AKM-ATORVASTATIN

What it is

AKM-ATORVASTATIN is supplied as white elliptical shaped film coated tablets containing 10 mg, 20 mg, 40 mg or 80 mg atorvastatin as atorvastatin calcium. Atorvastatin is a synthetic lipid-lowering agent and an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-Co-A to mevalonate, a precursor of sterols, including cholesterol.

Approved indications —

AKM-ATORVASTATIN is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. — AKM-ATORVASTATIN is indicated 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 and non-fatal stroke.

Dosing overview

AKM-ATORVASTATIN can be administered within the dosage range of 10 mg to 80 mg per day as a single daily dose. The majority of patients are controlled with 10 mg AKM-ATORVASTATIN once daily. A therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 4 weeks. AKM-ATORVASTATIN is for oral administration and 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 the 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. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Should an increase in ALT or AST of greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of AKM-ATORVASTATIN is recommended. Uncomplicated myalgia has been reported in atorvastatin-treated patients. 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 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. 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 compared to placebo, with an increased risk 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 stroke or transient ischaemic attack.

Contraindications

Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy and lactation. Women of childbearing potential, unless on an effective contraceptive and highly unlikely to conceive. Concomitant use with fusidic acid hemihydrate. Treatment with the Hepatitis C antivirals, glecaprevir/pibrentasvir.

PBS listing

Information regarding PBS listing status is not available in the provided source documents.

Regulatory history

AKM-ATORVASTATIN was first approved on 11 September 2017, with eight presentations registered on the Australian Register of Therapeutic Goods, including 10 mg, 20 mg, 40 mg and 80 mg film-coated tablet formulations available in blister packs and bottles.