Expiration date: 12/2025
The composition and form of issue:
Tablets, film-coated, prolonged action. 1 tablet contains:
fluvastatin sodium of 84.24 mg
(corresponding to 80 mg of fluvastatin)
other ingredients: microcrystalline cellulose hydroxypropyl methylcellulose (hypromellose) hydroxypropyl cellulose (hyprolose) potassium bicarbonate povidone magnesium stearate iron oxide yellow macrogol titanium dioxide
in blister packs of 7 or 14 PCs. in cardboard pack 1 or 2 blister card (14 pieces) or 4 blister packs (7 PCs.).
Method of application and dose:
Inside, regardless of meals, swallowing whole with a glass of water, 1 times a day. Since fluvastatin will not interact with substances being substrates for CYP3A4, is not expected its interaction with grapefruit juice.
Not identified reduction lipid lowering activity of fluvastatin when you assign it during or 4 hours after the evening meal.
Because the maximum lipid-lowering effect of the drug is to 4 weeks, the first revision of the dose is carried out depending on the achieved effect, at intervals of not less than 4 weeks. The therapeutic effect of the drug Lescol Forte remains at its long-term use.
Before the beginning of treatment the patient Lescol Forte must be translated into standard gipoholesterinovu diet. The diet must be followed during the entire treatment period.
The initial recommended dose is 80 mg (1 table. drug Lescol Forte 80 mg), 1 time per day. In mild cases of disease may be sufficient dose of fluvastatin 20 mg (1 caps. drug Lescol 20 mg). The initial dose should be individualized, taking into account the initial level of cholesterol/LDL and goals of therapy.
For patients with coronary heart disease after engineoptions operation the recommended starting dose is 80 mg/day.
Drug Lescol Forte effective when used in monotherapy. There are data to support the efficacy and safety of fluvastatin combined with nicotinic acid, or fibrates kolestiraminom.
Children and adolescents under 18 years of age
Children and adolescents over 9 years within 6 months before the start of drug therapy Lescol Forte and during the entire period of treatment should follow standard gipoholesterinovu diet.
The recommended starting dose is 80 mg (1 table. drug Lescol Forte 80 mg), 1 time per day. In mild cases of disease may be sufficient dose of fluvastatin 20 mg (1 caps. drug Lescol 20 mg). The initial dose should be adjusted individually according to the baseline LDL cholesterol and treatment goals.
The use of fluvastatina concurrently with nicotinic acid, cholestyramine or fibrates in children and adolescents has not been studied.
Patients with impaired renal function. Since fluvastatin is excreted mainly by the liver and less than 6% of the ingested dose excreted in the urine, patients with renal impairment of any severity is not necessary to carry out the correction of the dose.
Patients with impaired liver function. Contraindicated use of the drug Lescol Forte with active liver disease or persistent elevations of serum transaminase concentrations of unknown etiology.
Elderly patients. The efficacy and good tolerability of fluvastatin was demonstrated for patients older than 65 years of age and under that age. In the age group over 65 years the response to treatment was more pronounced, with any evidence of worst tolerability has been received. Thus, there is no need of changing the dose of the drug Lescol Forte, taking into account age.
