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| Drug class description : | Oestrogens / progestogens. |
| Generic Name : | Estradiol [oestradiol] valerate, medroxyprogesterone acetate |
| Drug description : | White, round tablets coded on one side with 1+2.5, 1+5 and 1+2.5, respectively. |
| Presentation : | Indivina 1mg/2.5mg: estradiol valerate 1mg, medroxyprogesterone 2.5mg. Indivina 1mg/5mg: estradiol valerate 1mg, medroxyprogesterone 5mg. Indivina 2mg/5mg: estradiol valerate 2mg, medroxyprogesterone 5mg. |
| Indications : | Replacement therapy for oestrogen deficiency symptoms and prophylaxis of osteoporosis in women more than three years after menopause with an intact uterus. |
| Adult Dosage : | One tablet daily without a tablet-free interval. Treatment is recommended to be initiated with Indivina 1mg/2.5mg tablet. Depending on the clinical response to treatment the dosage can then be adjusted to individual needs. For maintenance therapy the lowest effective dose should be used. should be used. In women with amenorrhoea and not taking HRT, or women who swap from another continuous combined HRT product, treatment with Indivina may start on any day. Women who switch from a cyclic HRT regimen should start treatment with Indivina one week after completion of the cycle. |
| Child Dosage : | Not applicable. |
| Contra Indications : | Pregnancy or suspected pregnancy. Lactation. Known, suspected or past history of breast cancer. Known or suspected oestrogen- dependent tumours (eg, endometrial cancer). Undiagnosed vaginal bleeding. Confirmed active venous thromboembolism (deep venous thrombosis, pulmonary embolism) within the past two years. A history of recurrent venous thromboembolism or known thrombophilic disease in a patient who is not already on anticoagulant treatment. Acute or chronic liver disease or a history of liver disease as long as liver function tests have failed to return to normal. Known hypersensitivity to the active substances or to any of the excipients. |
| Special Precautions : | Before initiating or reinstituting HRT, a complete personal and family medical history should be taken, together with a thorough general and gynaecological examination guided by the contraindications and warnings for use. Periodic check- ups during treatment are recommended. History of oestrogen-dependent tumours. Leiomyoma, endometriosis, hyperplasia of the endometrium. Fibrocystic disease of the breast. A history of thromboembolic disorders or the presence of risk factors (eg, personal or family history, severe obesity, systemic lupus erythematosus). Hypertension. Diabetes mellitus with vascular involvement. Liver disorders (eg, porphyria, liver adenoma, icterus). Cholelithiasis. (severe) headache. Cardiac or renal dysfunction. Asthma. Epilepsy. Prolonged immobilisation, major trauma or major surgery; where immobilsation is likely to follow elective surgery consider stopping HRT four to six weeks earlier. |
| Interactions : | Inducers of hepatic microsomal enzymes, eg, barbiturates, phenytoin, carbamazepine and rifampicin. Inhibitors of hepatic microsomal enzymes, eg, ketoconazole, griseofulvin, cyclosporin. |
| Adverse Reactions : | Most commonly, breast tenderness. Also, nausea, abdominal pain, headache, uterine bleeding, increase in size of uterine fibroids, weight increase/ decrease, oedema, breast enlargement, mood changes including anxiety and depressive mood, changes in libido. Uncommonly, dyspepsia, vomiting, flatulence, cholestasis, gallbladder disease, gall stones, dizziness, migraine, vaginal candidiasis, increase in blood pressure, leg cramps. Rarely, alopecia, hirsutism, rash, itching, venous thromboembolism. Very rarely, chloasma, erythema multiforme, erythema nodosum, haemorrhagic eruption. REASONS FOR IMMEDIATE DISCONTINUATION OF TREATMENT: Occurence of migraine-type headaches for the first time, frequent severe headaches, acute visual disturbances, signs of thrombophlebitis or thromboembolism, or any other possible prodromal symptoms of vascular occlusion. Rise in blood pressure. Jaundice. Pregnancy. Discontinue four to six weeks before major elective surgery and during immobilisation entailing risk of thrombosis. |
| Manufacturer : | Orion |
| Drug Availability : | (POM) |
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