Rosuvastatin: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
Rosuvastatin: clinical details
Prescribing considerations
- Assess cardiovascular indication, lipid profile, secondary causes of dyslipidaemia and modifiable risk factors.
- Review renal and hepatic function, alcohol intake, thyroid disease, previous statin or fibrate muscle toxicity, interacting medicines and other myopathy risk factors.
- Systemic exposure is increased in many patients of Asian ancestry and with certain SLCO1B1 or ABCG2 genotypes; product-specific prescribing restrictions apply.
- Paediatric treatment should be specialist-led.
- The oral solution contains ethanol; consider age, liver disease, pregnancy, epilepsy and concurrent ethanol- or propylene-glycol-containing medicines.
Contraindications and cautions
- Hypersensitivity to rosuvastatin or product excipients
- Active liver disease or unexplained persistent transaminase elevation exceeding the product threshold
- Severe renal impairment
- Existing myopathy
- Concomitant ciclosporin
- Concomitant sofosbuvir/velpatasvir/voxilaprevir
- Pregnancy, and breastfeeding according to selected product information
Monitoring
- Check lipid response and adherence after initiation or treatment changes.
- Check liver function before treatment and after initiation; investigate symptoms suggesting hepatic injury.
- Measure CK before treatment only when clinically indicated by myopathy risk; check promptly if unexplained muscle symptoms occur. Routine CK monitoring in asymptomatic patients is not recommended.
- Monitor renal function where impairment or increased exposure is a concern.
- Monitor INR when rosuvastatin treatment changes in a patient taking a vitamin K antagonist.
- In paediatric patients, include growth and pubertal development in specialist follow-up.
Clinical pharmacology
Rosuvastatin is a hydrophilic, transporter-dependent HMG-CoA reductase inhibitor acting mainly in the liver. It undergoes limited CYP metabolism, is largely excreted unchanged in faeces and has an elimination half-life of about 19 hours.
Formulation and product differences
- Film-coated tablets are swallowed and selected products contain lactose.
- Enebium is an orodispersible tablet that disintegrates on the tongue and may be swallowed with or without water.
- The oral solution is supplied with an oral syringe and contains ethanol; it should not be mixed with other medicines unless compatibility is established.
- Selected hard capsules may be swallowed intact, opened onto specified soft food without chewing the granules, or administered through a compatible nasogastric tube according to the product information.
- Excipients, storage instructions and suitability for manipulation differ between products; consult the exact product information.
Rosuvastatin preparations and strengths
Capsule
Route: Oral
Strengths: 5 mg, 10 mg, 20 mg, 40 mg
Dispersible tablet
Route: Oral
Strengths: 5 mg, 10 mg
Rosuvastatin interactions
Check all prescribed, non-prescribed and herbal medicines with a pharmacist or prescriber. Important examples include:
Ciclosporin
Markedly increases rosuvastatin exposure; concomitant use is contraindicated.
Sofosbuvir/velpatasvir/voxilaprevir
Markedly increases rosuvastatin exposure; concomitant use is contraindicated.
Some HIV or hepatitis antiviral combinations
May substantially increase rosuvastatin exposure and muscle-toxicity risk, requiring specialist review.
Gemfibrozil and other fibrates
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.