LOVASTATIN MYLAN Tablets Ref.[8308] Active ingredients: Lovastatin

The patient should be placed on a standard cholesterol-lowering diet before being given lovastatin. This diet should be continued during treatment with lovastatin. Any cause for secondary hypercholesterolemia should be excluded before initiation of treatment.

Hypercholesterolemia

The initial dose is generally 20 mg per day, given as a single dose with the evening meal. It has been shown that single daily doses given with the evening meal are more effective than the same dose given with breakfast, possibly because cholesterol synthesis takes place mainly at night. Patients with mild to moderate hypercholesterolemia may be treated with an initial dose of 10 mg lovastatin. Any dosage adjustments should be made at intervals of at least 4 weeks. A maximum of 80 mg should be given daily in a single dose or divided into 2 doses taken with breakfast and the evening meal. Two daily doses would appear to be more effective than one daily dose.

The dosage of lovastatin should be reduced if LDL-cholesterol levels drop below 75 mg/dL (1.94 mmol/L), or if total serum cholesterol concentrations fall below 140 mg/dL (3.6 mmol/L).

Concomitant treatment

Lovastatin is effective alone or in combination with bile-acid sequestrants.

In patients being given cyclosporine, danazol, gemfibrozil, other fibrates or lipid-lowering doses (≥1 g/day) of niacin at the same time as lovastatin, the maximum recommended dose is 20 mg/day. In patients taking amiodarone or verapamil concomitantly with lovastatin, the dose of lovastatin should not exceed 40 mg/day (see section 4.4. Special warnings and precautions for use Myopathy/Rhabdomyolysis and 4.5. Interactions with other medicinal products and other forms of interaction)

Dosage in renal insufficiency

Since lovastatin does not undergo significant renal excretion, moderate renal insufficiency does not necessitate any dosage reduction.

In patients with severe renal failure (creatinine clearance <30 ml/min) dosages over 20 mg/day should be carefully considered, and, if necessary, should be commenced with caution (see section 4.4. Special warnings and precautions for use Myopathy/Rhabdomyolysis and 5.0 Pharmacological properties).

Use in children and adolescents (<18 YEARS)

The use of lovastatin in children is not recommended, as safety and efficacy studies have not been established.

Use in the elderly

In a controlled trial of the treatment of patients in the over-sixty age group, the effects appeared to be identical to those in the remainder of the population and there was no marked increase in frequency of clinical or laboratory adverse findings.

Until further experience with overdose of lovastatin has been obtained, no specific treatment can be recommended. General measures for overdose should be applied and liver function should be monitored.

The dialysability of lovastatin and its metabolites is not known at present.

Five healthy volunteers received up to 200 mg lovastatin as a single dose without clinically significant adverse effects. A few cases of accidental overdose have been reported. None of the patients had specific symptoms, and all recovered without sequelae. The highest dose was 5-6 g.

Shelf-life: 2 years.

This medicinal product does not require any special storage conditions.

Aluminium/aluminium blister.

Pack sizes: 10, 28, 30, 50, 100. Not all pack sizes may be marketed.

No special requirements.