Rx Item-Amiloride Hcl 5mg Tab 1000 By Par Pharma

AMILORIDE HYDROCHLORIDE amiloride hydrochloride tablet
Rising Pharmaceuticals, Inc
DESCRIPTION
Amiloride HCl, an antikaliuretic-diuretic agent, is pyrazine-carbonyl-guanidine that is unrelated chemically to other known antikaliuretic or diuretic agents. It is the salt of moderately strong base (pKa 8.7). It is designated chemically as 3,5-diamino-6-chloro-N-(diaminomethylene) pyrazinecarboxamide monohydrochloride, dihydrate and has molecular weight of 302.12. Its empirical formula is 6 H8 CIN7 O?HCl?2H2 O
Each tablet for oral administration contains mg of Amiloride HCI, calculated on the anhydrous basis. Each tablet contains the following inactive ingredients: corn starch, crospovidone, lactose, magnesium stearate, microcrystalline cellulose and povidone.
CLINICAL PHARMACOLOGY
Amiloride HCl is 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 thiazide or loop diuretic, amiloride has been shown to decrease the enhanced urinary excretion of magnesium which occurs when thiazide or loop diuretic is used alone. Amiloride has potassium-conserving activity in patients receiving kaliureticdiuretic agents.
Indications and USAge
Amiloride HCl tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to:
a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic
b. 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.
WARNINGS
Hyperkalemia
Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. Hyperkalemia occurs commonly (about 10%) when amiloride is used without kaliuretic diuretic. This incidence is greater in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly. When amiloride is used concomitantly with thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1-2%. It is thus essential to monitor serum potassium levels carefully in any patient receiving amiloride, particularly when it is first introduced, at the time of diuretic dosage adjustments, and during any illness that could affect renal function.
DOSAGE AND ADMINISTRATION
Amiloride HCl tablets should be administered with food.
Amiloride HCl tablets, one mg tablet daily, should be added to the usual antihypertensive or diuretic dosage of kaliuretic diuretic. The dosage may be increased to 10 mg per day, if necessary. More than two mg tablets of amiloride HCl daily usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.
In treating patients with congestive heart failure after an initial diuresis has been achieved, potassium loss may also decrease and the need for amiloride HCl tablets should be re-evaluated. Dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

Rx Item-Amiloride Hcl 5mg Tab 1000 By Pa
NDC No.49884-0117-10 UPC/GTIN No.3-49884-11710-8 MPN No. 11710 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

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Par Pharma Inc

AMILORIDE HCL ORAL TABLET
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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