국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
Unit Dose Services
SPIRONOLACTONE
SPIRONOLACTONE 50 mg
ORAL
PRESCRIPTION DRUG
Spironolactone is 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 is 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 high in this condition. Spi
Product: 50436-4477 NDC: 50436-4477-2 30 TABLET, FILM COATED in a BOTTLE
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED UNIT DOSE SERVICES ---------- SPIRONOLACTONE TABLETS USP RX ONLY 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 is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Spironolactone tablets, 25 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Spironolactone tablets, 50 mg and 100 mg contain the following inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide, and triacetin. 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 mineralocor 전체 문서 읽기