Lescol XL 80 mg/1
fluvastatin sodium · TABLET, EXTENDED RELEASE · Sandoz Inc
Lescol XL is a tablet, extended release containing fluvastatin sodium at 80 mg/1, taken oral. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Lescol XL
- Generic Name
- fluvastatin sodium
- NDC Code (Product)
66758-211- Manufacturer
- Sandoz Inc
- Strength
- 80 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA021192
- Marketing Start
- 10/06/2000
Recall History
Novartis Pharmaceuticals Corp.
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LESCOL XL is 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. LESCOL XL is 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
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • LESCOL XL can be taken with or without food and may be taken at any time of the day. ( 2.1 ) • Do not break, crush or chew LESCOL XL tablets prior to administration. ( 2.1 ) • Adults : The recommended starting dose is 80 mg (administered as one 80 mg LESCOL XL once daily). ( 2.2 ) Children : The recommended dose is 80 mg once daily in pediatric patients 10 years of age and older who require 80 mg of fluvastatin. LESCOL XL is not recommended for dosage initiation in pediatric patients because the recommended starting dosage cannot be achieved with the available strength of 80 mg. ( 2.3 ) 2.1 Important Dosage Information • Take LESCOL XL tablets orally once daily as a single dose, with or without food. • Do not break, crush, or chew LESCOL XL tablets. • LESCOL XL is only available as an 80 mg tablet. LESCOL XL cannot be titrated [see Dosage and Administration (2.2, 2.3)] . • For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving LESCOL XL 80 mg daily, prescribe alternative LDL-C-lowering treatment. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating LESCOL XL. 2.2 Recommended Dos…
Contraindications
4 CONTRAINDICATIONS LESCOL XL is contraindicated in patients with: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)] . • Hypersensitivity to fluvastatin or any of the excipients in LESCOL XL. Hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome have been reported [see Adverse Reactions (6.2)] . • Acute liver failure or decompensated cirrhosis ( 4 ) • Hypersensitivity to fluvastatin or any excipient in LESCOL XL ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Gemfibrozil : Avoid use with LESCOL XL. ( 7.1 ) • Cyclosporine and Fluconazole : Avoid use with LESCOL XL. ( 7.1 ) • Fibrates, Lipid-modifying doses (≥ 1 g/day) of Niacin, and Colchicine : Consider if the benefit of concomitant use with LESCOL XL outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. ( 7.1 ) • Warfarin : Obtain an International Normalized Ratio (INR) before starting and frequently enough after initiation or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regular intervals. ( 7.2 ) • Glyburide : Monitor blood glucose levels when LESCOL XL is initiated. ( 7.2 ) • Phenytoin : Monitor plasma phenytoin levels when LESCOL XL treatment is initiated. ( 7.2 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with LESCOL XL Table 3 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with fluvastatin and instructions for preventing or managing them [see …
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)] • Hepatic Dysfunction [see Warnings and Precautions (5.3)] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4)] Most frequent adverse reactions occurring in ≥ 2.5% of subjects treated with LESCOL XL and more than placebo are: influenza-like symptoms, sinusitis, dyspepsia, urinary tract infection, bronchitis, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the fluvastatin capsule, clinical trials there were 2326 patients treated with fluvastatin (age range, 18 to 75 years, 44% women, 94% White,…
Frequently Asked Questions
What is Lescol XL used for?
Lescol XL contains fluvastatin sodium. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Lescol XL a controlled substance?
Lescol XL is not classified as a controlled substance by the DEA.
What is the generic name for Lescol XL?
The generic name for Lescol XL is fluvastatin sodium. There are 3 other brand versions of fluvastatin sodium.
What is the NDC code for Lescol XL 80 mg/1?
The NDC (National Drug Code) for Lescol XL 80 mg/1 is 66758-211, listed by Sandoz Inc.