国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Spironolactone tablets are indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone tablets are usually administered in conjunction with other heart failure therapies. Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require mor
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, supplied as: Bottle of 100 Tablets NDC 59746-216-01 Bottle of 500 Tablets NDC 59746-216-05 Bottle of 1,000 Tablets NDC 59746-216-10 Spironolactone Tablets, USP 50 mg are brown colored, round, biconvex, film-coated tablets debossed with ‘TL 217’ on one side and scored on the other side, supplied as: Bottle of 100 Tablets NDC 59746-217-01 Bottle of 500 Tablets NDC 59746-217-05 Spironolactone Tablets, USP 100 mg are brown colored, round, biconvex, film-coated tablets debossed with ‘TL 218’ on one side and scored on the other side, supplied as: Bottle of 100 Tablets NDC 59746-218-01 Bottle of 500 Tablets NDC 59746-218-05 Protect from light. Dispense in tight, light-resistant, child resistant container as defined in the USP. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SPIRONOLACTONE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SPIRONOLACTONE TABLETS. SPIRONOLACTONE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1960 INDICATIONS AND USAGE Spironolactone tablets are aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1) Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2) The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3). Treatment of primary hyperaldosternism for: (1.4) Short-term preoperative treatment Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia DOSAGE AND ADMINISTRATION Heart Failure: Initiate treatment at 25 mg once daily (2.2). Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses (2.3). Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses (2.3). Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient (2.4). DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg, and 100 mg (3) CONTRAINDICA 阅读完整的文件