TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

RedPharm Drug, Inc.

INN (mednarodno ime):

TRIAMTERENE

Sestava:

TRIAMTERENE 37.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do n

Povzetek izdelek:

Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/25 mg, are light green, round, scored tablets, debossed with Watson 424 and are available in bottles of 30, 100 and 500. Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, are yellow, round, scored tablets, debossed with Watson 348 and are available in bottles of 30, 100, 500 and 1000. Bottles of 30 and 100 tablets are provided with child-resistant closures. 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. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: November 2014

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
REDPHARM DRUG, INC.
----------
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
hydrochlorothaizide 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:
[Triamterene Chemical Structure]
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. Its structural formula is:
[Hydrochlorothiazide Chemical Structure]
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
h