Suliqineng Trimebutine Maleate Tablets

1. Indications and Usage
Menopausal Symptoms: Treatment of menopausal symptoms, including vasomotor symptoms (hot flashes), sleep disturbances, and psychological disturbances (depression, mood swings) associated with natural or surgical menopause.
2. Dosage and Administration
Adults: The recommended dosage is 1 tablet (3.6 mg) taken once daily.
Administration: Tablets should be swallowed whole with water.
Duration: Treatment should be reviewed regularly. The lowest effective dose should be used for the shortest duration necessary to manage symptoms.
3. Mechanism of Action
Receptor Binding: Trimebutine maleate acts as a modulator of estrogen receptors. It exerts estrogenic effects on the central nervous system, cardiovascular system, and bone, while showing anti-estrogenic effects on the endometrium and breast tissue.
Symptom Relief: By modulating these receptors, it helps alleviate vasomotor symptoms and reduces the risk of bone loss.
4. Safety and Warnings
Contraindications: Contraindicated in patients with known or suspected estrogen-dependent neoplasms (e.g., breast cancer), undiagnosed vaginal bleeding, active thromboembolic disorders, or severe liver disease.
Thromboembolism: There is an increased risk of venous thromboembolism (VTE) and arterial thromboembolism. Smoking and obesity increase this risk.
Cardiovascular and Bone Health: May cause fluid retention and affect lipid profiles. Long-term use is associated with bone density protection.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Breast tenderness, headache, nausea, abdominal pain, and vaginal bleeding or discharge.
Serious Risks: Increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke.
Other Effects: May cause mood changes, insomnia, and weight gain.
6. Drug Interactions
Cytochrome P450 Inducers: Concomitant use with drugs that induce CYP3A4 (e.g., rifampicin, phenytoin, St. John’s wort) may decrease the efficacy of the drug.
Anticoagulants: May potentiate the effects of oral anticoagulants (e.g., warfarin), requiring closer monitoring of INR.
Hormonal Contraceptives: May interfere with the action of hormonal contraceptives.
7. Pharmaceutical Information
Active Ingredient: Trimebutine Maleate.
Chemical Name: (2R,3R)-butane-2,3-diol;2-(2-dimethylaminoethoxy)phenyl]-2-methylpropanoate;ethanoic acid.
Molecular Formula: C18H27NO3·C2H4O2 (Molecular weight: 353.47).
Formulation: Tablets, typically 3.6 mg.
Storage: Store at room temperature (below 25°C) in a dry place.