Fluvastatin

Fluvastatin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2], Sheng Shi, M.D. [3]

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Overview

Fluvastatin is a HMG-COA Reductase Inhibitor that is FDA approved for the {{{indicationType}}} of Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia, Secondary Prevention of Cardiovascular Disease. Common adverse reactions include indigestion, nausea, headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Fluvastatin Tablet

• Dose range: 20 mg to 80 mg/ day.
• LESCOL/LESCOL XL can be administered orally as a single dose, with or without food.
• Do not break, crush or chew LESCOL XL tablets or open LESCOL capsules prior to administration.
• Do not take two LESCOL 40 mg capsules at one time.
• Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.
• For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one capsule in the evening, 80 mg as one LESCOL XL tablet administered as a single dose at any time of the day or 80 mg in divided doses of the 40 mg capsule given twice daily. For patients requiring LDL-C reduction to a goal of <25% a starting dose of 20 mg may be used.

Adult Patients with Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

• Indication

• as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
• as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:

• LDL-C remains ≥ 190 mg/dL or
• LDL-C remains ≥ 160 mg/dL and:

there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.

This image is provided by the National Library of Medicine.

Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals.

• Dosing information (LESCOL XL tablet)

• 80 mg PO qd at any time of the day.

• Dosing information (LESCOL capsule)

• Recommended starting dosage for LESCOL:

• 40 mg PO qd in the evening
• or 40 mg PO bid
• Do not take two LESCOL 40 mg capsules at one time.

Pediatric Patients (10-16 years of age) with Heterozygous Familial Hypercholesterolemia

• Dosing information (capsule)

• Recommended starting dosage: 20 mg PO qd , up to a maximum daily dose administered either as LESCOL capsules 40 mg PO bid
• Doses should be individualized according to the goal of therapy [see NCEP Pediatric Panel Guidelines and CLINICAL STUDIES (14)]1.

• Dosing information (tablet)

• 80 mg PO qd
• Doses should be individualized according to the goal of therapy [see NCEP Pediatric Panel Guidelines and CLINICAL STUDIES (14)]1.

Use with Cyclosporine

• Do not exceed a dose of 20 mg b.i.d. LESCOL in patients taking cyclosporine [see Drug Interactions 7.1].

Use with Fluconazole

• Do not exceed a dose of 20 mg b.i.d. LESCOL in patients taking fluconazole [see Drug Interactions 7.2].

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Acute coronary syndrome

• Dosing information

• Higher doses 17000936

Prophylaxis treatment of Atrial fibrillation

• Dosing information

• Not applicable 18242276

Prophylaxis treatment of Primary Cardiovascular event risk

• Dosing information

• Not applicable 17130382

Reduction of Cardiovascular event risk in patients with renal impairment

• Dosing information

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Fluvastatin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Fluvastatin sandbox in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Fluvastatin sandbox in pediatric patients.

Contraindications

There is limited information regarding Fluvastatin Contraindications in the drug label.

Warnings

There is limited information regarding Fluvastatin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Fluvastatin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Fluvastatin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Fluvastatin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Fluvastatin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluvastatin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fluvastatin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fluvastatin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Fluvastatin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Fluvastatin in geriatric settings.

Gender

There is no FDA guidance on the use of Fluvastatin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fluvastatin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fluvastatin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fluvastatin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fluvastatin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fluvastatin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Fluvastatin Administration in the drug label.

Monitoring

There is limited information regarding Fluvastatin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Fluvastatin and IV administrations.

Overdosage

There is limited information regarding Fluvastatin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Fluvastatin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Fluvastatin Mechanism of Action in the drug label.

Structure

There is limited information regarding Fluvastatin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Fluvastatin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Fluvastatin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Fluvastatin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Fluvastatin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Fluvastatin How Supplied in the drug label.

Storage

There is limited information regarding Fluvastatin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Fluvastatin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Fluvastatin sandbox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fluvastatin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Fluvastatin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.