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Fluvastatin oral

Updated 2 Feb 2023 | Statins


Oral formulations of fluvastatin sodium.

Drugs List

  • DORISIN XL 80mg prolonged release tablet
  • fluvastatin 20mg capsules
  • fluvastatin 40mg capsules
  • fluvastatin 80mg 24 hour modified release tablets
  • NANDOVAR XL 80mg prolonged release tablet
  • SINFATIX XL 80mg prolonged release tablet
  • Therapeutic Indications


    Heterozygous familial hypercholesterolaemia: Adjunct to diet
    Mixed dyslipidaemia (type IIb) - adjunct to diet
    Primary hypercholesterolaemia (type IIa) resistant to diet
    Secondary prevention of coronary events post percut. coronary intervention



    Doses should be individualised according to baseline LDL-C levels.
    LDL-C reduction to less than 25%: initial dose 20mg in the evening.
    LDL-C reduction greater than 25%: initial dose 40mg in the evening.

    Maintenance dose: 20mg to 80mg daily as a single or divided doses.
    Dose adjustments should be made at 4 week intervals. Maximum dose is 80mg per day.

    Secondary prevention in coronary heart disease
    80mg once a day or 40mg twice a day.


    Children aged 9 to 18 years with heterozygous familial hypercholesterolaemia.

    Doses should be individualised according to baseline LDL-C levels
    Initial dose: 20mg once a day.
    Dose adjustments should be made at 6 week intervals. Maximum dose 80mg per day, administered as 80mg once daily or 40mg twice daily.

    The use of fluvastatin in combination with nicotinic acid, colestyramine, or fibrates in children and adolescents has not been investigated.


    Children under 9 years
    Creatine kinase levels over 5 times upper limit of normal
    Elevated serum transaminases - if persistent and unexplained
    Serum transaminases above 3 times upper limit of normal
    Severe hepatic impairment

    Precautions and Warnings

    Children aged 9 to 18 years
    Family history of hereditary muscular disorders
    Females of childbearing potential
    High alcohol intake
    Major surgery
    Patients over 70 years
    Severe trauma
    Within 7 days of discontinuing fusidic acid
    Glucose-galactose malabsorption syndrome
    Hereditary muscular disorder
    History of hepatic impairment
    History of muscular toxicity secondary to fibrates
    History of muscular toxicity secondary to HMG-CoA reductase inhibitors
    History of non-traumatic rhabdomyolysis
    Lactose intolerance
    Renal impairment - creatinine clearance below 30 ml/minute

    Homozygous familial hypercholesterolaemia patients unlikely to benefit
    Correct hypothyroidism before treatment
    Exclude secondary causes of hypercholesterolaemia before treatment
    Not all available brands are licensed for all age groups
    Some brands contain lactose
    Administer 2 hours before or > 4 hours after any bile acid sequestrant
    Exclude pregnancy prior to initiation of treatment
    Measure creatine kinase levels prior to treatment if risk of rhabdomyolysis
    Perform liver function tests before commencing therapy
    Monitor creatine kinase levels in patients at risk of rhabdomyolysis
    Monitor creatine kinase levels in patients reporting myalgia
    Monitor patients with existing or tendency towards diabetes mellitus
    Repeat liver function tests within 3 months and at 12 months
    Advise patient to report any symptoms of interstitial lung disease
    Advise patients to report muscle pain/tenderness/weakness
    Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
    Discontinue if myopathy is suspected
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if ALT or AST persistently exceed 3 x ULN
    Discontinue if creatine kinase levels >5 times upper limit of normal
    Discontinue if evidence of interstitial lung disease
    Discontinue if muscular symptoms are severe
    Not licensed for all indications in all age groups
    Dietary restrictions should be maintained
    Female: Contraception required during and for 3 months after treatment

    Patients with unexplained diffuse myalgias, muscle tenderness or muscle weakness, and/or marked elevation of creatine kinase (CK) should be considered for myositis, myopathy and rhabdomyolysis.

    There is no current evidence to require monitoring of plasma CK in asymptomatic patients. If patients require creatine kinase measurement do not measure following strenuous exercise or in the presence of other factors affecting CK levels. If CK levels are significantly elevated at baseline, they should be re-measured 5 to 7 days later. If they remain elevated do not start treatment.

    If creatinine kinase levels return to normal and symptoms of myopathy resolve, treatment can be reinitiated at the lowest dose under close monitoring.

    Some evidence suggests that statins raise blood glucose and in some patients at risk of diabetes may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (raised fasting glucose, raised body mass index at baseline, history of hypertension and raised triglycerides) should be monitored both clinically and biochemically according to national guidelines.

    Pregnancy and Lactation


    Fluvastatin is contraindicated during pregnancy.

    At the time of writing there is limited published data regarding the use of fluvastatin during pregnancy. The manufacturer does not recommend using fluvastatin during pregnancy.

    Schaefer (2015) suggests that statins used for primary prevention should be discontinued when planning a pregnancy or when pregnancy is diagnosed. However, for women with severe metabolic disease a decision should be made by weighing up the risks and benefits. After statin exposure during the first trimester, a detailed ultrasound should be offered to ascertain normal foetal development. Briggs (2015) suggests that due to the requirement of cholesterol and products synthesized from cholesterol for the development of the foetus the use of fluvastatin is contraindicated.


    Fluvastatin is contraindicated during breastfeeding.

    At the time of writing, there is limited data regarding the use of fluvastatin during breastfeeding. The manufacturer does not recommend breastfeeding whilst taking fluvastatin. It is expected that fluvastatin is excreted into human milk.

    Side Effects

    Abdominal pain
    Anaphylactic reaction
    Creatine kinase increased
    Disturbances of sensation
    Erectile dysfunction
    Facial oedema
    Hypersensitivity reactions
    Immune mediated necrotizing myopathy
    Increase of liver transaminases
    Interstitial lung disease
    Joint pain
    Lupus erythematosus-like syndrome
    Memory loss
    Muscle weakness
    Precipitation of diabetes
    Sexual dysfunction
    Skin reactions
    Sleep disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2019

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Cadaff XL 80mg prolonged-release tablets. Torrent Pharma (UK) Ltd. Revised April 2017.
    Summary of Product Characteristics: Dorisin XL prolonged-release tablets. Aspire Pharma Ltd. Revised February 2019.
    Summary of Product Characteristics: Fluvastatin capsules 20mg. Teva UK Ltd. Revised October 2018.
    Summary of Product Characteristics: Fluvastatin capsules 40mg. Teva UK Ltd. Revised October 2018.
    Summary of Product Characteristics: Fluvastatin capsules 20mg. Gen UK Ltd. Revised October 2017.
    Summary of Product Characteristics: Fluvastatin capsules 40mg. Gen UK Ltd. Revised October 2017.
    Summary of Product Characteristics: Lescol XL 80mg. Novartis Pharmaceuticals UK Ltd. Revised December 2018.
    Summary of Product Characteristics: Sinfatix XL 80mg Prolonged release Tablets. Accord Healthcare Ltd. Revised April 2016.

    Drug Safety Update. MHRA Volume 5, issue 6 January 2012.
    Available at
    Last accessed: 28 March 2019

    NAPOS: The Drug Database for Acute Porphyria
    Available at:
    Last accessed: 28 March 2019

    NICE Evidence Services Available at: Last accessed: 25 March 2019

    US national Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Fluvastatin. Last revised: 31 October 2018
    Last accessed: 26 March 2019

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