Oral
Mixed dyslipidaemia
Adult: Dosage is individualised based on treatment goals, patient response and clinical practice guidelines. Initially, 5 or 10 mg once daily; may increase after 4 weeks if necessary. Usual Max: 20 mg once daily; a Max of 40 mg once daily may be used only in patients with severe hypercholesterolaemia at high CV risk who do not achieve the target cholesterol concentration at lower doses and who do not have risk factors for adverse effects. Patients with homozygous familial hypercholesterolaemia may be started on 20 mg once daily. Dosage may be increased at intervals of 2-4 weeks.
Child: Heterozygous familial hypercholesterolaemia: Initially, 5 mg once daily. Usual dose range: 6-9 years 5-10 mg once daily; 10-17 years 5-20 mg once daily. Familial homozygous hypercholesterolaemia: 6-17 years Initially, 5 or 10 mg once daily, depending on age, weight and prior statin use, may titrate dose up to Max of 20 mg once daily according to individual response and tolerability, and depending on treatment recommendations.
Elderly: >70 years Initially, 5 mg once daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | Contraindicated. |
30-60 | Initially, 5 mg once daily (Max: 20 mg once daily). |
Oral
Hypercholesterolaemia
Adult: Dosage is individualised based on treatment goals, patient response and clinical practice guidelines. Initially, 5 or 10 mg once daily; may increase after 4 weeks if necessary. Usual Max: 20 mg once daily; a Max of 40 mg once daily may be used only in patients with severe hypercholesterolaemia at high CV risk who do not achieve the target cholesterol concentration at lower doses and who do not have risk factors for adverse effects. Patients with homozygous familial hypercholesterolaemia may be started on 20 mg once daily. Dosage may be increased at intervals of 2-4 weeks.
Child: Heterozygous familial hypercholesterolaemia: Initially, 5 mg once daily. Usual dose range: 6-9 years 5-10 mg once daily; 10-17 years 5-20 mg once daily. Familial homozygous hypercholesterolaemia: 6-17 years Initially, 5 or 10 mg once daily, depending on age, weight and prior statin use, may titrate dose up to Max of 20 mg once daily according to individual response and tolerability, and depending on treatment recommendations.
Elderly: >70 years Initially, 5 mg once daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | Contraindicated. |
30-60 | Initially, 5 mg once daily (Max: 20 mg once daily). |
Oral
Prophylaxis of cardiovascular events in high-risk patients
Adult: 20 mg once daily.
Elderly: >70 years Initially, 5 mg once daily.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | Contraindicated. |
30-60 | Initially, 5 mg once daily (Max: 20 mg once daily). |
Special Populations: Patients of Asian ancestry; those with predisposing factors to myopathy (e.g. hypothyroidism, personal or familial history of hereditary muscular disorders; alcohol abuse): Initially, 5 mg once daily. 40 mg dose is contraindicated. Patients receiving concomitant therapy: Ciclosporin: Avoid use. If use cannot be avoided, Max rosuvastatin dose is 5 mg once daily. Gemfibrozil: Avoid use. If use cannot be avoided, initiate rosuvastatin at 5 mg once daily. Max: 10 mg once daily. Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir: Initiate rosuvastatin at 5 mg once daily. Max: 10 mg once daily. Pharmacogenomics: The SLCO1B1 gene, which encodes the transporter protein OATP1B1, and the efflux transporter ABCG2, both play a role in the disposition of rosuvastatin and mediate the hepatic uptake of statins. Genetic polymorphism in SLCO1B1 or ABCG2 may affect the plasma concentrations of rosuvastatin. rs4149056 (SLCO1B1) Patient with CC or CT genotype may have higher plasma concentrations of rosuvastatin but no change in LDL-cholesterol (LDL-C) levels has been noted. Other genetic and clinical factors may also influence the metabolism and response of the patient to rosuvastatin. Patient with TT genotype may have lower plasma concentrations of rosuvastatin but no change in LDL-C levels has been noted. Other genetic and clinical factors may also influence the metabolism and response of the patient to rosuvastatin. rs2231142 (ABCG2) Patient with GG genotype may have 1) lower plasma concentrations of rosuvastatin 2) reduced response to treatment as determined by a lower reduction in LDL-C. Other genetic and clinical factors may also influence a patient's response to rosuvastatin treatment and pharmacokinetics. Patient with GT genotype may have 1) lower plasma concentrations of rosuvastatin 2) reduced response to treatment as determined by a lower reduction in LDL-C, or may have 1) higher plasma concentrations of rosuvastatin 2) better response to treatment as determined by a higher reduction in LDL-C. Other genetic and clinical factors may also influence a patient's response to rosuvastatin treatment and pharmacokinetics. Patient with TT genotype may have 1) higher plasma concentrations of rosuvastatin 2) better response to treatment as determined by a higher reduction in LDL-C. Other genetic and clinical factors may also influence a patient's response to rosuvastatin treatment and pharmacokinetics.