Estradiol Benzoate Injection COMPOSITION Each 1 mL contains. estradiol benzoate 5 mg INDICATIONS Estrogen deficiency symptoms associated with the natural or surgical menopause. CONTRA-INDICATIONS -Pregnancy. -Cardiovascular or Cerebrovascular disorders. e.g. thrombophlebitis, thromboembolic processes or a history of these conditions. -Hypertension. -Severe migraine. -Liver disorders; cholestatic jaundice; a history of jaundice of pregnancy or jaundice due to estrogen/androgen use; Rotor syndrome and Dubin-Johnson syndrome. -Known or suspected estrogen-dependant tumours. -Endometrial hyperplasia. -Undiagnosed vaginal bleeding. -Haemoglobinopathies, e.g. sickle cell anaemia. -Porphyria. -Hyperlipoproteinemia, especially in the presence of other risk factors predisposing to cardiovascular disorders. -A history during pregnancy or previous estrogen use of severe pruritus, herpes gestationis or a deterioration of otosclerosis. WARNINGS If any signs of thromboembolic processes occur. treatment should be discontinued immediately. In patients using estrogen-containing preparations.the risk of deep-vein thrombosis may be increased when undergoing major surgery or prolonged immobilisation. DOSAGE AND DIRECTIONS FOR USE Climacteric symptoms: 1 injection of 1 mL every 3 to 4 weeks or with longer intervals, depending on the clinical need. should be administered by deep intramuscular injection. SIDE-EFFECTS AND SPECIAL PRECAUTIONS The following adverse reactions have been associated with either estrogen or androgen therapy or both: -Genito-urinary tract intermenstrual bleeding, endometrial proliferation, excessive production of cervical mucous, increase in size of uterine fibromyomata, aggravation of endometriosis, enlarged clitoris. -Breast tenderness, pain, enlargement, secretion. -Gastrointestinal tract nausea, vomiting, cholalithiasis, cholestatic jaundice. -Cardiovascular system thrombosis, rise of blood pressure. -Skin erythema nodosum, rash, oily skin, acne, hirsutism. -Eyes discomfort of the cornea if contact lenses are used. -Central nervous system headache, migraine, mood changes. -Various water and salt retention,reduced glucose tolerance, change in body mass, hoarseness or deepening of the voice. Case reports have been published of benign hepatic tumours. precautions In the presence of severe varicose veins the benefits of estrogen therapy must be weighed against the possible risks. Treatment should be discontinued if the results of liver function tests become abnormal or cholestatic jaundice appears. There are reports indicating an association between the use of estrogen-containing preparations and the occurrence of cholelithiasis. Pain in the breasts or excessive production of cervical mucous may be indicative of too high a dosage. If early signs of virilisation occur, e.g. hoarseness of the voice, treatment should be discontinued. The use of estrogen/androgen preparations may influence the results of certain laboratory tests. During prolonged treatment with estrogens/androgens, periodic medical examinations are advisable. Patients with the following conditions should be monitored: -latent or overt cardiac failure,renal dysfunction, epilepsy or migraine (or a history of these conditions), since estrogens/androgens may induce salt and water retention; -a history of hypertension; if hypertension develops, treatment should be discontinued; -sickle cell trait, since in special conditions, e.g. during infections or anoxia, estrogens may induce; -thromboembolic processes; -diabetes, since estrogens/androgens may influence the glucose tolerance and change the need for insulin or other antidiabetic medicines; -oestrogen-sensitive gynaecological disorders. e.g. uterine fibromyomata that may increase in size, and endometriosis which may be aggravated by estrogen treatment. The efficacy of Mixogen may be decreased by the concomitant administration of medicines such as the anti-epileptic agents and rifampicin. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT See 'Side-effects and special precautions'. CONDITIONS OF REGISTRATION Advertising to the professions only. IDENTIFICATION A clear, oily solution in 1 mL ampoules. PRESENTATION Boxes of 100 ampoules. STORAGE INSTRUCTIONS The ampoules should be protected from light and kept at temperatures below 30ºC. Keep out of reach of children.
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