LIPEX Tablet

In primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia, homozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia in patients who have not responded adequately to diet and other appropriate measures.

Dosage Schedule

Hypercholesterolaemia and Mixed Dyslipidemia: The recommended starting dose is 10-20mg once daily. Patients who require a large reduction in LDL-C may be started at 40mg once daily. The dosage range is 10-80mg once daily.

Homozygous Familial Hypercholesterolaemia: The dosage in patients with homozygous FH is 10-80 daily.

Heterozygous Familial Hypercholesterolaemia in Pediatric Patients (10-17 years of age): The recommended starting dose is 10mg/day: the maximum recommended dose is 20mg/day.

In active liver diseases (or persistently abnormal liver function tests) and in pregnancy (adequate contraception required during treatment and for 1 month afterwards) and breast-feeding.

Reversible myositis is a rare but significant side effects including abdominal pain, flatulence, diarrhoea, nausea and vomiting. Rash and hypersensitivity reactions have been reported rarely. Also insomnia, angioedema, anorexia, asthenia paraesthesia, peripheral neuropathy, alopecia, pruritus, impotence, chest pain, hypoglycaemia, hyperglycaemia reported; thrombocytopenia reported rarely.

The risk of myopathy during treatment with drugs of this class is increased with concurrent administration or cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. When Lipex and antacid suspension containing magnesium and aluminum hydroxide were co-administered, plasma concentrations of Lipex decreased.

Contraindicated.

Lipex should be used with caution in those with a history of liver disease or with a high alcohol intake (use should be avoided in active liver disease). Liver-function tests should be carried out before and within 1-3 months of starting treatment and thereafter at intervals of 6 months for 1 year, unless indicated sooner by signs or symptoms suggestive of hepatotoxicity. Treatment should be discontinued if serum transaminase concentration rises to, and persist at, 3 times the upper limit of the reference range.