Triamterene / Hydrochlorothiazide

Indications

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 tablets are 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 tablets 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION: Note: 37.5 mg/25 mg=37.5 mg triamterene and 25 mg hydrochlorothiazide 75 mg/50 mg=75 mg triamterene and 50 mg hydrochlorothiazide The usual dose of triamterene and hydrochlorothiazide 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 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 75 mg/50 mg tablet, daily or more than two 37.5 mg/25 mg tablets, daily.

Contraindications

CONTRAINDICATIONS: Hyperkalemia: Triamterene and hydrochlorothiazide should not be used in the presence of elevated serum potassium levels (greater than or equal to 5.5 mEq/liter). If hyperkalemia develops, this drug should be discontinued and a thiazide alone should be substituted.

Warnings and precautions

WARNINGS: Hyperkalemia: Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-conserving diuretic combinations, including triamterene and hydrochlorothiazide. Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment), or elderly or severely ill patients.

Pregnancy

Pregnancy: Teratogenic Effects: Triamterene and Hydrochlorothiazide Tablets: Animal reproduction studies to determine the potential for fetal harm by triamterene and hydrochlorothiazide tablets have not been conducted.

Storage and supply

HOW SUPPLIED: Product: 50090-1834 NDC: 50090-1834-0 30 TABLET in a BOTTLE NDC: 50090-1834-2 100 TABLET in a BOTTLE NDC: 50090-1834-5 90 TABLET in a BOTTLE

Source: Triamterene And Hydrochlorothiazide (Triamterene And Hydrochlorothiazide) — US FDA prescribing information, 2023-12-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.