Rosuvastatin 5mg, 10mg, 15mg and 20mg oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of rosuvastatin containing 5mg, 10mg, 15mg and 20mg.
Drugs List
Therapeutic Indications
Uses
Homozygous familial hypercholesterolaemia: Adjunct to diet
Mixed dyslipidaemia (type IIb) - adjunct to diet
Primary hypercholesterolaemia (hyperlipidaemia type IIa): Adjunct to diet
Risk reduction of cardiovascular events
Dosage
Adults
Treatment of hypercholesterolaemia
Initially 5mg or 10mg once daily in both statin naive patients and those switched from another HMG CoA reductase inhibitor, increased if necessary at intervals of at least 4 weeks up to 20mg daily.
The dosage can be increased again after a further 4 weeks to 30mg. Maximum dose is 40mg once daily.
The 30mg or 40mg once daily dose, should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who have not achieved a full response to 20mg once daily and in whom routine follow up will be performed.
Specialist supervision is recommended when the 30mg or 40mg dose is initiated.
Prevention of cardiovascular events
20mg once daily.
Asian ancestry
These patients should always be started on a dose of 5mg once daily. Maximum dose is 20mg once daily.
Patients predisposed to myopathy
These patients should always be started on a dose of 5mg once daily. Maximum dose is 20mg once daily.
Elderly
Patients above 70 years old should be started with a dose of 5mg once daily. For titration details (See Dosage; Adult).
Children
Heterozygous familial hypercholesterolaemia
Children aged 6 to 10 years old
The usual starting dose is 5mg once daily.
The usual dose range is 5mg to 10mg orally once daily.
Children aged 10 to 18 years old
The usual starting dose is 5mg once daily.
The usual dose range is 5mg to 20mg orally once daily. Titration should be conducted according to the individual response and tolerability in paediatric patients.
Homozygous familial hypercholesterolaemia
Children aged 6 to 18 years old
A starting dose of 5mg to 10mg once daily depending on age, weight and prior statin use is advised. Titration to the maximum dose of 20mg once daily should be conducted according to the individual response and tolerability in paediatric patients.
The recommended maximum dose is 20mg once daily.
Patients with Renal Impairment
Moderate renal impairment (creatinine clearance 30ml/minute to 60ml/minute)
The recommended starting dose is 5mg daily and may be titrated to a maximum of 20mg daily.
Patients with Hepatic Impairment
No increase in systemic exposure to rosuvastatin was seen in patients with Child-Pugh scores of 7 or below. However, increased systemic exposure has been observed in patients with Child-Pugh scores of 8 and 9. In these patients an assessment of renal function should be considered.
Additional Dosage Information
Genetic polymorphisms
Patients with SLCO1B1 (OATP1B1) and/or ABCG2 (BCRP) genetic polymorphisms are at a higher risk of increased rosuvastatin exposure and therefore, a lower daily dose is recommended in these patients.
Dose adjustments due to interactions
Adults
Concurrent use of bezafibrate, ciprofibrate and fenofibrate
Initially 5mg daily. 40mg dose is contraindicated.
Concurrent use of clopidogrel
Initially 5mg daily. Maximum dose 20mg daily.
Concurrent use of elbasvir with grazoprevir
Initially 5mg daily. Maximum dose 10mg daily.
Concurrent use of sofosbuvir with velpatasvir
Maximum dose 10mg daily.
Concurrent use of teriflunomide
Reduce dose by half.
Concurrent use of glecaprevir with pibrentasvir
Maximum dose 5mg daily.
Concurrent use of regorafenib
Maximum dose 5mg daily.
Concurrent use of atazanavir boosted with ritonavir
Initially 5mg daily. Maximum dose 10mg daily.
Concurrent use of lopinavir boosted with ritonavir
Initially 5mg daily. Maximum dose 20mg daily.
Children under 18 years
Concurrent use of glecaprevir with pibrentasvir
Maximum dose 5mg daily.
Concurrent use of atazanavir boosted with ritonavir
Initially 5mg daily. Maximum dose 10mg daily.
Concurrent use of lopinavir boosted with ritonavir
Initially 5mg daily. For maximum daily dose consult product literature.
Administration
For those with swallowing difficulties, rosuvastatin capsules may be given with soft food. The capsule should be opened carefully and the granules sprinkled on one teaspoon of soft food. Do not chew the granules.
For those with a nasogastric tube in place, rosuvastatin capsules may be administered via syringe. The capsule should be opened carefully and the granules emptied into the syringe barrel, then add water. The syringe should be shaken vigorously for 15 seconds and then administered immediately through the nasogastric tube into the stomach. See product literature for further details.
Contraindications
Children under 6 years
Creatine kinase levels over 5 times upper limit of normal
Predisposition to renal failure secondary to rhabdomyolysis
Within 7 days of discontinuing systemic fusidic acid
Active liver disease
Breastfeeding
Elevated serum transaminases - if persistent and unexplained
Hepatic impairment - Child-Pugh score greater than or equal to 9
Myopathy
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Serum transaminases above 3 times upper limit of normal
Precautions and Warnings
Asian ancestry
Children aged 6 to 18 years
Family history of hereditary muscular disorders
Females of childbearing potential
High alcohol intake
Impaired glucose tolerance
Patients over 70 years
Predisposition to myopathy or rhabdomyolysis
SLCO1B1 (OATP1B1) genetic polymorphism
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment - Child-Pugh score between 8 and 9
Hereditary muscular disorder
History of hepatic impairment
History of muscular toxicity secondary to fibrates
History of muscular toxicity secondary to HMG-CoA reductase inhibitors
Lactose intolerance
Renal impairment - creatinine clearance 30-60ml/minute
Advise patient dizziness may affect ability to drive or operate machinery
Correct hypothyroidism before treatment
Exclude secondary causes of hypercholesterolaemia before treatment
Some formulations contain lactose
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 monitor for and report any skin changes
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 and do not restart if severe cutaneous adverse reactions occur
Discontinue if ALT level exceed 3 times the upper limit of normal & persist
Discontinue if AST level exceed 3 times the upper limit of normal & persist
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
Avoid antacids within 2 hours of dose
Dietary restrictions should be maintained
Female: Contraception required during and for 3 months after treatment
Statin therapy has been associated with the development of myalgia, myopathy and rhabdomyolysis, particularly in patients receiving higher than 20mg doses.
Do not measure creatine kinase levels following strenuous exercise or in the presence of other factors affecting creatine kinase levels. If creatine kinase is greater than 5 times the upper limit of normal (ULN) levels prior to treatment, re-measure 5 to 7 days later. If symptoms of myopathy resolve and levels of creatinine kinase reduce, treatment can be reinitiated at the lowest dose and with close monitoring.
Some evidence suggests that statins, as a class, raise blood glucose levels. In some patients, at a high risk of future diabetes, rosuvastatin 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
Pregnancy
Rosuvastatin is contraindicated during pregnancy.
Use of rosuvastatin during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of rosuvastatin during pregnancy. However, as cholesterol is essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy.
Lactation
Rosuvastatin is contraindicated during breastfeeding.
Use of rosuvastatin when breastfeeding is contraindicated by the manufacturer. Animal data reports levels of rosuvastatin in the breast milk, however the presence in human breast milk and its effects on exposed infants are unknown.
Side Effects
Abdominal pain
Acute renal failure
Angioedema
Arthralgia
Asthenia
Constipation
Cough
Creatine kinase increased
Depression
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspnoea
Gynaecomastia
Haematuria
Headache
Hepatitis
Hypersensitivity reactions
Immune mediated necrotizing myopathy
Increase of liver transaminases
Insomnia
Interstitial lung disease
Jaundice
Lupus erythematosus-like syndrome
Memory loss
Muscle rupture
Myalgia
Myopathy
Myositis
Nausea
Nightmares
Oedema
Pancreatitis
Peripheral neuropathy
Polyneuropathy
Precipitation of diabetes
Proteinuria
Pruritus
Rash
Rhabdomyolysis
Sexual dysfunction
Sleep disturbances
Stevens-Johnson syndrome
Tendon disorder
Tendon rupture
Thrombocytopenia
Urticaria
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2022
Reference Sources
Summary of Product Characteristics: Crestor 5mg, 10mg, 20mg and 40mg film-coated tablets. AstraZeneca UK Limited. Revised August 2021.
Summary of Product Characteristics: Rosuvastatin 5mg hard capsules. Sun Pharmaceutical Industries Europe B.V. Revised October 2021.
Summary of Product Characteristics: Rosuvastatin 10mg hard capsules. Sun Pharmaceutical Industries Europe B.V. Revised October 2021.
Summary of Product Characteristics: Rosuvastatin 20mg hard capsules. Sun Pharmaceutical Industries Europe B.V. Revised October 2021.
Summary of Product Characteristics: Rosuvastatin 15mg film-coated tablets. Zentiva UK Ltd. Revised November 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 June 2022.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.