AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Mylan Pharmaceuticals Inc.

INN (Међународно име):

AMILORIDE HYDROCHLORIDE

Састав:

AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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. This fixed combination drug is not indicated for the initial therapy of edema or hyper

Резиме производа:

Amiloride Hydrochloride and Hydrochlorothiazide Tablets, USP are available containing 5 mg of anhydrous amiloride hydrochloride, USP and 50 mg of hydrochlorothiazide, USP. The 5 mg/50 mg tablets are light orange, round, scored tablets debossed with M above the score and 577 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0577-01 bottles of 100 tablets NDC 0378-0577-05 bottles of 500 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 4/2020 AHCTZ:R13

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- AMILORIDE
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Amiloride hydrochloride and hydrochlorothiazide tablets, USP combine
the potassium-conserving
action of amiloride hydrochloride with the natriuretic action of
hydrochlorothiazide.
Amiloride hydrochloride is designated chemically as
3,5-diamino-6-chloro-_N_-(diamino-
methylene)pyrazinecarboxamide monohydrochloride, dihydrate. It has the
following structural formula:
C H CLN O•HCL•2H O MW = 302.12
Hydrochlorothiazide is designated chemically as
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide. It has the following structural formula:
C H CLN O S MW = 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. In addition,
each tablet contains the following
inactive ingredients: croscarmellose sodium, FD&C Yellow No. 6
Aluminum Lake, lactose
monohydrate, magnesium stearate, pregelatinized starch (corn), and
sodium lauryl sulfate.
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
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