AMILORIDE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMILORIDE HYDROCHLORIDE ANHYDROUS (UNII: 7M458Q65S3) (AMILORIDE - UNII:7DZO8EB0Z3)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

AMILORIDE HYDROCHLORIDE ANHYDROUS

Composition:

AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL, INC.
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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.
Ami