TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Aphena Pharma Solutions - Tennessee, LLC

INN (Tarptautinis Pavadinimas):

TRIAMTERENE

Sudėtis:

TRIAMTERENE 37.5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 tablets 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

Produkto santrauka:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Triamterene and Hydrochlorothiazide Tablets, USP are available as follows: The 37.5 mg/25 mg tablets are green round tablets debossed with MYLAN on one side of the tablet and TH above the score and 1 below the score on the other side. They are available as follows: NDC 0378-1352-01 bottles of 100 tablets NDC 0378-1352-05 bottles of 500 tablets The 75 mg/50 mg tablets are yellow round tablets debossed with MYLAN on one side of the tablet and TH above the score and 2 below the score on the other side. They are available as follows: NDC 0378-1355-01 bottles of 100 tablets NDC 0378-1355-05 bottles of 500 tablets 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 JANUARY 2011 TRHCT:R4

Autorizacija statusas:

New Drug Application

Prekės savybės

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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DESCRIPTION
Triamterene and hydrochlorothiazide combines triamterene, a
potassium-conserving diuretic, with the
natriuretic agent, hydrochlorothiazide.
Each Triamterene and Hydrochlorothiazide Tablet, USP 37.5 mg/25 mg
contains:
Triamterene, USP . . . . . . . . 37.5 mg
Hydrochlorothiazide, USP . . . 25 mg
Each Triamterene and Hydrochlorothiazide Tablet, USP 75 mg/50 mg
contains:
Triamterene, USP . . . . . . . . . . 75 mg
Hydrochlorothiazide, USP . . . . 50 mg
Triamterene and hydrochlorothiazide tablets for oral administration
contain the following inactive
ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C
Yellow No. 10 Aluminum Lake,
magnesium stearate, microcrystalline cellulose, powdered cellulose and
sodium lauryl sulfate.
Additionally, the 37.5 mg/25 mg product contains FD&C Blue No. 1
Aluminum Lake.
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 which
may occur with hydrochlorothiazide use.
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide is a diuretic an