Livial

Livial

tibolone

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Tibolone
Indications/Uses
Estrogen 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 osteoporosis prevention.
Dosage/Direction for Use
1 tab daily. Women experiencing natural menopause Start treatment at least 12 mth after last natural bleed, surgical menopause Start treatment immediately. Changing from sequential HRT prep Start treatment the day following completion of prior regimen, continuous-combined HRT prep Start treatment at any time.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Hypersensitivity. Known, history or suspected breast cancer. Any history of arterial thromboembolic disease eg, angina, MI, stroke or transient ischaemic attack. Known or suspected estrogen-dependent malignant tumors eg, endometrial cancer. Previous or current VTE (DVT, pulmonary embolism). Known thrombophilic disorders eg, protein C & S, or antithrombin deficiency. Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Porphyria. Acute liver disease or history of liver disease as long as LFTs have failed to return to normal. Pregnancy & lactation.
Special Precautions
Discontinue treatment in case of jaundice or deterioration in liver function, significant increase in BP, new onset of migraine-type headache; if VTE develops. Temporarily discontinue HRT or treatment for 4-6 wk earlier if prolonged immobilisation is to follow elective surgery. Not intended for contraceptive use. Recurrence or aggravation of conditions during pregnancy or previous hormone treatment including leiomyoma or endometriosis, risk factors for estrogen dependent tumors (eg, 1st degree hereditary for breast cancer) & thromboembolic disorders, HTN, liver disorders (eg, liver adenoma), DM w/ or w/o vascular involvement, cholelithiasis, migraine or severe headache, SLE, history of endometrial hyperplasia, epilepsy, asthma, otosclerosis. Increased risk of endometrial cancer from increasing duration of use & of endometrial wall thickness; breast cancer; ischaemic stroke from 1st yr of treatment especially in older age. Slightly increased risk of ovarian cancer in long-term use (at least 5-10 yr). Premature menopause. Breakthrough bleeding & spotting during 1st mth of treatment. VTE (ie, DVT or pulmonary embolism) risk factors including use of estrogens, older age, major surgery, prolonged immobilization, obesity (BMI >30 kg/m2), pregnancy/postpartum period, SLE & cancer. MI in patients w/ or w/o existing CAD. Dose-dependent decrease in HDL cholesterol. Reduced levels of triglycerides & lipoprotein(a). Minor decrease in thyroid binding globulin & total T4. Decrease sex-hormone-binding globulin level. Patients w/ known thrombophilic states; pre-existing hypertriglyceridemia. Women on anticoagulant therapy. Carefully assess each woman for endometrial cancer in those w/ risk of stroke, breast cancer & those w/ intact uterus. Take complete personal & family medical history before initiating treatment. Perform periodic checkup during treatment. Investigate changes in breast using appropriate imaging tool eg, mammography; any irregular/unscheduled vag bleeding either on or off HRT to exclude malignancy before starting treatment. Report any breakthrough bleeding or spotting persisting after 6 mth of treatment. Screen patients w/ no personal history of VTE but w/ 1st degree relative w/ history of thrombosis at young age. Observe patients w/ cardiac or renal dysfunction for fluid retention. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. W/draw treatment immediately if pregnancy occurs. Increased risk of probable dementia in women who start using continuous combined or estrogen-only HRT after 65 yr.
Adverse Reactions
Lower abdominal pain; abnormal hair growth; vag & genital discharge, endometrial wall thickening, postmenopausal haemorrhage, breast tenderness, genital pruritus, vag candidiasis & haemorrhage, pelvic pain, cervical dysplasia, vulvovaginitis; increased wt, abnormal cervical smear.
Drug Interactions
Enhanced effect of anticoagulants eg, warfarin. Enhanced metabolism w/ CYP3A4 inducers eg, barbiturates, carbamazepine, hydantoins & rifampicin. Decreased effect & changes in uterine bleeding profile of oestrogens & progestogens w/ herbal prep containing St. John's wort (Hypericum perforatum). Concomitant use w/ CYP3A4 substrates eg, midazolam.
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
1 × 28's
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