Description
INDICATIONS AND DOSAGE
The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor.
The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response.
The usual starting dose is 10 mg once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day.
Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia
The majority of patients are controlled with Lipitor 10 mg once a day. A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The response is maintained during chronic therapy.
Heterozygous familial hypercholesterolaemia
Patients should be started with Lipitor 10 mg daily. Doses should be individualised and adjusted every 4 weeks to 40 mg daily. Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Homozygous familial hypercholesterolaemia
Only limited data are available.
The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.
Prevention of cardiovascular disease
In the primary prevention trials the dose was 10 mg/day. Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.
Renal impairment
No adjustment of dose is required.
Hepatic impairment
Lipitor should be used with caution in patients with hepatic impairment. Lipitor is contraindicated in patients with active liver disease.
Co-administration with other medicines
In patients taking the hepatitis C antiviral agents elbasvir/grazoprevir or letermovir for cytomegalovirus infection prophylaxis concomitantly with atorvastatin, the dose of atorvastatin should not exceed 20 mg/day.
Use of atorvastatin is not recommended in patients taking letermovir co-administered with ciclosporin.
Elderly
Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population.
Paediatric population
Hypercholesterolaemia
Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress.
For patients with Heterozygous Familial Hypercholesterolemia aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day. The dose may be increased to 80 mg daily, according to the response and tolerability. Doses should be individualised according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.
There are limited safety and efficacy data available in children with Heterozygous Familial Hypercholesterolemia between 6 to 10 years of age derived from open-label studies. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Other pharmaceutical forms/strengths may be more appropriate for this population.
Method of administration
Lipitor is for oral administration. Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
PREGNANCY AND LACTATION
Women of childbearing potential
Women of child-bearing potential should use appropriate contraceptive measures during treatment.
Pregnancy
Lipitor is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received.
Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia.
For these reasons, Lipitor should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with Lipitor should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.
Breast-feeding
It is unknown whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking Lipitor should not breast-feed their infants. Atorvastatin is contraindicated during breast-feeding.
Fertility
In animal studies atorvastatin had no effect on male or female fertility.
SIDE EFFECTS
nasopharyngitis, allergic reactions, hyperglycaemia, headache, dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia, haryngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhoea.
