Ciprofbrate is indicated as an adjunct to diet, exercise and weight reduction for the following:
Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
Mixed hyperlipidemia when a statin is contraindicated or not tolerated.
Other fibrates & HMG CoA reductase inhibitors: As Risk of myopathy, rhabdomyolysis and myoglobinuria may be increased if Ciprofbrate is used in combination with other fibrates and HMG CoA reductase inhibitors.Oral anticoagulant therapy: Caution should be exercised when Ciprofbrate is taken with oral anticoagulants. Concomitant oral anticoagulant therapy should be given at a reduced dosage and adjusted according to INR.
Hypersensitivity to the active substance or to any of the excipients
Severe hepatic impairment
Severe renal impairment (creatinine clearance <30 ml/min/1.73 m2)
Pregnancy and lactation or when pregnancy is suspected
Concurrent use with another fibrate
Special warnings: Patients with rare hereditary problems of galactose intolerance, lactose deficiency or glucose-galactose malabsorption should not take this medicine.Myalgia/myopathy: Patients should be advised to report unexplained muscle pain, tenderness or weakness immediately.Patients with impaired hepatic function: Periodic hepatic function tests are recommended (every 3 months for the first 12 months of treatment). Ciprofbrate treatment should be discontinued in case of increased AST and ALT levels to more than 3 times the upper limit of normal or if cholestatic liver injury is evidenced.
Store below 30°C. Protect from light and moisture. Keep the medicine out of reach of children.
Ciprofbrate reduces both LDL & VLDL and hence the levels of triglyceride and cholesterol associated with these lipoprotein fractions. It also increases levels of HDL cholesterol. Ciprofbrate is effective in the treatment of hyperlipidemia associated with high plasma concentrations of LDL and VLDL. There is evidence that treatment with fibrates may reduce coronary heart disease events.
There is no evidence that Ciprofbrate is teratogenic but signs of toxicity at high doses were observed in teratogenicity tests in animals. As there are no data on its use in human pregnancy, Ciprofbrate is contraindicated during pregnancy. As there are no data on its use in lactation, Ciprofbrate is contraindicated in nursing mothers.
