Livial

Livial

tibolone

Manufacturer:

Organon

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Tibolone
Indications/Uses
Treatment of oestrogen deficiency symptoms in postmenopausal women, >1 yr after menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow w/ some water or other drink.
Contraindications
Hypersensitivity. Known, past or suspected breast cancer; known or suspected oestrogen-dependent malignant tumours; undiagnosed genital bleeding; untreated endometrial hyperplasia. Previous or current VTE; known thrombophilic disorders; any history of arterial thromboembolic disease. Acute liver disease or history of liver disease as long as LFTs have failed to return to normal. Porphyria. Pregnancy & lactation.
Special Precautions
Do not add a separate progestogen. Investigate any irregular/unscheduled vag bleeding to exclude malignancy before starting treatment. Initiate treatment only for postmenopausal symptoms that adversely affect quality of life. Limited evidence regarding risks in treatment of premature menopause. Not intended for contraceptive use. Conditions that may recur or be aggravated during treatment: Leiomyoma or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours; HTN; liver disorders; DM w/ or w/o vascular involvement; cholelithiasis; migraine or severe headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Discontinue treatment in case of jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache. Risk of endometrial hyperplasia & carcinoma; breast cancer; ovarian cancer; VTE; ischaemic stroke. Very minor decrease of thyroid-binding globulin & total T4. Decreased level of sex-hormone-binding globulin. Risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after age of 65. Caution in patients w/ cardiac or renal dysfunction; women w/ pre-existing hypertriglyceridaemia. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. No relevant use in paed population.
Adverse Reactions
Lower abdominal pain; abnormal hair growth; vag discharge, endometrial wall thickening, postmenopausal haemorrhage, breast tenderness, genital pruritus, vag candidiasis, vag haemorrhage, pelvic pain, cervical dysplasia, genital discharge, vulvovaginitis; increased wt; abnormal cervical smear.
Drug Interactions
Enhanced effect of anticoagulants eg, warfarin. Potential interaction w/ CYP3A4 substrates. Enhanced metabolism w/ CYP3A4 inducers eg, barbiturates, carbamazepine, hydantoins, rifampicin, herbal prep containing St. John's wort.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03CX01 - tibolone ; Belongs to the class of other estrogens. Used in the treatment of menopausal symptoms.
Presentation/Packing
Form
Livial tab 2.5 mg
Packing/Price
30's
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