Atorvastatin Sandoz

Atorvastatin Sandoz Dosage/Direction for Use

atorvastatin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma

Marketer:

Novartis
Full Prescribing Info
Dosage/Direction for Use
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.
The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily (see Pharmacology: Pharmacodynamics under Actions). Atorvastatin should be used as an adjunct to other lipidlowering 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 (see Precautions).
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment (see Precautions). Atorvastatin is contraindicated in patients with active liver disease (see Contraindications).
Use in the elderly: Efficacy and safety in geriatric patients (65 years of age and older) using recommended doses are similar to those seen in the general population.
Paediatric use: 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: 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.
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