TRIAMTERENE HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NCS HealthCare of KY, Inc dba Vangard Labs

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. - 1.Triamterene and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. - 2.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 USP 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 unnecessar

Produkt oversigt:

Triamterene and hydrochlorothiazide tablets, USP for oral administration are available as: 37.5 mg/25 mg: peanut shaped, green tablets, scored on both sides, debossed SZ 431 on one side and plain on the reverse side and supplied as: NDC 0615-8103-39 blistercards of 30 75 mg/50 mg: peanut shaped, yellow tablets, scored on both sides, debossed SZ 418 on one side and plain on the reverse side. 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. 12-2016M 7445 Sandoz Inc. Princeton, NJ 08540

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TRIAMTERENE HYDROCHLOROTHIAZIDE- TRIAMTERENE AND HYDROCHLOROTHIAZIDE
TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, USP
DESCRIPTION
Triamterene and hydrochlorothiazide tablets USP combine triamterene, a
potassium-conserving diuretic
with the natriuretic agent hydrochlorothiazide. Each tablet for oral
administration contains 37.5 mg
triamterene USP and 25 mg hydrochlorothiazide USP or 75 mg triamterene
USP and 50 mg
hydrochlorothiazide USP. Inactive ingredients include lactose
anydrous, colloidal silicon dioxide,
croscarmellose sodium, D & C Yellow #10 Aluminum Lake, magnesium
stearate, and microcrystalline
cellulose. 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 a