AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Teva Pharmaceuticals USA, Inc.

INN (Jina la Kimataifa):

AMILORIDE HYDROCHLORIDE

Tungo:

AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

Amiloride hydrochloride and hydrochlorothiazide tablets, USP are available as: 5 mg/50 mg: Light yellow, round, scored, biconvex tablet. Debossed with 555 over 483 on the scored side and stylized barr on the other side. Each tablet contains 5 mg of anhydrous amiloride HCl, USP and 50 mg of hydrochlorothiazide, USP. 100 Tablets NDC 0555-0483-02 1000 Tablets NDC 0555-0483-05 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. Manufactured In Canada By:  Teva Canada Limited   Toronto, Canada M1B 2K9  Manufactured For:  Teva Pharmaceuticals   Parsippany, NJ 07054 Rev. D 12/2022

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- AMILORIDE
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
TEVA PHARMACEUTICALS USA, INC.
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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: C H CIN O•HCL•2H O 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:
6
8
7
2
C H CIN O S
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 wi