Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
AMILORIDE HYDROCHLORIDE (UNII: FZJ37245UC) (AMILORIDE - UNII:7DZO8EB0Z3)
Padagis US LLC
AMILORIDE HYDROCHLORIDE
AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg
ORAL
PRESCRIPTION DRUG
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: 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 anti-hypertensive 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). Amiloride HCl should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes. Amiloride HCl should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter). Amiloride HCl sh
Amiloride HCl Tablets, 5 mg, are off-white to light yellow, diamond-shaped, compressed tablets, embossed with "P291". They are supplied in bottles of 100 (NDC 0574-0292-01). Protect from moisture, freezing and excessive heat. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
New Drug Application Authorized Generic
AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET PADAGIS US LLC ---------- AMILORIDE HCL TABLETS, USP RX ONLY 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 ClN O•HCl•2H O and its structural formula is: Amiloride HCl is available for oral use as tablets containing 5 mg of anhydrous amiloride HCl. Each tablet contains the following inactive ingredients: calcium phosphate, lactose, magnesium stearate and starch 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 HCl has been shown to decrease the enhanced urinary excretion of magnesium which occurs when a thiazide or loop diuretic is used alone. Amiloride HCl has potassium-conserving activity in patients receiving kaliuretic-diuretic agents. Amiloride HCl is not an aldosterone antagonist and its effects are seen even in the absence of aldosterone. Amiloride HCl 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. 6 8 7 2 Amiloride HCl usually begins to act within 2 hours after an oral dose. Its effect on electrolyte excretion reaches a peak between 6 an read_full_document