AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMILORIDE HYDROCHLORIDE (UNII: FZJ37245UC) (AMILORIDE - UNII:7DZO8EB0Z3), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

A-S Medication Solutions

INN (International Name):

AMILORIDE HYDROCHLORIDE

Composition:

AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, 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 and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects. The fixed combination drug is not indicated for the initial therapy of edema or hypert

Product summary:

Product: 50090-0513 NDC: 50090-0513-1 30 TABLET in a BOTTLE NDC: 50090-0513-0 28 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- AMILORIDE
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
A-S MEDICATION SOLUTIONS
----------
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS USP
5 MG/50 MG
RX ONLY
DESCRIPTION
Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP combine
the potassium-
conserving action of amiloride hydrochloride with the natriuretic
action of
hydrochlorothiazide.
Amiloride HCl, USP is designated chemically as
_N_-amidino-3,5,-diamino-6-chloropyrazine-
carboxamide monohydrochloride dihydrate and its structural formula is:
C6H8CIN7O•HCL•2H2O M.W. 302.12
Hydrochlorothiazide, USP is designated chemically as
6-chloro-3,4-dihydro-2_H_-1, 2, 4-
benzo-thiadiazine-7-sulfonamide 1, 1-dioxide. Its structural formula
is:
C7H8CIN3O4S2 M.W. 297.74
It is a white, or practically white, crystalline powder which is
slightly soluble in water, but
freely soluble in sodium hydroxide solution.
Each tablet, for oral administration, contains 5 mg of amiloride
hydrochloride, USP
(calculated on the anhydrous basis) and 50 mg of hydrochlorothiazide,
USP.
INACTIVE INGREDIENTS: Croscarmellose sodium, D&C yellow no. 10
(aluminum lake),
lactose monohydrate, magnesium oxide, magnesium stearate,
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
Amiloride hydrochloride and hydrochlorothiazide tablets provide
diuretic and
antihypertensive activity (principally due to the hydrochlorothiazide
component), while
acting through the amiloride component to prevent the excessive
potassium loss that
may occur in patients receiving a thiazide diuretic. Due to its
amiloride component, the
urinary excretion of magnesium is less with amiloride and
hydrochlorothiazide than with
a thiazide or loop diuretic used alone (see PRECAUTIONS). The onset of
the diuretic
action of this product is within 1 to 2 hours and this action appears
to be sustained for
approximately 24 hours.
AMILORIDE HYDROCHLORIDE
Amiloride Hydrochloride is a potassium-conserving (antikaliuretic)
drug that possesses
weak (compared with thiazide diu