Lescol forte coated pills retard 80mg N28
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Active ingredients
Fluvastatin
Release form
Pills
Composition
Active ingredient: Fluvastatin; Concentration of active ingredient (mg): 80 mg
Indications
Adults (over 18), primary hypercholesterolemia and mixed dyslipidemia (type IIa and IIb according to Fredrickson's classification) in combination with diet therapy; coronary atherosclerosis in patients with ischemic heart disease and primary hypercholesterolemia, including a slight (to slow the progression of the disease); secondary prevention of major serious cardiovascular events (sudden cardiac death, myocardial infarction and coronary revascularization) in patients with coronary heart disease after percutaneous transluminal balloon angioplasty.; Children and adolescents (over 9 years old); heterozygous familial hypercholesterolemia in combination with diet therapy.
Contraindications
Hypersensitivity to fluvastatin or any inactive ingredient of the drug.; Active liver disease or a persistent increase in the concentration of serum transaminases of unknown etiology.; Pregnancy, breastfeeding period.
Dosage and administration
Tablets Lescol Forte can be taken once a day, regardless of the meal. Lescol Forte should be swallowed whole with a glass of water. There were no significant differences in the lipid-lowering effect of fluvastatin when administered with a meal or 4 hours after it was observed. Since fluvastatin does not interact with substances that are substrates for CYP3A4 isoenzyme, its interaction with grapefruit juice is not expected. No decrease in the hypolipidemic effect of fluvastatin was detected when administered during or 4 hours after the evening meal. 4 weeks, the first revision of the dose of the drug is carried out depending on the effect achieved, with an interval of at least 4 weeks. The therapeutic effect of Lescola Forte is preserved with its long-term use. Before the treatment with Lescol Forte, the patient must be transferred to a standard hypocholesterol diet. The diet must be observed during the whole period of treatment. The initial recommended dose is 80 mg (1 tablet Lescola Forte 80 mg) 1 time per day.In mild cases of disease, a dose of 20 mg fluvastatin (1 capsule of Lescol 20 mg) may be sufficient. The initial dose should be selected individually, taking into account the initial level of cholesterol / LDL and the goal of therapy. For patients with coronary heart disease after angioneoplastic surgery, the recommended initial dose is 80 mg per day.; Lescol Forte is effective when used as monotherapy. There is evidence of the efficacy and safety of fluvastatin when used in conjunction with nicotinic acid, cholestyramine or fibrates.; Children and adolescents under the age of 18.; Children and adolescents over 9 years of age for 6 months prior to the start of Lescol forta therapy adhere to the standard hypocholesterol diet.; The recommended initial dose is 80 mg (1 tablet Lescola Forte 80 mg) 1 time per day. In mild cases of disease, a dose of 20 mg fluvastatin (1 Lescol 20 mg capsule) may be sufficient. Initial doses should be selected individually in accordance with the baseline level of Xc-LDL and treatment goals. The use of fluvastatin at the same time as nicotinic acid, colestiramine or fibrates in children and adolescents has not been studied.; Patients with impaired renal function; only less than 6% of the dose delivered to the body is excreted in the urine, in patients with impaired renal function of any degree of severity, there is no need to adjust the dose of the drug.; Patients with impaired liver function; P The use of Lescola Forte with active liver disease or a persistent increase in serum transaminase concentrations of unknown etiology is motivated.; Elderly patients; The efficacy and good tolerability of fluvastatin has been demonstrated for patients over 65 years of age and younger. In the age group over 65, the response to treatment was more pronounced, with no evidence of worse tolerability. Thus, there is no need to change the dose of Lescola Forte with regard to age.
Side effects
The following adverse events are listed in frequency, starting with the most frequent.The frequency of occurrence of undesirable reactions was evaluated as follows: arising "very often" - ≥1 / 10, "often" - ≥1 / 100 ≤1/10, "sometimes" - ≥1 / 1000 ≤1 / 100, "rarely" - ≥ 1/10 000 ≤ 1/1000, "very rarely" - ≤ 1/10000, including individual messages. Within each group, identified by frequency of occurrence, adverse reactions are distributed in order of decreasing their importance. Among the observed side effects of the drug, minor symptoms of the gastrointestinal tract, insomnia and headache were most often noted. Of the hematopoietic system and lymphatic system : very rarely - thrombocytopenia.; Mental disorders: often insomnia.; From the nervous system: often - headache; very rarely - paresthesia, dysesthesia, hypoesthesia, possibly associated with the underlying disease. From the vascular system: very rarely - vasculitis. From the gastrointestinal tract: often - dyspepsia, abdominal pain, nausea; very rarely - pancreatitis.; From the liver: very rarely - hepatitis.; From the skin and subcutaneous tissue: rarely - hypersensitivity reactions such as rash, urticaria; very rarely - other skin reactions (eczema, dermatitis, bullous rash), swelling of the face, angioedema. From the musculoskeletal system: rarely - myalgia, muscle weakness, myopathy; very rarely - myositis, rhabdomyolysis, lupus-like reactions.; Laboratory values; Increase in serum transaminase concentrations to values more than 3 times higher than the upper limit of normal (1-2%) .; Marked increase in creatine phosphonophoresin (CPK) levels - more than 5-fold excess of the upper limit of normal (0.3-1%). The safety profile of fluvastatin in children and adolescents with heterozygous family hypercholesterolemia, which was evaluated in two clinical studies, did not differ from that established for adults. In both clinical studies in children and adolescents, normal growth and sexual development were observed.