Bisoprolol fumarate is indicated in the management of hypertension.

Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5-40 mg, while hydrochlorothiazide is effective in doses of 15-50 mg. In clinical trials of bisoprolol/hydrochlorothiazide combination therapy using bisoprolol doses of 2.5-20 mg hydrochlorothiazide doses of 6.25-25 mg, the antihypertensive effects increased with increasing doses of either component.

The adverse effects (see WARNINGS) of bisoprolol are a mixture of dose-dependent phenomena (primarily bradycardia, diarrhea, asthenia and fatigue) and dose-independent phenomena (e.g., occasional rash); those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., possibly pancreatitis); the dose-dependent for each being much more common than the dose-independent phenomena. The latter consist of those few that are truly idiosyncratic in nature or those that occur with such low frequency that a dose relationship may be difficult to discern. Therapy with a combination of bisoprolol and hydrochlorothiazide will be associated with both sets of dose-independent adverse effects, and to minimize these, it may be appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. On the other hand, regimens that combine low doses of bisoprolol and hydrochlorothiazide should produce minimal dose dependent adverse effects, e.g., bradycardia, diarrhea, asthenia and fatigue, and minimal dose-dependent adverse metabolic effects, i.e., decreases in serum potassium (see CLINICAL PHARMACOLOGY).

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 fumarate. 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 with electrolyte disturbance if they are switched to bisoprolol fumarate.

Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of bisoprolol fumarate, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with bisoprolol fumarate tablets up to the maximum recommended dose 20/12.5 mg (two 10/6.25 mg tablets) once daily, as appropriate,

Replacement Therapy: The combination may be substituted for the titrated individual components.

Cessation of Therapy: If withdrawal of bisoprolol fumarate therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.

Patients with Renal or Hepatic Impairment: As noted in WARNINGS, caution must be used in dosing/titrating patients with hepatic impairment or renal dysfunction. Since there is no indication that hydrochlorothiazide is dialyzable, and limited data suggest that bisoprolol is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.

Elderly Patients: Dosage adjustment on the basis of age is not usually necessary, unless there is also significant renal or hepatic dysfunction (see WARNINGS).

Children: There is no pediatric experience with bisoprolol fumarate.

ZIAC®-2.5 mg/6.25 mg Tablets (bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg) are yellow, round, convex, film coated tablets, engraved with a script "LL" within an engraved heart shape on one side and "B" above "12" on the other; approximately 1/4' in diameter, supplied as follows:

NDC 0005-3238-23 - Bottle of 100

ZIAC®-5 mg/6.25 mg Tablets (bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg) are pink, round, convex, film coated tablets, engraved with a script "LL" within an engraved heart shape on one side and "B" above "13" on the other; approximately 9/32' in diameter, supplied as follows:

NDC 0005-3234-23 - Bottle of 100

ZIAC®-10 mg/6.25 mg Tablets (bisoprolol fumarate 10 mg and hydrochlorothiazide 6.25 mg) are white, round, convex, film coated tablets, engraved with a script "LL" within an engraved heart shape on one side and "B" above "14" on the other; approximately 9/32' in diameter, supplied as follows:

NDC 0005-3235-38 - Bottle of 30 with child resistant closure

Store at controlled room temperature 15-30° (59-86°) in a well-closed container.

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