Treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Prevention of osteoporosis in women who have gone through the menopause and are at high risk of fractures, but cannot take other medicines used to prevent osteoporosis.
Drugs for menopausal symptoms: Hormone replacement therapy
Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 3α−OH and 3β−OH metabolite) have predominantly estrogenic activity; a third metabolite (δ4-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.
Treatment of symptoms resulting from the natural or surgical menopause: The recommended dose is 2.50 mg once daily.
Prevention of post-menopausal bone mineral density loss: The recommended dose is 2.50 mg once daily.
Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months. Review should be needed for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment.
Starting Tibolone: Women experiencing a natural menopause should commence treatment with Tibolone at least 12 months after their last natural bleed. In case of a surgical menopause,treatment with Tibolone may commence immediately.
Interaction
Since Tibolone may increase blood fibrinolytic activity, it may enhance the effect of anticoagulants. This effect has been demonstrated with warfarin. Therefore, the simultaneous use of Tibolone and warfarin should be monitored, especially when starting or stopping concurrent Tibolone treatment, and the warfarin dose should be appropriately adjusted.
Gastrointestinal disorders like abdominal pain,skin and subcutaneous tissue disorders like abnormal hair growth, acne, reproductive system and breast disorders like vaginal discharge, endometrial hypertrophy, postmenopausal haemorrhage, breast tenderness, genital pruritus, vaginal candidiasis, cervical dysplasia etc.
USFDA pregnancy category D. Tibolone is contraindicated in lactating women
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