lipomax

Lipomax® 

Atorvastatin 10mg, 20mg, 40mg

Tablets for oral use

Product leaflet summary

Therapeutic Indications:

  • Hypercholesterolemia

LIPOMAX is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), Apo lipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia including familial

hypercholesterolemia (heterozygous variant) or combined (mixed) hyperlipidemia.  (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other no pharmacological measures is inadequate.

LIPOMAX is also indicated to reduce total-C and LDL-C in adults with homozygous familiar hypercholesterolemia along with 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.

 

Dosage and Administration

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.

 

Contraindications

− Hypersensitivity to the active substance or to any of the excipients of this medicinal product

− Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal

− During pregnancy, while breastfeeding and in women of childbearing potential not using appropriate contraceptive measures.

 

 

Pregnancy and Lactation

Pregnancy:  

LIPOMAX is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women.

Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolemia.

For these reasons, LIPOMAX should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with LIPOMAX should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.

 

Lactation:

It is not known whether atorvastatin or its metabolites are excreted in human milk. Women taking LIPOMAX should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.

 

Fertility:

In animal studies atorvastatin had no effect on male or female fertility.

 

Ability to drive and use machinery

LIPOMAX has negligible influence on the ability to drive and use machines.

Package Presentation:

1- A box of 30 tablets each contains 10 mg Atorvastatin.

2- A box of 30 tablets each contains 20 mg Atorvastatin.

3- A box of 30 tablets each contains 40 mg Atorvastatin.