国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
NuCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Spironolactone tablets are indicated in the management of: Primary hyperaldosteronism for: 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). 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. Spironolactone tablets are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Cirrhosis of the liver accompanied by edema and/or ascites : Aldosterone levels may be exceptionally hi
Spironolactone Tablets, USP 25 mg are brown colored, round, biconvex, film-coated tablets debossed with 'TL 216' on one side and plain on the other side. Bottle of 30 NDC 68071-3112-3 Bottle of 60 NDC 68071-3112-6 Bottle of 90 NDC 68071-3112-9 Bottles of 120 NDC 68071-3112-1 Bottles of 180 NDC 68071-3112-8 For more information, call 1-800-313-4623. Protect from light. Dispense in tight, light-resistant, child resistant container as defined in the USP. Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Rx Only Manufactured by: Jubilant Generics Limited Roorkee - 247661, India Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised: February/2015
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED NUCARE PHARMACEUTICALS, 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 oral tablets contain 25 mg, 50 mg, or 100 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 USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, iron oxide red, iron oxide yellow and iron oxide black. 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. Spiro 阅读完整的文件