Livial

Livial

tibolone

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Tibolone
Indications/Uses
Complaints resulting from natural or artificial 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: Take at the same time each day.
Contraindications
Hypersensitivity. Known, past or suspected breast cancer; estrogen-dependent malignant tumors; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous, idiopathic or current VTE; known thrombophilic disorders; history of arterial thromboembolic disease; acute or history of liver disease; porphyria. Pregnancy & lactation.
Special Precautions
Not intended for contraceptive use. Risk of stroke, breast & endometrial cancer, intact uterus. Exclude malignancy prior to therapy; irregular/unscheduled vag bleeding. Leiomyoma or endometriosis; risk factors for thromboembolic disorders & estrogen-dependent tumors; HTN; liver disorders; DM w/ or w/o vascular involvement; cholelithiasis; migraine or severe headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Discontinue in case of jaundice or deterioration in liver function, significant BP increase, new onset of migraine-type headache develops. Preexisting hypertriglyceridemia. Women on anticoagulant treatment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Cardiac or renal dysfunction. Pregnancy & lactation. Elderly >65 yr.
Adverse Reactions
Lower abdominal pain; abnormal hair growth; vag discharge, candidiasis & haemorrhage, endometrial wall thickening, postmenopausal haemorrhage, breast tenderness, genital pruritus & discharge, pelvic pain, cervical dysplasia, vulvovaginitis; increased wt, abnormal cervical smear.
Drug Interactions
Enhanced effect of anticoagulants eg, warfarin. Enhanced metabolism by barbiturates, carbamazepine, hydantoin & rifampicin. Induced metabolism by 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
28's
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