Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
SPIRONOLACTONE
SPIRONOLACTONE 25 mg
ORAL
PRESCRIPTION DRUG
Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and Hydrochlorothiazide Tablets are Indicated for: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate. The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate. Aldosterone levels may be exceptionally high in this condition. Spironolactone and hydrochlorothiazide tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. For nephrotic patients when treatment of the und
Spironolactone and Hydrochlorothiazide Tablets are available containing 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. The tablets are ivory, round, biconvex tablets debossed with M above the score and 41 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 54868-0699-2 bottles of 30 tablets NDC 54868-0699-1 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for 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 REV JANUARY 2005 SPHZ:R16
Abbreviated New Drug Application
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE - SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET PHYSICIANS TOTAL CARE, INC. ---------- RX ONLY WARNING Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS). Spironolactone and hydrochlorothiazide should be used only in those conditions described under INDICATIONS AND USAGE. Unnecessary use of this drug should be avoided. Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension. Edema or hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant. DESCRIPTION Each tablet of spironolactone and hydrochlorothiazide contains 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. Spironolactone, an aldosterone antagonist, is 17-hydroxy-7α- mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula, molecular formula, and molecular weight: C H O S M.W. = 416.59 Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3,4-dihydro-2H-1,2,4- 24 32 4 benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula, molecular formula, and molecular weight: C H ClN O S M.W. = 297.75 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 25 mg of spironolactone and 25 mg of hydrochlorothiazide and the following inactive ingredients: colloidal silicon dioxide, D&lC yellow #10 aluminum lake HT, FD&C yellow #6 aluminum lake HT, lactose, magnesium stearate, microcrystalline cellulose, menthol, peppermint oil, sodium lauryl sulfate, sodium starch glycolate and starch. ACTIONS/CLINIC Lugege kogu dokumenti