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Oroxadin

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Indications:

recommended for the treatment of primary dyslipoproteinaemias, including types IIa, IIb, III and IV (hypercholesterolaemia, hypertriglyceridaemia and combined forms) - refractory to appropriate dietary treatment. Dietary measures should be continued during therapy.

Contraindications:

Severe hepatic impairment. Severe renal impairment. Pregnancy and lactation. Concurrent use with another fibrate. Hypersensitivity to the active substance or to any component of the product.

Adverse reactions:

Cutaneous disorders: Cutaneous reactions mainly allergic have been reported: rashes, urticaria and pruritus, and very rarely photosensitivity. As with other drugs in this class, a low occurrence of alopecia has been reported. Muscular disorders: As with other fibrates, elevation of serum creatine phosphokinase (CPK), myalgia and myopathy including myositis and rare cases of rhabdomyolysis have been reported. In the majority of cases muscle toxicity is reversible when treatment is withdrawn. Neurological disorders: Occasional reports of headache, vertigo. Dizziness, drowsiness have only rarely been reported in association with ciprofibrate. As with other drugs of this class, a low occurrence of impotence has been reported. Gastro-intestinal disorders: There have been occasional reports of gastrointestinal symptoms including nausea, vomiting, diarrhoea, dyspepsia, and abdominal pain. Generally, these side effects were mild to moderate in nature and occurred early on, becoming less frequent as treatment progressed. Hepato-biliary disorders: As with other fibrates, abnormal liver function tests have been observed occasionally. Very rare cases of cholestasis or cytolysis have been reported. Exceptional cases with chronic evolution have been observed. Pulmonary disorders: Isolated cases of pneumonitis or pulmonary fibrosis have been reported. General disorders: Tiredness has only rarely been reported in association with ciprofibrate.

Interactions:

Other fibrates: As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates.HMG CoA reductase inhibitors: As with other fibrates, the risk of myopathy, rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with HMG CoA reductase inhibitors. The benefits of combined use should be carefully weighed against the risks. Physicians contemplating concomitant therapy with HMG CoA reductase inhibitors should consult the of the relevant HMG CoA reductase inhibitor as some higher doses are contraindicated / not recommended with fibrates. * Combination requiring caution Oral anticoagulant therapy: Ciprofibrate is highly protein bound and therefore likely to displace other drugs from plasma protein binding sites. Ciprofibrate has been shown to potentiate the effect of warfarin, indicating that concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR. * Combination to be taken into account Oral hypoglycaemics: A possible interaction should be considered. Oestrogens: Oestrogens can raise lipid levels. Although a pharmacodynamic interaction may be suggested, no clinical data are currently available.

Warnings:

Patients with rare hereditary problems of galactose intolerance, the Lapp 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. CPK levels should be assessed immediately in patients reporting these symptoms. Treatment should be discontinued if CPK levels are greater than ten times the upper limit of the normal range, if levels rise progressively or if there is other evidence of myopathy. - Doses of 200mg ciprofibrate per day or greater have been associated with a high risk of rhabdomyolysis. Therefore the daily dose should not exceed 100mg. - Impaired renal function and any situation of hypoalbuminaemia such as nephrotic syndrome, high alcohol intake or hypothyroidism may increase the risk of myopathy. - As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates or HMG CoA reductase inhibitors. Use with caution in patients with impaired hepatic function. Periodic hepatic function tests are recommended. Ciprofibrate treatment should be discontinued if significant transaminases abnormalities persist or if cholestatic liver injury is evidenced. Secondary causes of dyslipidaemia, such as hypothyroidism, should be excluded or corrected prior to commencing any lipid lowering drug treatment. Special precautions for use Association with oral anticoagulant therapy: concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR. If after a eriod of administration lasting several months, a satisfactory reduction in serum lipid concentrations has not been obtained, additional or different therapeutic measures must be considered.

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