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  • Lipanor
    / CTS


    Active Ingredient
    Ciprofibrate 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    30 X 100 mg

    not in the basket chart 9595 12067

    Related information


    Dosage

    Adults: The recommended dosage is 100 mg per day. This dose should not be exceeded.
    Elderly patients: As for adults, but carefully observe “Precautions”.
    Children: Not recommended since safety and efficacy in children have not been established.
    Use in impaired renal function: In moderate renal impairment it is recommended that dosage be reduced to one capsule every other day. Patients should be carefully monitored. Ciprofibrate should not be used in severe renal impairment In combination with dietary measures, this medicinal product is a long-term symptomatic treatment, in which efficacy must be periodically monitored.
    For full details see prescribing information.


    Indications

    Primary hyperlipidemia resistant to appropriate dietary management, including hypercholesterolemia, hypertryglyceridaem., combined hyperlipidemia (types 11a, 11b, III, IV).


    Contra-Indications

    Severe hepatic impairment, Severe renal impairment, Hypersensitivity to the active substance or to one of the excipients, Pregnancy and lactation, Concurrent use with another fibrate and Previous phototoxicity caused by fibrates


    Special Precautions

    Secondary causes of dyslipidaemia, such as hypothyroidism, should be excluded or corrected prior to commencing any lipid lowering drug treatment.
    In patients with hypertriglyceridaemia, ciprofibrate may cause an increase of the LDL level.
    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. Therapy should be discontinued if myopathy is diagnosed or if markedly elevated CPK levels (levels exceeding 5 times the normal range) occur.
    Doses of 200mg ciprofibrate per day or greater have been associated with a high risk of rhabdomyolysis. Therefore the daily dose should not exceed 100 mg.
    Impaired hepatic function
    Use with caution. 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.
    Special precautions for use
    Association with oral anticoagulant therapy: concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR
    See prescribing information for full details


    Side Effects

    Muscle disorders: as with other fibrates, cases of muscle damage (diffuse myalgia,myopathy including myositis, painful sensitivity, weakness), along with exceptionalcases of rhabdomyolysis, sometimes severe, have been reported. These are usually reversible when treatment is discontinued.
    Effects occurring at the start of treatment and less common thereafter:
    Digestive or gastrointestinal disorders, such as nausea, vomiting, dyspepsia, diarrhea, abdominal discomfort. Generally, these side effects were mild to moderate in nature and occurred early on, becoming less frequent as treatment progressed. Headaches, vertigo, dizziness, rare cases of drowsiness, fatigue or sleeping disorders. Other undesirable effects have also been reported.
    Skin reactions: pruritus, urticaria, rash, eczema, photosensitivity reactions in exceptional cases (as with other fibrates), alopecia.
    Blood and lymphatic system disorder: Thrombocytopenia- Frequency not known.
    As with other fibrates, uncommon cases of elevated transaminase levels have been observed. Very rare cases of cholestasis or cytolysis have also been reported.
    As with other medicinal products in this class, a few cases of impotence have been reported.
    Isolated cases of interstitial pneumopathy and/or pulmonary fibrosis have beenreported.
    General disorders: Fatigue has only rarely been reported in association with ciprofibrate. At present, no controlled studies are available enabling assessment of the long-term undesirable effects in general and, more specifically, the risk of cholelithiasis. However, isolated cases of cholelithiasis have been reported.


    Drug interactions

    Not recommended combinations
    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. Some of the HMG CoA reductase inhibitor at high 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. This may increase the effects of drugs like phenytoin, tolbutamide and other sulphonylurea derivatives and coumarin-like anticoagulants. 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
    Cholestyramine and colestipol may reduce the absorption of ciprofibrate. These drugs should not be taken together or close to each other.
    See prescribing information for full details.


    Pregnancy and Lactation

    There is no evidence that ciprofibrate is teratogenic but signs of toxicity at high doseswere observed in teratogenisity tests in animals and ciprofibrate is excreted in the breastmilk of lactating rats. As there are no data on its use in human pregnancy and lactation,ciprofibrate is contra-indicated during pregnancy and in nursing mothers.


    Overdose

    There are rare reports of overdose with ciprofibrate but in these cases there are no adverse events that are specific to overdose. There are no specific antidotes to ciprofibrate. Treatment of overdose should be symptomatic. Gastric lavage and appropriate supportive care may be instituted if necessary. Ciprofibrate is non- dialyzable.


    Manufacturer
    CTS Chemical Industries Ltd
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