Atorvastatin, 10/20/40 mg tab

Hypercholesterolemia:

• as a supplement to a diet to reduce elevated total cholesterol, LDL cholesterol, apo-B and triglycerides in over 10 year-old children, adolescents and adults with primary hypercholesterolemia, including familial hypercholesterolemia (heterozygous version) or combined (mixed) hyperlipidemia type IIa or IIb respectively (according to Fredrickson’s classification), when the response to diet or other non-drug therapies are insufficient;
• to reduce high total cholesterol and LDL cholesterol in adults with homozygous familial hypercholesterolemia as a supplement to other lipid-lowering therapies (for example, LDL-apheresis) or if such treatments are not available.

Preventive treatment of cardiovascular complications:

• in the preventive treatment of cardiovascular events in adult patients at high risk of developing primary cardiovascular events, as a supplement to the correction of other risk factors;
• in the secondary preventive treatment of cardiovascular complications in patients with coronary heart disease in order to reduce mortality, myocardial infarction, stroke, rehospitalizations for cardiac angina and the need for revascularization.

The drug is to be taken by mouth, at any time of the day, with or without food.

Before starting administering Atorvastatin Medisorb, the patient should be advised to keep to a standard low-cholesterol diet and to follow it through during the entire period of therapy. The dosage varies from 10 mg to 80 mg once per day and is established based on the concentration of LDL-C, the goal of therapy and the individual patient’s response to the therapy. For most patients, the starting dose is 10 mg once a day.

The maximum daily dosage is 80 mg.

At the beginning of treatment and/or during an increase in the dosage of Atorvastatin Medisorb, it is necessary to control the concentration of lipids in blood plasma and adjust the dosage of the drug accordingly every 2−4 weeks.

• In primary hypercholesterolemia and combined (mixed) hyperlipidemia: For most patients, the recommended single dose of Atorvastatin Medisorb is 10 mg per day. The therapeutic effect occurs within 2 weeks and usually reaches its maximum after 4 weeks. With long-term treatment, the effect is preserved;
• in homozygous familial hypercholesterolemia: In most cases, 80 mg is administered once per day (with a decrease in the concentration of LDL-C by 18−45%).
• in heterozygous familial hypercholesterolemia: starting dose is 10 mg per day. The dose should be established individually, evaluation of the dose relevance is to be done every 4 weeks with a possible increase to 40 mg per day. Then either the dose can be increased to a maximum of 80 mg per day, or it is possible to combine atorvastatin at a dose of 40 mg per day with sequestrants of bile acids;
• in the preventive treatment of cardiovascular complications: in primary preventive treatment studies, the dose of atorvastatin was 10 mg per day. You may need to increase the dose in order to achieve the values of LDL-cholesterol consistent with current guidelines;
• administering in children aged from 10 to 18 with heterozygous familial hypercholesterolemia: the recommended starting dose is 10 mg per day. The dose may be increased up to 20 mg per day, depending on the clinical effect. Expertise in administering a dosage of more than 20 mg (corresponding to a dose of 0.5 mg/kg) is limited. The dosage should be titrated depending on the purpose of lipid-lowering therapy. Dosage modification should be done at intervals of once every 4 weeks or less often;
• liver dysfunction: When liver function is insufficient, the dose of Atorvastatin Medisorb is to be reduced combined with regular monitoring of the serum activity of liver transaminases: aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
• administration in combination with other drugs: if necessary, combined with cyclosporine, telaprevir or tipranavir/ritonavir, the dose of Atorvastatin Medisorb should not exceed 10 mg per day (see the «Special Instructions» section).

Please take due care while applying the lowest effective dose of Atorvastatin Medisorb with simultaneous administration of HIV protease inhibitors, hepatitis C protease inhibitors (boceprevir), clarithromycin and itraconazole. If simultaneous administration with boceprevir is necessary, the dose of atorvastatin should not exceed 40 mg per day.

Shelf life
3 years. Prohibited to use after expiry date.

Storage conditions
Store in a dry place at a temperature below +25°С.

Terms of sale
RX only.