fluvastatin sodium
Drug Details
- Generic Name
- fluvastatin sodium
- Brand Names
- Lescol XL, FLUVASTATIN SODIUM ER
- Application Number
- NDA021192
- Sponsor
- Sandoz Inc
- NDC Codes
- 2
- Dosage Forms
- TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- FLUVASTATIN SODIUM
Indications and Usage
1 INDICATIONS AND USAGE Fluvastatin sodium extended-release tablets are indicated: • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. • As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily. Fluvastatin sodium extended-release tablets are indicated ( 1 ): • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. • As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg