ROSUVASTATIN

Indications & Dose:

Primary hypercholesterolaemia (type IIaincluding heterozygous familial hypercholesterolaemia), mixed dyslipidaemia (type IIb), or homozygous familial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures

• BY MOUTH

Adult 18–69 years: Initially 5–10 mg once daily, then increased if necessary to 20 mg once daily, dose to be increased at intervals of at least 4 weeks

Adult (patients of Asian origin): Initially 5 mg once daily, then increased if necessary up to 20 mg once daily, dose to be increased at intervals of at least 4 weeks.

%Adult 70 years and over: Initially 5 mg once daily, then increased if necessary up to 20 mg once daily, dose to be increased at intervals of at least 4 weeks

Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia (type IIb), or homozygous familial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures and who have risk factors for myopathy or rhabdomyolysis

• BY MOUTH

Adult: Initially 5 mg once daily, then increased if necessary up to 20 mg once daily, dose to be increased at intervals of at least 4 weeks

Severe primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia (type IIb), or homozygous familial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures, in patients with high cardiovascular risk (under expert supervision) l

• BY MOUTH

Adult: Initially 5–10 mg once daily, increased if necessary to 20 mg once daily, then increased if necessary to 40 mg once daily, dose to be increased at intervals of at least 4 weeks Prevention of cardiovascular events in patients at high risk of a first cardiovascular event

•   BY MOUTH

Adult 18–69 years: 20 mg once daily

Adult (patients of Asian origin): Initially 5 mg once daily, then increased if necessary up to 20 mg once daily.  

Adult 70 years and over: Initially 5 mg once daily, then increased if necessary up to 20 mg once daily

Prevention of cardiovascular events in patients at high risk of a first cardiovascular event and with risk factors for myopathy or rhabdomyolysis  

• BY MOUTH

Adult: Initially 5 mg once daily, then increased if necessary up to 20 mg once daily

DOSE ADJUSTMENTS DUE TO INTERACTIONS

Initially 5mg once daily with concomitant fibrate increased if necessary to max. 20mg daily. For dose adjustments with concomitant atazanavir, clopidogrel, darunavir, dronedarone, eltrombopag, ezetimibe, itraconazole, lopinavir, or tipranavir, consult product literature. Maximum dose 5 mg with concomitant ombitasvir, paritaprevir, and ritonavir given with dasabuvir, but maximum 10mg daily with concomitant ombitasvir, paritaprevir, and ritonavir given without dasabuvir.

Contraindications:

Active liver disease; unexplained persistent elevations of serum transaminases; pregnancy and lactation 

Side Effects:

CNS: Headache, paresthesia

CV: Hypertension, angina pectoris, vasodilation, palpitation, arrhythmias

EENT: Pharyngitis, bronchitis, in~reased cough, flu syndrome, rhinitis, sinusitis, pneumonia

GI: Proteinuria, constipation, nausea, diarrhea, dyspepsia, gastroenteritis, gastritis, hepatitis, vomiting, flatulence, pancreatitis, periodontal abscess

GU: UTI, kidney failure, proteinuria

HEME: thrombocytopenia, leucopenia

METAB: diabetes mellitus, hyperglycemia, thyroid function abnormalities

MS: Myalgia, asthenia, back pain, arthritis, myasthenia, myopathy, rhabdomyolysis

RESP: Dyspnea, asthma

SKIN: Rash, pruritus, photosensitivity reaction, face edema, vesiculobullous rash, urticaria, angioedema

Cautions:

Precautions:

Liver function abnormality; alcohol abuse; history of liver disease; predisposing factors to myopathy (renal impairment, advanced age, and hypothyroidism, combined use with fibrates or niacin); 2-foldelevation in serum levels possible in patients of Japanese and Chinese ancestry - titrate dose accordingly; unexplained persistent proteinuria 

Interaction:

Drugs 

Cyclosporine: Increase in rosuvastatin mean Cmax and meanAUC m

Warfarin: Coadministration with stable warfarin therapy resuIted in clinically significant hypoprothrombinemia (INR>4)

Gemfibrozil: Increase in rosuvastatin mean Cmax and meanAUC m

Magnesium and aluminum containing antacids: Decreased absorption; separate by 2 hr

Warnings:

Adverse Effects:

Lactations:

Pregnancy category X; not recommended for nursing mothers

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: