RVP

Drug Catalog - Product Detail

TRIAMTERENE W/HCTZ TAB. TB 75/50MG 500

NDC Mfr Size Str Form
00781-1008-05 SANDOZ 500 75-50MG TABLET
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Description
DESCRIPTION Triamterene and hydrochlorothiazide tablets combine triamterene, a potassium-conserving diuretic with the natriuretic agent hydrochlorothiazide. Each tablet for oral administration contains 37.5 mg triamterene and 25 mg hydrochlorothiazide or 75 mg triamterene and 50 mg hydrochlorothiazide. Inactive ingredients include croscarmellose sodium, D & C Yellow #10 Aluminum Lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate. The 37.5 mg/25 mg tablet also contains FD & C Blue #1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is: Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4, benzothiadiazine-7-sulfonamide 1, 1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is: Structure 1 Structure 2
How Supplied
HOW SUPPLIED Triamterene and hydrochlorothiazide tablets, USP for oral administration are available as: 37.5 mg/25 mg: round, green, partial scored tablets, debossed GG 165 on one side and plain on the reverse side and supplied as: NDC 0781-1123-01 bottles of 100 NDC 0781-1123-05 bottles of 500 NDC 0781-1123-10 bottles of 1000 75 mg/50 mg: round, yellow, scored tablets, debossed GG 172 on one side and plain on the reverse side and supplied as: NDC 0781-1008-01 bottles of 100 NDC 0781-1008-05 bottles of 500 NDC 0781-1008-10 bottles of 1000 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container.
Indications & Usage
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. Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide 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 arrhythmias, etc.). Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs such as beta-blockers. Since 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
DOSAGE AND ADMINISTRATION The usual dose of triamterene and hydrochlorothiazide tablets 37.5 mg/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 triamterene and hydrochlorothiazide tablets, 75 mg/50 mg, is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS ). There is no experience with the use of more than one triamterene and hydrochlorothiazide tablet 75 mg/50 mg daily or more than two triamterene and hydrochlorothiazide tablets 37.5 mg/25 mg daily. Clinical experience with the administration of two triamterene and hydrochlorothiazide tablets 37.5 mg/25 mg 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 triamterene and hydrochlorothiazide tablets 75 mg/50 mg directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to one triamterene and hydrochlorothiazide tablet 37.5 mg/25 mg directly. In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked, therapy may be initiated with triamterene and hydrochlorothiazide tablets 37.5 mg/25 mg. If an optimal blood pressure response is not obtained with this product the dose should be increased to two tablets daily as a single dose, or to one triamterene and hydrochlorothiazide tablet 75 mg/50 mg daily. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS: Drug Interactions ). Clinical studies have shown patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 to 50 mg of hydrochlorothiazide and 50 to 100 mg of triamterene may be safely changed to one triamterene and hydrochlorothiazide tablet 37.5 mg/25 mg daily. All patients changed from less bioavailable formulations of triamterene and hydrochlorothiazide to this tablet formulation should be monitored clinically and for serum potassium after the transfer.