TRIAMTERENE AND HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

NuCare Pharmaceuticals,Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 is 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 arryhthmias, etc.). 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 developme

Produktsammanfattning:

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg are available for oral administration as yellow, oval bioconvex tablets, scored and engraved “75” bisect “50” on one side, “APO” on the other side. They are supplied as follows: NDC 66267-207-30 Bottles of 30 NDC 66267-207-45 Bottles of 45 NDC 66267-207-60 Bottles of 60 NDC 66267-207-90 Bottlesd of 90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. APOTEX INC. TRIAMTERENE HYDROCHLOROTHIAZIDE TABLETS, USP 37.5 mg/25 mg and 75 mg/50 mg Revised September 2011 Rev. 2

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, 37.5 MG/ 25 MG AND 75
MG/50 MG
DESCRIPTION
Triamterene and hydrochlorothiazide combines triamterene, a
potassium-conserving diuretic, with the
natriuretic agent, hydrochlorothiazide.
Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP
contains 37.5 mg of
Triamterene, USP and 25 mg of Hydrochlorothiazide, USP.
Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP
contains 75 mg of Triamterene,
USP and 50 mg of Hydrochlorothiazide, USP.
Triamterene and hydrochlorothiazide tablets for oral administration
contains the following inactive
ingredients: lactose monohydrate, magnesium stearate, microcrystalline
cellulose, and sodium starch
glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow
No.10 Aluminum Lake and 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.
The following is the structural formula:
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -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.
The following is the structural
formula:
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 and antihypertensive