Tibolone Tablets: Hormone Replacement Therapy for Postmenopausal Women

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Composition:

Tibolone contains 2.5 milligrams of tibolone in each tablet.

Properties:

Tibolone is one of a group of medicines called hormone replacement therapy (HRT). Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. Tibolone prevents osteoporosis following menopause or ovariectomy.

Pharmacodynamic properties:

Following oral administration, tibolone is rapidly metabolized into three compounds which all contribute to the pharmacological effects of Tibolone. Two of these metabolites (3α-OH-tibolone and 3β-OH-tibolone) have estrogen-like activity, whereas the third metabolite (Δ4-isomer of tibolone) has progestogenic and androgenic-like activities.

Pharmacokinetics:

Following oral administration, tibolone is rapidly and extensively absorbed. The consumption of food has no significant effects on the extent of absorption. Due to rapid metabolism, the plasma levels of tibolone are very low. The plasma levels of the Δ4-isomer of tibolone are also very low. Therefore, some of the pharmacokinetic parameters could not be determined. Peak plasma levels of the 3α-OH and the 3β-OH metabolites are higher but accumulation does not occur.

Starting to take Tibolone:

Normally, Tibolone should not be taken until 12 months after the last natural period. If your patient has never used HRT before, then start taking Tibolone straight away. If your patient has been changing over from another type of HRT, the patient will start Tibolone immediately in case of changing from period-free HRT and the patient will wait after the end of the period in case of HRT with period. In case of patients with ovariectomy and endometriosis, Tibolone can be started straight away.

Indications:

  • Treatment of estrogen deficiency symptoms (including vasomotor symptoms, depressed mood, decreased libido) in postmenopausal women.
  • Prevention of osteoporosis in postmenopausal women.

Dosage Administration:

One tablet daily, preferably at the same time each day.

  • Missing dose: should be immediately taken as soon as it is remembered, unless it is more than twelve hours late, the next tablet should be taken at the usual time.
  • No dose adjustment is necessary for the elderly.

Contra Indications:

  • Pregnancy;
  • Known, past, or suspected breast cancer;
  • Known or suspected estrogen-dependent malignant tumors. (e.g., endometrial cancer);
  • Undiagnosed vaginal bleeding;
  • Untreated endometrial hyperplasia;
  • Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);
  • Any history of arterial thromboembolic disease (e.g., angina, myocardial infarction, stroke, or TIA);
  • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;
  • Known hypersensitivity to the active substance, or to any of the excipients.
  • Porphyria.

Precautions and Warnings:

Tibolone should not be taken until twelve months after the last natural menstrual period. If Tibolone is taken sooner than this, the risk of irregular menstrual bleeding may be increased. Regular (6-monthly) medical check-ups are recommended during treatment with Tibolone.

Effects on the heart or circulation:

Heart disease: HRT is not recommended for women who have heart disease or have had heart disease recently. There is a risk of possible interaction with other medicinal products and other forms of interaction, e.g.,

  • Anticoagulants: the use of Tibolone and Warfarin needs careful monitoring and an appropriate adjustment of the Warfarin dose
  • Barbiturates, Carbamazepine, and Hydantoins
  • Rifampicin

Pregnancy and lactation:

Tibolone is contraindicated in pregnant and lactating women.

Side Effects:

Serious side effects are rare: this may include yellow skin (jaundice) or signs of a blood clot while taking Tibolone, the patient should stop taking it and consult a doctor straight away. These are warning signs of a blood clot:

  • Sudden or severe headache
  • Weakness or numbness in an arm or leg
  • Dizziness or fainting
  • Sudden disturbances in vision
  • Slurred speech
  • Feeling breathless.

Packing:

Box of 3 strips each containing 10 tablets.

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