Centiva (Ciprofibrate)
Ciprofibrate reduces both LDL & VLDL and hence the levels of triglyceride and cholesterol associated with these lipoprotein fractions. It also increases levels of HDL cholesterol.
Description
Ciprofibrate reduces both LDL & VLDL and hence the levels of triglyceride and cholesterol associated with these lipoprotein fractions. It also increases levels of HDL cholesterol. Ciprofibrate 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.
Presentation
Centiva Tablet: Each tablet contains Ciprofibrate BP 100 mg.
Indications
Ciprofibrate 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.
Dosage & Administration
Adults: The recommended dose is one Centiva Tablet (Ciprofibrate 100mg) per day. This dose should not be exceeded.
Patients with renal insufficiency: In moderate renal impairment (creatinine clearance 30-80 ml/min/1.73m2) it is recommended that dosage be reduced to one tablet every other day. Patients should be carefully monitored. Ciprofibrate
should not be used in severe renal impairment (creatinine clearance <30 ml/min/1.73m2).
Patients with hepatic insufficiency: Use with caution in patients with impaired hepatic function. Ciprofibrate 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.
Contrainidications
Ciprofibrate may be contraindicated in patients with:
✔ Hypersensitivity to the active substance or to any of the excipients
✔ Severe hepatic impairment
✔ Severe renal impairment (creatinine clearance <30 ml/min/1.73m2)
✔ Pregnancy and lactation or when pregnancy is suspected
✔ Concurrent use with another fibrate.
Warning & Precautions
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). Ciprofibrate 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.
Side effects
Headache, Dizziness, Somnolence, Vertigo, Nausea, Vomiting, Diarrhea, Dyspepsia, Abdominal pain, Rash, Alopecia, Myalgia, Fatigue.
Drug interaction
Other fibrate & HMG CoA reductase inhibitors: As Risk of myopathy, rhabdomyolysis and myoglobinuria may be increased if Ciprofibrate is used in combination with other fibrate and HMG CoA reductase inhibitors.
Oral anticoagulant therapy: Caution should be exercised when Ciprofibrate is taken with oral anticoagulants. Concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR.
Use in special groups
Use in Pregnancy: There is no evidence that Ciprofibrate 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, Ciprofibrate is contraindicated during
pregnancy.
Lactation: As there are no data on its use in lactation, Ciprofibrate is contraindicated in nursing mothers.
Packing
Centiva Tablet: Each box contains 30’s tablets in blister pack.
