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.
Indication
Menopausal vasomotor symptoms, [hot flushes, sweating, vaginal dryness & less elasticity, mood disorders, anxiety etc.], postmenopausal and post oophorectomy osteoporosis, improvement of bone-mineral density, Vaginal atrophy, Prevention of frequent UTI, urinary incontinence in postmenopausal women.
Contra Indication
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.
Dose
N/A
Side Effect
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.
Pregnancy Category
Name :
D
Description
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Mode of Action
Tibolone is a steroid that possesses oestrogenic, progestogenic and weak androgenic properties.
Interaction
Enzyme inducers eg, barbiturates, phenytoin, carbamazepine and rifampicin may accelerate tibolone metabolism. Increased anticoagulant effects of warfarin.
Pregnancy Category Note
N/A
Adult Dose
Oral
Menopausal vasomotor symptoms;
Adult: 2.5 mg daily.
Symptomatic relief occurs within few days, but optimal results are obtained minimum after 3 months.
Prophylaxis of postmenopausal osteoporosis
Adult: 2.5 mg daily.
To prevent osteoporosis in post-menopausal women or after oophorectomy an uninterrupted longer (5-10 years) therapy is needed.
Starting Tibolone:
In case of natural menopause: To avoid irregular & abnormal bleeding, Tibolone should be started at least 12 months after last natural bleeding.
In case of artificial menopause: Treatment should be started immediately.
In case of switching over from other conventional HRT: If someone switches from estrogen-only preparation, she should start after a withdrawal bleeding. If someone switches from sequential HRT preparation she should wait for the completion of the progestogen phase. If someone switches from continuous combined HRT, she can start any time.
In case of missed pill: If no more than 12 hours have passed, the pill should be taken immediately. Otherwise the next dose should be continued as before.
Child Dose
N/A
Renal Dose
N/A
Administration
May be taken with or without food.
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.