Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
AMILORIDE HYDROCHLORIDE ANHYDROUS (UNII: 7M458Q65S3) (AMILORIDE - UNII:7DZO8EB0Z3)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: - help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic. - prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, 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 HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic. Amiloride HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride HCl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amilo
Each yellow compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “Par 117”. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in the USP. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET BRYANT RANCH PREPACK ---------- AMILORIDE HYDROCHLORIDE TABLETS DESCRIPTION Amiloride HCl, an antikaliuretic-diuretic agent, is a pyrazine-carbonyl-guanidine that is unrelated chemically to other known antikaliuretic or diuretic agents. It is the salt of a moderately strong base (pKa 8.7). It is designated chemically as 3,5-diamino-6-chloro-N- (diaminomethylene) pyrazinecarboxamide monohydrochloride, dihydrate and has a molecular weight of 302.12. Its empirical formula is C H CIN O•HCl•2H O and its structural formula is: Each tablet for oral administration contains 5 mg of Amiloride HCI, calculated on the anhydrous basis. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 lake, magnesium stearate, microcrystalline cellulose and silicon dioxide. CLINICAL PHARMACOLOGY Amiloride HCl is a potassium-conserving (antikaliuretic) drug that possesses weak (compared with thiazide diuretics) natriuretic, diuretic, and antihypertensive activity. These effects have been partially additive to the effects of thiazide diuretics in some clinical studies. When administered with a thiazide or loop diuretic, amiloride has been shown to decrease the enhanced urinary excretion of magnesium which occurs when a thiazide or loop diuretic is used alone. Amiloride has potassium-conserving activity in patients receiving kaliureticdiuretic agents. Amiloride HCl is not an aldosterone antagonist and its effects are seen even in the absence of aldosterone. Amiloride exerts its potassium sparing effect through the inhibition of sodium reabsorption at the distal convoluted tubule, cortical collecting tubule and collecting duct; this decreases the net negative potential of the tubular lumen and reduces both potassium and hydrogen secretion and their subsequent excretion. This mechanism accounts in large part for the potassium sparing action of amiloride. Amilori Pročitajte cijeli dokument