Ciprofibrate

Ciprofibrate is a fibrate class medication indicated as an adjunct to diet, exercise and weight reduction for the treatment of severe hypertriglyceridemia with or without low HDL cholesterol, and mixed hyperlipidemia when a statin is contraindicated or not tolerated. Ciprofibrate reduces both LDL and 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.

• Severe hypertriglyceridemia (with or without low HDL cholesterol)
• Mixed hyperlipidemia (when a statin is contraindicated or not tolerated)

Ciprofibrate reduces both LDL and 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.

Ciprofibrate activates lipoprotein lipase and reduces VLDL synthesis, thereby lowering triglyceride and cholesterol levels while increasing HDL cholesterol.

Adult Dose: 100 mg once daily (1 tablet per day). This dose should not be exceeded.

Renal Dose: Moderate renal impairment (CrCl 30-80 ml/min/1.73 m²): 1 tablet (100 mg) every other day. Severe renal impairment (CrCl <30 ml/min/1.73 m²): Should not be used.

Hepatic Dose: Use with caution in impaired hepatic function. Discontinue if AST and ALT levels rise 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.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Take it at the same time every day.

If you miss a dose of Ciprofibrate, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common Side Effects:

• Headache
• Dizziness
• Somnolence
• Vertigo
• Nausea
• Vomiting
• Diarrhea
• Dyspepsia
• Abdominal pain
• Rash
• Alopecia
• Myalgia
• Fatigue

Serious Side Effects: Myopathy, rhabdomyolysis, myoglobinuria, elevated liver enzymes.

• Myalgia/myopathy: Report unexplained muscle pain, tenderness or weakness immediately.
• Hepatic function tests: Recommended every 3 months for the first 12 months of treatment.
• Patients with rare hereditary problems of galactose intolerance, lactose deficiency or glucose-galactose malabsorption should not take this medicine.
• Contraindicated during pregnancy and lactation.

• Hypersensitivity to the active substance or to any of the excipients
• Severe hepatic impairment
• Severe renal impairment (CrCl <30 ml/min/1.73 m²)
• Pregnancy and lactation
• Concurrent use with another fibrate

Other fibrates & HMG CoA reductase inhibitors: Risk of myopathy, rhabdomyolysis and myoglobinuria may be increased.

Oral anticoagulant therapy: Caution should be exercised. Concomitant oral anticoagulant therapy should be given at a reduced dosage and adjusted according to INR.

No food interactions have been found or established.

There is no evidence that Ciprofibrate is teratogenic but signs of toxicity at high doses were observed in animal studies. Contraindicated during pregnancy.

As there are no data on its use in lactation, Ciprofibrate is contraindicated in nursing mothers.

Not recommended since safety and efficacy in children has not been established.

As for adults but precautions should be taken for age more than 70 years.

Renal Impairment: Moderate (CrCl 30-80): 1 tablet every other day. Severe (CrCl <30): Should not be used.

Hepatic Impairment: Use with caution. Discontinue if AST and ALT rise to more than 3 times the upper limit of normal or if cholestatic liver injury is evidenced.

Information on Ciprofibrate overdosage is not available. Consult a physician if overdose is suspected.

Store below 30°C. Protect from light and moisture. Keep out of reach of children.

Ciprofibrate