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:

Padagis US LLC

INN (International Name):

AMILORIDE HYDROCHLORIDE

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 kaliuretic-diuretic agents in congestive heart failure or hypertension to: 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 anti-hypertensive 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. Amiloride HCl should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter). Amiloride HCl sh

Product summary:

Amiloride HCl Tablets, 5 mg, are off-white to light yellow, diamond-shaped, compressed tablets, embossed with "P291". They are supplied in bottles of 100 (NDC 0574-0292-01). Protect from moisture, freezing and excessive heat. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET
PADAGIS US LLC
----------
AMILORIDE HCL TABLETS, USP
RX ONLY
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 ClN
O•HCl•2H O and its
structural formula is:
Amiloride HCl is available for oral use as tablets containing 5 mg of
anhydrous amiloride
HCl. Each tablet contains the following inactive ingredients: calcium
phosphate, lactose,
magnesium stearate and starch
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 HCl has
been shown to decrease the enhanced urinary excretion of magnesium
which occurs
when a thiazide or loop diuretic is used alone. Amiloride HCl has
potassium-conserving
activity in patients receiving kaliuretic-diuretic agents.
Amiloride HCl is not an aldosterone antagonist and its effects are
seen even in the
absence of aldosterone.
Amiloride HCl 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.
6
8
7
2
Amiloride HCl usually begins to act within 2 hours after an oral dose.
Its effect on
electrolyte excretion reaches a peak between 6 an