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Varda
Vardenafil
Varda
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Varda
Vardenafil
Varda
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Vardamate
Vardenafil
Vardamate
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Vardamate
Vardenafil
Vardamate
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Vardena
Vardenafil
Vardena
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Vardena
Vardenafil
Vardena
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Varen
Chloramphenicol (Ophthalmic)
Varen
Chloramphenicol (Ophthalmic)
Indications
Whipple’s disease
Indication detailsView
Chloramphenicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.
Therapeutic classView
Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides
PharmacologyView
Chloramphenicol is a broad-spectrum bacteriostatic antibiotic which acts through the inhibition of bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.
DosageView
Adult and Children: Instill 1 or 2 drops in the conjunctival sac 4-6 times per day for the first 72 hours and then every 4 hours thereafter. Treatment should be continued for approximately 7 days, but should not be continued for more than 3 weeks without re-evaluation by the physician.
Side effectsView
The systemic adverse reaction has not been observed within short-term topical use of Chloramphenicol. The most frequently reported adverse reactions have been burning, stinging, conjunctival hyperemia, blood dyscrasia, allergic or inflammatory reactions, vesicular and maculopapular dermatitis.
ContraindicationsView
It is contraindicated in individuals with a history of hypersensitivity to Chloramphenicol or any ingredients of the preparation.
PrecautionsView
Chloramphenicol ophthalmic solution should never be given for minor infections or for prophylaxis. Repeated course and prolonged treatment should be avoided. Blood dyscrasias (granulocytopenia, thrombocytopenia and moderate anaemia) may occur after prolonged ophthalmic use.
InteractionsView
Chymotrypsin may be inhibited if given simultaneously with Chloramphenicol.
Pregnancy & lactationView
Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physicians.
Overdose effectsView
Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of antibiotic.
StorageView
Store in a cool (between 2°C-8°C) and dry place, protect from light, keep out of reach of children. Do not touch the dropper tip to the surface since this may contaminate the solution. Do not use after 30 days of the first opening.
Varigestrol
Megestrol Acetate
Varigestrol
Megestrol Acetate
Indication detailsView
Megestrol Tablet is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used instead of currently accepted procedures such as surgery, radiation, or chemotherapy.
Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.
Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.
PharmacologyView
Megestrol Acetate is a synthetic, antineoplastic and progestational drug. While the precise mechanism by which Megestrol Acetate produces its antineoplastic effects against endometrial carcinoma is unknown at the present time, inhibition of pituitary gonadotrophin production and resultant decrease in estrogen secretion may be factors. The antineoplastic action of megestrol acetate on carcinoma of the breast is effected by modifying the action of other steroid hormones and by exerting a direct cytotoxic effect on tumor cells. In metastatic cancer, hormone receptors may be present in some tissues but not others. The receptor mechanism is a cyclic process whereby estrogen produced by the ovaries enters the target cell, forms a complex with cytoplasmic receptor and is transported into the cell nucleus. There it induces gene transcription and leads to the alteration of normal cell functions. Pharmacologic doses of megestrol acetate not only decrease the number of hormone-dependent human breast cancer cells but also are capable of modifying and abolishing the stimulatory effects of estrogen on these cells.
Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.
Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.
DosageView
Tablet:
- Breast cancer: 160 mg/day
- Endometrial carcinoma: 40-320 mg/day in divided doses.
- At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of Megestrol.
Side effectsView
Weight Gain: Weight gain is a frequent side effect of Megestrol Acetate. This gain has been associated with increased appetite and is not necessarily associated with fluid retention.
Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.
Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.
Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.
Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.
Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.
Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.
ContraindicationsView
History of hypersensitivity to Megestrol Acetate or any component of the formulation. Known or suspected pregnancy.
PrecautionsView
General: Close surveillance is indicated for any patient treated for recurrent or metastatic cancer. Use with caution in patients with a history of thromboembolic disease.
Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.
Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.
InteractionsView
Pharmacokinetic studies show that there are no significant alterations in pharmacokinetics parameters of Zidovudine or Rifabutin to warrant dosage adjustment when Megestrol Acetate is administered with these drugs. The effects of Zidovudine or Rifabutin on the pharmacokinetics of Megestrol Acetate were not studied.
Pregnancy & lactationView
Pregnancy Category D. The use of progestational agents during the first four months of pregnancy is not recommended. Very small amounts (approximately 0.1%) are excreted in mother's milk. It is however, not known whether these amounts exert any harmful effect on the newborn. Because of the potential for adverse effects on the new born, nursing should be discontinued during treatment with Megestrol Acetate.
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Overdose effectsView
No serious unexpected side effects have resulted from studies involving Megestrol Acetate administered in dosages as high as 1600 mg/day.
StorageView
Store at or below 25°C. Protect from heat, light & moisture.
Varilrix
Varicella Virus Vaccine
Varilrix
Varicella Virus Vaccine
Indications
Varicella infection
Indication detailsView
This is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.
Therapeutic classView
Vaccines, Anti-sera & Immunoglobulin
PharmacologyView
Varicella Virus Vaccine induces both cell-mediated and humoral immune responses to varicella-zoster virus. The relative contributions of humoral immunity and cell-mediated immunity to protection from varicella are unknown.
DosageView
Each 0.5 mL dose of Varicella Virus Vaccine is administered subcutaneously. Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.
Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measles-containing vaccine and a dose of Varicella Virus Vaccine if the vaccines are not given concurrently.
Adolescents (≥13 years of age) and Adults: Two doses of Varicella Virus Vaccine are administered at a minimum interval of 4 weeks.
Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measles-containing vaccine and a dose of Varicella Virus Vaccine if the vaccines are not given concurrently.
Adolescents (≥13 years of age) and Adults: Two doses of Varicella Virus Vaccine are administered at a minimum interval of 4 weeks.
Side effectsView
Frequently reported (≥10%) adverse reactions in children ages 1 to 12 years include:
- fever ≥102.0°F (38.9°C) oral: 14.7%
- injection-site complaints: 19.3%
- fever ≥100.0°F (37.8°C) oral: 10.2%
- injection-site complaints: 24.4%
- varicella-like rash (injection site)
- varicella-like rash (generalized)
ContraindicationsView
Severe Allergic Reaction: Do not administer Varicella Virus Vaccine to individuals with a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine.
Immunosuppression: Do not administer Varicella Virus Vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.
Moderate or Severe Febrile Illness: Do not administer Varicella Virus Vaccine to individuals with an active febrile illness with fever >38.5°C.
Active Untreated Tuberculosis: Do not administer Varicella Virus Vaccine to individuals with active, untreated tuberculosis (TB).
Pregnancy: Do not administer Varicella Virus Vaccine to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm.
Immunosuppression: Do not administer Varicella Virus Vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.
Moderate or Severe Febrile Illness: Do not administer Varicella Virus Vaccine to individuals with an active febrile illness with fever >38.5°C.
Active Untreated Tuberculosis: Do not administer Varicella Virus Vaccine to individuals with active, untreated tuberculosis (TB).
Pregnancy: Do not administer Varicella Virus Vaccine to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm.
PrecautionsView
Evaluate individuals for immune competence prior to administration of Varicella Virus Vaccine if there is a family history of congenital or hereditary immunodeficiency. Avoid close contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus. Immune Globulins (IG) and other blood products should not be given concomitantly with Varicella Virus Vaccine. Avoid use of salicylates for 6 weeks following administration of Varicella Virus Vaccine to children and adolescents.
InteractionsView
Reye syndrome has been reported in children and adolescents following the use of salicylates during wild-type varicella infection. Administration of immune globulins and other blood products concurrently with Varicella Virus Vaccine vaccine may interfere with the expected immune response. Varicella Virus Vaccine vaccination may result in a temporary depression of purified protein derivative (PPD) tuberculin skin sensitivity.
Pregnancy & lactationView
Varicella Virus Vaccine is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella syndrome. No increased risk for miscarriage, major birth defect or congenital varicella syndrome was observed in a pregnancy exposure registry that monitored outcomes after inadvertent use. There are no relevant animal data.
It is not known whether varicella vaccine virus is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Varicella Virus Vaccine, and any potential adverse effects on the breastfed child from Varicella Virus Vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
It is not known whether varicella vaccine virus is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Varicella Virus Vaccine, and any potential adverse effects on the breastfed child from Varicella Virus Vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
Pediatric usageView
Pediatric Use: No clinical data are available on safety or efficacy of varicella virus vaccine in children less than 12 months of age.
Geriatric Use: Clinical studies of varicella virus vaccine did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of varicella virus vaccine did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.
ReconstitutionView
Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of Varicella Virus Vaccine because these substances may inactivate the vaccine virus. When reconstituting the vaccine, use only the sterile diluent supplied with Varicella Virus Vaccine. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus. To reconstitute the vaccine, withdraw the total volume of supplied sterile diluent and inject into the lyophilized vaccine vial. Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white compact crystalline plug. Varicella Virus Vaccine, when reconstituted, is a clear, colorless to pale yellow liquid. Withdraw the entire amount of reconstituted vaccine, inject the total volume and discard vial. To minimize loss of potency, administer Varicella Virus Vaccine immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes. Do not freeze reconstituted vaccine. Do not combine Varicella Virus Vaccine with any other vaccine through reconstitution or mixing.
StorageView
Store between 2-8° C. Do not freeze. Protect from light. Keep out of the reach of children.
Varivax
Varicella Virus Vaccine
Varivax
Varicella Virus Vaccine
Indications
Varicella infection
Indication detailsView
This is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.
Therapeutic classView
Vaccines, Anti-sera & Immunoglobulin
PharmacologyView
Varicella Virus Vaccine induces both cell-mediated and humoral immune responses to varicella-zoster virus. The relative contributions of humoral immunity and cell-mediated immunity to protection from varicella are unknown.
DosageView
Each 0.5 mL dose of Varicella Virus Vaccine is administered subcutaneously. Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.
Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measles-containing vaccine and a dose of Varicella Virus Vaccine if the vaccines are not given concurrently.
Adolescents (≥13 years of age) and Adults: Two doses of Varicella Virus Vaccine are administered at a minimum interval of 4 weeks.
Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measles-containing vaccine and a dose of Varicella Virus Vaccine if the vaccines are not given concurrently.
Adolescents (≥13 years of age) and Adults: Two doses of Varicella Virus Vaccine are administered at a minimum interval of 4 weeks.
Side effectsView
Frequently reported (≥10%) adverse reactions in children ages 1 to 12 years include:
- fever ≥102.0°F (38.9°C) oral: 14.7%
- injection-site complaints: 19.3%
- fever ≥100.0°F (37.8°C) oral: 10.2%
- injection-site complaints: 24.4%
- varicella-like rash (injection site)
- varicella-like rash (generalized)
ContraindicationsView
Severe Allergic Reaction: Do not administer Varicella Virus Vaccine to individuals with a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine.
Immunosuppression: Do not administer Varicella Virus Vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.
Moderate or Severe Febrile Illness: Do not administer Varicella Virus Vaccine to individuals with an active febrile illness with fever >38.5°C.
Active Untreated Tuberculosis: Do not administer Varicella Virus Vaccine to individuals with active, untreated tuberculosis (TB).
Pregnancy: Do not administer Varicella Virus Vaccine to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm.
Immunosuppression: Do not administer Varicella Virus Vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.
Moderate or Severe Febrile Illness: Do not administer Varicella Virus Vaccine to individuals with an active febrile illness with fever >38.5°C.
Active Untreated Tuberculosis: Do not administer Varicella Virus Vaccine to individuals with active, untreated tuberculosis (TB).
Pregnancy: Do not administer Varicella Virus Vaccine to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm.
PrecautionsView
Evaluate individuals for immune competence prior to administration of Varicella Virus Vaccine if there is a family history of congenital or hereditary immunodeficiency. Avoid close contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus. Immune Globulins (IG) and other blood products should not be given concomitantly with Varicella Virus Vaccine. Avoid use of salicylates for 6 weeks following administration of Varicella Virus Vaccine to children and adolescents.
InteractionsView
Reye syndrome has been reported in children and adolescents following the use of salicylates during wild-type varicella infection. Administration of immune globulins and other blood products concurrently with Varicella Virus Vaccine vaccine may interfere with the expected immune response. Varicella Virus Vaccine vaccination may result in a temporary depression of purified protein derivative (PPD) tuberculin skin sensitivity.
Pregnancy & lactationView
Varicella Virus Vaccine is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella syndrome. No increased risk for miscarriage, major birth defect or congenital varicella syndrome was observed in a pregnancy exposure registry that monitored outcomes after inadvertent use. There are no relevant animal data.
It is not known whether varicella vaccine virus is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Varicella Virus Vaccine, and any potential adverse effects on the breastfed child from Varicella Virus Vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
It is not known whether varicella vaccine virus is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Varicella Virus Vaccine, and any potential adverse effects on the breastfed child from Varicella Virus Vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
Pediatric usageView
Pediatric Use: No clinical data are available on safety or efficacy of varicella virus vaccine in children less than 12 months of age.
Geriatric Use: Clinical studies of varicella virus vaccine did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of varicella virus vaccine did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.
ReconstitutionView
Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of Varicella Virus Vaccine because these substances may inactivate the vaccine virus. When reconstituting the vaccine, use only the sterile diluent supplied with Varicella Virus Vaccine. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus. To reconstitute the vaccine, withdraw the total volume of supplied sterile diluent and inject into the lyophilized vaccine vial. Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white compact crystalline plug. Varicella Virus Vaccine, when reconstituted, is a clear, colorless to pale yellow liquid. Withdraw the entire amount of reconstituted vaccine, inject the total volume and discard vial. To minimize loss of potency, administer Varicella Virus Vaccine immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes. Do not freeze reconstituted vaccine. Do not combine Varicella Virus Vaccine with any other vaccine through reconstitution or mixing.
StorageView
Store between 2-8° C. Do not freeze. Protect from light. Keep out of the reach of children.
Varizil
Metronidazole
Varizil
Metronidazole
Indications
Vaginal trichomoniasis
Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
- The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
- The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
- In the treatment of urogenital trichomoniasis.
- Bacterial vaginosis (also known as non-specific vaginitis).
- All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
- Giardiasis.
- Acute ulcerative gingivitis.
- Anaerobically infected leg ulcers and pressure sores.
- Acute dental infections due to anaerobic organisms.
- Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView
Tablet and Suspension:
Trichomoniasis (Adults & Children over 10 yrs)-- 200 mg tid or 400 mg bid for 7 days
- 800 mg in the morning and 1-2 gm at night for 2 days
- 2 gm as a single dose for 1 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- Children 7-10 yrs: 1 gm once daily
- Children 3-7 yrs: 600-800 mg once daily
- Children 1-3 yrs: 500 mg once daily
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- Children 1-10 yrs: 7.5 mg/kg tid
Vaginal Gel:
The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.
Suppository:
Anaerobic Infections-- Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
- Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
- Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
- Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.
IV Infusion:
Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.- Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
- Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
- If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
- Metronidazole should be administered with caution to patients with hepatic encephalopathy.
- Patients should be warned that metronidazole may darken urine.
InteractionsView
- Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
- Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
- Lithium: Plasma levels of lithium may be increased by metronidazole.
- Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
- Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
- 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
- Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.
Varizil
Metronidazole
Varizil
Metronidazole
Indications
Vaginal trichomoniasis
Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
- The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
- The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
- In the treatment of urogenital trichomoniasis.
- Bacterial vaginosis (also known as non-specific vaginitis).
- All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
- Giardiasis.
- Acute ulcerative gingivitis.
- Anaerobically infected leg ulcers and pressure sores.
- Acute dental infections due to anaerobic organisms.
- Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView
Tablet and Suspension:
Trichomoniasis (Adults & Children over 10 yrs)-- 200 mg tid or 400 mg bid for 7 days
- 800 mg in the morning and 1-2 gm at night for 2 days
- 2 gm as a single dose for 1 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- Children 7-10 yrs: 1 gm once daily
- Children 3-7 yrs: 600-800 mg once daily
- Children 1-3 yrs: 500 mg once daily
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- Children 1-10 yrs: 7.5 mg/kg tid
Vaginal Gel:
The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.
Suppository:
Anaerobic Infections-- Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
- Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
- Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
- Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.
IV Infusion:
Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.- Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
- Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
- If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
- Metronidazole should be administered with caution to patients with hepatic encephalopathy.
- Patients should be warned that metronidazole may darken urine.
InteractionsView
- Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
- Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
- Lithium: Plasma levels of lithium may be increased by metronidazole.
- Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
- Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
- 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
- Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.
Varnafil
Vardenafil
Varnafil
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Varnafil
Vardenafil
Varnafil
Vardenafil
Indications
Erectile dysfunction
Indication detailsView
Vardenafil is used to treat erectile dysfunction (ED).
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
DosageView
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Side effectsView
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
ContraindicationsView
Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
PrecautionsView
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
InteractionsView
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Pregnancy & lactationView
Vardenafil is not indicated for women.
Overdose effectsView
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
StorageView
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Varni
Varenicline Tartrate
Varni
Varenicline Tartrate
Indications
Smoking cessation aid
Indication detailsView
Varenicline is indicated for use as an aid to smoking cessation treatment.
Therapeutic classView
Drugs used in substance dependence
PharmacologyView
Varenicline binds with high affinity and selectivity at α4β2 neuronal nicotinic acetylcholinereceptors. The efficacy of Varenicline in smoking cessation is believed to be the result of varenicline's activity at α4β2 sub-type of the nicotinic receptor where its binding produces agonist activity, while simultaneously preventing nicotine binding to these receptors.
Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to α4β2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine. Varenicline blocks the ability of nicotine to activate α4β2 receptors and thus to stimulate the central nervous mesolimbic dopamine system, believed to be the neuronal mechanism underlying reinforcement and reward experienced upon smoking. Varenicline is highly selective and binds more potently to α4β2 receptors than to other common nicotinic receptors ( >500-fold α3β4, >3,500fold α7, >20,000-fold α1βγδ), or to non-nicotinic receptors and transporters (> 2,000-fold). Varenicline also binds with moderate affinity (Ki = 350 nM) to the 5-HT3 receptor.
Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to α4β2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine. Varenicline blocks the ability of nicotine to activate α4β2 receptors and thus to stimulate the central nervous mesolimbic dopamine system, believed to be the neuronal mechanism underlying reinforcement and reward experienced upon smoking. Varenicline is highly selective and binds more potently to α4β2 receptors than to other common nicotinic receptors ( >500-fold α3β4, >3,500fold α7, >20,000-fold α1βγδ), or to non-nicotinic receptors and transporters (> 2,000-fold). Varenicline also binds with moderate affinity (Ki = 350 nM) to the 5-HT3 receptor.
DosageView
Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt.
The patient should set a date to stop smoking. Begin Varenicline dosing one week before this date. Alternatively, the patient can begin Varenicline dosing and then quit smoking between days 8 and 35 of treatment.
The recommended dose of Varenicline is 1 mg twice daily following a 1-week titration as follows:
For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with Varenicline. Patients should begin Varenicline dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue Varenicline treatment for an additional 12 weeks, for a total of 24 weeks of treatment. Encourage patients to attempt quitting sooner if they feel ready
Patients who are motivated to quit, and who did not succeed in stopping smoking during prior Varenicline therapy for reasons other than intolerability due to adverse events or who relapsed after treatment, should be encouraged to make another attempt with Varenicline once factors contributing to the failed attempt have been identified and addressed.
Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of Varenicline.
The patient should set a date to stop smoking. Begin Varenicline dosing one week before this date. Alternatively, the patient can begin Varenicline dosing and then quit smoking between days 8 and 35 of treatment.
The recommended dose of Varenicline is 1 mg twice daily following a 1-week titration as follows:
- Days 1-3: 0.5 mg once daily
- Days 4-7: 0.5 mg twice daily
- Day 8-end of treatment: 1 mg twice daily
For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with Varenicline. Patients should begin Varenicline dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue Varenicline treatment for an additional 12 weeks, for a total of 24 weeks of treatment. Encourage patients to attempt quitting sooner if they feel ready
Patients who are motivated to quit, and who did not succeed in stopping smoking during prior Varenicline therapy for reasons other than intolerability due to adverse events or who relapsed after treatment, should be encouraged to make another attempt with Varenicline once factors contributing to the failed attempt have been identified and addressed.
Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of Varenicline.
AdministrationView
Varenicline should be taken orally after eating and with a full glass of water.
Side effectsView
Nasopharyngitis, bronchitis, sinusitis, increased wt, decreased &/or increased appetite, abnormal dreams, insomnia, headache, somnolence, dizziness, dysgeusia, dyspnea, cough, nausea, GERD, vomiting, constipation, diarrhea, abdominal distension & pain, toothache, dyspepsia, flatulence, dry mouth, rash, pruritus, arthralgia, myalgia, back pain, chest pain, fatigue, abnormal liver function test.
ContraindicationsView
Known hypersensitivity to varenicline or to any of the excipients in the product (microcrystalline cellulose, dibasic calcium phosphate, anhydrous, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry Blue/White and Opadry Clear).
PrecautionsView
Discontinue use if changes in behavior or thinking, agitation or depressed mood, anxiety, psychosis, mood swings, aggressive behavior, agitation, depressed mood, suicidal ideation & behavior. Concomitant use in patients attempting to quit smoking. Patients with history of seizures or other conditions that potentially lower seizure threshold. Report if patients had history of psychiatric illness prior to initiation. Hypersensitivity reactions including angioedema, swelling of the face, mouth (tongue, lips, gums), neck (throat & larynx) & extremities. Severe cutaneous reactions including Stevens-Johnson syndrome & erythema multiforme (rare).
Special Precautions for Disposal and Other Handling: No special requirements for disposal.
Special Precautions for Disposal and Other Handling: No special requirements for disposal.
InteractionsView
May increase intoxicating effects of alcohol.
Pregnancy & lactationView
Use in Pregnancy: Category C. There are no adequate and well-controlled studies in pregnant women. Varenicline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Use in Lactation: It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on whether to discontinue breast-feeding or to discontinue therapy with varenicline should be made taking into account the benefit of breast-feeding to the child and the benefit of varenicline therapy to the woman
Use in Lactation: It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on whether to discontinue breast-feeding or to discontinue therapy with varenicline should be made taking into account the benefit of breast-feeding to the child and the benefit of varenicline therapy to the woman
Varox
Rivaroxaban
Varox
Rivaroxaban
Indications
Stroke
Indication detailsView
Rivaroxaban 2.5 mg:
- For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine.
- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE
- For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
Therapeutic classView
Oral Anti-coagulants
PharmacologyView
Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
DosageView
Rivaroxaban 2.5 mg:
- The recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
- Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal.
- Treatment of DVT & PE: 15 mg orally twice daily with food for the first 21 days for the initial treatment of acute DVT or PE. After the initial treatment period, 20 mg orally once daily with food for the remaining treatment.
- Prevention in the risk of recurrence of DVT and of PE: 20 mg once daily with food.
- Prophylaxis of DVT following Hip replacement surgery: 10 mg once daily for 35 days.
- Prophylaxis of DVT following knee replacement surgery: 10 mg once daily for 12 days.
Side effectsView
The most common side effects of Rivaroxaban have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity of Rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.
PrecautionsView
Early discontinuation of Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding. Signs or symptoms of neurological impairment should be monitored in case of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
InteractionsView
Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in Rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of Rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of Rivaroxaban and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.
Pregnancy & lactationView
Rivaroxaban is a pregnancy category C drug. There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established. It is not known if Rivaroxaban is excreted in human milk. The safety and efficacy of Rivaroxaban has not been established in breastfeeding women.
Overdose effectsView
Overdose of Rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. A specific antidote for Rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of Rivaroxaban overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
StorageView
Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.
Varox
Rivaroxaban
Varox
Rivaroxaban
Indications
Stroke
Indication detailsView
Rivaroxaban 2.5 mg:
- For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine.
- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE
- For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
Therapeutic classView
Oral Anti-coagulants
PharmacologyView
Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
DosageView
Rivaroxaban 2.5 mg:
- The recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
- Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal.
- Treatment of DVT & PE: 15 mg orally twice daily with food for the first 21 days for the initial treatment of acute DVT or PE. After the initial treatment period, 20 mg orally once daily with food for the remaining treatment.
- Prevention in the risk of recurrence of DVT and of PE: 20 mg once daily with food.
- Prophylaxis of DVT following Hip replacement surgery: 10 mg once daily for 35 days.
- Prophylaxis of DVT following knee replacement surgery: 10 mg once daily for 12 days.
Side effectsView
The most common side effects of Rivaroxaban have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity of Rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.
PrecautionsView
Early discontinuation of Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding. Signs or symptoms of neurological impairment should be monitored in case of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
InteractionsView
Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in Rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of Rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of Rivaroxaban and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.
Pregnancy & lactationView
Rivaroxaban is a pregnancy category C drug. There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established. It is not known if Rivaroxaban is excreted in human milk. The safety and efficacy of Rivaroxaban has not been established in breastfeeding women.
Overdose effectsView
Overdose of Rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. A specific antidote for Rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of Rivaroxaban overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
StorageView
Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.
Vascare
Trimetazidine Dihydrochloride
Vascare
Trimetazidine Dihydrochloride
Indications
Meniere’s disease
Indication detailsView
Trimetazidine Dihydrochloride is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs
PharmacologyView
Trimetazidine Dihydrochloride is the first 3- keto acyl CoA thiolase inhibitor (KAT), a metabolic anti-ischemic agent with proven benefits for all coronary patients. Trimetazidine Dihydrochloride inhibits fatty acid pathway by inhibiting 3-keto acyl CoA thiolase enzyme and transfers oxygen to glucose pathway. Since glucose pathway is more efficient in producing energy, the same oxygen produces more energy and makes the heart more active. Moreover, the aerobic oxidation of glucose stops production of lactic acid, which prevents angina pectoris.
DosageView
The recommended dose of Trimetazidine is 35 mg twice daily or 20 mg tablet thrice daily during meals. The benefit of the treatment should be assessed after three months and Trimetazidine should be discontinued if there is no treatment response.
Side effectsView
Trimetazidine is safe and well tolerated. The Common side effects associated with Trimetazidine are dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia
ContraindicationsView
Trimetazidine is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also is contraindicated in patients with Parkinson’s disease, parkinsonian symptoms, tremors, restless legs movement disorders, severe renal impairment.
PrecautionsView
Trimetazidine is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is also not a treatment for myocardial infarction.
InteractionsView
No drug interaction so far has been reported. In particular, no interaction has been reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.
Pregnancy & lactationView
There is no data on the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy. It is unknown whether Trimetazidine is excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Vasco
Vitamin C [Ascorbic acid]
Vasco
Vitamin C [Ascorbic acid]
Indications
Vitamin C deficiency
Indication detailsView
Vitamin C is indicated for prevention and treatment of scurvy. It may be indicated in pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria, dental caries, pyorrhea, acne, infertility, atherosclerosis, fractures, leg ulcers, hay fever, vascular thrombosis prevention, levodopa toxicity, succinyl-choline toxicity, arsenic toxicity etc. To reduce the risk of stroke in the elderly, long-term supplementation with Vitamin C is essential.
Therapeutic classView
Vitamin-C Preparations
PharmacologyView
vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.
DosageView
Oral administration-
- For the prevention of scurvy: 1 tablet daily
- For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
- For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
- In other cases: 1 tablet daily or as directed by the physician.
- Maximum safe dose is 2000 mg daily in divided doses.
- Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
- For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
- The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
- To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Side effectsView
Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.
PrecautionsView
Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.
InteractionsView
Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.
Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.
Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.
Pregnancy & lactationView
The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.
StorageView
Should be stored in a dry place below 30˚C.
Vasco
Vitamin C [Ascorbic acid]
Vasco
Vitamin C [Ascorbic acid]
Indications
Vitamin C deficiency
Indication detailsView
Vitamin C is indicated for prevention and treatment of scurvy. It may be indicated in pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria, dental caries, pyorrhea, acne, infertility, atherosclerosis, fractures, leg ulcers, hay fever, vascular thrombosis prevention, levodopa toxicity, succinyl-choline toxicity, arsenic toxicity etc. To reduce the risk of stroke in the elderly, long-term supplementation with Vitamin C is essential.
Therapeutic classView
Vitamin-C Preparations
PharmacologyView
vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.
DosageView
Oral administration-
- For the prevention of scurvy: 1 tablet daily
- For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
- For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
- In other cases: 1 tablet daily or as directed by the physician.
- Maximum safe dose is 2000 mg daily in divided doses.
- Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
- For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
- The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
- To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Side effectsView
Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.
PrecautionsView
Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.
InteractionsView
Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.
Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.
Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.
Pregnancy & lactationView
The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.
StorageView
Should be stored in a dry place below 30˚C.