Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
Avera McKennan Hospital
SPIRONOLACTONE
SPIRONOLACTONE 25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET AVERA MCKENNAN HOSPITAL ---------- SPIRONOLACTONE TABLETS, USP WARNING Spironolactone Tablets have been shown to be a tumorigen in chronic toxicity studies in rats (see _Precautions_). Spironolactone Tablets should be used only in those conditions described under _Indications and Usage. _Unnecessary use of this drug should be avoided. DESCRIPTION Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ- lactone acetate, which has the following structural formula: Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow # 6. ACTIONS / CLINICAL PHARMACOLOGY _Mechanism of action: _Spironolactone is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents that act more proximally in the renal tubule. _Aldosterone antagonist activity: _Increased levels of the mineralocorticoid, aldosterone, are present in primary and secondary hyperaldosteronism. Edematous states in which secondary aldosteronism is usually involved include congestive heart failure, hepatic cirrhosis, and the nephrotic syndrome. By competing with aldosterone for receptor sites, spironolactone provides effective the Przeczytaj cały dokument