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Bisten
Bisoprolol Hemifumarate
Bisten
Bisoprolol Hemifumarate
Indications
Hypertension
Indication detailsView
Bisoprolol is indicated in-
- Hypertension
- Angina
- Moderate to severe heart failure
Therapeutic classView
Anti adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Bisoprolol Hemifumarate is the most selective ß1 blocker. It displays highest level of affinity for the ß1 receptor than any other beta-blocker available up to now. Selectively blocks ß1 adrenergic receptor in the heart and vascular smooth muscle and reduces heart rate and cardiac output resulting in decrease of arterial hypertension. Lipid metabolism can be adversely affected by ß-blockers, in patients with non-ß1 selective ß1-blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective HDL-cholesterol, in long-term therapy.
DosageView
Adult: In the treatment of mild to moderate hypertension, Bisoprolol fumarate must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily either added to a diuretic or alone. If the response to 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. An appropriate interval for dose titration is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small incremental benefit.
Children: Safety and effectiveness in children have not been established.
Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.
Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction
Children: Safety and effectiveness in children have not been established.
Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.
Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction
Side effectsView
Bisoprolol, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for several days. The most common side effects, whether or not caused by Bisoprolol, are: headache, fatigue, urinary tract infection, rhinitis or sinusitis (inflammation in the nose), diarrhea, dizziness, peripheral edema (swelling of the ankles), joint pain, cough, insomnia (trouble sleeping), nausea (feeling like vomiting), and sore throat. You must seek medical attention immediately if you experience an allergic reaction with symptoms of rash, itching, swelling, dizziness or trouble breathing.
Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.
Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.
ContraindicationsView
In patients with cardiogenic shock, overt heart failure, second or third degree A-V block, right ventricular failure secondary to pulmonary hypertension and sinus bradycardia.
PrecautionsView
Monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals during long-term treatment with bisoprolol.
InteractionsView
Other β-blocking Agents: Bisoprolol fumarate should not be combined with other β-blocking agents.
Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.
Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).
Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.
Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.
Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).
Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.
Pregnancy & lactationView
Pregnancy: Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day, which is 375 times the maximum recommended human daily dose. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day. Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5 mg/kg/day, which is 31 times the maximum recommended human daily dose, but was embryolethal (increased early resorptions) at 12.5 mg/kg/day. There are no studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.
Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Bisten Plus
Bisoprolol Fumarate + Hydrochlorothiazide
Bisten Plus
Bisoprolol Fumarate + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Bisoprolol plus Hydrochlorothiazide is indicated in the treatment of Hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Bisoprolol Fumarate and Hydrochlorothiazide have been used individually and in combination for the treatment of hypertension. The antihypertensive effects of these agents are additive; Hydrochlorothiazide 6.25 mg significantly increases the antihypertensive effect of Bisoprolol Fumarate. The incidence of hypokalemia with the Bisoprolol Fumarate and Hydrochlorothiazide 6.25 mg combination is significantly lower than with Hydrochlorothiazide 25 mg. Bisoprolol Fumarate is a β1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing or intrinsic sympathomimetic activities in its therapeutic dose range. Hydrochlorothiazide is a benzothiadiazine diuretic. Thiazides affect renal tubular mechanisms of electrolyte reabsorption and increase excretion of sodium and chloride in approximately equivalent amounts
DosageView
Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5 to 40 mg, while Hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of Bisoprolol/Hydrochlorothiazide combination therapy using Bisoprolol doses of 2.5 to 20 mg and Hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component.
Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of this conbination, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with this tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
Replacement Therapy: The combination may be substituted for the titrated individual components.
Therapy Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with 2.5-20 mg Bisoprolol daily may instead be given this conbination. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to this conbination.
Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of this conbination, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with this tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
Replacement Therapy: The combination may be substituted for the titrated individual components.
Therapy Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with 2.5-20 mg Bisoprolol daily may instead be given this conbination. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to this conbination.
Side effectsView
Generally well tolerated. Most side effects have been mild and transient. Side effects which may occur: fatigue, dizziness, headache, bradycardia, arrhythmia, peripheral ischemia, chest pain, palpitations, rhythm disturbances, cold extremities, claudication, orthostatic hypotension, diarrhoea, constipation, nausea, dyspepsia, rhinitis, pharyngitis etc.
ContraindicationsView
It is contraindicated in patients in cardiogenic shock, overt cardiac failure, second or third degree AV block, marked sinus bradycardia, anuria and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
PrecautionsView
Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop. If withdrawal of this combination therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.
InteractionsView
This combination drug may potentiate the action of other antihypertensive agents used concomitantly. This combination drug should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored because the added beta-adrenergic blocking action of Bisoprolol Fumarate may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that this combination drug be discontinued for several days before the withdrawal of clonidine. This combination drug should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes) or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Pregnancy & lactationView
Use in Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Bisoprolol Fumarate and Hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Use in Nursing Mothers: Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of Bisoprolol Fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in Nursing Mothers: Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of Bisoprolol Fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
There are limited data on overdose with this combination product. The most frequently observed signs expected with overdosage of a beta-blocker are bradycardia and hypotension. Lethargy is also common and with severe overdoses, delirium, coma, convulsions, and respiratory arrest have been reported to occur. Congestive heart failure, bronchospasm, and hypoglycemia may occur. With thiazide diuretics, acute intoxication is rare. The most prominent feature of overdose is acute loss of fluid and electrolytes. Signs and symptoms include cardiovascular (tachycardia, hypotension, shock), neuromuscular (weakness, confusion, dizziness, cramps of the calf muscles, paresthesia, fatigue, impairment of consciousness), gastrointestinal (nausea, vomiting, thirst), renal (polyuria, oliguria, or anuria), and laboratory findings (hypokalemia, hyponatremia, hypochloremia, alkalosis, increased BUN [especially in patients with renal insufficiency]).
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Bisten Plus
Bisoprolol Fumarate + Hydrochlorothiazide
Bisten Plus
Bisoprolol Fumarate + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Bisoprolol plus Hydrochlorothiazide is indicated in the treatment of Hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Bisoprolol Fumarate and Hydrochlorothiazide have been used individually and in combination for the treatment of hypertension. The antihypertensive effects of these agents are additive; Hydrochlorothiazide 6.25 mg significantly increases the antihypertensive effect of Bisoprolol Fumarate. The incidence of hypokalemia with the Bisoprolol Fumarate and Hydrochlorothiazide 6.25 mg combination is significantly lower than with Hydrochlorothiazide 25 mg. Bisoprolol Fumarate is a β1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing or intrinsic sympathomimetic activities in its therapeutic dose range. Hydrochlorothiazide is a benzothiadiazine diuretic. Thiazides affect renal tubular mechanisms of electrolyte reabsorption and increase excretion of sodium and chloride in approximately equivalent amounts
DosageView
Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5 to 40 mg, while Hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of Bisoprolol/Hydrochlorothiazide combination therapy using Bisoprolol doses of 2.5 to 20 mg and Hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component.
Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of this conbination, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with this tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
Replacement Therapy: The combination may be substituted for the titrated individual components.
Therapy Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with 2.5-20 mg Bisoprolol daily may instead be given this conbination. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to this conbination.
Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of this conbination, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with this tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
Replacement Therapy: The combination may be substituted for the titrated individual components.
Therapy Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with 2.5-20 mg Bisoprolol daily may instead be given this conbination. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to this conbination.
Side effectsView
Generally well tolerated. Most side effects have been mild and transient. Side effects which may occur: fatigue, dizziness, headache, bradycardia, arrhythmia, peripheral ischemia, chest pain, palpitations, rhythm disturbances, cold extremities, claudication, orthostatic hypotension, diarrhoea, constipation, nausea, dyspepsia, rhinitis, pharyngitis etc.
ContraindicationsView
It is contraindicated in patients in cardiogenic shock, overt cardiac failure, second or third degree AV block, marked sinus bradycardia, anuria and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
PrecautionsView
Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop. If withdrawal of this combination therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.
InteractionsView
This combination drug may potentiate the action of other antihypertensive agents used concomitantly. This combination drug should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored because the added beta-adrenergic blocking action of Bisoprolol Fumarate may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that this combination drug be discontinued for several days before the withdrawal of clonidine. This combination drug should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes) or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Pregnancy & lactationView
Use in Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Bisoprolol Fumarate and Hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Use in Nursing Mothers: Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of Bisoprolol Fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in Nursing Mothers: Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of Bisoprolol Fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
There are limited data on overdose with this combination product. The most frequently observed signs expected with overdosage of a beta-blocker are bradycardia and hypotension. Lethargy is also common and with severe overdoses, delirium, coma, convulsions, and respiratory arrest have been reported to occur. Congestive heart failure, bronchospasm, and hypoglycemia may occur. With thiazide diuretics, acute intoxication is rare. The most prominent feature of overdose is acute loss of fluid and electrolytes. Signs and symptoms include cardiovascular (tachycardia, hypotension, shock), neuromuscular (weakness, confusion, dizziness, cramps of the calf muscles, paresthesia, fatigue, impairment of consciousness), gastrointestinal (nausea, vomiting, thirst), renal (polyuria, oliguria, or anuria), and laboratory findings (hypokalemia, hyponatremia, hypochloremia, alkalosis, increased BUN [especially in patients with renal insufficiency]).
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Bisten Plus
Bisoprolol Fumarate + Hydrochlorothiazide
Bisten Plus
Bisoprolol Fumarate + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Bisoprolol plus Hydrochlorothiazide is indicated in the treatment of Hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Bisoprolol Fumarate and Hydrochlorothiazide have been used individually and in combination for the treatment of hypertension. The antihypertensive effects of these agents are additive; Hydrochlorothiazide 6.25 mg significantly increases the antihypertensive effect of Bisoprolol Fumarate. The incidence of hypokalemia with the Bisoprolol Fumarate and Hydrochlorothiazide 6.25 mg combination is significantly lower than with Hydrochlorothiazide 25 mg. Bisoprolol Fumarate is a β1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing or intrinsic sympathomimetic activities in its therapeutic dose range. Hydrochlorothiazide is a benzothiadiazine diuretic. Thiazides affect renal tubular mechanisms of electrolyte reabsorption and increase excretion of sodium and chloride in approximately equivalent amounts
DosageView
Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5 to 40 mg, while Hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of Bisoprolol/Hydrochlorothiazide combination therapy using Bisoprolol doses of 2.5 to 20 mg and Hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component.
Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of this conbination, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with this tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
Replacement Therapy: The combination may be substituted for the titrated individual components.
Therapy Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with 2.5-20 mg Bisoprolol daily may instead be given this conbination. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to this conbination.
Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of this conbination, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with this tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
Replacement Therapy: The combination may be substituted for the titrated individual components.
Therapy Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with 2.5-20 mg Bisoprolol daily may instead be given this conbination. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to this conbination.
Side effectsView
Generally well tolerated. Most side effects have been mild and transient. Side effects which may occur: fatigue, dizziness, headache, bradycardia, arrhythmia, peripheral ischemia, chest pain, palpitations, rhythm disturbances, cold extremities, claudication, orthostatic hypotension, diarrhoea, constipation, nausea, dyspepsia, rhinitis, pharyngitis etc.
ContraindicationsView
It is contraindicated in patients in cardiogenic shock, overt cardiac failure, second or third degree AV block, marked sinus bradycardia, anuria and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
PrecautionsView
Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop. If withdrawal of this combination therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.
InteractionsView
This combination drug may potentiate the action of other antihypertensive agents used concomitantly. This combination drug should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored because the added beta-adrenergic blocking action of Bisoprolol Fumarate may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that this combination drug be discontinued for several days before the withdrawal of clonidine. This combination drug should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes) or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Pregnancy & lactationView
Use in Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Bisoprolol Fumarate and Hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Use in Nursing Mothers: Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of Bisoprolol Fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in Nursing Mothers: Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of Bisoprolol Fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
There are limited data on overdose with this combination product. The most frequently observed signs expected with overdosage of a beta-blocker are bradycardia and hypotension. Lethargy is also common and with severe overdoses, delirium, coma, convulsions, and respiratory arrest have been reported to occur. Congestive heart failure, bronchospasm, and hypoglycemia may occur. With thiazide diuretics, acute intoxication is rare. The most prominent feature of overdose is acute loss of fluid and electrolytes. Signs and symptoms include cardiovascular (tachycardia, hypotension, shock), neuromuscular (weakness, confusion, dizziness, cramps of the calf muscles, paresthesia, fatigue, impairment of consciousness), gastrointestinal (nausea, vomiting, thirst), renal (polyuria, oliguria, or anuria), and laboratory findings (hypokalemia, hyponatremia, hypochloremia, alkalosis, increased BUN [especially in patients with renal insufficiency]).
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Biva
Bivalirudin
Biva
Bivalirudin
Indications
Unstable angina
Indication detailsView
Bivalirudin is indicated for:
- Anticoagulant in Patients Undergoing PTCA/PCI or PCI with HITS/HITTS
- Unstable Angina/Non-ST-Elevation MI (Off-label)
- STEMI Undergoing Primary PCI (Off-label)
- Heparin-induced Thrombocytopenia
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release. The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.
In in vitro studies, bivalirudin inhibited both soluble (free) and clot-bound thrombin, was not neutralized by products of the platelet release reaction, and prolonged the activated partialthromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT) of normal human plasma in a concentration-dependent manner. The clinical relevance of these findings is unknown.
In in vitro studies, bivalirudin inhibited both soluble (free) and clot-bound thrombin, was not neutralized by products of the platelet release reaction, and prolonged the activated partialthromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT) of normal human plasma in a concentration-dependent manner. The clinical relevance of these findings is unknown.
DosageView
PCI/PTCA: IV Bolus dose of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/h for duration of PCI procedure. Five minutes after bolus dose, obtain ACT and administer additional bolus of 0.3 mg/kg if indicated.
HIT/HITTS: IV Bolus dose of 0.75 mg/kg, followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.
Continuation of Therapy: IV Infusion may be continued for up to 4 h post-procedure as indicated. After 4 h, an additional IV infusion of 0.2 mg/kg/h for up to 20 h may be given if needed.
Concomitant Therapy: Bivalirudin is intended for concurrent use with aspirin (300 to 325 mg/day).
HIT/HITTS: IV Bolus dose of 0.75 mg/kg, followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.
Continuation of Therapy: IV Infusion may be continued for up to 4 h post-procedure as indicated. After 4 h, an additional IV infusion of 0.2 mg/kg/h for up to 20 h may be given if needed.
Concomitant Therapy: Bivalirudin is intended for concurrent use with aspirin (300 to 325 mg/day).
AdministrationView
- For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial administration.
- Reconstitute powder for injection with 5 mL sterile water for injection. Gently swirl until powder is dissolved.
- For initial bolus infusion, further dilute each reconstituted via in 50 mL of 5% dextrose in water or sodium chloride 0.9% for injection to yield a final concentration of 5 mg/mL.
- For low rate infusion, further dilute each reconstituted vial in 500 mL of 5% dextrose in water or sodium chloride 0.9% for injection to yield a final concentration of 0.5 mg/mL.
- Do not mix with the following drugs in the same IV line: alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine, prochlorperazine, reteplase, streptokinase, vancomycin.
- Reconstituted bivalirudin should be a clear to slightly opalescent, colorless to slightly yellow solution. Do not administer if reconstituted or diluted solution is discolored, cloudy, or contains particulate matter.
- Maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels.
- Discard any unused reconstituted or diluted solution.
Side effectsView
- Bleeding, Body as a Whole: fever,infection, sepsis;
- Cardiovascular: hypotension, syncope, vascular anomaly,ventricular fibrillation;
- Nervous: cerebral ischemia, confusion, facialparalysis;
- Respiratory: lung edema;
- Urogenital: kidney failure, oliguria.
ContraindicationsView
Bivalirudin is contraindicated in patients with: Active major
bleeding & Hypersensitivity (e.g., anaphylaxis) to Bivalirudin or its components
bleeding & Hypersensitivity (e.g., anaphylaxis) to Bivalirudin or its components
PrecautionsView
Bleeding Events: Although most bleeding associated with the use of Bivalirudin in PCI/PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of Bivalirudin administration. Bivalirudin should be used with caution in patients with disease states associated with an increased risk of bleeding.
Coronary Artery Brachy therapy: An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Bivalirudin in gamma brachytherapy. If a decision is made to use Bivalirudin during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels.
Coronary Artery Brachy therapy: An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Bivalirudin in gamma brachytherapy. If a decision is made to use Bivalirudin during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels.
InteractionsView
Co-administration of Bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events.
Pregnancy & lactationView
Pregnancy Category B. No adequate and well-controlled studies in pregnant women. As animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Bivalirudin is intended for use with aspirin . Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Bivalirudin and aspirin should be used together during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether bivalirudin is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Bivalirudin is administered to a nursing woman.
Nursing Mothers: It is not known whether bivalirudin is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Bivalirudin is administered to a nursing woman.
Pediatric usageView
Renal Impairment: The clearance of Bivalirudin was reduced approximately 20% in patients with moderate and severe renal impairment and was reduced approximately 80% in dialysis-dependent patients.The infusion dose of Bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment
Pediatric Use: The safety and effectiveness of Bivalirudin in pediatric patients have not been established.
Geriatric Use: Elderly patients experienced more bleeding events than younger patients. Patients treated with Bivalirudin experienced fewer bleeding events in each age stratum, compared to heparin.
- ClCr 30 to 50 mL/min: Administer infusion at rate of 1.75 mg/kg/h.
- ClCr less than 30 mL/min: Reduce infusion rate to 1 mg/kg/h.
Pediatric Use: The safety and effectiveness of Bivalirudin in pediatric patients have not been established.
Geriatric Use: Elderly patients experienced more bleeding events than younger patients. Patients treated with Bivalirudin experienced fewer bleeding events in each age stratum, compared to heparin.
Overdose effectsView
Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Bivalirudin have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis . Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Bivalirudin immediately and monitor the patient closely for signs of bleeding. There is no known antidote to Bivalirudin. Bivalirudin is hemodialyzable
ReconstitutionView
Do not freeze reconstituted or diluted Bivalirudin. Reconstituted material may be stored at 2-8º C for up to 24 hours. Diluted Bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
StorageView
Store at temperature not exceeding 30º C in a dry place. Do not freeze. Keep out of reach of children
Bivara
Brivaracetam
Bivara
Brivaracetam
Indications
Partial seizures
Indication detailsView
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Brivaracetam injection in pediatric patients has not been established, Brivaracetam injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).
Therapeutic classView
Adjunct anti-epileptic drugs
PharmacologyView
The precise mechanism by which Brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.
Brivaracetam binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivaracetam is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action
Brivaracetam binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivaracetam is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action
DosageView
Adults (16 Years and older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day).
Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
Pediatric Patients (4 Years to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily
Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.
Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
Pediatric Patients (4 Years to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily
Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.
AdministrationView
Brivaracetam injection should be administered intravenously over 2 to 15 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. Brivaracetam injection is for single dose only.
Side effectsView
Most common adverse reactions (at least 5% for Brivaracetam and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea or vomiting.
ContraindicationsView
Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam
PrecautionsView
Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation.
Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Brivaracetam.
Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart Brivaracetam if hypersensitivity occurs.
Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn.
Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Brivaracetam.
Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart Brivaracetam if hypersensitivity occurs.
Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn.
InteractionsView
Rifampin: Because of decreased concentrations, increasing Brivaracetam dosage in patients on concomitant rifampin is recommended.
Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant Brivaracetam.
Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Brivaracetam.
Levetiracetam: Brivaracetam had no added therapeutic benefit when co-administered with levetiracetam.
Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant Brivaracetam.
Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Brivaracetam.
Levetiracetam: Brivaracetam had no added therapeutic benefit when co-administered with levetiracetam.
Pregnancy & lactationView
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Brivaracetam, during pregnancy. No data are available regarding the presence of brivaracetam in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Studies in lactating rats have shown excretion of brivaracetam or metabolites in milk
Pediatric usageView
Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.
Renal Impairment: Dose adjustments are not required for patients with impaired renal function.
Renal Impairment: Dose adjustments are not required for patients with impaired renal function.
StorageView
Store at 25°C; excursions permitted between 15°C to 30°C
Bivara
Brivaracetam
Bivara
Brivaracetam
Indications
Partial seizures
Indication detailsView
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Brivaracetam injection in pediatric patients has not been established, Brivaracetam injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).
Therapeutic classView
Adjunct anti-epileptic drugs
PharmacologyView
The precise mechanism by which Brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.
Brivaracetam binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivaracetam is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action
Brivaracetam binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivaracetam is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action
DosageView
Adults (16 Years and older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day).
Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
Pediatric Patients (4 Years to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily
Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.
Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
Pediatric Patients (4 Years to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily
Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.
AdministrationView
Brivaracetam injection should be administered intravenously over 2 to 15 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. Brivaracetam injection is for single dose only.
Side effectsView
Most common adverse reactions (at least 5% for Brivaracetam and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea or vomiting.
ContraindicationsView
Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam
PrecautionsView
Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation.
Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Brivaracetam.
Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart Brivaracetam if hypersensitivity occurs.
Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn.
Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Brivaracetam.
Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart Brivaracetam if hypersensitivity occurs.
Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn.
InteractionsView
Rifampin: Because of decreased concentrations, increasing Brivaracetam dosage in patients on concomitant rifampin is recommended.
Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant Brivaracetam.
Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Brivaracetam.
Levetiracetam: Brivaracetam had no added therapeutic benefit when co-administered with levetiracetam.
Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant Brivaracetam.
Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Brivaracetam.
Levetiracetam: Brivaracetam had no added therapeutic benefit when co-administered with levetiracetam.
Pregnancy & lactationView
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Brivaracetam, during pregnancy. No data are available regarding the presence of brivaracetam in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Studies in lactating rats have shown excretion of brivaracetam or metabolites in milk
Pediatric usageView
Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.
Renal Impairment: Dose adjustments are not required for patients with impaired renal function.
Renal Impairment: Dose adjustments are not required for patients with impaired renal function.
StorageView
Store at 25°C; excursions permitted between 15°C to 30°C
Bizi
Iron Polymaltose Complex + Vitamin B Complex + Zinc
Bizi
Iron Polymaltose Complex + Vitamin B Complex + Zinc
Indications
Vitamin deficiency
Indication detailsView
This syrup is indicated for the treatment and prevention of Iron, Vitamin B complex and Zinc deficiencies, specially during pregnancy and lactation.
Therapeutic classView
Iron & Vitamin Combined preparations
PharmacologyView
This syrup is the preparation of Iron, Vitamin B complex and Zinc. In this preparation, Iron is present as Iron (III) Hydroxide Polymaltose Complex. Iron (III) Hydroxide Polymaltose Complex facilitates a controlled absorption of the iron when it comes in contact with the mucosal cell surface. Due to non-ionic nature, this Iron (III) Hydroxide Polymaltose Complex is more stable than conventional Iron form.
DosageView
Adults: 5 ml-10 ml (1-2 teaspoonful) 3 times daily or as recommended by the physician.
Children: 5 ml (1 teaspoonful) 3 times daily or as recommended by the physician.
Infants: 0.33 ml/kg body weight daily or as recommended by the physician.
Children: 5 ml (1 teaspoonful) 3 times daily or as recommended by the physician.
Infants: 0.33 ml/kg body weight daily or as recommended by the physician.
Side effectsView
This syrup is generally well tolerated. However, a few side effects of oral Iron preparations, including nausea, vomiting, constipation or diarrhoea may occur.
ContraindicationsView
It is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
PrecautionsView
Caution should be taken in the conditions where there is a risk of Iron overload, such as hemochromatosis, thalassemia, hemosiderosis or hemolytic anemia.
InteractionsView
Since Iron is complex bound, ionic interaction with foodstuff components (phytates, oxalates, tannin etc.) and concomitant administrations of medicaments (tetracyclines, antacids) are unlikely to occur.
Pregnancy & lactationView
Recommended in pregnancy & lactation
Pediatric usageView
Recommended in children
Overdose effectsView
In case of overdose, epigastric pain, diarrhoea, vomiting, metabolic acidosis and convulsion may occur. Should seek emergency medical attention in case of overdose. Initially an emetic should be given and then gastric lavage & general supportive measures should be employed.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Bizoran
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Black Cohos
Black Cohosh [Cimicifuga Racemosa]
Black Cohos
Black Cohosh [Cimicifuga Racemosa]
Indications
Vertigo
Indication detailsView
Black Cohosh is indicated in Premenstrual discomfort, Dysmenorrhea, Menopausal complaints such as hot flashes, heart palpitations, nervousness, irritability, sleep disturbances, tinnitus, vertigo, perspiration and depression.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Black cohosh (Cimicifuga racemosa) is popular as an alternative to hormonal therapy in the treatment of menopausal (climacteric) symptoms such as hot flashes, mood disturbances, diaphoresis, palpitations and vaginal dryness.
DosageView
1-2 capsules daily or as directed by the physician. Duration of treatment should be maximum six months at a time.
Side effectsView
Black cohosh is safe for most people. It might cause some mild side effects such as stomach upset, cramping, headache, rash, a feeling of heaviness, and weight gain. Occasional gastrointestinal discomfort may occur.
ContraindicationsView
No significant contraindication is observed.
PrecautionsView
Black cohosh should be used cautiously in patients with liver disease, kidney disease and seizure disorders.
InteractionsView
Black cohosh may interact with birth control pills, hormone replacement therapy, sedatives or antihypertensive.
Pregnancy & lactationView
Not recommended during pregnancy due to an increased risk of spontaneous abortion. Not recommended during lactation.
StorageView
Store in a cool and dry place, away from light & moisture. Keep out of reach of children.
Blast
Bilastine
Blast
Bilastine
Indications
Urticaria
Indication detailsView
Bilastine is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.
DosageView
Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.
Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 to 11 years: 4 ml once daily.
Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 to 11 years: 4 ml once daily.
Side effectsView
The most commonly reported side effects in clinical trial are headache, dizziness, somnolence and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.
ContraindicationsView
Bilastine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet.
PrecautionsView
Co-administration of Bilastine and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.
InteractionsView
Concomitant intake of Bilastine and Ketoconazole or Erythromycin or Diltiazem increased C max of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.
Pregnancy & lactationView
There are no or limited amount of data from the use of Bilastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Bilastine during pregnancy. The excretion of Bilastine in milk has not been studied in humans. A decision must be made taking into account the benefit of breast-feeding for the child and the benefit of Bilastine therapy for the mother.
Pediatric usageView
Efficacy and safety of Bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Bilastine should not be used in these age groups.
Overdose effectsView
In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) frequency of treatment-emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.
StorageView
Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.
Blast
Bilastine
Blast
Bilastine
Indications
Urticaria
Indication detailsView
Bilastine is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.
DosageView
Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.
Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 to 11 years: 4 ml once daily.
Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 to 11 years: 4 ml once daily.
Side effectsView
The most commonly reported side effects in clinical trial are headache, dizziness, somnolence and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.
ContraindicationsView
Bilastine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet.
PrecautionsView
Co-administration of Bilastine and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.
InteractionsView
Concomitant intake of Bilastine and Ketoconazole or Erythromycin or Diltiazem increased C max of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.
Pregnancy & lactationView
There are no or limited amount of data from the use of Bilastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Bilastine during pregnancy. The excretion of Bilastine in milk has not been studied in humans. A decision must be made taking into account the benefit of breast-feeding for the child and the benefit of Bilastine therapy for the mother.
Pediatric usageView
Efficacy and safety of Bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Bilastine should not be used in these age groups.
Overdose effectsView
In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) frequency of treatment-emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.
StorageView
Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.
Bleocin
Bleomycin Sulfate
Bleocin
Bleomycin Sulfate
Indications
Testicular cancer
Indication detailsView
Bleomycin sulfate should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:
Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin sulfate is poorer in patients with previously irradiated head and neck cancer.
Lymphomas: Hodgkin’s disease, non-Hodgkin’s lymphoma.
Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin sulfate has also been shown to be useful in the management of Malignant Pleural Effusion
Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin sulfate is poorer in patients with previously irradiated head and neck cancer.
Lymphomas: Hodgkin’s disease, non-Hodgkin’s lymphoma.
Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin sulfate has also been shown to be useful in the management of Malignant Pleural Effusion
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Although the exact mechanism of action of bleomycin sulfate is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.
Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis. When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin sulfate acts as a sclerosing agent.
Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis. When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin sulfate acts as a sclerosing agent.
DosageView
Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.
Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin’s disease: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of Bleomycin sulfat appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Bleomycin sulfat is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin’s disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion: 60 units administered as a single dose bolus intrapleural injection
Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin’s disease: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of Bleomycin sulfat appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Bleomycin sulfat is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin’s disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion: 60 units administered as a single dose bolus intrapleural injection
Side effectsView
Common side effects of Bleomycin Sulfate include injection site reactions (pain, redness, warmth, itching, or swelling), fever, chills, vomiting, loss of appetite, weight loss, darkening or discoloration of the skin, changes in fingernails or toenails, itching, or pain near your tumor.
ContraindicationsView
Acute pulmonary infection or greatly reduced lung function. Concomitant brentuximab, cisplatin or oxygen. Lactation.
PrecautionsView
Caution should be taken in patient with severe heart disease, Renal impairment, Elderly & Pregnancy.
InteractionsView
Increased incidence and severity of lung toxicity with previous or concurrent radiotherapy to the chest. Combination with vinca alkaloids may result to a syndrome corresponding to morbus Raynaud, ischaemia which can lead to necrosis of peripheral parts of the body (fingers, toes, nose tip). May reduce the absorption of phenytoin. Increased risk of agranulocytosis with clozapine.
Pregnancy & lactationView
Pregnancy Category D. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving Bleomycin Sulfate therapy.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Bleomycin in pediatric patients have not been established.
Geriatric Use: In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients
Geriatric Use: In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients
Overdose effectsView
Symptoms: Hypotension, fever, rapid pulse and general symptoms of shock.
Management: Symptomatic. In case of resp complications, treat with a corticosteroid and a broad-spectrum antibiotic.
Management: Symptomatic. In case of resp complications, treat with a corticosteroid and a broad-spectrum antibiotic.
ReconstitutionView
IM/SC: Add 1-5 mL or 2-10 mL of sterile water for inj, NaCl 0.9% inj, or bacteriostatic water for inj to the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing 3-15 IU/mL.
IV: Add 5 mL or 10 mL of NaCl 0.9% into the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing ≤3 IU/mL. Admin slowly over a 10-min period. Intrapleural: Dissolve 60 IU of bleomycin in 50-100 mL NaCl 0.9% inj.
IV: Add 5 mL or 10 mL of NaCl 0.9% into the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing ≤3 IU/mL. Admin slowly over a 10-min period. Intrapleural: Dissolve 60 IU of bleomycin in 50-100 mL NaCl 0.9% inj.
StorageView
Store between 2-8°C. Protect from light and should not be used after the expiration date is reached.
Bleonix
Bleomycin Sulfate
Bleonix
Bleomycin Sulfate
Indications
Testicular cancer
Indication detailsView
Bleomycin sulfate should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:
Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin sulfate is poorer in patients with previously irradiated head and neck cancer.
Lymphomas: Hodgkin’s disease, non-Hodgkin’s lymphoma.
Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin sulfate has also been shown to be useful in the management of Malignant Pleural Effusion
Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin sulfate is poorer in patients with previously irradiated head and neck cancer.
Lymphomas: Hodgkin’s disease, non-Hodgkin’s lymphoma.
Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin sulfate has also been shown to be useful in the management of Malignant Pleural Effusion
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Although the exact mechanism of action of bleomycin sulfate is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.
Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis. When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin sulfate acts as a sclerosing agent.
Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis. When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin sulfate acts as a sclerosing agent.
DosageView
Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.
Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin’s disease: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of Bleomycin sulfat appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Bleomycin sulfat is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin’s disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion: 60 units administered as a single dose bolus intrapleural injection
Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin’s disease: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of Bleomycin sulfat appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Bleomycin sulfat is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin’s disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion: 60 units administered as a single dose bolus intrapleural injection
Side effectsView
Common side effects of Bleomycin Sulfate include injection site reactions (pain, redness, warmth, itching, or swelling), fever, chills, vomiting, loss of appetite, weight loss, darkening or discoloration of the skin, changes in fingernails or toenails, itching, or pain near your tumor.
ContraindicationsView
Acute pulmonary infection or greatly reduced lung function. Concomitant brentuximab, cisplatin or oxygen. Lactation.
PrecautionsView
Caution should be taken in patient with severe heart disease, Renal impairment, Elderly & Pregnancy.
InteractionsView
Increased incidence and severity of lung toxicity with previous or concurrent radiotherapy to the chest. Combination with vinca alkaloids may result to a syndrome corresponding to morbus Raynaud, ischaemia which can lead to necrosis of peripheral parts of the body (fingers, toes, nose tip). May reduce the absorption of phenytoin. Increased risk of agranulocytosis with clozapine.
Pregnancy & lactationView
Pregnancy Category D. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving Bleomycin Sulfate therapy.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Bleomycin in pediatric patients have not been established.
Geriatric Use: In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients
Geriatric Use: In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients
Overdose effectsView
Symptoms: Hypotension, fever, rapid pulse and general symptoms of shock.
Management: Symptomatic. In case of resp complications, treat with a corticosteroid and a broad-spectrum antibiotic.
Management: Symptomatic. In case of resp complications, treat with a corticosteroid and a broad-spectrum antibiotic.
ReconstitutionView
IM/SC: Add 1-5 mL or 2-10 mL of sterile water for inj, NaCl 0.9% inj, or bacteriostatic water for inj to the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing 3-15 IU/mL.
IV: Add 5 mL or 10 mL of NaCl 0.9% into the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing ≤3 IU/mL. Admin slowly over a 10-min period. Intrapleural: Dissolve 60 IU of bleomycin in 50-100 mL NaCl 0.9% inj.
IV: Add 5 mL or 10 mL of NaCl 0.9% into the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing ≤3 IU/mL. Admin slowly over a 10-min period. Intrapleural: Dissolve 60 IU of bleomycin in 50-100 mL NaCl 0.9% inj.
StorageView
Store between 2-8°C. Protect from light and should not be used after the expiration date is reached.
Blextin
Bilastine
Blextin
Bilastine
Indications
Urticaria
Indication detailsView
Bilastine is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.
DosageView
Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.
Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 to 11 years: 4 ml once daily.
Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 to 11 years: 4 ml once daily.
Side effectsView
The most commonly reported side effects in clinical trial are headache, dizziness, somnolence and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.
ContraindicationsView
Bilastine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet.
PrecautionsView
Co-administration of Bilastine and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.
InteractionsView
Concomitant intake of Bilastine and Ketoconazole or Erythromycin or Diltiazem increased C max of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.
Pregnancy & lactationView
There are no or limited amount of data from the use of Bilastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Bilastine during pregnancy. The excretion of Bilastine in milk has not been studied in humans. A decision must be made taking into account the benefit of breast-feeding for the child and the benefit of Bilastine therapy for the mother.
Pediatric usageView
Efficacy and safety of Bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Bilastine should not be used in these age groups.
Overdose effectsView
In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) frequency of treatment-emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.
StorageView
Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.
Bliss
Silymarin [Milk thistle]
Bliss
Silymarin [Milk thistle]
Indications
Jaundice
Indication detailsView
Silymarin (Milk thistle) is indicated for the treatment and prevention of-
- Liver disease, (non-alcoholic & alcoholic)
- Liver cirrhosis, (non-alcoholic & alcoholic)
- Infectious hepatitis
- Drug-induced hepatitis
- Liver disease secondary to diabetes mellitus
- Toxicity of narcotics
- Fatty liver
- Jaundice
Therapeutic classView
Cholagogues, Cholelitholytics & Hepatic Protectors, Herbal and Nutraceuticals
PharmacologyView
Silymarin, a flavonoid complex of Silybum marianum or Milk thistle, is the biologically active component. It provides hepatocellular protection through toxin blockade at the membrane level, enhances protein synthesis, antioxidant activity, anti-fibrotic activity and possible anti-inflammatory or immunomodulating effects.
DosageView
1 capsule 2 to 3 times daily or as directed by a physician.
Side effectsView
Well tolerated in the recommended dose. Occasionally a mild laxative effect may observe.
ContraindicationsView
Contraindicated in patient with a known hypersensitivity to silymarin.
InteractionsView
Concomitant use of silymarin and butyrophenones or phenothiazines has resulted in the reduction of lipid peroxidation.
Pregnancy & lactationView
No experience is available about the use of Silymarin 70 mg or 140 mg during pregnancy and lactation. Therefore, if needed Silymarin 70 mg or 140 mg should be taken with caution according to the physician’s advice.
StorageView
Store in a cool & dry place, away from light & moisture. Keep out of reach of children.
Bloatnil
Simethicone
Bloatnil
Simethicone
Indications
Upper Gl bloating
Indication detailsView
Flatulence, abdominal distention, fullness, gas and windy colic: Simethicone is an excellent and effective antiflatulent. It is used for relief of the painful symptoms of excess gas in the digestive tract. Such gas is frequently caused by excessive swallowing of air or by eating foods that disagree. Simethicone drop is especially used in infants, acts in the stomach and intestines. Thus Simethicone enables freeing and eliminating the gas more easily by belching or passing flatus.
Large bowel preparation: Addition of Simethicone to a polyethylene glycol bowel preparation produces symptomatic improvement prior to investigation in the management of accidental ingestion of foaming detergents.
Treatment of poisoning: Simethicone has an anecdotal use as an antifoaming agent in the management of accidental ingestion of foaming detergents.
Large bowel preparation: Addition of Simethicone to a polyethylene glycol bowel preparation produces symptomatic improvement prior to investigation in the management of accidental ingestion of foaming detergents.
Treatment of poisoning: Simethicone has an anecdotal use as an antifoaming agent in the management of accidental ingestion of foaming detergents.
Therapeutic classView
Anti-dyspeptic/Carminatives
PharmacologyView
Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract.
Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.
Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.
DosageView
Take after meals and at bedtime. Can be given with infant's feeds. Shake the bottle well before each use.
Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).
Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.
Adults:
Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).
Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.
Adults:
- 40-125 mg (0.6 ml-1.9 ml Simethicone Paediatric Drops) 4 times daily, up to 500 mg/day (7.5 ml Simethicone Paediatric Drops) or
- 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).
Side effectsView
Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.
PrecautionsView
Do not exceed 12 doses per day except under the advice and supervision of a physician.
InteractionsView
There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.
Pregnancy & lactationView
Pregnant women: No data are available to suggest any harmful effects.
Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.
Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.
StorageView
Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.