Maxzide (Triamterene / Hydrochlorothiazide) - Indications and Dosage

INDICATIONS AND USAGE

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.

1. MAXZIDE (triamterene and hydrochlorothiazide) is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
2. MAXZIDE is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.).

MAXZIDE may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since MAXZIDE (triamterene and hydrochlorothiazide) may enhance the actions of these drugs, 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. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in 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.

DOSAGE AND ADMINISTRATION

The usual dose of MAXZIDE-25 MG is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS). The usual dose of MAXZIDE is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS). There is no experience with the use of more than one MAXZIDE tablet daily or more than two MAXZIDE-25 MG tablets daily. Clinical experience with the administration of two MAXZIDE-25 MG tablets daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction.

Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to MAXZIDE (triamterene and hydrochlorothiazide) directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to MAXZIDE-25 MG (37.5 mg triamterene/25 mg hydrochlorothiazide) directly.

In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked therapy may be initiated with MAXZIDE-25 MG. If an optimal blood pressure response is not obtained with MAXZIDE-25 MG, the dose should be increased to two MAXZIDE-25 MG tablets daily as a single dose, or one MAXZIDE tablet daily. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS, Drug Interactions).

Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25-50 mg hydrochlorothiazide and 50-100 mg triamterene may be safely changed to one MAXZIDE-25 MG tablet daily. All patients changed from less bioavailable formulations to MAXZIDE should be monitored clinically and for serum potassium after the transfer.

HOW SUPPLIED

MAXZIDE® (triamterene and hydrochlorothiazide) tablets are bowtie-shaped, flat-faced beveled, light yellow tablets, engraved with MAXZIDE on one side and scored on the other with B on the left and M8 on the right of the score. Each tablet contains 75 mg of triamterene, USP and 50 mg of hydrochlorothiazide, USP. They are supplied as follows:

NDC 62794-460-01—Bottle of 100 with CRC

NDC 62794-460-05—Bottle of 500

NDC 62794-460-88—Unit Dose 10 × 10s

MAXZIDE®-25 MG (triamterene and hydrochlorothiazide) tablets are bowtie-shaped, flat-faced beveled, light green tablets, engraved with MAXZIDE on one side and scored on the other with B on the left and M9 on the right of the score. Each tablet contains 37.5 mg of triamterene, USP and 25 mg of hydrochlorothiazide, USP. They are supplied as follows:

NDC 62794-464-01—Bottle of 100 with CRC

NDC 62794-464-05—Bottle of 500

NDC 62794-464-88—Unit Dose 10 × 10s

STORE AT CONTROLLED ROOM TEMPERATURE 15-30°C (59-86°F).

PROTECT FROM LIGHT.

Dispense in a tight, light-resistant, child-resistant container.

BERTEK PHARMACEUTICALS INC.

Research Triangle Park, N.C. 27709-4149

Revised December 2002

BKMAX-R6