AMILORIDE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMILORIDE HYDROCHLORIDE (UNII: FZJ37245UC) (AMILORIDE - UNII:7DZO8EB0Z3)

Available from:

Cadila Healthcare Limited

INN (International Name):

AMILORIDE HYDROCHLORIDE

Composition:

AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET
CADILA HEALTHCARE LIMITED
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AMILORIDE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Amiloride hydrochloride, 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
molecular formula is C H CIN O•HCl•2H O and its structural formula
is:
Amiloride hydrochloride is a pale-yellow to greenish-yellow powder. It
is freely soluble in
dimethylsulphoxide; slightly soluble in water, ethyl alcohol and
isopropyl alcohol; sparingly soluble in
methyl alcohol; practically insoluble in acetone, chloroform, diethyl
ether and ethyl acetate.
Each amiloride hydrochloride tablet intended for oral administration
contains 5 mg of amiloride
hydrochloride, calculated on the anhydrous basis. In addition, each
tablet contains the following inactive
ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C
yellow #10 aluminum lake, dibasic
calcium phosphate dihydrate, FD & C yellow #6 aluminum lake, magnesium
stearate, microcrystalline
cellulose and povidone.
CLINICAL PHARMACOLOGY
Amiloride hydrochloride 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 hydrochloride is not an aldosterone antagonist and its
effects are seen even in the absence of
aldosterone.
A