OPSONIN PHARMA LTD.
BISOPROLOL FUMARATE + HYDROCHLOROTHIAZIDE
Bisoprolol plus Hydrochlorothiazide is indicated in the treatment of Hypertension.
Combined antihypertensive preparations
Bisoprolol is a beta1 selective (cardio selective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range. Hydrochlorothiazide is a diuretic (benzothiadiazine) affecting the distal renal tubular mechanism increase excretion of sodium and chloride and resulting reduced blood volume or Cardiac output. Individually Bisoprolol Fumarate and Hydrochlorothiazide used as antihypertensive agent and combination of these two drugs brings maximum response in treatment of hypertension. Hydrochlorothiazide significantly increases the antihypertensive effect of Bisoprolol Fumarate. The incidence of hypokalemia is less due to low dose of Hydrochlorothiazide.
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 Bisoprolol & Hydrochlorothiazide, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with Bisoprolol & Hydrochlorothiazide 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 Bisoprolol & Hydrochlorothiazide. 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 Bisoprolol & Hydrochlorothiazide.
This combination drug may potentiate the action of other antihypertensive agents when 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 may produce excessive reduction of sympathetic activity. This combination should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists verapamil and benzothiazepine diltiazem classes or anti-arrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate
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.
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.
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Lactation: Bisoprolol alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers
There are limited data on overdose with bisoprolol fumarate and hydrochlorothiazide. 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.
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
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.