The preparation is indicated for use as an adjunct to diet and other non-pharmacological treatments (eg physical exercise, weight loss) in the following cases: treatment of severe hypertriglyceridemia with low levels of high density (HDL) cholesterol or without; mixed hyperlipidemia, if the use of statins is contraindicated or they are not tolerated.
Composition:
One capsule contains 100 mg of ciprofibrate. The preparation contains lactose.
Action:
The drug reduces cholesterol and triglycerides in the serum from the group of fibrates. The reduction in cholesterol is a consequence of the reduction in the percentage of low density atherosclerotic fractions (VLDL and LDL) following the inhibition of cholesterol biosynthesis in the liver. Typically, the production of HDL cholesterol also increases. Both of these factors improve the distribution of cholesterol in the blood serum. The VLDL + LDL / HDL index is significantly reduced. Cyprofibrate also has antiplatelet and fibrinolytic activity. After oral administration, it is absorbed quickly and almost completely. The maximum concentration in the blood plasma occurs within 2 h after administration. The drug is largely bound to plasma proteins. T0,5 in the blood plasma is about 17 h. It is excreted in the urine in unchanged form and in the form of glucuronic acid connections.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Pregnancy or suspected pregnancy and breastfeeding. Severe liver dysfunction. Severe kidney problems. Combination therapy with another fibrate.
Precautions:
Due to the risk of myopathy in the event of unexplained muscle pain, tenderness or weakness in the course of treatment, the patient should immediately see a doctor. In these patients, creatine phosphokinase (CPK) should be measured immediately. Treatment should be discontinued if myopathy is found or a significant increase in CPK activity (more than 5 times more than the normal value). The risk of myopathy may be greater for the following risk factors: renal dysfunction and any case of hypoalbuminemia, such as nephrotic syndrome; Hypothyroidism; alcohol abuse; age over 70 years; hereditary muscular disorders in a patient or family history of his or her family; Toxic effects on muscles after using another fibrate (history). The risk of rhabdomyolysis and myoglobinuria may be higher if ciprofibrate is used in combination with other fibrates or HMG-CoA reductase inhibitors. The drug should be used with caution in patients with impaired hepatic function. It is recommended to check liver function periodically (every 3 months during the first 12 months of treatment). Treatment with cyprofibrate should be discontinued if AST and ALT elevations are more than 3 times above the upper limit of normal or if cholestatic damage is found. Because existing hypothyroidism can cause secondary dyslipidemia, it should be recognized and corrected before starting treatment. If, after several months of treatment, serum lipid levels are not satisfactorily controlled, additional or other treatments should be considered. Due to the lack of sufficient data on the safety of the medicine in children and the lack of data on effects on growth organisms, the use of ciprofibrate in this group of patients may only be considered for severe lipid disorders in which ciprofibrate therapy is appropriate. The preparation contains lactose - it should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug is contraindicated for use during pregnancy and breast-feeding women.
Orally. Adults: the recommended dose is 100 mg ciprofibrate (1 capsule) per day. Do not use a larger dose. When a proper diet is used at the same time, the preparation is taken in long-term symptomatic treatment, whose effectiveness should be periodically controlled. In patients with moderate renal impairment, it is recommended to reduce the dose to 100 mg every other day. Carefully monitor the patient. Do not use ciprofibrate in patients with severe renal impairment.
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