AMILORIDE HYDROCHLORIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Carilion Materials Management

INN (nume internaţional):

AMILORIDE HYDROCHLORIDE ANHYDROUS

Compoziție:

AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic 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 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). 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. Hyperkalemia Amiloride HCl should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter). Antik

Rezumat produs:

Product: 68151-0162 NDC: 68151-0162-0 1 TABLET in a PACKAGE

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

AMILORIDE HYDROCHLORIDE- AMILORIDE HYDROCHLORIDE TABLET
CARILION MATERIALS MANAGEMENT
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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.
Amiloride usually begins to act