ATOMED

What it is

ATOMED is atorvastatin calcium trihydrate, 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 (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD, to reduce the risk of non-fatal myocardial infarction (MI) and non-fatal stroke.

Dosing overview

ATOMED can be administered within the dosage range of 10 mg to 80 mg/day as a single daily dose. The majority of patients with primary hypercholesterolaemia and mixed dyslipidaemia are controlled with 10 mg atorvastatin once a day. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy and the patient's response, and lipid levels should be re-analysed within 4 weeks after initiation and/or upon titration. 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, with persistent increases >3 times the upper limit of normal occurring in 0.7% of patients in clinical trials, with incidence varying by dose from 0.2% at 10 mg to 2.3% at 80 mg. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Uncomplicated myalgia has been reported in atorvastatin-treated patients, and myopathy, defined as muscle ache or muscle weakness in conjunction with increases in creatine kinase >10 times the upper limit of normal, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine kinase. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin must not be co-administered with fusidic acid, as 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 (SPARCL) 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 (2.3%) compared to placebo (1.4%).

Contraindications

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

Regulatory history

ATOMED atorvastatin tablets in 10 mg, 20 mg, 40 mg and 80 mg strengths were first listed on the Australian Register of Therapeutic Goods on 13 January 2022 as film-coated blister packs.