TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

PD-Rx Pharmaceuticals, Inc.

INN (Nome Internazionale):

TRIAMTERENE

Composizione:

TRIAMTERENE 37.5 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 tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. - Triamterene and hydrochlorothiazide tablets, USP 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, USP 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 ha

Dettagli prodotto:

Triamterene and Hydrochlorothiazide Tablets, USP are available as follows: The 37.5 mg/25 mg tablets are green, round, scored 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 43063-424-30 bottles of 30 tablets NDC 43063-424-90 bottles of 90 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.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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 and antihyperte