Indications

This combination tablet of flupentixol and melitracen is indicated for treating:

• Anxiety
• Depression
• Apathy
• Psychogenic depression
• Depressive neuroses
• Masked depression
• Psychosomatic conditions with anxiety and apathy
• Menopausal depression
• Dysphoria and depression in alcoholics and drug addicts

Pharmacology

This medication combines two well-known compounds:

• Flupentixol: A neuroleptic with its own anxiolytic and antidepressant properties when given in small doses.
• Melitracen: A bipolar thymoleptic that has activating properties at low doses.

When combined, these two compounds create a preparation with antidepressant, anxiolytic, and activating properties. The maximum serum concentration for both is reached in about 4 hours. Flupentixol has a biological half-life of about 35 hours, and melitracen's is about 19 hours. The combination does not seem to affect the individual pharmacokinetic properties of either drug.

Dosage & Administration

• Adults: The usual dose is 2 tablets daily, taken orally in the morning and at noon. In severe cases, the morning dose may be increased to 2 tablets.
• Elderly patients: The usual dose is 1 tablet in the morning.
• Maintenance dose: Typically 1 tablet in the morning. For severe restlessness or insomnia during the acute phase, additional sedative treatment is recommended.

Interaction

• This tablet may enhance the effects of alcohol, barbiturates, and other CNS depressants.
• Do not take it with MAO inhibitors, as this can cause hypertensive crises.
• It may reduce the effect of antihypertensive medications like guanethidine and enhance the effects of adrenaline and noradrenaline.

Contraindications

This medication is contraindicated in patients with:

• The immediate recovery phase after a heart attack (myocardial infarction).
• Defects in bundle-branch conduction.
• Untreated narrow-angle glaucoma.
• Acute intoxication from alcohol, barbiturates, or opiates. It should not be given to patients who have taken an MAO inhibitor within the last two weeks. It is also not recommended for patients who are excitable or overactive, as its activating effect may worsen these symptoms.

Side Effects

At the recommended doses, side effects are rare but may include transient restlessness and insomnia.

Pregnancy & Lactation

This tablet should preferably not be used during pregnancy and lactation.

Precautions & Warnings

If a patient was previously on a sedative tranquilizer, that medication should be withdrawn gradually before starting this one.

Overdose Effects

Overdose symptoms are primarily related to melitracen's anticholinergic effects. Extrapyramidal symptoms from flupentixol may also occur but are less common. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal should be administered as soon as possible. Epinephrine (adrenaline) must not be used. Convulsions can be treated with diazepam, and extrapyramidal symptoms with biperiden.

Therapeutic Class

This medication is classified as a combined anxiolytic and anti-depressant drug.

Storage Conditions

Store in a dry place at a temperature not exceeding 30°C. Protect from light. Keep out of the reach of children.