CFB
Cheaper & Alternative Brands
Same generic (Ciprofibrate), same form (Tablet)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
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.
Dosage & Administration
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 m
2
) 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 m
2
).
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.
Contraindications
Hypersensitivity to the active substance or to any of the excipients
Severe hepatic impairment
Severe renal impairment (creatinine clearance <30 ml/min/1.73 m
2
)
Pregnancy and lactation or when pregnancy is suspected
Concurrent use with another fibrate
Side Effects & Adverse Reactions
Headache, Dizziness, Somnolence, Vertigo, Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain, Rash, Alopecia, Myalgia, Fatigue.
Warnings & 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). 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.
Pharmacology & Mechanism of Action
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.