TRIAMTERENE HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carilion Materials Management

INN (International Name):

TRIAMTERENE

Composition:

TRIAMTERENE 37.5 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 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 arrhythmias, 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 developmen

Product summary:

Product: 68151-3112 NDC: 68151-3112-0 1 TABLET in a PACKAGE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMTERENE HYDROCHLOROTHIAZIDE- TRIAMTERENE AND HYDROCHLOROTHIAZIDE
TABLET
CARILION MATERIALS MANAGEMENT
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TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, USP
DESCRIPTION
Triamterene and hydrochlorothiazide tablets combine triamterene, a
potassium-conserving diuretic with
the natriuretic agent hydrochlorothiazide. Each tablet for oral
administration contains 37.5 mg
triamterene and 25 mg hydrochlorothiazide or 75 mg triamterene and 50
mg hydrochlorothiazide.
Inactive ingredients include croscarmellose sodium, D & C Yellow #10
Aluminum Lake,
hydroxypropyl methylcellulose, magnesium stearate, microcrystalline
cellulose, polysorbate 80, and
sodium bicarbonate. The 37.5 MG/25 MG tablet also contains FD & C Blue
#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.
TRIAMTERENE
Triamterene is a potassium conserving (antikaliuretic) diuretic with
relatively weak natriuretic
properties. It exerts its diuretic effect on the distal renal tubule
to inhibit the reabsorption of sodium in
exchange for potassium and hydrogen. With this action, tria