Vasilip is a monocomponent lipid-lowering drug.
Release form and composition
The drug is produced in the form of tablets in a film coating with a concentration of the active substance of 10, 20, 40 or 80 mg. Tablets are delivered to pharmacies packaged in 7 pieces in blisters, 2, 4, 8 or 12 blisters per pack.
Simovastatin is used as an active ingredient in Vasilip tablets. Excipients: magnesium stearate, lactose monohydrate, pregelatinized starch, microcrystalline cellulose, butyl hydroxyanisol, corn starch, ascorbic acid, anhydrous citric acid.
The composition of the film shell: titanium dioxide, talc, propylene glycol, hypromellose.
Indications for use
The main indications for the use of Vasilip are primary hypercholesterolemia (a pathological condition characterized by an elevated concentration of cholesterol in the blood) or mixed dyslipidemia (a pathological condition characterized by a violation of the metabolism of lipoproteins and fats and a violation of their ratio in the serum). The drug is prescribed as an addition to the diet, as well as in situations where weight loss, exercise and other non-drug measures do not give the expected effect.
As a supplement to the main lipid-lowering therapy, a special diet, LDL-apheresis, in case of low effectiveness of the listed measures, Vasilip is also indicated for patients with homozygous (transmitted from both parents) inherited hypercholesterolemia.
According to the instructions, Vasilip can be prescribed as a prophylactic agent:
- To reduce the death rate from cardiovascular diseases;
- To reduce the incidence rate among patients in whom certain clinical manifestations of atherosclerotic diseases of the heart and blood vessels are noted;
- Patients diagnosed with diabetes mellitus (if the concentration of cholesterol in the blood is normal or elevated).
In addition, the use of Vasilip allows you to adjust the factors that increase the risk of atherosclerosis and cardiovascular diseases, as well as increases the effectiveness of cardioprotective therapy.
The instructions to Vasilip indicate that the drug is contraindicated:
- Patients with liver disease in the active phase;
- People who, for unclear reasons, have a steadily increased activity of hepatic aminotransferases (AST and ALT);
- In combination with cytochrome P450 CYP3A4 system isoenzyme inhibitors (for example, with HIV protease inhibitors, itraconazole, clarithromycin, ketoconazole, telithromycin, erythromycin, nefazodone);
- Pregnant and lactating women;
- In pediatric practice (due to the lack of data on the safety of funds for children and adolescents under 18);
- When hypersensitivity to simvastatin and / or other components of the drug.
Dosing and Administration
For hypercholesterolemia, Vasilip is prescribed from 10 to 80 mg per day. The entire dose should be taken at one dose, in the evening, without reference to food intake. Begin treatment with a dosage of 10 mg per day. Application of Vasilip in the starting dose is shown for one month, then it is gradually increased (maintaining at least 4-week intervals between increases). The highest therapeutic dosage should not exceed 80 mg per day.
With homozygous hypercholesterolemia, the daily dose is determined depending on the severity of the clinical picture and is 40 or 80 mg with a once-daily intake in the evening. Treatment of hypercholesterolemia without fail complements a special diet.
Patients with coronary heart disease begin taking the drug with a dose of Vasilip equal to 20 mg per day. The highest therapeutic dosage for this category of patients should not exceed 40 mg. The rules for its enhancement are similar, as in the treatment of hyperlipidemia.
For patients who are undergoing treatment with fibrates or nicotinic acid, the effective dose is 5 mg, the highest is 10 mg per day.
According to the instructions to Vasilip, the following side effects may occur during treatment with this drug:
- Gastrointestinal dysfunction: constipation, nausea, abdominal pain, diarrhea, flatulence, dyspepsia, hepatitis, vomiting, pancreatitis, jaundice, increased activity of hepatic aminotransferases, alkaline phosphatase, creatine phosphonase;
- Impaired function of the nervous system and sensory organs: headache, peripheral neuropathy, paresthesias, insomnia, dizziness, blurred vision, asthenia, convulsions, changes in taste;
- Disorders of the musculoskeletal system: myopathy, muscle cramps, rhabdomyolysis, myalgia;
- Allergic and immunopathological reactions;
- Dermatological reactions: skin rash, itching, alopecia;
- Acute renal failure (due to rhabdomyolysis);
- Decreased potency.
For the elderly, patients with renal insufficiency in a mild or moderately severe form do not need to be changed. In severe renal failure, the recommended dose is 10 mg. It is allowed to increase it only as a last resort and under the supervision of a physician.
If necessary, the use of simvastatin in combination with cyclosporine in patients undergoing organ transplantation, Vasilip prescribed in a dose of 5-10 mg per day.
The following drugs are manufactured with the same active ingredient: Simvastin, Avestatin, Zokor, Aterostat, Simgal, Holvasim, Simvor, Sincard.
According to the mechanism of action, analogues of Vasilip are: Akorta, Atomax, Atorvoks, Krestor, Lipona, Lovastatin, TG-tor, Medostatin, Tulp, Novostat, Roxera, Rosart, Rosuvastin.
Terms and conditions of storage
Vasilip is a preparation of List B, which should be stored at a temperature not exceeding 30 ° C. Shelf life of tablets - 3 years.