Formulary
Fluvastatin: Indications, Dosing, Side Effects and Interactions
Statins competitively inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved in cholesterol synthesis, especially in the liver.
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Fluvastatin: Indications, Dosing, Side Effects and Interactions
Statins competitively inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved in cholesterol synthesis, especially in the liver.
Drug action
Statins competitively inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved in cholesterol synthesis, especially in the liver.
Indications and dose
**Adjunct to diet in primary hypercholesterolaemia or combined (mixed) hyperlipidaemia (types IIa and IIb)**
- **Adult** (By Mouth Using Immediate-Release Medicines): Initially 20-40 mg daily, dose to be taken in the evening, increased if necessary up to 80 mg daily in 2 divided doses, dose to be adjusted at intervals of at least 4 weeks.
- **Adult** (By Mouth Using Modified-Release Medicines): 80 mg daily, dose form is not appropriate for initial dose titration.
**Prevention of coronary events after percutaneous coronary intervention**
- **Adult** (By Mouth Using Immediate-Release Medicines): 80 mg daily.
- **Adult** (By Mouth Using Modified-Release Medicines): 80 mg daily, dose form is not appropriate for initial dose titration.
**Heterozygous familial hypercholesterolaemia for fluvastatin**
- **Child 9-17 years** (By mouth using immediate-release medicines): Initially 20 mg daily, dose to be taken in the evening, then adjusted in steps of 20 mg daily (max. per dose 40 mg twice daily), adjusted at intervals of at least 6 weeks; maximum 80 mg per day.
- **Child 9-17 years** (By mouth using modified-release medicines): 80 mg daily, dose form is not appropriate for initial dose titration.
Cautions
Risk factors for muscle toxicity, including myopathy or rhabdomyolysis Cautions, further information Muscle effects Muscle toxicity can occur with all statins, however the likelihood increases with higher doses and in certain patients. Statins should be used with caution in patients at increased risk of muscle toxicity. This includes the elderly, those with a personal or family history of muscular disorders, history of muscular toxicity or unexplained persistent muscle pain, history of liver disease, a high alcohol intake, known genetic polymorphisms-consult product literature, renal impairment, hypothyroidism, or those who undertake strenuous exercise. M See also Monitoring requirements . Hypothyroidism Hypothyroidism should be managed adequately before starting treatment with a statin.
Side effects
Common or very common Arthralgia; asthenia; constipation; diarrhoea; dizziness; flatulence; gastrointestinal discomfort; headache; muscle complaints; nausea; sleep disorders; thrombocytopenia Uncommon Alopecia; hepatic disorders; memory loss; pancreatitis; paraesthesia; sexual dysfunction; skin reactions; vomiting Rare or very rare Lupus-like syndrome; myopathy; peripheral neuropathy; tendon disorders Frequency not known Depression; diabetes mellitus (in those at risk); interstitial lung disease; neuromuscular dysfunction Side-effects, further information Muscle effects Although myalgia has been reported commonly in patients receiving statins, muscle toxicity truly attributable to statin use is rare. The risk of myopathy, myositis, and rhabdomyolysis associated with statin use is also rare. If muscle pain, weakness, or cramps occur during treatment, creatine kinase concentrations should be measured; if the concentration is more than 5 times the ULN (in the absence of strenuous exercise), treatment should be discontinued. If muscular symptoms are severe and cause daily discomfort, treatment discontinuation should be considered, even if creatine kinase concentrations are less than 5 times the ULN. If symptoms resolve and creatine kinase concentrations return to normal, the statin can be reintroduced, or introduction of an alternative statin can be considered, at the lowest dose and the patient monitored closely. Diabetes Statins should not be discontinued if there is an increase in the blood-glucose concentration as the benefits continue to outweigh the risks. Interstitial lung disease If patients develop symptoms such as dyspnoea, cough, and weight loss, they should seek medical attention. Side-effects For fluvastatin Rare or very rare Angioedema; face oedema; muscle weakness; sensation abnormal; vasculitis
Interactions
**Severe interactions:**
- Statins No clinically significant pharmacokinetic interactions were seen when ezetimibe was co-administered with atorvastatin, simvastatin, pravastatin, lovastatin, fluvastatin or rosuvastatin.
**Other interactions (24):**
- HMG CoA reductase inhibitors (Atorvastatin, Simvastatin, Fluvastatin): The risk of myopathy and rhabdomyolysis increases (dose-dependent) when fluconazole is coadministered with HMG-CoA reductase...
- HMG-CoA reductase inhibitors atorvastatin fluvastatin simvastatin Interaction not studied.
- Interactions to be considered The anticoagulant effect may be potentiated by concomitant administration of the following drugs: allopurinol; anabolic steroids; androgens; anti-arrhythmic...
- Pravastatin Fluvastatin Interaction not studied with any of the components of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Gilead.
- Fluvastatin or Pravastatin Fluvastatin, Pravastatin: No clinical relevant interaction expected.
- Fluvastatin is partially metabolised by CYP2C9.
Pregnancy
Statins should be avoided in pregnancy (discontinue 3 months before attempting to conceive) as congenital anomalies have been reported and the decreased synthesis of cholesterol possibly affects fetal development.
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
In general, manufacturers advise caution (risk of increased exposure); avoid in active disease or unexplained persistent elevations in serum transaminases.
Renal impairment
Dose adjustments Doses above 40 mg daily should be initiated with caution if creatinine clearance less than 30 mL/minute (limited information available), M see Prescribing in renal impairment .
Medicinal forms
Tablet,Capsule
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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