Generic

Bisoprolol Fumarate + Hydrochlorothiazide

Indications

The combination of Bisoprolol and Hydrochlorothiazide is used to treat hypertension.

Pharmacology

Bisoprolol fumarate and hydrochlorothiazide have been used alone or in combination to treat hypertension. The antihypertensive effects of these drugs are additive; 6.25 mg of hydrochlorothiazide significantly increases the antihypertensive effect of bisoprolol fumarate. The incidence of hypokalemia in the combination of bisoprolol fumarate and 6.25 mg hydrochlorothiazide was significantly lower than that of 25 mg hydrochlorothiazide. Bisoprolol fumarate is a selective (cardioselective) β1 adrenergic receptor blocker with no significant intrinsic sympathomimetic or membrane stabilizing activity within its therapeutic dose range. Hydrochlorothiazide is a benzothiadiazine diuretic. Thiazides affect the renal tubular electrolyte reabsorption mechanism and increase the excretion of approximately equal amounts of sodium and chloride.

Dosage & Administration

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.

Interaction

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.

Contraindications

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.

Side Effects

In general, it is well tolerated. The majority of adverse effects have been minor and short-lived. Fatigue, dizziness, headache, bradycardia, arrhythmia, peripheral ischemia, chest discomfort, palpitations, rhythm abnormalities, cold extremities, claudication, orthostatic hypotension, diarrhoea, constipation, nausea, dyspepsia, rhinitis, pharyngitis, etc. are some of the side symptoms that may occur.

Pregnancy & Lactation

Use during 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 demonstrates a risk to the fetus.

Use in nursing mothers: The use of bisoprolol fumarate alone or in combination with hydrochlorothiazide in nursing mothers has not been studied. Thiazides are excreted in human milk. A small amount of bisoprolol fumarate was detected in the milk of lactating rats. Since breastfeeding babies can have serious adverse reactions, it is necessary to decide whether to discontinue breastfeeding or to stop taking the drug, taking into account the importance of the drug to the mother.

Precautions & Warnings

Certain people on thiazide diuretics may develop hyperuricemia or severe gout. Dry mouth, thirst, weakness, lethargy, sleepiness, restlessness, muscle aches or cramps, muscular exhaustion, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting are all warning indications or symptoms of fluid and electrolyte imbalance. Hypokalemia can occur. If you want to stop taking this combo therapy, you should do so gradually over a two-week period. Patients should be closely monitored.

Therapeutic Class

Combined antihypertensive preparations

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.