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Indication & Dosage |
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| Oral |
| MENOPAUSAL VASOMOTOR SYMPTOMS AND PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS |
| Adult:
2.5 mg daily. |
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| Administration |
May be taken with or without food. |
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| Precautions |
Liver disease, history or risk factors of thromboembolic disorder, impaired glucose tolerance, hypercholesterolaemia, hypertriglyceridaemia, hypertension, cholelithiasis, SLE, uterine fibroids, endometriosis and history of endometrial hyperplasia. Disorders that may be worsened by fluid retention, eg. renal dysfunction, migraine, epilepsy. Discontinue in the event of thromboembolic or abnormal liver function results, significant increase in BP, new onset of migraine-type headache. Not recommended in women within 1 yr of menopause because of irregular vaginal bleeding. Stop tibolone 4 wk before elective surgery especially when prolonged immobilisation after surgery is expected. Adjustment of antidiabetic medications may be needed. |
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Potentially Life-threatening
Adverse Drug Reactions |
Weight gain; dizziness; rash; pruritus; headache; migraine; visual disturbances; GI symptoms; facial hair growth; altered liver function; ankle oedema; depression; arthralgia or myalgia; irregular vaginal bleeding. |
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| Adverse Drug Reactions |
Breast or endometrial cancer and stroke. |
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| Interactions |
Enzyme inducers eg, barbiturates, phenytoin, carbamazepine and rifampicin may accelerate tibolone metabolism. Increased anticoagulant effects of warfarin. |
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