MEDOSTATIN table. 20 mg

INGREDIENTS:

Each tablet contains 20 mg of the active ingredient lovastatin / lovastatin / and excipients - lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, butylated hydroxyanisole, magnesium stearate, aluminum indigotine blue dye / E132 /

Pharmacotherapeutic group:

Antihiperlipidemichen agent classified as HMG-CoA reductase inhibitor.

INDICATIONS:

Treatment of hiperlipideniya:

Medostatin indicated as an adjunct to diet in the case of primary hiperholestrerolemiya, due to high levels of low-density lipoproteins in patients at risk for coronary disease when the response to diet with restriction of saturated fat and cholesterol and other nonpharmacological measures alone has been inadequate .

  The therapeutic efficacy of lovastatin in patients with type III hiperlipoproteinemiya or patients with elevated total cholesterol, because elevated levels of intermediate density lipoproteins have not been studied 

The effect of lovastatin-induced changes in lipoprotein levels, including serum cholesterol on cardiovascular morbidity and mortality has not been determined.

CONTRAINDICATIONS:

Administration of lovastatin is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet. In patients with active liver disease or unexplained sustained increase in serum transaminases. Like all medicines of this Pharmacotherapeutic group, administration of lovastatin during pregnancy and lactation is contraindicated.

PRECAUTIONS:

Prior to initiating therapy with lovastatin should attempt to control hypercholesterolemia with appropriate diet, exercise, weight reduction in obese patients and treatment of comorbidities.

Hepatic dysfunction:

During treatment should be tested liver function tests. Serum transaminases should be monitored before initiation of treatment and then every 6 weeks during the first 3 months of treatment, every 8 weeks during the remainder of the first year, and then at 6-month intervals. Patients with elevations of serum transaminases should be given special attention and study in these patients should be repeated, and then be done more often. If the transaminase levels show evidence of progression, particularly if they have risen three times the upper limits of normal and persist, administration of the drug should be discontinued.

Skeletal muscle

During treatment with lozastatin may appear myalgia. In patients treated with lozastatin can often be observed transient mild elevation of creatine phosphokinase. However, only 0.5% of patients develop myopathy. Myopathy should be suspected in any patient with diffuse muscle pain, muscle tenderness or weakness, particularly if accompanied by malaise or fever.

The benefits and risks of treatment with lozastatin should be evaluated for patients predisposed to occurrence of renal failure and rhabdomyolysis, hypotension, several acute infections, treatment with uncontrolled seizures, major surgery, trauma.

PREGNANCY and BREAST-FEEDING:

The safety in pregnant women. Lovastatin should be administered to women of childbearing age only when such patients are unlikely to conceive and have been informed of the potential risks. If a woman becomes pregnant while receiving lozastatin, the medicinal product should be discontinued.

It is not known whether lozastatin is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, women receiving the drug should discontinue nursing.

DOSAGE AND ADMINISTRATION:

The patient should be placed on a standard cholesterol-lowering diet before treatment lozastatin that should continue during treatment with the drug. Medostatin should be administered with meals. 

The recommended starting dose is 20 mg orally daily, once with the evening meal. In patients with very high concentrations of cholesterol initial dose is 2 tablets Medostatin.

Recommended doses range from 20 to 80 mg daily, taken one or two doses. Maximum recommended dose is 80 mg.

SIDE EFFECTS:

Lovastatin is generally well tolerated. 

The most common drug reactions occurring with an incidence greater than 1%: 

Gastrointestinal - constipation, flatulence, abdominal pain, heartburn, nausea. 

Musculo-skeletal - muscle cramps, myalgia. 

Nervous system - dizziness, headache 

Skin - rash, itching 

Sense organs - blurred vision, changes in taste.