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Atorvastatin

Atorvastatin
Film-coated tablets 10 mg 
Film-coated tablets 20 mg 
Film-coated tablets 40 mg 
Film-coated tablets 80 mg

Prescription-only medicine
Medicine reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION


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.

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-cholesterol 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. 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.

Patient with Renal Impairment

No adjustment of dose is required.

Patient with Hepatic Impairment

Atorvastatin should be used with caution in patients with hepatic impairment. Atorvastatin is contraindicated in patients with active liver disease.

Use in the 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 aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Titration should be conducted according to the individual response and tolerability in paediatric patients. Safety information for paediatric patients treated with doses above 20 mg, corresponding to about 0.5 mg/kg, is limited. There is limited experience in children between 6-10 years of age. 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.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

COMPOSITION

Each film-coated tablet contains 10 mg atorvastatin (in form of atorvastatin calcium trihydrate), excipients.
Each film-coated tablet contains 20 mg atorvastatin (in form of atorvastatin calcium trihydrate), excipients.
Each film-coated tablet contains 40 mg atorvastatin (in form of atorvastatin calcium trihydrate), excipients.
Each film-coated tablet contains 80 mg atorvastatin (in form of atorvastatin calcium trihydrate), excipients.

THERAPEUTIC INDICATIONS

Hypercholesterolaemia
Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Atorvastatin is also indicated to reduce total cholesterol C and LDL-cholesterol in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.

CONTRAINDICATIONS

Atorvastatin is contraindicated in patients:
– with hypersensitivity to the active substance or to any of the excipients of this medicinal product,
– with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal,
– during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures.

PACKAGING

Box with 30 film-coated tablets of 10 mg (3 blisters with 10 film-coated tablets)
Box with 30 film-coated tablets of 20 mg (3 blisters with 10 film-coated tablets)
Box with 30 film-coated tablets of 40 mg (3 blisters with 10 film-coated tablets)
Box with 30 film-coated tablets of 80 mg (3 blisters with 10 film-coated tablets)