P :Contraindicated in pregnancy
L :Contraindicated in lactation
||See TERMINOLOGY & ABBREVIATIONS ||
|Indication & Dosage||
Treatment of symptoms resulting from the natural or
surgical menopause: The recommended dose is 2.5 mg once daily.
|Administration||May be taken with or without food.
â€¢ Pregnancy and lactation
|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 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|