A fixed-dose combination of a thioxanthene neuroleptic (flupenthixol) and a tricyclic antidepressant (melitracen). It is primarily used in the management of mild to moderate depression and anxiety, particularly when associated with psychosomatic disorders, apathy, and withdrawal. The combination is believed to provide a balanced effect, with flupenthixol counteracting agitation and melitracen elevating mood, while minimizing the side effect profile of each individual component.
Adult: Initially, 1 tablet (Flupenthixol 0.5mg + Melitracen 10mg) once daily in the morning or evening. May be increased to 1 tablet twice daily (morning and noon/evening) based on response and tolerance. Maximum: 3 tablets per day in divided doses.
Note: Administer with or without food. Swallow whole with a glass of water. Avoid taking late in the evening if it causes insomnia. Do not crush or chew. Consistent daily timing is recommended.
The combination works via complementary mechanisms. Flupenthixol is a potent dopamine D1/D2 receptor antagonist with mild anticholinergic and sedative properties. Melitracen is a tricyclic antidepressant that inhibits the reuptake of norepinephrine and serotonin (5-HT) in the central nervous system, thereby increasing their synaptic concentrations. The net effect is a modulation of mood, drive, and anxiety with a lower incidence of side effects compared to higher doses of either drug alone.
Pregnancy: Category C: Animal studies show adverse effects. Use only if potential benefit justifies potential fetal risk. Avoid especially in first trimester and near term (neonatal withdrawal/anticholinergic symptoms).
Driving: May impair alertness, reaction time, and motor coordination, especially during initial treatment or dose changes. Patients should be cautioned against driving or operating machinery until their individual response is known.
| Monoamine Oxidase Inhibitors (MAOIs) - e.g., Phenelzine, Selegiline | Risk of serotonin syndrome, hyperpyrexia, convulsions, death. | Contraindicated |
| Other CNS Depressants (Alcohol, Benzodiazepines, Opioids) | Additive sedation, impaired psychomotor performance, respiratory depression. | Major |
| Anticholinergic drugs (e.g., Atropine, Trihexyphenidyl, TCAs) | Increased anticholinergic side effects (dry mouth, constipation, urinary retention, confusion). | Moderate |
| Antihypertensives (especially alpha-blockers, guanethidine) | Potentiation of hypotensive effect. | Moderate |
| QT-prolonging drugs (e.g., Class IA/III antiarrhythmics, Macrolides, Fluoroquinolones) | Increased risk of torsades de pointes. | Major |
| SSRIs/SNRIs (e.g., Fluoxetine, Paroxetine) | Increased plasma levels of TCA (melitracen) via CYP2D6 inhibition, risk of serotonin syndrome. | Moderate to Major |
| Sympathomimetics (e.g., Adrenaline, Noradrenaline) | Enhanced pressor response, risk of arrhythmias. | Moderate |
| Warfarin | Melitracen may potentiate anticoagulant effect; monitor INR closely. | Moderate |
Same composition (Flupenthixol (0.5mg) + Melitracen (10mg)), different brands: