Simvatin

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Simvatin
20130617-Simvatin

Lipid-lowering drug (statin).

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Composition
Active substance: simvastatin;
Each tablet contains 10 mg of simvastatin;
Each tablet contains 20 mg of simvastatin;
excipients: lactose, maize starch, microcrystalline cellulose, sodium starch, magnesium stearate, povidone, Opadry OY-L white.
Pharmacotherapeutic group
Lipid-lowering drugs. Drugs for reducing serum cholesterol and triglyceride levels. АТС С10А А01.
Indications
The drug is prescribed to patients with coronary heart disease (CHD) or at high risk of coronary heart disease.
Simvatin® is administered in patients at high risk of CHD (with or without hyperlipidemia), e.g. in patients with diabetes, peripheral vessel disease, coronary heart disease, or a history of stroke or other cerebrovascular disease.
Simvatin® reduces the risk of major vascular events (total number of cases, which includes non-fatal myocardial infarction, CHD mortality, stroke and the need for revascularization surgery), and reduces the need for revascularization procedures in peripheral and other non-coronary vessels; reduces the risk of major coronary events (total number of cases, which includes non-fatal myocardial infarction and CHD mortality), and reduces the need for coronary revascularization procedures (including coronary artery bypass surgery and percutaneous transluminal coronary angioplasty), reduces the risk of stroke, total mortality by means of reducing CHD mortality, and the number of hospitalizations due to stenocardia. Patients with hypercholesterolemia.
Simvatin® is indicated as an adjunctive  therapy to diet to reduce elevated total cholesterol, LDL cholesterol, triglycerides, apolipoprotein B (Apo B) and to increase HDL cholesterol in patients with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (Fredrickson type IIa hyperlipidemia) or mixed hypercholesterolemia (Fredrickson type IIb hyperlipidemia), when the response to diet and other non-pharmacologic measures has been inadequate. So, Simvatin® reduces the LDL-C/ HDL-C ratio, total cholesterol/ HDL-C ratio.
Simvatin® is indicated for hypertriglyceridemia (Fredrickson type IV hyperlipidemia).
Simvatin® is indicated for primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
Simvatin® is also indicated as an adjunct to diet and other therapies in patients with homozygous familial hypercholesterolemia to reduce total cholesterol, LDL-C and Apo B.
Сontraindications
Hypersensitivity to any component of the preparation. Active hepatic diseases; unknown and persistent elevated serum transaminases levels. Pregnancy and lactation. Pediatric use.
Dosage and administration
Simvatin® daily doses from10 mg to 80 mg should be taken once daily in the evening. When a dose of Simvatin® is selected it should be titrated with an interval not less than 4 week up to maximum daily dose of 80 mg to be taken once daily in the evening.
PATIENTS WITH CORONARY HEART DISEASE (CHD) OR AT HIGH RISK OF CORONARY HEART DISEASE. The usual starting dose of Simvatin® for patients at high risk of CHD (with or without hyperlipidemia) – diabetic patients, patients with peripheral vessel disease, coronary heart disease, or a history of stroke or other cerebrovascular disease – is 40 mg once daily to be taken in the evening. The drug therapy can be initiated simultaneously with diet and exercise therapy.
PATIENTS WITH HYPERCHOLESTEROLEMIA (NOT LISTED ABOVE IN THE RISK CATEGORY). Before treatment with Simvatin® patients should be advised to adhere to a cholesterol-lowering diet for a whole course of treatment. The usual starting dose is 20 mg a day in a single dose to be taken in the evening. For patients who require a significant (more than by 45%) decrease of LDL the starting dose may be 40 mg a day to be taken in the evening. For patients with mild or moderate hypercholesterolemia Simvatin® may be prescribed in a 10 mg starting dose. Dose adjustment should be carried out as indicated above, when necessary.
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA. Based on the results of the controlled clinical study the recommended dose of Simvatin® for patients with homozygous familial hypercholesterolemia is 40 mg daily to be taken in a single dose in the evening or 80 mg daily to be taken in three doses: 20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening. For such patients Simvatin® is prescribed as an adjunct to another cholesterol-lowering therapy (e.g., LDL apheresis) or if such treatments are unavailable.
CONCOMITANT TREATMENT Simvatin® is effective as a monotherapy and also in combination with the bile acid sequestrants. For patients administering cyclosporine, gemfibrozil or other fibrates, or lipid-lowering doses of niacin (≥ 1 g/ day) concurrently with Simvatin® the maximum recommended dose of Simvatin® is 10 mg a day. For patients who receive amiodarone or verapamil concurrently with Simvatin® the daily dose of Simvatin® must not exceed 20 mg.
Side effects
Simvastatin is generally well tolerated, but in some cases the adverse reactions may develop:
Allergic and skin reactions: skin rash, itching, alopecia;
Gastrointestinal disorders: constipation, nausea, flatulence, dyspepsia, abdominal pain, diarrhea, vomiting, pancreatitis, rare – hepatitis/ jaundice;
Nervous system disorders: headache, paresthesia, asthenia, dizziness, seizures, peripheral neuropathy;
Musculoskeletal disorders: myalgia, rare – myopathy, rhabdomyolysis;
Blood disorders: anemia; Others: rare – angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, ESR increase, arthritis, arthralgia, urticaria, light sensibility, fever, flushing, dyspnea and malaise.
Marketing authorization
UA/8899/01/01, UA/8899/01/02