Description
Generics: Bisoprolol Fumarate + Hydrochlorothiazide
Dosage Form: Tablet.
Indications:
- Bisoprolol is used to treat hypertension and angina.
- Heart failure ranging from mild to severe
Pharmacology:
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.
Dosage guideline:
Once daily.
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.
Route of administration: Orally.
Interaction:
This combination medicine may enhance the effects of other antihypertensive medications used at the same time. Other beta-blocking medications should not be taken with this combo therapy. Patients using catecholamine-depleting medicines like reserpine or guanethidine should be constantly watched because Bisoprolol Fumarate’s additional beta-adrenergic blocking action may cause an excessive reduction in sympathetic activity. If clonidine therapy is to be stopped, it is recommended that this combo medicine be stopped for many days before the clonidine is stopped. When cardiac depressants or inhibitors of AV conduction, such as calcium antagonists (especially of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes) or antiarrhythmic medicines, such as disopyramide, are administered concurrently, this combination medication should be used with caution. Beta-blockers and digitalis glycosides both delay atrioventricular conduction and lower heart rate. Concurrent use can put you at risk for 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:
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 & Lactation:
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.
Precautions & Warnings:
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.
Therapeutic Class:
Combined antihypertensive preparations
Storage Conditions:
Keep below 30°C temperature, Keep in a dry place, away from light and heat. Keep out of the reach of children.
Manufactured by: Aristopharma  Ltd.
