Ubilon

Indications

• Symptom Relief for Menopausal Women: Ubilon is used to treat symptoms associated with natural or surgical menopause in postmenopausal women.
• Prevention of Osteoporosis: It is indicated for preventing osteoporosis in postmenopausal women who are at high risk of fractures and cannot tolerate other osteoporosis medications.

Pharmacology

Ubilon (Tibolone) is a synthetic steroid with estrogenic, androgenic, and progestogenic properties. Upon oral administration, Tibolone is rapidly metabolized into metabolites that exhibit various hormonal effects:

• Estrogenic Effects: The 3α−OH and 3β−OH metabolites mimic estrogen, helping alleviate menopause-related symptoms such as hot flashes and vaginal dryness.
• Progestogenic and Androgenic Effects: The δ4-isomer and parent compound provide progestogenic and androgenic benefits, improving libido and mood while also preventing bone loss after menopause.

Dosage & Administration

• Standard Dosage: Take 1 tablet (2.5 mg) of Ubilon per day. Swallow with water or another beverage at the same time each day.
• Onset of Action: Symptom improvement is usually seen within a few weeks, with optimal results after at least 3 months of continued use.
• Starting Treatment: Begin treatment with Tibolone 12 months after your last natural period (natural menopause). For surgical menopause, start immediately.
• Switching from HRT: If switching from sequential or continuous combined hormone replacement therapy (HRT), begin Tibolone therapy at the appropriate times as per the instructions.

Missed Dose

If you miss a dose, take it as soon as you remember, unless it’s within 12 hours of your next dose. In that case, skip the missed dose and resume the usual schedule. Skipping doses may increase the chance of breakthrough bleeding.

Interactions

Although no direct interactions have been reported, enzyme-inducing drugs (e.g., barbiturates, carbamazepine, rifampicin) may reduce the effectiveness of Ubilon. It may also enhance the effects of blood thinners by increasing fibrinolytic activity, so monitor anticoagulant therapy.

Contraindications

• Pregnancy and Lactation: Not for use during pregnancy or breastfeeding.
• Hormone-Sensitive Conditions: Contraindicated in cases of hormone-dependent tumors, cardiovascular diseases, thromboembolic disorders, and severe liver diseases.
• Unexplained Vaginal Bleeding: Should not be used in cases of unknown vaginal bleeding.

Side Effects

• Common Side Effects: Headaches, nausea, dizziness, abdominal discomfort, weight gain, mood changes, and mild vaginal bleeding (mostly in the early stages of treatment).
• Serious Reactions: Rare, but include changes in skin, severe depression, or edema. Contact your doctor if any unusual symptoms occur.

Pregnancy & Lactation

• Pregnancy: Contraindicated during pregnancy. If pregnancy occurs during treatment, discontinue use immediately.
• Breastfeeding: Not recommended during lactation due to the lack of safety data.

Precautions & Warnings

• Use cautiously in women with renal dysfunction, liver disease, epilepsy, or a history of migraines, diabetes, or cholesterol imbalance. Regular check-ups are advised for women with these conditions.
• Monitor closely for any adverse reactions or changes in health status.

Overdose Effects

Ubilon has a low toxicity profile, and overdose symptoms are rare. In the event of an overdose, symptoms like nausea, vomiting, or withdrawal bleeding may occur. Seek medical help for symptomatic treatment if necessary.

Therapeutic Class

• Category: Hormone Replacement Therapy (HRT) for menopausal symptoms.

Storage Conditions

• Store in a cool, dry place away from light. Keep out of the reach of children.