Liprox®

Lovastatinum
20 mg tablets

Composition

Each tablet contains 20 mg lovastatin (Lovastatinum) as well as auxiliary substances: microcrystalline cellulose, lactose monohydrate, modified starch, magnesium stearate and indigotin wax up to the total mass of 200 mg.

Mechanism of action

Lovastatin inhibits cholesterol synthesis and decreases its serum concentration. The drug increases the HDL to LDL cholesterol ratio and slightly decreases triglyceride concentration. The effects of lovastatin are usually observed after 4 - 6 weeks of continuous therapy. Following oral administration, lovastatin accumulates in the liver, and small amounts of the drug reach the circulation. The substance is slowly excreted from the organism, mainly with feces.

Therapeutical indications

Primary hypercholesterolemia (type II a and II b), together with appropriate diet in order to decrease total and LDL-cholesterol in patients, in whom treatment with diet or other methods was not fully effective.
In coronary artery atherosclerosis in patients with increased serum cholesterol concentration, in whom diet or other means of cholesterol reductions were not sufficiently effective. Therapy with lovastatin does not release from the obligation of adherence to low-cholesterol diet.

Contraindications

Hypersensitivity to lovastatin or any of the drug components, pregnancy and lactation, active liver disease, severe renal insufficiency, increased transaminase activities, conditions of skeletal muscles (myopathies) and obstruction in bile ducts (cholestasis). Do not use the drug in children and adolescents as well as in patients with excessive alcohol intake.

Special warnings and precautions

In case of increased transaminase activity, both before and during lovastatin intake, even in the absence of any other symptoms, lovastatin should be withdrawn. Care should be taken in patients with a history of hepatic disease. Patients with renal insufficiency, whose creatinine clearance is less than 30 ml/min should not receive lovastatin in doses exceeding 20 mg daily. Treatment with lovastatin should be discontinued in the course of acute infectious diseases, before major surgeries, following traumas or in patients with severe metabolic or electrolyte disturbances, endocrynological diseases, hypotension and status epilepticus. Lovastatin may lead to unexplained weakness, muscle pains, malaise and increased body temperature. Should this happen, the doctor must decide whether the drug should be continued or withdrawn. Alcohol consumption in prohibited during therapy with lovastatin.

Use during pregnancy and lactation

Administration of lovastatin in pregnancy and during breast-feeding is strongly contraindicated. In women in reproductive age lovastatin may be used only together with a reliable form of contraception. If, during therapy with lovastatin, a woman becomes pregnant, the drug should be immediately withdrawn. Women taking lovastatin should be aware of the possibility of adverse influence of the drug on the developing fetus. If it is found necessary to give the drug to a woman during lactation, breast-feeding should be stopped.

Influence on ability to drive

Lovastatin does not influence psychophysical ability and does not limit the ability to drive.

Interactions with other drugs

Administration of lovastatin together with immmunosupresants, anti-neoplastic drugs, other drugs that lower cholesterol concentration, such as gemfibrosil, fibrates, niacin (nicotinic acid) at a dose of ł 1 mg daily, as well as with erythromycin or some other antibiotics may cause skeletal muscles damage and sometimes lead to renal insufficiency.
Anticoagulants belonging to the group of coumarine derivatives, when used simultaneously with lovastatin, prolong the prothrombin time.

Dosage and administration

In any case the doctor will make the decision of the initiation of the therapy as well as of the dosage level.
The most frequently recommended starting dose is 20 mg daily (1 tablet) taken with the evening meal. Should this dose fail to produce at least 20% decrease of the LDL-cholesterol, it may be increased every four weeks by 20 mg. Maximal recommended daily dose may not exceed 80 mg (4 tablets). The doses of 40 mg daily and more may be taken in two equal divided doses with morning and evening meal.
In patients simultaneously taking immunosuppresants, as well as in patients with renal insufficiency and disturbed bile flow, the initial dose should not be greater than 10 mg daily (1 tablet). The dose of the drug should be reduced when total cholesterol concentration is reduced to less than 140 mg/100 ml (3.6 mmol/L), and LDL-cholseterol concentration is reduced to less than 75 mg/100 mL (1.49 mmol/L).

Overdose

There are no specific symptoms of lovastatin overdose. When lovastatin overdose is suspected, inform the doctor who will take appropriate symptomatic measures and will assess hepatic function.

Undesirable effects

Undesirable effects are rare, usually mild and transient. The most frequently observed effects include gastrointestinal disturbances (flatulence, diarrhea, constipation, nausea, dry mouth), muscle cramps and muscle and joint pains, insomnia, vertigo, headache, sight disturbances and skin rash. Lovastatin may lead to increased transaminase and creatine kinase concentration in blood serum.

Available packages

Cartoon containing 28 tablets.