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  • Estelle-35
    / Taro


    Active Ingredient *
    Cyproterone (acetate) 2 mg
    Ethinylestradiol 0.035 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    21

    full basket chart 11996 5407

    Tablets

    3 X 21

    full basket chart 11997 5408

    Related information


    Dosage

    The usual dosage is generally one tablet, every day, at a fixed time, for 21
    days and afterwards, a 7-day break.
    See prescribing information for full details.


    Indications

    Signs of androgenization in women such as pronounced forms of acne, androgenic alopecia and mild form of hirsutism.


    Contra-Indications

    Pregnancy, lactation. Thrombotic disorders and a history of thromboembolic diseases of family members, sickle – cell anemia, disorders of lipid metabolism and other conditions in which, in individual cases, there is known or suspected to be a much increased risk of thrombosis. Acute or severe chronic liver diseases, Dubin-Johnson syndrome, Rotor syndrome, history during pregnancy of idiopathic jaundice or severe pruritis, history of herpes gestationis, mammary or endometrial carcinoma, abnormal vaginal bleeding of unknown cause, history of deterioration of otosclerosis during pregnancy, previous or existing liver tumors, severe diabetes with vascular changes.


    Special Precautions

    Liver function tests should be performed pre-treatment and whenever any symptoms or signs suggestive of hepatoxicity occur. Combined oral contraceptives must not be taken during treatment. The following conditions require strict medicdbal supervision: Diabetes mellitus, tendency towards diabetes mellitus, hypertension, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur, a liver tumor should be included in the differential-diagnostic considerations. Reasons for stopping medicdbation immediately: Occurrence of migraine. Frequent or unusually severe headaches. Acute disturbances of vision, suspicion of thrombosis or infarction. Jaundice. Six weeks before elective operations and during immobilization. Significant rise in blood pressure. Pregnancy. Examination of the pelvic organs, breasts and blood pressure should proceed the prescribing of Estelle-35, and should be repeated regularly. History of severe depressive states, varicose veins, diabetes, hypertension, epilepsy, otosclerosis, multiple sclerosis, porphyria, tetany, disturbed liver function, gallstones, cardiovascular diseases, renal diseases, chloasma, uterine fibroids, asthma, wearing of contact lenses or any disease that is prone to worsen during pregnancy. Blood estimations are recommended regularly during treatment. Chronic alcoholics. Adrenal function should be monitored during treatment.


    Side Effects

    Nausea, vomiting, headaches, gastric upsets, breast tension, changed body weight or libido, depressive moods, chloasma. Menstrual changes: Reduction of flow, missed menstruation (pregnancy must be excluded before a new course of tablets is started), intermenstrual bleeding (appears to be generally of no significance, except where it indicates errors of tablet-taking, or where the possibility of interaction with other drugs exist. If irregular bleeding is persistent, an organic cause should be considered.) In women taking Estelle-35, the content of protein-bound iodine in blood serum should not be used for the evaluation of thyroid function. May accelerate erythrocyte sedimentation in the absence of any disease. Increases in plasma copper, iron and alkaline phosphatase have also been recorded.


    Drug interactions

    Alcohol. Rifampicin, griseofulvin, barbiturates, phenytoin, primidone, carbamazepine. Tetracyclines, ampillicin, coumarin anticoagulants. Bile acids, danazol, oral hypoglycemics, insulin. Theophylline, cyclosporin.


    Manufacturer
    Douglas Pharmaceuticals
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