TRIAMTERENE AND HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Preferred Pharmaceuticals, Inc.

INN:

TRIAMTERENE

composition:

TRIAMTERENE 37.5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 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 development of toxemia in pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous r

leaflet_short:

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: Bottle of 30 – 68788-9791-3 Bottle of 60 – 68788-9791-6 Bottle of 90 – 68788-9791-9 Bottle of 100 – 68788-9791-1 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, are yellow, round, scored tablets, debossed with Watson 348 and are available in bottles of: Bottle of 30 – 68788-9792-3 Bottle of 60 – 68788-9792-6 Bottle of 90 – 68788-9792-9 Bottle of 100 – 68788-9792-1 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 2014 Repackaged By: Preferred Pharmaceuticals Inc.

authorization_status:

Abbreviated New Drug Application

SPC

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
TRIAMTERENE AND
HYDROCHLOROTHIAZIDE
TABLETS, USP
REVISED: NOVEMBER 2014
RX ONLY
DESCRIPTION:
Triamterene and hydrochlorothiazide tablets, USP, combines
triamterene, a potassium-conserving
diuretic, with the natriuretic agent, hydrochlorothiazide. Triamterene
and hydrochlorothiazide tablets
are available in two strengths. Each triamterene and
hydrochlorothiazide tablet, 75 mg/50 mg, contains
triamterene, USP, 75 mg and hydrochlorothiazide, USP, 50 mg. Each
triamterene and
hydrochlorothaizide tablet, 37.5 mg/25 mg, contains triamterene, USP,
37.5 mg and hydrochlorothiazide,
USP, 25 mg.
Both strengths of triamterene and hydrochlorothiazide tablets for oral
administration contain the
following inactive ingredients: anhydrous lactose, microcrystalline
cellulose, polacrilin potassium,
polyethylene glycol 8000, povidone, and magnesium stearate.
Triamterene and hydrochlorothiazide
tablets, 37.5 mg/25 mg also contain FD&C Blue #2.
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 wh