Drug reference
Short-term treatment of symptoms of oestrogen deficiency (including women being treated with gonadotrophin releasing hormone analogues)| Osteoporosis prophylaxis in women at high risk of fractures when other prophylaxis contra-indicated or not tolerated ▶BY MOUTH ▶Adult: 2.5 mg daily
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Acute porphyrias p. 1120. history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke or TIA). history of breast cancer. history of venous thromboembolism. liver disease (where liver function tests have failed to return to normal) . oestrogen-dependent cancer. thrombophilic disorder. uninvestigated or undiagnosed vaginal bleeding. untreated endometrial hyperplasia
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Diabetes (increased risk of heart disease). epilepsy. factors predisposing to thromboembolism. history of breast nodules—closely monitor breast status (risk of breast cancer). history of endometrial hyperplasia. history of fibrocystic disease—closely monitor breast status (risk of breast cancer). history of liver disease. hypertriglyceridaemia. hypophyseal tumours. migraine (or migraine-like headaches). presence of antiphospholipid antibodies (increased risk of thrombotic events). prolonged exposure to unopposed oestrogens may increase risk of developing endometrial cancer. risk factors for oestrogen-dependent tumours (e.g. breast cancer in first-degree relative). risk of stroke CAUTIONS, FURTHER INFORMATION ▶Other conditions The product literature advises caution in other conditions including hypertension, renal disease, asthma, epilepsy, sickle-cell disease, melanoma, otosclerosis, multiple sclerosis, and systemic lupus erythematosus (but care required if antiphospholipid antibodies present). Evidence for caution in these conditions is unsatisfactory and many women with these conditions may stand to benefit from HRT.
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Unsuitable for use in the premenopause (unless being treated with gonadotrophin-releasing hormone analogue) and as (or with) an oral contraceptive. Also unsuitable for use within 12 months of last menstrual period (may cause irregular bleeding). If transferring from cyclical HRT, start at end of regimen; if transferring from continuous-combined HRT, start at any time.
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→Appendix 1: tibolone
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▶Common or very common Breast abnormalities. cervical dysplasia. endometrial thickening. gastrointestinal discomfort. genital abnormalities. hair growth abnormal. increased risk of infection. pelvic pain. postmenopausal haemorrhage. vaginal discharge. vaginal haemorrhage. weight increased ▶Uncommon Oedema. skin reactions ▶Frequency not known Arthralgia. dementia. depression. dizziness. erythema nodosum. gallbladder disorder. headaches. increased risk of ischaemic stroke. myalgia. neoplasms. vision disorders SIDE-EFFECTS, FURTHER INFORMATION Vaginal bleeding Investigate for endometrial cancer if bleeding continues beyond 6 months or after stopping treatment. Reasons to withdraw treatment Withdraw treatment if signs of thromboembolic disease, abnormal liver function tests, or signs of cholestatic jaundice.
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Avoid; toxicity in animal studies.
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Avoid.
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Manufacturer advises caution; avoid in acute disease.
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Monitoring Patients with renal impairment should be closely monitored (risk of fluid retention).
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There can be variation in the licensing of different medicines containing the same drug. Endocrine system Tablet ▶Tibolone (Non-proprietary) Tibolone 2.5 mg Tibolone 2.5mg tablets | 28 tablet P £10.36 DT = £7.81 | 84 tablet P £23.43–£31.08 ▶Livial (Merck Sharp & Dohme Ltd) Tibolone 2.5 mg Livial 2.5mg tablets | 28 tablet P £10.36 DT = £7.81 | 84 tablet P £31.08 OESTROGENS COMBINED WITH PROGESTOGENS
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2.5 mg daily
First-line fragment. Read the complete Indications and Dose section above.
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