ATORSTAT

What it is

ATORSTAT contains atorvastatin calcium trihydrate and is available in 10 mg, 20 mg, 40 mg and 80 mg tablet strengths. The tablets are white to off-white, elliptical, film-coated tablets. Atorvastatin is a synthetic lipid-lowering agent and an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of sterols, including cholesterol.

Approved indications

— Treatment of patients with hypercholesterolaemia as an adjunct to diet. — In hypertensive patients with multiple risk factors for coronary heart disease which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic coronary heart disease, to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.

Dosing overview

ATORSTAT can be administered within the dosage range of 10 mg to 80 mg per day as a single daily dose. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy and the patient's response. The majority of patients with primary hypercholesterolaemia and mixed dyslipidaemia are controlled with 10 mg atorvastatin once a day, with a therapeutic response evident within two weeks and maximum response usually achieved within four weeks. Atorvastatin can be taken at any time of the day, with or without food.

Key safety warnings

Moderate elevations of serum transaminases have been reported following therapy with atorvastatin. Persistent increases in serum transaminases greater than 3 times the upper limit of normal occurred in 0.7% of patients who received atorvastatin in clinical trials, with an incidence of 0.2%, 0.2%, 0.6% and 2.3% for 10 mg, 20 mg, 40 mg and 80 mg doses respectively. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Myopathy, defined as muscle ache or muscle weakness in conjunction with increases in creatine kinase values greater than 10 times the upper limit of normal, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin therapy should be discontinued if markedly elevated creatine kinase levels occur or if myopathy is diagnosed or suspected. Atorvastatin must not be co-administered with fusidic acid. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving concomitant fusidic acid and statins. A post-hoc analysis of a clinical study in patients without known coronary heart disease who had a recent stroke or transient ischaemic attack showed a higher incidence of haemorrhagic stroke in patients on atorvastatin 80 mg (55/2365, 2.3%) compared to placebo (33/2366, 1.4%). The increased risk of haemorrhagic stroke was observed in patients who entered the study with prior haemorrhagic stroke or prior lacunar infarct. The potential risk of haemorrhagic stroke should be carefully considered before initiating treatment with atorvastatin in patients with recent (1–6 months) stroke or transient ischaemic attack.

Contraindications

ATORSTAT is contraindicated in hypersensitivity to any component of this medication, active liver disease or unexplained persistent elevations of serum transaminases, and in pregnancy and lactation. ATORSTAT is also contraindicated in women of childbearing potential, unless on an effective contraceptive and highly unlikely to conceive. Concomitant use with fusidic acid hemihydrate and treatment with the hepatitis C antivirals glecaprevir/pibrentasvir are contraindicated.

PBS listing

ATORSTAT is registered on the Australian Register of Therapeutic Goods in 10 mg, 20 mg, 40 mg and 80 mg tablet strengths, first listed on 13 January 2022.

Regulatory history

ATORSTAT atorvastatin 10 mg, 20 mg, 40 mg and 80 mg tablets were first listed on the ARTG on 13 January 2022.