Country: United States
Language: English
Source: NLM (National Library of Medicine)
Triamterene (UNII: WS821Z52LQ) (Triamterene - UNII:WS821Z52LQ), Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)
Rebel Distributors Corp
Triamterene
Triamterene 37.5 mg
ORAL
PRESCRIPTION DRUG
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. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent developmen
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 21695-496-30 bottles of 30 NDC 21695-496-90 bottles of 90 75 mg/50 mg — round, yellow, scored tablets, debossed GG 172 on one side and plain on the reverse side and supplied as: NDC 21695-497-30 bottles of 30 NDC 21695-497-90 bottles of 90 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. Sandoz Inc. Princeton, NJ 08540 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
TRIAMTERENE HYDROCHLOROTHIAZIDE- TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET REBEL DISTRIBUTORS CORP ---------- TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, USP RX ONLY 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 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 structural formula is: CLINICAL PHARMACOLOGY Triamterene and hydrochlorothiazide is a diuretic, antihypertensive drug product, principally due to its hydrochlorothiazide component; the triamterene component reduces the excessive potassium loss which may occur with hydrochlorothiazide use. TRIAMTERENE Triamterene is a potassium conserving (antikaliuretic) diuretic with relatively weak natriuretic properties. It exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen. With this action, triamterene increases sodium excretion and reduces the excessive l Read the complete document