Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
AMILORIDE HYDROCHLORIDE (UNII: FZJ37245UC) (AMILORIDE - UNII:7DZO8EB0Z3), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Teva Pharmaceuticals USA, Inc.
AMILORIDE HYDROCHLORIDE
AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg
ORAL
PRESCRIPTION DRUG
Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride hydrochloride and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects. The fixed combination drug is not indicated for the initial therapy of edema or hypert
Amiloride hydrochloride and hydrochlorothiazide tablets, USP are available as: 5 mg/50 mg: Light yellow, round, scored, biconvex tablet. Debossed with 555 over 483 on the scored side and stylized barr on the other side. Each tablet contains 5 mg of anhydrous amiloride HCl, USP and 50 mg of hydrochlorothiazide, USP. 100 Tablets NDC 0555-0483-02 1000 Tablets NDC 0555-0483-05 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. Manufactured In Canada By: Teva Canada Limited Toronto, Canada M1B 2K9 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 12/2022
Abbreviated New Drug Application
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET TEVA PHARMACEUTICALS USA, INC. ---------- AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/50 MG RX ONLY DESCRIPTION Amiloride hydrochloride and hydrochlorothiazide tablets, USP combine the potassium- conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide. Amiloride HCl, USP is designated chemically as _N_-amidino-3,5,-diamino-6-chloropyrazine- carboxamide monohydrochloride dihydrate and its structural formula is: C H CIN O•HCL•2H O M.W. 302.12 Hydrochlorothiazide, USP is designated chemically as 6-chloro-3,4-dihydro-2_H_-1, 2, 4- benzo-thiadiazine-7-sulfonamide 1, 1-dioxide. Its structural formula is: 6 8 7 2 C H CIN O S M.W. 297.74 It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet, for oral administration, contains 5 mg of amiloride hydrochloride, USP (calculated on the anhydrous basis) and 50 mg of hydrochlorothiazide, USP. INACTIVE INGREDIENTS: Croscarmellose sodium, D&C yellow no. 10 (aluminum lake), lactose monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose. CLINICAL PHARMACOLOGY Amiloride hydrochloride and hydrochlorothiazide tablets provide diuretic and antihypertensive activity (principally due to the hydrochlorothiazide component), while acting through the amiloride component to prevent the excessive potassium loss that may occur in patients receiving a thiazide diuretic. Due to its amiloride component, the urinary excretion of magnesium is less with amiloride and hydrochlorothiazide than with a thiazide or loop diuretic used alone (see PRECAUTIONS). The onset of the diuretic action of this product is within 1 to 2 hours and this action appears to be sustained for approximately 24 hours. AMILORIDE HYDROCHLORIDE Amiloride Hydrochloride is a potassium-conserving (antikaliuretic) drug that possesses weak (compared wi Leggi il documento completo