Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Atorstan is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia including familial hypercholesterolemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other non pharmacological measures is inadequate.
Atorstan is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular events in adult patients estimated to have a high risk for first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
The patient should be placed on a standard cholesterol-lowering diet before receiving Atorstan. This diet should continue during treatment with Atorstan.
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.
The majority of patients are controlled with Atorstan 10 mg once a day. A therapeutic response is evident within two weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The response is maintained during chronic therapy.
Patients should be started with Atorstan 10 mg daily. Doses should be individualised and adjusted every four weeks to 40 mg daily. Thereafter, either the dose may be increased to a maximum of 80 mg daily. A bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Only limited data are available (see section 5.1).
The dose of atorvastatin in patients with homozygous familial hypercholesterolaemia is 10 to 80 mg daily (see section 5.1). 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.
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.
No adjustment of dose is required (see section 4.4).
Atorstan should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2). Atorstan is contraindicated in patients with active liver disease (see section 4.3).
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 20mg/day (see sections 4.4 and 4.5).
Use of atorvastatin is not recommended in patients taking letermovir co-administered with ciclosporin (se sections 4.4 and 4.5).
Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population.
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 (seesection5.1). 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. The dose titration to 80 mg daily is supported by study data in adults and by limited clinical data from studies in children with Heterozygous Familial Hypercholesterolemia (see sections 4.8 and 5.1).
There are limited safety and efficacy data available in children with Heterozygous Familial Hypercholesterolemia between 6 to 10 years of age derivedfromopen-labelstudies. Atorvastatin is not indicated in the treatment of patients below the age of 10 years. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Other pharmaceutical forms/strengths may be more appropriate for this population.
Atorstan 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.
Specific treatment is not available for atorvastatin overdosage. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
3 years.
Store below 25°C. Protect from light and moisture.
Aluminium/Aluminium blisters. Pack-sizes of 14, 28, 30, 100 and 1000 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
