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Basic Drug Info
Drug Name:Bisoprolol Fumarate Hydrochlorothiazide
Manufacturer:Watson Laboratories, Inc.
Other Info:



Clinical Trials:


Indications and Usage
Bisoprolol and hydrochlorothiazide is indicated in the management of hypertension.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Contraindications
Bisoprolol and hydrochlorothiazide is contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Heart failure -- inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.

Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Sinus bradycardia -- A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI)

Anuria -- Absence of urine formation. It is usually associated with complete bilateral ureteral (URETER) obstruction, complete lower urinary tract obstruction, or unilateral ureteral obstruction when a solitary kidney is present.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Cardiac FailureIn general, beta-blocking agents should be avoided in patients with overt congestive heart failure.

However, in some patients with compensated cardiac failure, it may be necessary to utilize these agents.

In such situations, they must be used cautiously.Patients Without a History of Cardiac FailureContinued depression of the myocardium with beta-blockers can, in some patients, precipitate cardiac failure.

At the first signs or symptoms of heart failure, discontinuation of bisoprolol and hydrochlorothiazide should be considered.

In some cases bisoprolol and hydrochlorothiazide therapy can be continued while heart failure is treated with other drugs.Abrupt Cessation of TherapyExacerbations of angina pectoris and, in some instances, myocardial infarction or ventricular arrhythmia, have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers.

Such patients should, therefore, be cautioned against interruption or discontinuation of therapy without the physician’s advice.

Even in patients without overt coronary artery disease, it may be advisable to taper therapy with bisoprolol and hydrochlorothiazide over approximately 1 week with the patient under careful observation.

If withdrawal symptoms occur, beta-blocking therapy should be reinstituted, at least temporarily.Peripheral Vascular DiseaseBeta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.

Caution should be exercised in such individuals.Bronchospastic DiseasePATIENTS WITH BRONCHOSPASTIC PULMONARY DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS.

Because of the relative beta1-selectively of bisoprolol fumarate, bisoprolol and hydrochlorothiazide may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate other antihypertensive treatment.

Since beta1-selectivity is not absolute, the lowest possible dose of bisoprolol and hydrochlorothiazide should be used.

A beta2 agonist (bronchodilator) should be made available.Anesthesia and Major SurgeryIf bisoprolol and hydrochlorothiazide treatment is to be continued perioperatively, particular care should be taken when anesthetic agents that depress myocardial function, such as ether, cyclopropane, and trichloroethylene are used.

See OVERDOSAGE for information on treatment of bradycardia and hypotension.Diabetes and HypoglycemiaBeta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.

Nonselective beta-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels.

Because of the beta1-selectivity, this is less likely with bisoprolol.

However, patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned about these possibilities.

Also, latent diabetes mellitus may become manifest and diabetic patients given thiazides may require adjustment of their insulin dose.

Because of the very low dose of HCTZ employed, this may be less likely with bisoprolol and hydrochlorothiazide.ThyrotoxicosisBeta-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia.

Abrupt withdrawal of beta-blockade may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate thyroid storm.Renal DiseaseCumulative effects of the thiazides may develop in patients with impaired renal function.

In such patients, thiazides may precipitate azotemia.

In subjects with creatinine clearance less than 40 mL/min, the plasma half-life of bisoprolol is increased up to threefold, as compared to healthy subjects.

If progressive renal impairment becomes apparent, bisoprolol and hydrochlorothiazide should be discontinued.

(See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism).Hepatic DiseaseBisoprolol and hydrochlorothiazide should be used with caution in patients with impaired hepatic function or progressive liver disease.

Thiazides may alter fluid and electrolyte balance, which may precipitate hepatic coma.

Also, elimination of bisoprolol is significantly slower in patients with cirrhosis than in healthy subjects.

(See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism).

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