TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Disponibbli minn:

Actavis Pharma, Inc.

INN (Isem Internazzjonali):

TRIAMTERENE

Kompożizzjoni:

TRIAMTERENE 37.5 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

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