Tablet, Generic Name: Tibolone, Manufacturer: Incepta Pharmaceuticals Ltd.
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Indications
Symptoms of postmenopausal women caused by natural or surgical menopause are treated. Preventing osteoporosis in women who have gone through menopause and are at high risk of fractures but are unable to take other osteoporosis medications.
Pharmacology
Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 3α−OH and 3β−OH metabolite) have predominantly estrogenic activity; a third metabolite (δ4-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.
Dosage & Administration
The dose is one Tibolone tablet per day (2.5 mg daily). The tablet should be swallowed with some water or other drink, preferably at the same time in each day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.
Starting Tibolone Tablet: Women experiencing a natural menopause should commence treatment with Tibolone tablet at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone tablet may commence immediately.
Switching from a sequential or continuous combined HRT (Hormone Replacement Therapy) preparation: If changing from a sequential HRT preparation, treatment with Tibolone should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.
Missed dose: A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the later case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting
Interaction
In clinical practice, no cases of interactions between Tibolone and other medications have been documented. On a theoretical level, however, the following possible interactions should be considered: Barbiturates, carbamazepine, hydantoins, and rifampicin are examples of enzyme-inducing drugs that may increase Tibolone metabolism and therefore reduce its therapeutic efficacy. Tibolone may improve the action of anticoagulants by increasing blood or fibrinolytic activity (lower fibrinogen levels; higher AT III, plasminogen, and fibrinolytic activity values).
Contraindications
Pregnancy and lactation, hormone-dependent tumors known or suspected, cardiovascular or cerebrovascular diseases, active deep vein thrombosis, thromboembolic disorders, vaginal hemorrhage of unknown cause, and severe liver problems are all contraindications.
Side Effect
Vaginal bleeding or spotting may occur on occasion, especially during the first few months of therapy. Headaches and migraines, oedema, dizziness, pruritus, increased body weight, nausea, stomach discomfort, rash, and depression are some of the other side effects.
Pregnancy & Lactation
Tibolone tablets are not recommended for use during pregnancy. If you become pregnant while taking this pill, you should stop using it right away. There are no clinical data on exposed pregnancies available for this pill. Lactating women should avoid using tibolone tablets.
Precautions & Warnings
Renal dysfunction, history of liver illness, epilepsy, migraine, hypercholesterolemia, poor carbohydrate metabolism, diabetes mellitus, and cholestatic jaundice are all risk factors for cholestatic jaundice.
Storage Conditions
Keep in a cool & dry place. Protect from light. Keep out of the reach of children.
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