TRIAMTERENE AND HYDROCHLOROTHIAZIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules may enhance the action of these agents, 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 of pregnancy, and there is no satisfactory evidence that they are u

Product summary:

Triamterene and Hydrochlorothiazide Capsules, USP are available containing 37.5 mg triamterene, USP and 25 mg hydrochlorothiazide, USP in opaque olive and opaque rich yellow capsules imprinted in black ink with MYLAN over 2537 on both body and cap. They are available as follows: NDC 0378-2537-01 bottles of 100 capsules NDC 0378-2537-10 bottles of 1000 capsules 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2020 TMHZ:R7

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Each capsule of triamterene and hydrochlorothiazide for oral use, with
opaque olive and opaque rich
yellow body, contains hydrochlorothiazide 25 mg and triamterene 37.5
mg, and is imprinted in black ink
with MYLAN over 2537 on both body and cap. Hydrochlorothiazide is a
diuretic/antihypertensive
agent and triamterene is an antikaliuretic agent.
Hydrochlorothiazide is slightly soluble in water. It is soluble in
dilute ammonia, dilute aqueous sodium
hydroxide, and dimethylformamide. It is sparingly soluble in methanol.
Hydrochlorothiazide is
6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7- sulfonamide
1,1-dioxide,
and its structural formula is:
At 50°C, triamterene is practically insoluble in water (less than
0.1%). It is soluble in formic acid,
sparingly soluble in methoxyethanol, and very slightly soluble in
alcohol.
Triamterene is 2,4,7-Triamino-6-phenylpteridine and its structural
formula is:
Inactive ingredients consist of black iron oxide, colloidal silicon
dioxide, croscarmellose sodium,
FD&C Blue No. 1, gelatin, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
polysorbate 80, sodium bicarbonate, sodium lauryl sulfate, titanium
dioxide and yellow iron oxide.
The black imprinting ink also contains the following inactive
ingredients: black iron oxide, D&C
Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue
No. 2 Aluminum Lake,
FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
Triamterene and Hydrochlorothiazide Capsules, USP 37.5 mg/25 mg meet_
USP Dissolution Test 3._
CLINICAL PHARMACOLOGY
Triamterene and hydrochlorothiazide capsules are a
diuretic/antihypertensive drug product that combine
natriuretic and antikaliuretic effects. Each component complements the
action of the other. The
hydrochlorothiazide component blocks the reabsorption of sodium and
chloride ions, and thereby
increases the quantity of sodium traversing t