Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
Triamterene (UNII: WS821Z52LQ) (Triamterene - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Aphena Pharma Solutions - Tennessee, LLC
ORAL
PRESCRIPTION DRUG
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 developme
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 100 (NDC 60505-2656-1) Bottles of 500 (NDC 60505-2656-5) Bottles of 6,500 (NDC 60505-2656-7) Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg are available for oral administration as yellow, oval biconvex tablets, scored and engraved “75” bisect “50” on one side, “APO” on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-2657-1) Bottles of 500 (NDC 60505-2657-5) Bottles of 7,000 (NDC 60505-2657-7) 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 and 75 mg/50 mg Revised September 2020 Rev. 3
Abbreviated New Drug Application
TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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 an Citiți documentul complet