Dosage Form: Tablet
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.
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.
Adults: The recommended dose is Ciprofbrate 100 mg per day. This dose should not be exceeded.
Patients with renal insufficiency: In moderate renal impairment (creatinine clearance 30-80 ml/min/1.73 m2) it is recommended that dosage be reduced to one tablet every other day. Patients should be carefully monitored. Ciprofbrate should not be used in severe renal impairment (creatinine clearance <30 ml/min/1.73 m2).
Patients with hepatic insufficiency: Use with caution in patients with impaired hepatic function. 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.
Elderly: As for adults but precautions should be taken for Age more than 70 years.
Paediatric population: Not recommended since safety and efficacy in children has not been established.
Route of administration: Orally
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
Headache, Dizziness, Somnolence, Vertigo, Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain, Rash, Alopecia, Myalgia, Fatigue.
Pregnancy & Lactation:
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.
Precautions & Warnings:
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.
Anti-hypertensive, Other Anti-anginal & Anti-ischaemic drugs
Store below 30°C. Protect from light and moisture. Keep the medicine out of reach of children.
Manufactured by: Eskayef Pharmaceuticals Ltd.