Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Mylan Institutional Inc.
SPIRONOLACTONE
SPIRONOLACTONE 25 mg
ORAL
PRESCRIPTION DRUG
Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, 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: Edematous conditions for patients with: Congestive heart failure: - 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. Cirrhosis of the liver accompanied by edema and/or ascites: - Aldosterone levels may be exceptionally high in this cond
Spironolactone and Hydrochlorothiazide Tablets, USP are available containing 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. The 25 mg/25 mg tablets are ivory, round, unscored tablets debossed with M over 41 on one side of the tablet and blank on the other side. They are available as follows: NDC 42292-017-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12688 9/21
Abbreviated New Drug Application
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE- SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET MYLAN INSTITUTIONAL INC. ---------- 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. = 416.57 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-2 _H_-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula, molecular formula and molecular weight: 24 32 4 C H ClN O S M.W. = 297.74 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, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, L-menthol, microcrystalline cellulose, peppermint oil, sodium lauryl sulfate and sodium starch glycolate (potato). ACTIONS/CLINICAL PHARMACOLOGY MECHANISM OF ACTION Spironolactone and hydrochlorothiazide tablets are a combination of two diuretic agents with different but complementary mechanisms and sites of action, thereby providing additive diuretic and antihypertensive effects. Additionally, the spironolactone component helps to minimize the potassium loss characteristically induced by the thiazide component. The diuretic effect of spironolactone is mediated through its action as a specific pharmacologic antagonist of aldosterone, primarily by competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Hyd Lestu allt skjalið