AMENA Tibolone 2.5mg Tablet 28's
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Features
- Tibolone
Description
Indications/Uses
Dosage/Direction for Use
Starting Tibolone: Women experiencing a natural menopause should commence treatment with tibolone at least 12 months after their last menstrual bleed. In case of surgical menopause, treatment with Tibolone, may commence immediately.
Switching from a sequential or continuous combined HRT 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 latter 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.
Administration
Contraindications
Special Precautions
Adverse Reactions
Endometrial hyperplasia and endometrial carcinoma have been rarely reported after investigation of uterine bleeding in women receiving tibolone therapy, 1, 2 as has exacerbation of adenomyosis 3. Some of these women had previously received oestrogens. The authors of 1 report concluded that it was unclear whether tibolone was an aetiological agent or a cofactor in these cases, 1 and they emphasized that, although tibolone has progestogenic properties, it cannot be expected to reverse pre-existing endometrial hyperplasia or to protect against the development of endometrial malignancy.
The acute toxicity of tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur, even when several tablets or capsules are taken simultaneously. In cases of acute overdose, nausea, vomiting and vaginal bleeding in females may occur. No specific antidote is known. Symptomatic treatment can be given if necessary.
Storage
Action
Pharmacokinetic: After oral administration, peak-plasma concentrations are attained in 1 to 4 hours. Tibolone is rapidly metabolized into 3 active metabolites, 2 of which have predominantly oestrogenic activity while the third, like the parent compound, has predominantly progestogenic activity. Metabolites are excreted in the bile and eliminated in the faeces. A small amount is excreted in the urine.