País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
Blenheim Pharmacal, Inc.
SPIRONOLACTONE
SPIRONOLACTONE 25 mg
ORAL
PRESCRIPTION DRUG
Spironolactone tablets, USP are indicated in the management of: Primary hyperaldosteronism for: - Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. - Short-term preoperative treatment of patients with primary hyperaldosteronism. 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 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). Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edema
Spironolactone Tablets, USP 25 mg are white, film-coated, round tablets, debossed “AN” above “511” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-511-03 Bottles of 60: NDC 65162-511-06 Bottles of 90: NDC 65162-511-09 Bottles of 100: NDC 65162-511-10 Bottles of 500: NDC 65162-511-50 Bottles of 1000: NDC 65162-511-11 100 (10 x 10) Blister packs: NDC 65162-511-60 (Carton of 100 unit doses in blister packs, 10 cards of 10 tablets each) Spironolactone Tablets, USP 50 mg are yellow, film-coated, round tablets, debossed “AN” bisect “514” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-514-03 Bottles of 60: NDC 65162-514-06 Bottles of 90: NDC 65162-514-09 Bottles of 100: NDC 65162-514-10 Bottles of 500: NDC 65162-514-50 Bottles of 1000: NDC 65162-514-11 100 (10 x 10) Blister packs: NDC 65162-514-60 (Carton of 100 unit doses in blister packs, 10 cards of 10 tablets each) Spironolactone Tablets, USP 100 mg are beige, film-coated, round tablets, debossed “AN” on above bisect and “515” below bisect on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-515-03 Bottles of 60: NDC 65162-515-06 Bottles of 90: NDC 65162-515-09 Bottles of 100: NDC 65162-515-10 Bottles of 500: NDC 65162-515-50 Bottles of 1000: NDC 65162-515-11 100 (10 x 10) Blister packs: NDC 65162-515-60 (Carton of 100 unit doses in blister packs, 10 cards of 10 tablets each) 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 BLENHEIM PHARMACAL, INC. ---------- 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 th Leia o documento completo