国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Spironolactone (UNII: 27O7W4T232) (Spironolactone - UNII:27O7W4T232)
Preferred Pharmaceuticals Inc.
Spironolactone
Spironolactone 25 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
Spironolactone tablets, USP are supplied as follows: Spironolactone tablets 25 mg, white, round, unscored, debossed MP 35 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE [ENTER DRUG NAME] SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR [ENTER DRUG NAME]. INITIAL U.S. APPROVAL: [ENTER YEAR] RECENT MAJOR CHANGES Click here to enter Recent Major Changes SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 5/2019 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING 1 INDICATIONS AND USAGE Hypokalemia 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.2 Abuse 9.3 Dependence 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION 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. 1 INDICATIONS AND USAGE 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 阅读完整的文件