Fluvastatin Sodium 40 mg/1
fluvastatin · CAPSULE · Mylan Pharmaceuticals Inc.
Fluvastatin Sodium is a capsule containing fluvastatin at 40 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Fluvastatin Sodium
- Generic Name
- fluvastatin
- NDC Code (Product)
0378-8021- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 40 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090595
- Marketing Start
- 04/11/2012
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.
Aidapak Services, LLC
Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD73597_1, EXP: 5/31/2014.
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 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
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Fluvastatin sodium extended-release tablets 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 fluvastatin sodium extended-release tablets prior to administration. (2.1) Adults : The recommended starting dose is 80 mg (administered as one 80 mg fluvastatin sodium extended-release tablet 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. Fluvastatin sodium extended-release tablets are 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 fluvastatin sodium extended-release tablets orally once daily as a single dose, with or without food. Do not break, crush, or chew fluvastatin sodium extended-release tablets. Fluvastatin sodium extended-release tablet is only available as an 80 mg tablet. Fluvastatin sodium extended-release tablets cannot be titrated [see Dosage and Administration (2.2, 2.3)]. For patients that require a high-intensity statin or are una…
Contraindications
4 CONTRAINDICATIONS Fluvastatin sodium extended-release tablets are 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 fluvastatin sodium extended-release tablets. 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 fluvastatin sodium extended-release tablets (4)
Drug Interactions
7 DRUG INTERACTIONS Gemfibrozil : Avoid use with fluvastatin. (7.1) Cyclosporine and Fluconazole : Avoid use with fluvastatin. (7.1) Fibrates, Lipid-modifying doses (≥ 1 g/day) of Niacin, and Colchicine : Consider if the benefit of concomitant use with fluvastatin 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 fluvastatin is initiated. (7.2) Phenytoin : Monitor plasma phenytoin levels when fluvastatin treatment is initiated. (7.2) 7.1 Drug Interactions That Increase the Risk of Myopathy and Rhabdomyolysis with Fluvastatin 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 Warnings and…
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 fluvastatin sodium extended-release tablets and more than placebo are: influenza-like symptoms, sinusitis, dyspepsia, urinary tract infection, bronchitis, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 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 2,326 patients treated with fluvastatin (age range, …
Frequently Asked Questions
What is Fluvastatin Sodium used for?
Fluvastatin Sodium contains fluvastatin. It is a capsule taken oral. Consult your doctor for specific uses.
Is Fluvastatin Sodium a controlled substance?
Fluvastatin Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Fluvastatin Sodium?
The generic name for Fluvastatin Sodium is fluvastatin. There are 8 other brand versions of fluvastatin.
What is the NDC code for Fluvastatin Sodium 40 mg/1?
The NDC (National Drug Code) for Fluvastatin Sodium 40 mg/1 is 0378-8021, listed by Mylan Pharmaceuticals Inc..