TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Preferred Pharmaceuticals Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 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 development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous

Огляд продуктів:

Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/ 25 mg are available for oral administration as green, oval biconvex tablets, scored and engraved “37.5” bisect “25” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30 (NDC 68788-7893-3) Bottles of 60 (NDC 68788-7893-6) Bottles of 90 (NDC 68788-7893-9) Bottles of 100 (NDC 68788-7893-1) Dispense with a child-resistant closure in a tight, light-resistant container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. APOTEX INC. TRIAMTERENE HYDROCHLOROTHIAZIDE TABLETS, USP 37.5 mg/25 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Repackaged By: Preferred Pharmaceuticals Inc. Revised September 2020 Rev. 3 Repackaged By: Preferred Pharmaceuticals Inc.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, 37.5 MG/ 25 MG AND 75
MG/50
MG
DESCRIPTION
Triamterene and hydrochlorothiazide combines triamterene, a
potassium-conserving
diuretic, with the natriuretic agent, hydrochlorothiazide.
Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP
contains 37.5 mg
of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP.
Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP
contains 75 mg of
Triamterene, USP and 50 mg of Hydrochlorothiazide, USP.
Triamterene and hydrochlorothiazide tablets for oral administration
contains the
following inactive ingredients: lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, and sodium starch glycolate. In addition,
the 37.5 mg/25 mg
tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.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. The following is the
structural formula:
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. The following is the structural formula:
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.
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide is a diuretic and antihyperten