AMILORIDE HYDROCHLORIDE- 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:

Rising Pharmaceuticals, Inc

INN (International Name):

AMILORIDE HYDROCHLORIDE

Composition:

AMILORIDE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 tablets have little additive diuretic or antihypertensive effect when added to a thiazide diuretic. Amiloride HCl 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 HCl tablets, result in an increas

Product summary:

Each yellow round compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “ Σ ” on one side and “5” on the other. They are available in bottles of 100’s (NDC ##64980-151-01). Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Manufactured by: Sigmapharm Laboratories, LLC Bensalem, PA 19020 OS005-02 REV. 0209

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET
RISING PHARMACEUTICALS, INC
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AMILORIDE HYDROCHLORIDE TABLETS, USP
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: corn starch,
crospovidone, lactose, magnesium
stearate, microcrystalline cellulose and povidone.
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.
Amiloride usually begins to act within 2 hours after an oral dose. Its
effect on electrolyte exc