AMILORIDE HYDROCHLORIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

WINDLAS BIOTECH LIMITED

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Amiloride hydrochloride tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic 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. 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 hydrochloride has little additive diuretic or antihypertensive effect when added to a thiazide diuretic. Amiloride hydrochloride tablets should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride hydrochloride, result in an increased ri

Ringkasan produk:

Amiloride Hydrochloride Tablets USP, 5 mg are yellow colored, may be spotted, round shaped, biconvex, uncoated tablets, debossed with "671" on one side and plain on the other side and are supplied as follows: NDC 57721-671-06 in bottle of 30 tablets NDC 57721-671-16 in bottle of 90 tablets NDC 57721-671-01 in bottle of 100 tablets NDC 57721-671-05 in bottle of 500 tablets NDC 57721-671-10 in bottle of 1000 tablets NDC 57721-671-30 in unit-dose blister cartons of 100 (10 X 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Cadila Healthcare Ltd. Baddi, India Distributed by: Windlas Inc. 325 Sharon Park Drive PMB # 202 Menlo Park, CA 94025 Rev.: 12/17

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET
WINDLAS BIOTECH 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
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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
hydrochloride has been shown to decrease the enhanced urinary
excretion of
magnesium which occurs when a thiazide or loop diuretic is used alone.
Amiloride
hydrochloride has potassium-conserving activity in patients receiving
kaliuretic-diuretic
agents.
Amiloride hydrochloride is not an aldosterone antagonist and its
effects are seen ev