Index
Induces the reduction of plasma cholesterol and triglycerides.
Indications
It is indicated for treating primary hyperlipidemia resistant to appropriate dietary measures, including hypercholesterolemia, hypertriglyceridemia, and combined hyperlipidemia (types IIa, IIb, III, and IV of the Frederickson classification).
Oroxadin Pharmacological Action
Ciprofibrate is a broad spectrum lipid modulator. An effective complement of the diet in controlling high concentrations of HDL cholesterol and VLDL is an effective complement of the diet in managing high concentrations of HDL and VLDL cholesterol and triglycerides.
Ciprofibrate increases the level of HDL cholesterol. The absorption of ciprofibrate in the human species is rapid and almost complete.
The maximum plasma concentration is reached in approximately 1 hour in patients fasting or with a delay of 2 to 3 hours in the patients fed; the terminal half-life, determined in volunteers by study with isotope C14, was 88.6 ± 11.5 hours.
The elimination may be significantly slower in severe renal failure.
Dose
Adults: The recommended dose is one tablet of OROXADIN (100 mg) per day.
Elderly: Same dosage for adults, but carefully observing warnings and precautions.
Children: Ciprofibrate is not recommended since efficacy and tolerability have not been established in this age group.
Renal insufficiency: Half of the dose can be adequate by administering one tablet (100 mg) every other day in patients with moderate renal insufficiency. Do not use OROXADIN in cases of severe renal insufficiency.
Contraindications of Oroxadin
Oroxadin is contraindicated in case of severe hepatic or renal failure, pregnancy and lactation, and patients with hypersensitivity to ciprofibrate.
Warnings and Precautions of Oroxadin
General: Use caution in patients with impaired liver function. It is recommended to regularly perform liver function tests, including alanine aminotransferase (ALT or SGPT). Treatment with ciprofibrate should be discontinued in case of persistent changes in liver enzymes.
Use caution in patients with impaired renal function. If serum lipid levels are not controlled satisfactorily after several months of treatment, additional or alternative therapeutic measures should be considered.
Pregnancy and lactation: There is no evidence that ciprofibrate is teratogenic, but signs of toxicity have been observed with high doses in teratogenicity tests in animals.
Ciprofibrate is excreted in the milk of rats. Considering that there are no data on its use during pregnancy and lactation in the human species, ciprofibrate is contraindicated in pregnancy and during lactation.
Interactions of Oroxadin
Because of its high binding to plasma proteins, ciprofibrate can displace other substances from its protein bonds.
Ciprofibrate can potentiate the effect of warfarin, and therefore a possible concomitant treatment with oral anticoagulants should be done at reduced posology, under the control of prothrombin time.
There is a potential for interaction with oral hypoglycaemic agents, but the available data do not point to the appearance of significant clinical problems.
As for other fibrates, the risk of rhabdomyolysis and myoglobinuria can be increased when ciprofibrate is associated with HMG-CoA reductase inhibitors or other fibrates.
As with other fibrates, the action of ciprofibrate can be inhibited by oral contraceptives, although to date, there are no data on this.
Adverse Reactions of Oroxadin
Occasional cases of headache, vertigo, skin reactions and gastrointestinal symptoms (nausea, vomiting, diarrhea, dyspepsia ) have been reported. Such responses were usually mild or moderate, occurred at the beginning of treatment, and became less frequent with the continuation of therapy.
As with other medications of the same type, cases of myalgia and myopathy have been reported, including myositis and isolated cases of rhabdomyolysis.
Myopathic involvement seems to be related to the dose, and therefore the recommended amount of 100 mg daily should not be exceeded. Patients should be instructed to promptly notify the physician about the occurrence of myalgia, sensitivity to palpation, or muscle weakness.
In patients with these symptoms, serum creatine kinase (CPK) levels should be immediately verified, stopping treatment if myopathy is diagnosed or very high CPK levels. In most cases, the muscular toxicity is reversible with the suspension of the treatment.
