Each film-coated tablet contains:

Active ingredients: Atorvastatin (as atorvastatin calcium trihydrate) – 20mg;

For a full list of excipients, see section List of excipients.

Posology

The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on this diet during treatment with Atorvastatin.

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 Atorvastatin 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 Atorvastatin 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 (see section Pharmacodynamic properties).

The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily (see section Pharmacodynamic properties). 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.

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 (see sections Special warnings and precautions for use and Interaction with other medicinal products and other forms of interaction). Use of atorvastatin is not  recommended in patients  taking letermovir co- administered with ciclosporin (see sections Special warnings and precautions for use and Interaction with other medicinal products and other forms of interaction).

Patients with renal impairment

No adjustment of dose is required (see section Special warnings and precautions for use).

Patients with hepatic impairment

Atorvastatin should be used with caution in patients with hepatic impairment (see sections Special warnings and precautions for use and Pharmacokinetic properties). Atorvastatin is contraindicated in patients with active liver disease (see section Contraindications).

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 (see section Pharmacodynamic properties). 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 FamilialHypercholesterolemia (see sections Undesirable effects and Pharmacodynamic properties).

Other pharmaceutical forms/strengths may be more appropriate for this population.

Method of administration

Atorvastatin 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.

Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA-reductase inhibitors

ATC code: C10AA05

List of excipients

Tablet core:

microcrystalline cellulose,

lactose monohydrate,

povidone,

maize starch,

sodium starch glycolate,

magnesium stearate,

calcium hydrogen phosphate;

Tablet coating:

hypromellose,

titanium dioxide,

propylene glycol,

talc purified.

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134482/1734095746965.pdf