1 tablet contains Atorvastatin 10 mg

Dosage

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

The dose should be individualized 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 hypercholesterolemia and combined (mixed) hyperlipidemia

The majority of patients are controlled with Lolip® 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 hypercholesterolemia

Patients should be started with Lolip® 10 mg daily. Doses should be individualized 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 hypercholesterolemia

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.

Patients with renal impairment

No adjustment of dose is required.

Patients with hepatic impairment

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

Elderly patients

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.

Method of administration: Lolip® 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.a