This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

DYAZIDE is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.

DYAZIDE is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

DYAZIDE may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since DYAZIDE may enhance the action of these agents, dosage adjustments may be necessary.

Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.

The usual dose of DYAZIDE is one or two capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect (see WARNINGS, Hyperkalemia).

Capsules containing 25 mg hydrochlorothiazide and 37.5 mg triamterene, in bottles of 1,000 capsules; in Patient-Pak™ unit-of-use bottles of 100.

They are supplied as follows:

NDC 0007-3650-22-in Patient-Pak™ unit-of-use bottles of 100.

NDC 0007-3650-30-bottles of 1,000.

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Dispense in a tight, light-resistant container.

GlaxoSmithKline, Research Triangle Park, NC 27709. June 2007. FDA revision date: 5/18/2007

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