Clinical Pharmacology Details


ATORVASTATIN


View Drug Forms

Indications & Dose:

Primary hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures | Combined (mixed) hyperlipidaemia in patients who have not responded adequately to diet and other appropriate measures



Adult: Usual dose 10 mg once daily; increased if necessary up to 80 mg once daily, dose to be increased at intervals of at least 4 weeks


Heterozygous familial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures | Homozygous familial hypercholestrolaemia in patients who have not responded adequately to diet and other appropriate measures



Adult: Initially 10 mg once daily, then increased to 40 mg once daily, dose to be increased at intervals of at least 4 weeks; maximum 80 mg per day


Primary prevention of cardiovascular events in patients at high risk of a first cardiovascular event



Adult: 20 mg once daily, dose can be increased if necessary continued Secondary prevention of cardiovascular events



Adult: 80 mg once daily


DOSE ADJUSTMENTS DUE TO INTERACTIONS


Reduced dose required (max. 10mg daily) with concomitant ciclosporin, or tipranavir combined with ritonavir—seek specialist advice.Maximum dose of 40 mg once daily when combined with anion-exchange resin for heterozygous familial hypercholesterolaemia

Contraindications:

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


 

Side Effects:

CNS: Headache


CV: Migraine, palpitation, postural hypotension, syncope, vasodilation


EENT: Amblyopia, dry eyes, taste disturbances, tinnitus


GI: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastroenteritis, LFT abnormalities


HEME: Anemia, ecchymosis, petechia, thrombocytopenia


METAB: Hyperglycemia, increased creatinine phosphokinase


MS: Arthralgia, leg cramps, myalgia


SKIN: Pruritus, rash


MISC: Face edema, fever, flu-like syndrome, malaise, photosensitivity


 

Cautions:

Precautions:

Liver dysfunction


Pregnancy; not recommended for nursing mothers


 

Interaction:

Drugs 


Azole antifungals (fluconazole, itraconazole, ketoconazole, miconazole): Increased atorvastatin levels; increased risk of rhabdomyolysis


Bile acid sequestrants (cholestyramine, colestipol):25% reduction in atorvastatin plasma levels if coadministered


Cyclosporine: Concomitant administration increases risk of severe myopathy or rhabdomyolysis


Digoxin: Elevation of digoxin level (approximately 20%)


Erythromycin: Increased atorvastatin concentrations (approximately 40%); increased risk of rhabdomyolysis


Fibric acid: Increased risk of severe myopathy,especially with high statin doses


Nefazodone: Increased atorvastatin levels;increased risk of rhabdomyolysis


Niacin: Concomitant administration increases risk of severe myopathy or rhabdomyolysis


Oral contraceptives: Coadministration increases AUC for norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively


 


 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: