Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Mylan Institutional Inc.
TRIAMTERENE
TRIAMTERENE 75 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, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. - Triamterene and hydrochlorothiazide tablets, USP 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, USP may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide tablets 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 ha
Triamterene and Hydrochlorothiazide Tablets, USP are available as follows: The 75 mg/50 mg tablets are yellow, round, scored tablets debossed with MYLAN on one side of the tablet and TH above the score and 2 below the score on the other side. They are available as follows: NDC 51079-433-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-6916 R5 8/19
New Drug Application
TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET MYLAN INSTITUTIONAL INC. ---------- DESCRIPTION Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet, USP 37.5 mg/25 mg contains: Triamterene, USP . . . . . . . . 37.5 mg Hydrochlorothiazide, USP . . . 25 mg Each Triamterene and Hydrochlorothiazide Tablet, USP 75 mg/50 mg contains: Triamterene, USP . . . . . . . . . . 75 mg Hydrochlorothiazide, USP . . . . 50 mg Triamterene and hydrochlorothiazide tablets for oral administration contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate. Additionally, the 37.5 mg/25 mg product contains FD&C Blue No. 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: 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. HYDROCHLOROTHIAZIDE Hydrochlorothiazide is a diuretic and antihypertens Přečtěte si celý dokument