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  • Danol 200
    / Sanofi


    Active Ingredient
    Danazol 200 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    60 X 200 mg

    partial basket chart 11063 4565

    Related information


    Dosage

    Should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patient’s response. A reduction in dosage once a satisfactory response has been achieved may prove possible. In fertile females, treatment should be started during menstruation, on the first day.
    Women of childbearing age should employ non-hormonal contraception throughout the course of treatment.  Endometriosis: 200-800 mg daily, for 3-6 months. Increase if normal cyclical bleeding still persists after two months of therapy. A higher dosage (not exceeding 800 mg daily) may be needed for severe disease. Prophylaxis of hereditary angioedema: Initial dose: 200 mg 2 or 3 x daily until desired initial response is obtained. Maintenance dose is determined by decreasing the initial dosage by 50% or less at intervals of 1-3 months or longer, depending on the frequency of attacks prior to treatment. Lowest effective maintenance dose should be sought for continuous preventive treatment. Daily dosage may be increased by up to 200 mg if condition is not controlled at lower doses.
    Elderly: Not recommended.
    Children: Not recommended.             


    Indications

    Treatment of endometriosis amenable to hormonal management. Treatment of hereditary angioedema.


    Contra-Indications

    Pregnancy, lactation, markedly impaired hepatic, renal or cardiac function. Porphyria, active thrombosis or thromboembolic disease and a history of such events. Androgen dependent tumor, undiagnosed abnormal genital bleeding. Concomitant administration with simvastatin.


    Special Precautions

    In the event of virilization, treatment should be withdrawn. Should be stopped if any clinically significant adverse event arises, and particularly if there is evidence of papilloedema, headache, visual, disturbances or other signs or symptoms of raised intracranial pressure, jaundice or other indication of significant hepatic disturbance, thrombosis or thromboembolism. No safety data are available in relation to repeated courses of treatment over time. The use of danazol might increase the baseline risk of ovarian cancer in patients treated for endometriosis. Patients with hepatic or renal disease, hypertension or other cardiovascular disease and in any state which may be exacerbated by fluid retention as well as in diabetes mellitus, polycythemia, epilepsy, lipoprotein disorder, and in those who have shown marked or persistent androgenic reaction to previous gonadal steroid therapy. Patients with migraine. Presence of known or suspected malignant disease. The presence of hormone-dependent carcinoma should be excluded before treatment initiation. Appropriate laboratory monitoring should be considered, which may include periodic measurement of hepatic function and hematological state. Should be initiated during menstruation. Women of childbearing age should employ non-hormonal contraception throughout the course of treatment. The lowest effective dose should always be sought. Patient monitoring consists of hepatic function determinations, pregnancy test (if treatment is not started during menstruation), semen volume and viscosity determinations and sperm count and motility determinations. May increase the calcemic response in primary hypoparathyroidism necessitating a reduction in dosage. May interfere with laboratory determinations.
    Pregnancy and lactation: Should not be used during pregnancy. Breast-feeding should be discontinued.


    Side Effects

    Weight gain, increased appetite, acne and seborrhea. Hirsutism, hair loss, voice change, sore throat. Menstrual disturbances, insulin resistance may be increased in diabetes mellitus. Aggravated epilepsy, backache and muscle cramps, creatine phosphokinase levels may rise. Hypertension, palpitations, tachycardia, benign intracranial hypertension. Increase in red cell and platelet count, fluid retention, possible psychical reactions.
    See prescribing information for full details.


    Drug interactions

    Anti-convulsant therapy: Danazol may affect the plasma level of carbamazepine and possibly the patient’s response to this agent and to phenytoin. With phenobarbitone it is likely that similar interaction would occur. Anti-diabetic therapy: Danazol can cause insulin resistance.
    Oral anti-coagulant therapy: Danazol can potentiate the action of warfarin. Anti-hypertensive therapy: Possibly through promotion of fluid retention, Danazol can oppose the action of anti-hypertensive agents.
    Cyclosporin and tacrolimus: Danazol can increase the plasma level of cyclosporin and tacrolimus, leading to an increase of the renal toxicity of these drugs.
    Concomitant steroids: Although specific instances have not been described, it is likely that interactions will occur between Danazol and gonadal steroid therapy.
    Migraine therapy: Danazol may itself provoke migraine and possibly reduce the effectiveness of medication to prevent that condition.
    Ethyl alcohol: Subjective intolerance in the form of nausea and shortness of breath has been reported.
    Alpha calcidol: Danazol may increase the calcaemic response in primary hypoparathyroidism necessitating a reduction in dosage of this agent. Interactions with laboratory function tests: Danazol treatment may interfere with laboratory determination of testosterone or plasma proteins.
    Statins: The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins metabolised by CYP3A 4. The concomitant administration of danazol with simvastatin is contraindicated.
    See prescribing information for full details


    Pregnancy and Lactation

    Pregnancy: Should not be used during pregnancy There is epidemiological and toxicological evidence of hazard in human pregnancy. Danazol is known to be associated with the risk of virilisation to the female foetus if administered during human pregnancy. Women of childbearing age should be advised to use an effective, non-hormonal, method of contraception. If the patient conceives during therapy, treatment should be stopped.
    Lactation: Danazol has the theoretical potential for androgenic effects in breast-fed infants and therefore either therapy or breast-feeding should be discontinued.

     


    Overdose

    Available evidence suggests that acute overdose would be unlikely to give rise to immediate serious reaction.
    In the case of acute overdose, consideration should be given to reducing the absorption of the drug with activated charcoal and the patient should be kept under observation in case of any delayed reactions.


    Manufacturer
    Zentiva K.S., Czech Republic
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