Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
AMILORIDE HYDROCHLORIDE (UNII: FZJ37245UC) (AMILORIDE - UNII:7DZO8EB0Z3), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
AMILORIDE HYDROCHLORIDE
AMILORIDE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Baca dokumen lengkapnya