Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
Sandoz Inc
SPIRONOLACTONE
SPIRONOLACTONE 25 mg
ORAL
PRESCRIPTION DRUG
Spironolactone tablets, USP are indicated in the management of: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Aldosterone levels may be exceptionally high in this condition. Spironolactone is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. For nephrotic patients when treatm
Spironolactone tablets, USP, 25 mg are round, scored, film-coated, white tablets debossed GG85 on one side and plain on the reverse side. They are available for oral administration and supplied as: NDC 0781-1599-01 bottles of 100 NDC 0781-1599-05 bottles of 500 NDC 0781-1599-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED SANDOZ INC ---------- SPIRONOLACTONE TABLETS, USP WARNING Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS). Spironolactone should be used only in those conditions described under INDICATIONS AND USAGE. Unnecessary use of this drug should be avoided. DESCRIPTION Spironolactone tablets, USP for oral administration contain 25 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, starch (corn), titanium dioxide, and peppermint. 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 nephrotic syndrome. By competing with aldosterone for receptor sites, spironolactone provides effective therapy for the edema and ascites in those conditions. Spironolactone counteracts secondary aldosteronism induced by the volume depletion and associated sodium loss caused by active diuretic therapy. Przeczytaj cały dokument