10-15 mg/kg wkly as a single dose;
- High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.
- 80-300 mg/m2 daily as a single dose, or
- 300-600 mg/m2 wkly as a single dose, or
- 600-1,500 mg/m2 as a single dose or
- Short infusion at 10- to 20-day intervals.
Oral (Child)-
Nephrotic syndrome:- 2 mg/kg daily for 8-12 wk.
- Max cumulative dose: 168 mg/kg.
- Max duration: 90 days.
Oral (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly in divided dose.
- Alternatively, 100-300 mg daily in divided doses, or
- 50-250 mg/m2 daily or 80-300 mg/m2 daily in divided doses.
AdministrationView
Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
Side effectsView
Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.
ContraindicationsView
Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.
PrecautionsView
Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.
InteractionsView
Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
ReconstitutionView
Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.
StorageView
Store at or below 25°C.
Endoxan
Cyclophosphamide
Endoxan
Cyclophosphamide
Indications
Vasculitis
Indication detailsView
Malignant Diseases:
Cyclophosphamide is indicated for the treatment of:- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
- Multiple myeloma
- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast
Minimal Change Nephrotic Syndrome in Pediatric Patients:
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.
DosageView
Intravenous (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly as a single dose;
- Moderate dose regimen: 10-15 mg/kg wkly as a single dose;
- High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.
- 80-300 mg/m2 daily as a single dose, or
- 300-600 mg/m2 wkly as a single dose, or
- 600-1,500 mg/m2 as a single dose or
- Short infusion at 10- to 20-day intervals.
Oral (Child)-
Nephrotic syndrome:- 2 mg/kg daily for 8-12 wk.
- Max cumulative dose: 168 mg/kg.
- Max duration: 90 days.
Oral (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly in divided dose.
- Alternatively, 100-300 mg daily in divided doses, or
- 50-250 mg/m2 daily or 80-300 mg/m2 daily in divided doses.
AdministrationView
Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
Side effectsView
Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.
ContraindicationsView
Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.
PrecautionsView
Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.
InteractionsView
Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
ReconstitutionView
Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.
StorageView
Store at or below 25°C.
Endurex
Mumshik
Endurex
Mumshik
Indications
Premature ejaculation
Indication detailsView
Mumshik is indicated in-
- Physical & nervous debility
- Premature ejaculation
- Spermatorrhoea
- Paralysis
- Facial paralysis
- Loss of sensation.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Mumshik is a powerful aphrodisiac capsule. Unique formulation of Mumshik with the combination of precious natural ingredients makes it a safe and effective nervine tonic, cephalic tonic, cardio tonic, hepato tonic & sexual tonic.
DosageView
2 capsules 1-2 time(s) daily or as prescribed by the registered physician.
Side effectsView
No significant side effect has been observed in therapeutic dosage.
ContraindicationsView
There is no known contraindication.
PrecautionsView
Keep out of reach of children.
StorageView
Store in a cool and dry place away from light.
Enegra
Sildenafil Citrate
Enegra
Sildenafil Citrate
Indications
Pulmonary arterial hypertension
Indication detailsView
Sildenafil is indicated for the treatment of erectile dysfunction.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
DosageView
The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
AdministrationView
Sildenafil may takes longer time to work if you take it with a heavy meal.
Side effectsView
The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.
ContraindicationsView
Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.
PrecautionsView
Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.
InteractionsView
Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Enema
Monobasic sodium phosphate + Dibasic sodium phosphate
Enema
Monobasic sodium phosphate + Dibasic sodium phosphate
Indications
Constipation
Indication detailsView
This is used for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.
Therapeutic classView
Other laxative preparations
DosageView
Adults and children, 12 years and over: One Bottle per day.
Children between 2 and 11 years: Use this laxative preparation.
Children under 2 years: Do not use.
If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
Children between 2 and 11 years: Use this laxative preparation.
Children under 2 years: Do not use.
If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
AdministrationView
- Remove the orange protective shield from this before inserting.
- With steady pressure, gently insert this bottle tip into the rectum with a slight side-to-side movement, with the tip pointing toward the navel. Insertion may be easier if the person receiving this bears down as if having a bowel movement. This helps relax the muscles around the anus.
- Stop using if the tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If this bottle tip causes rectal bleeding or pain, get immediate medical care.
- Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
- Remove the tip from the rectum and maintain position until the urge to evacuate is strong (usually 1 to 5 minutes).
- Left-side position: Lie on left side with knee bent, and arms resting comfortably.
- Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.
ContraindicationsView
Using more than one bottle in 24 hours can be harmful. Do not use without asking a doctor:
- For more than 3 days
- If you have kidney disease
- If you have heart problems
- If you are dehydrated
- When abdominal pain, nausea, or vomiting are present.
PrecautionsView
Ask a doctor before using this product if you:
- Are 55 years old or older
- Are on a sodium-restricted diet
- Have a sudden change in bowel habits lasting more than 2 weeks
- Already used a laxative for more than 1 week
- Rectal bleeding
- No bowel movement or no liquid comes out of the rectum after 30 minutes
- Symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal)
Pregnancy & lactationView
If pregnant or breastfeeding, ask a health professional before use.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Energin
Betacarotene + Vitamin C + Vitamin E
Energin
Betacarotene + Vitamin C + Vitamin E
Indications
Vitamin deficiency
Indication detailsView
Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows:
β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.
β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.
Therapeutic classView
Anti-oxidant Multivitamin preparations
PharmacologyView
Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.
Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.
vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.
Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.
vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.
DosageView
This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.
Side effectsView
β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.
Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
ContraindicationsView
Carocet is contraindicated in patients with hypersensitivity to any of its components.
PrecautionsView
There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.
InteractionsView
Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.
Pregnancy & lactationView
β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.
StorageView
Should be stored in a dry place below 30˚C.
Enerton
Balarista
Enerton
Balarista
Indications
Painful muscle spasm
Indication detailsView
This syrup is effective in physical debility, boosts strength & energy, improves the muscle tone, excellent tonic for sportsmen and asthma patients, useful in debility after fever and painful condition especially in sportsmen and geriatric patients.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Sida cordifolia: Sida cordifolia contains ephedrine, acts as a CNS stimulant. It produces strength and encourages muscular tone. Constituents include ephedrine (1%) and phytosterols. Sida cordifolia is also effective as an antiasthmatic as it contains some bronchodilating alkaloid. It would be useful for people who participate in outdoor sports rather than people who participate in indoor sports.
Withania somnifera: Root contains several alkaloids like withasomines, withanolides and steroidal lactones. It is adaptogen, anti- inflammatory, anxiolytic, immunomodulator, tonic and aphrodisiac.
Vanda roxburghii: The roots are used in bronchitis & rheumatism. Heptacosane and octacosanol shows anti-inflammatory activity.
Ricinus communis: Eranda is sweet, light, bitter and purgative. Castor oil is especially adapted for young children and child bearing women. It is a reputed remedy for all kinds of rheumatic affections. It cures dyspnoea, flatulence, visceral pain, lumbago and headache.
Elettaria cardamomum: Elettaria cardamomum has carminative and stimulant properties.
Syzygium aromaticum: The eugenol and acetyl eugenol of Syzygium aromaticum oil inhibit arachidonate-adrenaline and collagen induced platelet aggregation.
Vetiveria zizanoides: Its root is tonic,diuretic, stomachic and antispasmodic. It contains essential oil with some other alkaloids which act on dyspepsia, indigestion, diarrhea and vomiting.
Tribulus terrestris: Seed acts as a tonic. It improves vitality and luster of the skin to prevent wrinkle. It also acts as a uterine tonic and used in debility after child birth.
Withania somnifera: Root contains several alkaloids like withasomines, withanolides and steroidal lactones. It is adaptogen, anti- inflammatory, anxiolytic, immunomodulator, tonic and aphrodisiac.
Vanda roxburghii: The roots are used in bronchitis & rheumatism. Heptacosane and octacosanol shows anti-inflammatory activity.
Ricinus communis: Eranda is sweet, light, bitter and purgative. Castor oil is especially adapted for young children and child bearing women. It is a reputed remedy for all kinds of rheumatic affections. It cures dyspnoea, flatulence, visceral pain, lumbago and headache.
Elettaria cardamomum: Elettaria cardamomum has carminative and stimulant properties.
Syzygium aromaticum: The eugenol and acetyl eugenol of Syzygium aromaticum oil inhibit arachidonate-adrenaline and collagen induced platelet aggregation.
Vetiveria zizanoides: Its root is tonic,diuretic, stomachic and antispasmodic. It contains essential oil with some other alkaloids which act on dyspepsia, indigestion, diarrhea and vomiting.
Tribulus terrestris: Seed acts as a tonic. It improves vitality and luster of the skin to prevent wrinkle. It also acts as a uterine tonic and used in debility after child birth.
DosageView
Adult (above 12 years): 1-2 teaspoonfuls (5-10 ml) three times a day.
Side effectsView
This is well tolerated within the recommended dose.
ContraindicationsView
There is no evidence available on contraindication. But caution should be taken in hypertension, DM, BPH, cardiovascular diseases and with other CNS stimulant.
Pregnancy & lactationView
It is not recommended during pregnancy.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Enigma
Sildenafil Citrate
Enigma
Sildenafil Citrate
Indications
Pulmonary arterial hypertension
Indication detailsView
Sildenafil is indicated for the treatment of erectile dysfunction.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
DosageView
The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
AdministrationView
Sildenafil may takes longer time to work if you take it with a heavy meal.
Side effectsView
The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.
ContraindicationsView
Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.
PrecautionsView
Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.
InteractionsView
Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Enigma
Sildenafil Citrate
Enigma
Sildenafil Citrate
Indications
Pulmonary arterial hypertension
Indication detailsView
Sildenafil is indicated for the treatment of erectile dysfunction.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
DosageView
The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
AdministrationView
Sildenafil may takes longer time to work if you take it with a heavy meal.
Side effectsView
The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.
ContraindicationsView
Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.
PrecautionsView
Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.
InteractionsView
Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Enjofil
Sildenafil Citrate
Enjofil
Sildenafil Citrate
Indications
Pulmonary arterial hypertension
Indication detailsView
Sildenafil is indicated for the treatment of erectile dysfunction.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
DosageView
The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
AdministrationView
Sildenafil may takes longer time to work if you take it with a heavy meal.
Side effectsView
The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.
ContraindicationsView
Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.
PrecautionsView
Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.
InteractionsView
Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Enjofil
Sildenafil Citrate
Enjofil
Sildenafil Citrate
Indications
Pulmonary arterial hypertension
Indication detailsView
Sildenafil is indicated for the treatment of erectile dysfunction.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
DosageView
The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
AdministrationView
Sildenafil may takes longer time to work if you take it with a heavy meal.
Side effectsView
The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.
ContraindicationsView
Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.
PrecautionsView
Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.
InteractionsView
Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Enliven
Imatinib Mesylate
Enliven
Imatinib Mesylate
Indication detailsView
- Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.
- Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
- Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
- Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
- Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
- Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown.
- Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR a fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown.
- Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.
- Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors.
- Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.
Therapeutic classView
Targeted Cancer Therapy, Tyrosine Kinase Inhibitor
PharmacologyView
Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR beta). Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Absorption and Distribution: Imatinib is well absorbed after oral administration with Cmax achieved within 2 4 hours post-dose. Mean absolute bioavailability is 98%. Mean Imatinib AUC increases proportionally with increasing doses ranging from 25 mg to 1,000 mg. There is no significant change in the pharmacokinetics of Imatinib on repeated dosing, and accumulation is 1.5- to 2.5- fold at a steady state when Imatinib is dosed once daily. At clinically relevant concentrations of Imatinib, binding to plasma proteins in in vitro experiments is approximately 95%, mostly to albumin and 1-acid glycoprotein.
Metabolism: CYP3A4 is the major enzyme responsible for metabolism of Imatinib. Other cytochrome P450 enzymes, such as CYP1A2, CYP2D6, CYP2C9, and CYP2C19, play a minor role in its metabolism. The main circulating active metabolite in humans is the N-demethylated piperazine derivative, formed predominantly by CYP3A4. It shows in vitro potency similar to the parent Imatinib. The plasma AUC for this metabolite is about 15% of the AUC for Imatinib. The plasma protein binding of N-demethylated metabolite CGP74588 is similar to that of the parent compound.
Excretion: Imatinib elimination is predominately in the feces, mostly as metabolites. Based on the recovery of compound(s) after an oral 14C-labeled dose of Imatinib, approximately 81% of the dose was eliminated within 7 days, in feces (68% of dose) and urine (13% of dose). Unchanged Imatinib accounted for 25% of the dose (5% urine, 20% feces), the remainder being metabolites. Following oral administration in healthy volunteers, the elimination half-lives of Imatinib and its major active metabolite, the N-demethyl derivative (CGP74588), are approximately 18 and 40 hours, respectively.
Absorption and Distribution: Imatinib is well absorbed after oral administration with Cmax achieved within 2 4 hours post-dose. Mean absolute bioavailability is 98%. Mean Imatinib AUC increases proportionally with increasing doses ranging from 25 mg to 1,000 mg. There is no significant change in the pharmacokinetics of Imatinib on repeated dosing, and accumulation is 1.5- to 2.5- fold at a steady state when Imatinib is dosed once daily. At clinically relevant concentrations of Imatinib, binding to plasma proteins in in vitro experiments is approximately 95%, mostly to albumin and 1-acid glycoprotein.
Metabolism: CYP3A4 is the major enzyme responsible for metabolism of Imatinib. Other cytochrome P450 enzymes, such as CYP1A2, CYP2D6, CYP2C9, and CYP2C19, play a minor role in its metabolism. The main circulating active metabolite in humans is the N-demethylated piperazine derivative, formed predominantly by CYP3A4. It shows in vitro potency similar to the parent Imatinib. The plasma AUC for this metabolite is about 15% of the AUC for Imatinib. The plasma protein binding of N-demethylated metabolite CGP74588 is similar to that of the parent compound.
Excretion: Imatinib elimination is predominately in the feces, mostly as metabolites. Based on the recovery of compound(s) after an oral 14C-labeled dose of Imatinib, approximately 81% of the dose was eliminated within 7 days, in feces (68% of dose) and urine (13% of dose). Unchanged Imatinib accounted for 25% of the dose (5% urine, 20% feces), the remainder being metabolites. Following oral administration in healthy volunteers, the elimination half-lives of Imatinib and its major active metabolite, the N-demethyl derivative (CGP74588), are approximately 18 and 40 hours, respectively.
DosageView
Adults with Ph+ CML CP: 400 mg/day
Adults with Ph+ CML AP or BC: 600 mg/day
Pediatrics with Ph+ CML CP: 340 mg/m2/day
Adults with Ph+ ALL: 600 mg/day
Pediatrics with Ph+ ALL: 340 mg/m2/day
Adults with MDS/MPD: 400 mg/day
Adults with ASM: 100 mg/day or 400 mg/day
Adults with HES/CEL: 100 mg/day or 400 mg/day
Adults with DFSP: 800 mg/day
Adults with metastatic and/or unresectable GIST: 400 mg/day
Adjuvant treatment of adults with GIST: 400 mg/day
Patients with mild to moderate hepatic impairment: 400 mg/day
Patients with severe hepatic impairment: 300 mg/day
All doses of Imatinib should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400-mg tablet to reduce exposure to iron.
Adults with Ph+ CML AP or BC: 600 mg/day
Pediatrics with Ph+ CML CP: 340 mg/m2/day
Adults with Ph+ ALL: 600 mg/day
Pediatrics with Ph+ ALL: 340 mg/m2/day
Adults with MDS/MPD: 400 mg/day
Adults with ASM: 100 mg/day or 400 mg/day
Adults with HES/CEL: 100 mg/day or 400 mg/day
Adults with DFSP: 800 mg/day
Adults with metastatic and/or unresectable GIST: 400 mg/day
Adjuvant treatment of adults with GIST: 400 mg/day
Patients with mild to moderate hepatic impairment: 400 mg/day
Patients with severe hepatic impairment: 300 mg/day
All doses of Imatinib should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400-mg tablet to reduce exposure to iron.
Side effectsView
The following serious adverse reactions are described elsewhere in the labeling:
- Fluid Retention and Edema
- Hematologic Toxicity
- Congestive Heart Failure and Left Ventricular Dysfunction
- Hepatotoxicity
- Hemorrhage
- Gastrointestinal Disorders
- Hypereosinophilic Cardiac Toxicity
- Dermatologic Toxicities
- Hypothyroidism
- Growth Retardation in Children and Adolescents
- Tumor Lysis Syndrome
- Impairments Related to Driving and Using Machinery
- Renal Toxicity
PrecautionsView
- Edema and severe fluid retention have occurred. Weigh patients regularly and manage unexpected rapid weight gain by drug interruption and diuretics.
- Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred. Manage with dose reduction, dose interruption, or discontinuation of treatment. Perform complete blood counts weekly for the first month, biweekly for the second month, and periodically thereafter.
- Severe congestive heart failure and left ventricular dysfunction have been reported, particularly in patients with comorbidities and risk factors. Monitor and treat patients with cardiac disease or risk factors for cardiac failure.
- Severe hepatotoxicity, including fatalities may occur. Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction.
- Grade 3/4 hemorrhage has been reported in clinical studies in patients with newly diagnosed CML and with GIST. Gl tumor sites may be the source of Gl bleeds in GIST. Gastrointestinal (Gl) perforations, some fatal, have been reported.
- Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of Imatinib in patients with conditions associated with high eosinophil levels (e.g., HES, MDS/MPD, and ASM).
- Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have been reported with the use of Imatinib.
- Hypothyroidism has been reported in thyroidectomy ZyvaxatX patients undergoing levothyroxine replacement. Closely monitor TSH levels in such patients.
- Fetal harm can occur when administered to a pregnant woman. Apprise women of the potential harm to the fetus, and to avoid pregnancy when taking Imatinib.
- Growth retardation occurring in children and pre-adolescents receiving Imatinib has been reported. Close monitoring of growth in children under Imatinib treatment is recommended.
- Tumor Lysis Syndrome. Close monitoring is recommended.
- Reports of motor vehicle accidents have been received in patients receiving Imatinib. Caution patients about driving a car or operating machinery.
- Renal Toxicity. A decline in renal function may occur in patients receiving Imatinib. Evaluate renal function at baseline and during therapy, with attention to risk factors for renal dysfunction.
InteractionsView
Agents Inducing CYP3A Metabolism: Concomitant administration of Imatinib and strong CYP3A4 inducers may reduce total exposure of imatinib; consider alternative agents.
Agents Inhibiting CYP3A Metabolism: Concomitant administration of Imatinib and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase. Grapefruit juice may also increase plasma concentrations of imatinib; avoid grapefruit juice).
Interactions with Drugs Metabolized by CYP3A4: Imatinib will increase plasma concentration of CYP3A4 metabolized drugs (e.g., triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, etc.). Use caution when administering Imatinib with CYP3A4 substrates that have a narrow therapeutic window. Because warfarin is metabolized by CYP2C9 and CYP3A4, use low-molecular weight or standard heparin instead of warfarin in patients who require anticoagulation.
Interactions with Drugs Metabolized by CYP2D6: Use caution when administering Imatinib with CYP2D6 substrates that have a narrow therapeutic window.
Agents Inhibiting CYP3A Metabolism: Concomitant administration of Imatinib and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase. Grapefruit juice may also increase plasma concentrations of imatinib; avoid grapefruit juice).
Interactions with Drugs Metabolized by CYP3A4: Imatinib will increase plasma concentration of CYP3A4 metabolized drugs (e.g., triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, etc.). Use caution when administering Imatinib with CYP3A4 substrates that have a narrow therapeutic window. Because warfarin is metabolized by CYP2C9 and CYP3A4, use low-molecular weight or standard heparin instead of warfarin in patients who require anticoagulation.
Interactions with Drugs Metabolized by CYP2D6: Use caution when administering Imatinib with CYP2D6 substrates that have a narrow therapeutic window.
Pregnancy & lactationView
Women of childbearing potential: Women of childbearing potential must be advised to use effective contraception during treatment and for at least 15 days after stopping treatment with Imatinib.
Pregnancy: There are limited data on the use of imatinib in pregnant women. There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Imatinib. Studies in animals have however shown reproductive toxicity and the potential risk for the foetus is unknown. Imatinib should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Breast-feeding: There is limited information on imatinib distribution on human milk. Studies in two breast feeding women revealed that both imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk. Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (-10% of a therapeutic dose). However, since the effects of low-dose exposure of the infant to imatinib are unknown, women should not breast-feed during treatment and for at least 15 days after stopping treatment with Imatinib.
Fertility: In non-clinical studies, the fertility of male and female rats was not affected, although effects on reproductive parameters were observed. Studies on patients receiving Imatinib and its effect on fertility and gametogenesis have not been performed. Patients concerned about their fertility on Imatinib treatment should consult with their physician.
Pregnancy: There are limited data on the use of imatinib in pregnant women. There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Imatinib. Studies in animals have however shown reproductive toxicity and the potential risk for the foetus is unknown. Imatinib should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Breast-feeding: There is limited information on imatinib distribution on human milk. Studies in two breast feeding women revealed that both imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk. Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (-10% of a therapeutic dose). However, since the effects of low-dose exposure of the infant to imatinib are unknown, women should not breast-feed during treatment and for at least 15 days after stopping treatment with Imatinib.
Fertility: In non-clinical studies, the fertility of male and female rats was not affected, although effects on reproductive parameters were observed. Studies on patients receiving Imatinib and its effect on fertility and gametogenesis have not been performed. Patients concerned about their fertility on Imatinib treatment should consult with their physician.
Overdose effectsView
Experience with doses higher than the recommended therapeutic dose is limited. In the event of overdose the patient should be observed and an appropriate symptomatic treatment given. Generally, the reported outcome in these cases was "improved" or "recovered". Events that have been reported at different dose ranges are as follows:
Adult Population:
Adult Population:
- 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
- 1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase,
- increased bilirubin, gastrointestinal pain.
- 6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, and increased transaminases.
- 8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
StorageView
Store below 30°C, in a cool and dry place. Keep away from light. Keep out of the reach of children.
EnoFab
Fenofibrate
EnoFab
Fenofibrate
Indications
Hypertriglyceridaemia
Indication detailsView
Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.
Therapeutic classView
Fibrates
PharmacologyView
Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.
DosageView
- For the treatment of adult patients with hypercholesterolemia or mixed hyperlipidemia, the initial dose of Fenofibrate is 200 mg per day.
- For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day.
- Dose should be individualized according to patient response. Fenofibrate should be given with meal there by, optimizing the bioavailability of the medication. Or, as directed by the registered physician.
Side effectsView
Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.
ContraindicationsView
Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.
PrecautionsView
Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.
InteractionsView
Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.
Pregnancy & lactationView
Fenofibrate is not recommended for pregnant women.
Overdose effectsView
There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Enocam
Tenoxicam
Enocam
Tenoxicam
Indications
Pain and inflammation associated with musculoskeletal and joint disorders
Indication detailsView
Tenoxicam is indicated for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system:
- Rheumatoid arthritis.
- Osteoarthritis.
- Arthrosis.
- Ankylosing spondylitis.
- Extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of the shoulders (shoulder-hand syndrome) or hips, strains, and sprains.
- Acute gout.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties and it also inhibits platelet aggregation. Tenoxicam inhibits prostaglandin biosynthesis. In-vitro tests of leukocyte peroxidase suggest that tenoxicam may act as a scavenger for active oxygen at the site of inflammation. Tenoxicam is a potent in-vitro inhibitor of human metalloproteinases (stromelysin and collagenase), which induce cartilage breakdown. These pharmacological effects explain, at least in part, the therapeutic benefit of Tenoxicam in the treatment of painful inflammatory and degenerative disorders of the musculoskeletal system. Tenoxicam showed no mutagenic, carcinogenic or teratogenic effects in animals. As with other prostaglandin inhibitors, renal and gastrointestinal effects, increased incidence of dystocia and delayed parturition were observed in animal safety studies.
DosageView
Standard dosage: For all indications except acute gout, a daily dosage of 20 mg should be given at the same time of day.
In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.
In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.
Special dosage instructions: In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for children and adolescents.
In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.
In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.
Special dosage instructions: In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for children and adolescents.
AdministrationView
The tablets should be taken with a glass of water. It is preferable to take this medicine during or immediately after a meal.
Side effectsView
Based on clinical trials including large numbers of patients, Tenoxicam proved to be well tolerated in the recommended dose. Usually, the undesirable effects reported were mild and transient. In a small proportion of patients, the interruption of treatment due to undesirable effects was necessary. Local tolerance of Tenoxicam given parenterally was good. The following undesirable effects have been reported:
Frequency is greater than 1%-
Frequency is greater than 1%-
- Gastrointestinal tract: gastric, epigastric and abdominal discomfort, dyspepsia, heartburn, nausea.
- Central nervous system: dizziness, headache.
- Gastrointestinal tract: constipation, diarrhea, stomatitis, gastritis, vomiting, ulcers, Gl-bleeding including hematemesis and melena.
- Central nervous system: fatigue, sleep disturbances, appetite loss, dry mouth, vertigo.
- Skin: itching (also in the anal region after rectal administration), erythema, exanthema, rash, urticaria.
- Urinary tract and kidneys: increase in BUN or creatinine, edema.
- Liver and biliary tract: increased liver enzyme activity.
- Cardiovascular system: palpitations.
- Gastrointestinal tract: Gl-perforation.
- Central nervous system: visual disturbances.
- Skin: Stevens-Johnson and Lyell's syndrome, photosensitivity reaction, vasculitis.
- Blood: anemia, agranulocytosis, leukopenia, thrombocytopenia.
- Hypersensitivity reactions: dyspnea, asthma, anaphylaxis, angioedema.
- Cardiovascular system: elevated blood pressure, mainly in patients treated with cardiovascular drugs.
- Liver/Biliary tract: hepatitis.
ContraindicationsView
Tenoxicam must not be administered to patients:
- known to be hypersensitive to the drug;
- in whom salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) induce symptoms of asthma, rhinitis, or urticaria;
- suffering or having suffered from the disease of the upper gastrointestinal tract, such as gastritis, gastric and duodenal ulcer.
PrecautionsView
NSAIDs inhibit renal prostaglandin synthesis and consequently may have an undesirable effect on renal hemodynamics and on salt and water balance. It is necessary to adequately monitor the patient with a special emphasis on cardiac and renal function (BUN, creatinine, development of edema, weight gain, etc.) when giving Tenoxicam to patients with conditions that could increase their risk of developing renal failure, such as pre-existing renal disease, impaired renal function in diabetics, hepatic cirrhosis, congestive heart failure, volume depletion or concomitant treatment with potentially nephrotoxic drugs, diuretics and corticosteroids. Tenoxicam inhibits platelet aggregation and may affect hemostasis. Tenoxicam has no significant influence on blood coagulation factors, coagulation time, prothrombin time or activated thromboplastin time. Patients having coagulation disorders or receiving drug therapy that interferes with hemostasis should, however, be carefully observed when Tenoxicam is administered. Any patient being treated with Tenoxicam who presents with symptoms of gastrointestinal disease should be closely monitored. If peptic ulceration or gastrointestinal bleeding occurs, Tenoxicam should be immediately withdrawn. If severe skin reactions (e.g. Lyell's or Stevens-Johnson syndrome) occur, the treatment should be discontinued immediately. Adverse eye findings have been reported with Tenoxicam. Thus ophthalmic evaluation is recommended for patients who develop visual disturbances. Because of the high plasma protein binding of tenoxicam, caution is required when plasma albumin levels are markedly reduced. In common with anti-inflammatory drugs, Tenoxicam may mask the usual signs of infection. Tenoxicam Tablets should not be given to patients who either dislike or do not tolerate milk products.
InteractionsView
As in the case of other NSAIDs, salicylate displaces tenoxicam from protein-binding sites and increases clearance and volume of distribution of tenoxicam. Concurrent treatment with salicylate or other NSAIDs should be avoided because of increased risk of gastrointestinal undesirable reactions. The co-administration of some NSAIDs and methotrexate has been associated with reduced renal tubular secretion of methotrexate, higher plasma concentrations of methotrexate, and severe methotrexate toxicity. Therefore, caution should be exercised when Tenoxicam is administered concurrently with methotrexate. No clinically relevant interaction was found in the small number of patients receiving concomitant treatment with gold, penicillamine or probenecid. As Tenoxicam may decrease the renal clearance of lithium, their concomitant administration may lead to increased plasma levels and toxicity of lithium. The plasma levels of lithium should be closely monitored. As with NSAIDs in general, Tenoxicam should not be administered concurrently with K-sparing diuretics. There is a known interaction between these two classes of compounds, which may cause hyperkalemia and renal failure. No clinically significant interaction between Tenoxicam and furosemide was noted, but Tenoxicam attenuates the blood pressure-lowering effect of hydrochlorothiazide. As known from other NSAIDs, Tenoxicam might attenuate the antihypertensive effects of alpha-adrenergic blockers and ACE-inhibitors. No interactions have been reported between NSAIDs and centrally-acting alpha agonists or calcium channel blockers. There was no clinically relevant interaction when Tenoxicam was administered together with atenolol. During clinical trials no interaction was reported for patients treated concomitantly with digitalis products. Thus concurrent dosing of Tenoxicam and digoxin appears to be without major risk. No interaction has been found with concomitantly administered antacids, cimetidine, warfarin and phenprocoumon at the recommended dosages. The clinical effect of oral antidiabetic drugs (glibornuride, glibenclamide, tolbutamide) was likewise not modified by Tenoxicam. Nevertheless, careful monitoring is recommended when patients concomitantly receive anticoagulants or oral antidiabetic drugs. No clinically relevant interaction has been found between Tenoxicam and low molecular weight heparin.
Pregnancy & lactationView
NSAIDs have an inhibitory effect on prostaglandin synthesis and, when given during late pregnancy, may cause the closure of the fetal ductus arteriosus, prolong labor and delay parturition. Treatment during the third trimester of pregnancy should be avoided. Based on findings from single-dose administration, a very small amount (approximately 0.2%) of tenoxicam passes into breast milk. There is no evidence of adverse reactions in breast-fed infants of mothers taking Tenoxicam. Nevertheless, infants should be weaned or the drug discontinued.
Pediatric usageView
Use in Children & adolescent: Tenoxicam is not recommended for use in patients under 16 years of age, as the dose and indications in this population have not been established.
Effects on ability to drive and use machines: Patients experiencing adverse events that might affect driving or using machines, such as vertigo, dizziness or visual disturbances should refrain from driving a car or using machines.
Effects on ability to drive and use machines: Patients experiencing adverse events that might affect driving or using machines, such as vertigo, dizziness or visual disturbances should refrain from driving a car or using machines.
Overdose effectsView
Although there is no experience of acute overdosage with Tenoxicam, it may be expected that the signs and symptoms mentioned under Undesirable effects would be more pronounced. Overdose should be countered by conventional measures to reduce absorption (e.g. gastrolavage and charcoal) and speed up elimination (e.g. cholestyramine).
StorageView
Do not store above 30°C, protect from light & moisture. Keep out of the reach of children.