PCI  :Contraindicated in pregnancy

LCI  :Contraindicated in lactation

Molecule Info

 |See TERMINOLOGY & ABBREVIATIONS |
Indication & Dosage
  • Treatment of symptoms resulting from the natural or surgical menopause in post menopausal womenWomen above 60 years of age should only start with LIVIAL treatment when they are intolerant of or contraindicated for other medicinal products approved for the treatment of oestrogen deficiency symptoms. 
  • Prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.

Treatment of symptoms resulting from the natural or surgical menopause: The recommended dose is 2.5 mg once daily.
Prevention of post-menopausal bone mineral density loss: The recommended dose is 2.5 mg once daily.

Administration May be taken with or without food.
Contraindications

• Pregnancy and lactation
• Known, past or suspected breast cancer – Tibolone (LIVIAL) increased the risk of breast cancer recurrence in a placebo-controlled trial
• Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
• Undiagnosed genital bleeding
• Untreated endometrial hyperplasia
• Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
• Known thrombophilic disorders (e.g protein C, protein S, or antithrombin deficiency)
• Any history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke or TIA)
• Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal.
• Known hypersensitivity to the active substance or to any of the excipients
• Porphyria

Special 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 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.
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. Please consult manufacturer's PIL (Prescribing Information Leaflet) for detailed drug interactions.
Pharmacology 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.
ATC Classification G03CX01 - tibolone.

Brand/Product Info


Total Products : 7       
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
LIVIAL Nuvista Pharma Limited Tibolone 2.5mg Tablet 28's: 1875.00 MRP
MENOREST Renata Limited Tibolone 2.5mg Tablet 28's: 561.96 MRP
RENORMA 2.5 Square Pharmaceuticals Ltd. Tibolone 2.5mg Tablet 3x10's: 603.90 MRP
TIBO Popular Pharmaceuticals Ltd. Tibolone 2.5mg Tablet 30's: 602.40 MRP
TIBONE Techno Drugs Tibolone 2.5mg Tablet 30's: 450.00 MRP
TIBONOR Eskayef Bangladesh Ltd Tibolone INN 2.5mg Tablet 30's MRP: 600.00
Ubilon Incepta Pharmaceuticals Limited Tibolone INN 2.5 mg Tablet 10x3's:MRP 600 Tk