দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Actavis Pharma, Inc.
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 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. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do no
Triamterene and Hydrochlorothiazide Tablets USP, 37.5 mg/25 mg, are light green, round, scored tablets, debossed with Watson 424 and are available in bottles of 100 (NDC 0591-0424-01) and 500 (NDC 0591-0424-05). Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, are yellow, round, scored tablets, debossed with Watson 348 and are available in bottles of 100 (NDC 0591-0348-01), 500 (NDC 0591-0348-05), and 1000 (NDC 0591-0348-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: November 2020
Abbreviated New Drug Application
TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET ACTAVIS PHARMA, INC. ---------- TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, USP REVISED: NOVEMBER 2020 RX ONLY DESCRIPTION: Triamterene and hydrochlorothiazide tablets, USP combine triamterene USP, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets, USP are available in two strengths. Each triamterene and hydrochlorothiazide tablet USP, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothiazide tablet USP, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, and povidone. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue No. 2 Aluminum Lake. Triamterene, USP is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene, USP is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is: C H N TRIAMTERENE, USP Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7- sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP 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. 12 11 7 Its molecular weight is 297.73. Its structural formula is: C H CLN O S HYDROCHLOROTHIAZIDE, USP CLINICAL PHARMACOLOGY: Triamterene and hydrochlorothiazide is a diuretic, antihypertensive drug product, princ সম্পূর্ণ নথি পড়ুন