Tibolone

Indications
 Oral
Menopausal vasomotor symptoms, Prophylaxis of postmenopausal osteoporosis
Adult: 2.5 mg daily.
Contraindications
 Known or suspected oestrogen dependent tumours in women, present or history of breast cancer, undiagnosed vaginal bleeding, severe liver disease, history or current CV or cerebrovascular disorders, untreated endometrial hyperplasia, porphyria, pregnancy and lactation, premenopausal women.
Warnings / 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.
Adverse 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.
Potentially Fatal: Breast or endometrial cancer and stroke.
Drug Interactions
 Enzyme inducers eg, barbiturates, phenytoin, carbamazepine and rifampicin may accelerate tibolone metabolism. Increased anticoagulant effects of warfarin.
See Below for More tibolone Drug Interactions
Mechanism of Actions
 Tibolone is a steroid that possesses oestrogenic, progestogenic and weak androgenic properties.
Absorption: Rapidly and extensively absorbed after oral admin. Peak plasma concentrations after 1-1.5 hr (oral).
Metabolism: Converted into 3 active metabolites with 2 having predominantly oestrogenic property and 1 with progestogenic and androgenic property.
Excretion: Faeces (via the bile); via the urine (about 30% of a dose). The 2 main metabolites have an elimination half-life of about 7 hr.
Administration
 May be taken with or without food.
ATC Classification
 G03CX01 - tibolone ; Belongs to the class of other estrogens. Used in the treatment of menopausal symptoms.
Available As
  • Tibolone 2.5 mg

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