TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Lake Erie Medical DBA Quaity Care Products LLC

INN (Διεθνής Όνομα):

TRIAMTERENE

Σύνθεση:

TRIAMTERENE 37.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/25 mg, are light green, round, scored tablets, debossed with Watson 424 55700-394-30 55700-394-90 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, are yellow, round, scored tablets, debossed with Watson 348 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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
LAKE ERIE MEDICAL DBA QUAITY CARE PRODUCTS LLC
----------
TRIAMTERENE AND
HYDROCHLOROTHIAZIDE
TABLETS, USP
REVISED: NOVEMBER 2014
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
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:
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 po