TRIAMTERENE AND 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:

Unit Dose Services

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:

NDC:50436-6810-1 in a BOTTLE of 30 TABLETS NDC:50436-6810-3 in a BOTTLE of 90 TABLETS

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
UNIT DOSE SERVICES
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REVISED: APRIL 2012 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS USP
RX ONLY
DESCRIPTION:
Triamterene and hydrochlorothiazide tablets USP, combines triamterene,
a potassium-conserving
diuretic, with the natriuretic agent, hydrochlorothiazide. Triamterene
and hydrochlorothiazide tablets
are available in two strengths. Each triamterene and
hydrochlorothiazide tablet, 75 mg/50 mg, contains
triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each
triamterene and hydrochlorothazide
tablet, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and
hydrochlorothiazide USP, 25 mg.
Both strengths of triamterene and hydrochlorothiazide tablets for oral
administration contain the
following inactive ingredients: anhydrous lactose, microcrystalline
cellulose, polacrilin potassium,
polyethylene glycol 8000, povidone, and magnesium stearate.
Triamterene and hydrochlorothiazide
tablets, 37.5 mg/25 mg also contain FD&C Blue #2.
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 -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: _H_
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 hy