ATORVACHOL

What it is

Atorvachol contains atorvastatin as calcium trihydrate, available in tablet strengths of 10 mg, 20 mg, 40 mg and 80 mg. Atorvastatin is a synthetic lipid-lowering agent and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (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. — Reduction of the risk of non-fatal myocardial infarction and non-fatal stroke 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.

Dosing overview

Atorvachol can be administered within the dosage range of 10–80 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. After initiation and/or upon titration of atorvastatin, lipid levels should be re-analysed within 4 weeks and dosage adjusted according to the patient's response. The majority of patients are controlled with 10 mg atorvastatin once a day. Atorvachol is for oral administration and can be taken at any time of the day, with or without food.

Key safety warnings

Uncomplicated myalgia has been reported in atorvastatin-treated patients. Myopathy, defined as muscle aching 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. The risk of myopathy and rhabdomyolysis is increased with concurrent administration of drugs that increase the systemic concentration of atorvastatin. Physicians considering combined therapy with atorvastatin and fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, human immunodeficiency virus/hepatitis C virus protease inhibitors, hepatitis C virus non-structural protein 5A/5B inhibitors, letermovir, or lipid-lowering doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration. 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 (2.3%) compared to placebo (1.4%). The increased risk of haemorrhagic stroke was observed particularly 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. 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. The incidence of these abnormalities was 0.2, 0.2, 0.6, and 2.3% for 10 mg, 20 mg, 40 mg, and 80 mg respectively.

Contraindications

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

PBS listing

The document provided does not contain information about PBS listing details including strength, item count, restriction type, or ex-manufacturer price. This section cannot be completed from the available source material.

Regulatory history

Atorvachol atorvastatin tablets (10 mg, 20 mg, 40 mg and 80 mg) were first listed on the Australian Register of Therapeutic Goods on 23 September 2011.