Drug Catalog - Product Detail
AMILORIDE TB 5MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0117-01 | PAR PHARMACEUTICAL | 100 | 5MG | TABLET |
PACKAGE FILES
Generic Name
AMILORIDE HYDROCHLORIDE
Substance Name
AMILORIDE HYDROCHLORIDE ANHYDROUS
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA070346
Description
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 6 H 8 CIN 7 O•HCl•2H 2 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. this is the structure.
How Supplied
HOW SUPPLIED Each yellow compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “Par 117”. They are available in bottles of 100’s (NDC #49884-117-01) and 1000’s (NDC #49884-117-10). Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in the USP. Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam-603 103. Made in India Mfg. Lic. No.: TN00002121 OS117-01-74-01 Issued: 07/2021
Indications & Usage
INDICATIONS AND USAGE 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). 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Amiloride HCl should be administered with food. Amiloride HCl, one 5 mg tablet daily, should be added to the usual antihypertensive or diuretic dosage of a kaliuretic diuretic. The dosage may be increased to 10 mg per day, if necessary. More than two 5 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 should be re-evaluated. Dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis. If it is necessary to use amiloride HCl alone (see INDICATIONS), the starting dosage should be one 5 mg tablet daily. This dosage may be increased to 10 mg per day, if necessary. More than two 5 mg tablets 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.