Fluvastatin


Concise Prescribing Info
Indications/Uses
Hyperlipidaemias.
Dosage/Direction for Use
Adult : PO Initial: 20-40 mg once daily in the evening, may increase at intervals of at least 4 wk. Max: 80 mg/day.
Dosage Details
Oral
Hyperlipidaemias
Adult: Initially, 20-40 mg once daily in the evening, may increase at intervals of 4 wk to max 80 mg/day.
Child: Heterozygous familial hypercholesterolaemia: 9-16 yr 20 mg once daily. If necessary, may increase dose at 6-wkly intervals to 40 mg bid or 80 mg once daily as modified-release.
Renal Impairment
Mild to moderate: No dosage adjustment needed.
Administration
May be taken with or without food.
Contraindications
Acute liver disease or unexplained persistent elevation of serum aminotransferases. Pregnancy and lactation. Avoid admin of two 40 mg conventional cap at one time.
Special Precautions
History of liver disease and hereditary muscular disorders; high alcohol intake; patients who undergone major surgery and under immunosuppressive agents. Manage hypothyroidism prior to treatment. Severe renal impairment.
Adverse Reactions
Headache, nausea, abdominal pain, dyspepsia, diarrhoea, bronchitis, sinusitis, insomnia, fatigue, myopathy, myalgia and UTI. Increased blood creatinine phosphokinase and transaminase.
Potentially Fatal: Severe rhabdomyolysis w/ acute renal failure. Hepatitis, pancreatitis. Rare: Stevens-Johnson syndrome, anaphylaxis, toxic epidermal necrolysis.
MonitoringParameters
Monitor creatine kinase (CK) periodically and LFT. Discontinue if there is significant or persistent increase in CK levels, serum aminotransferase levels or evidence of myopathy.
Overdosage
Management: Symptomatic and supportive treatment.
Drug Interactions
Bleeding and increased prothrombin time w/ coumarin anticoagulants. May increase the risk of myopathy rhabdomyolysis w/ HIV protease inhibitors, colchicine, bezafibrate, ciprofibrate or niacin (nicotinic acid), ciclosporin and fluconazole. Reduced bioavailability w/ concomitant rifampicin.
Action
Description: Fluvastatin acts by competitively inhibiting HMG-CoA reductase, the enzyme for cholesterol synthesis. It reduces total cholesterol, triglycerides, LDL and VLDL concentrations in plasma. It also increases HDL concentrations.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the GI tract. Absolute bioavailability: Approx 24%. Time to peak plasma concentration: Cap: 1 hr; extended release tab: 3 hr.
Distribution: Volume of distribution: 0.35 L/kg. Plasma protein binding: >98%.
Metabolism: Undergoes extensive first-pass hepatic metabolism. Converted to inactive and active metabolites by oxidative metabolism mainly via CYP2C9 isoenzyme and in small amount via CYP3A4 isoenzyme.
Excretion: Via faeces (approx 90%) and urine (approx 6%). Elimination half-life: Cap: <3 hr; extended release tab: 9 hr.
Storage
Store between 15-30°C.
References
Anon. Fluvastatin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/10/2013.

Buckingham R (ed). Fluvastatin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/10/2013.

Joint Formulary Committee. Fluvastatin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/10/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Fluvastatin Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 12/10/2013.

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury. U.S. FDA. https://www.fda.gov/. Accessed 12/10/2013.

Disclaimer: This information is independently developed by MIMS based on Fluvastatin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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