Formulary
Tibolone: Indications, Dosing, Side Effects and Interactions
Tibolone clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Tibolone: Indications, Dosing, Side Effects and Interactions
Tibolone clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**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**
- **Adult** (By Mouth): 2.5 mg daily.
Cautions
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); 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
Contraindications
Acute porphyrias ; history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke, or TIA); history of breast cancer; oestrogen-dependent cancer; thrombophilic disorder; undiagnosed vaginal bleeding; untreated endometrial hyperplasia; venous thromboembolism
Side effects
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.
Interactions
**Other interactions (6):**
- Since Livial may increase blood fibrinolytic activity, it may enhance the effect of anticoagulants.
- This effect has been demonstrated with warfarin.
- Caution should therefore be exercised during the simultaneous use of Livial and anticoagulants, especially when starting or stopping concurrent Livial treatment.
- If necessary, the dose of warfarin should be adjusted.
- There is limited information regarding pharmacokinetic interactions with tibolone An in vivo study showed that simultaneous treatment of tibolone affects pharmacokinetics of the cytochrome P450 3A4...
- Compounds that induce CYP3A4 activity such as barbiturates, carbamazepine, hydantoins and rifampicin may enhance the metabolism of tibolone and thus affect its therapeutic effect.
Pregnancy
Avoid; toxicity in animal studies.
Breast feeding
Avoid.
Hepatic impairment
Avoid in acute or history of liver disease, where liver function tests have failed to return to normal. M Caution in liver disorders e.g. liver adenoma. M
Renal impairment
Caution (risk of fluid retention). M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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