AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

AMILORIDE HYDROCHLORIDE

Composição:

AMILORIDE HYDROCHLORIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 ed

Resumo do produto:

Amiloride hydrochloride and hydrochlorothiazide tablets are available containing 5 mg of anhydrous amiloride hydrochloride and 50 mg of hydrochlorothiazide. The tablets are scored, light orange, round tablets debossed with M577 on the scored side and the other side being blank. They are available as follows: STORE AT CONTROLLED ROOM TEMPERATURE 15°–30°C (59°–86°F). 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 REVISED MARCH 2003 AHCTZ:R11

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE - AMILORIDE
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
Like other potassium-conserving diuretic combinations, amiloride and
hydrochlorothiazide may
cause hyperkalemia (serum potassium levels greater than 5.5 mEq per
liter). In patients without
renal impairment or diabetes mellitus, the risk of hyperkalemia with
this combination product is
about 1 to 2 percent. This risk is higher in patients with renal
impairment or diabetes mellitus
(even without recognized diabetic nephropathy). Since hyperkalemia, if
uncorrected, is potentially
fatal, it is essential to monitor serum potassium levels carefully in
any patient receiving amiloride
hydrochloride and hydrochlorothiazide, particularly when it is first
introduced, at the time of
dosage adjustments, and during any illness that could affect renal
function.
DESCRIPTION
Amiloride hydrochloride and hydrochlorothiazide tablets combine the
potassium-conserving action of
amiloride hydrochloride with the natriuretic action of
hydrochlorothiazide.
Amiloride HCl is designated chemically as 3,5-diamino-6-chloro-_N_-
(diaminomethylene)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 (calculated on the
anhydrous basis) and 50 mg of hydrochlorothiazide. In addition, each
tablet contains the following
inactive ingredients: croscarmellose sodium, lactose (hydrous),
magnesium stearate, pregelatinized
starch, sodium lauryl sulfate, and FD&C Yellow #6 Aluminum Lake.
6
8
7
2
7
8
3
4
2
CLINICAL PHARMACOLOGY
Amilorid