TRIAMTERENE AND HYDROCHLOROTHIAZIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Mylan Institutional Inc.

INN (Nome Internazionale):

HYDROCHLOROTHIAZIDE

Composizione:

HYDROCHLOROTHIAZIDE 25 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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 51079-935-20 – Unit dose blister packages of 100 (10 cards of 10 capsules 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-7146 R6 11/17

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
Each triamterene and hydrochlorothiazide capsule for oral
administration contains hydrochlorothiazide
25 mg and triamterene 37.5 mg. 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
The triamterene and hydrochlorothiazide capsule is a
diuretic/antihypertensive drug product that
combines 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 the distal tubule and the
volume of water excreted. A portion
of the additional sodium presented to the distal tu