MELIT®– Flupentixol & Melitracen BP & INN

Chemical Name:
Flupentixol: (EZ)-2-[4-[3-[2-(trifluoromethyl) thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethanol
Melitracen: 3-(10,10-dimethylanthracen-9(10H)-ylidene)-N,N-dimethylpropan-1-amine

Description:Flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and Melitracen – a bipolar thymoleptic with activating properties in low doses. In combination, the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximum serum concentration is reached in about 4 hours after oral administration of Flupentixol and in about 4 hours after oral administration of Melitracen. The biological half-life of Flupentixol is about 35 hours and that of Melitracen is about 19 hours. The combination of Flupentixol and Melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

— 0.5 mg+10 mg mg 5×10 Tablets

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MELIT®– Flupentixol & Melitracen BP & INN

COMPOSITION
Melit® tablet: Each film coated tablet contains Flupentixol dihydrochloride BP equivalent to Flupentixol 0.5mg and Melitracen hydrochloride INN equivalent to Melitracen 10mg.

PHARMACOLOGY
Flupentixol+ Melitracen consists of two well-known and well proven compounds. Flupentixol- a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses and Melitracen – a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of Melitracen. The biological half-life of flupentixol is about 35 hours and that of Melitracen is about 19 hours. The combination of Flupentixol and Melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

INDICATION
Anxiety, Depression such as (Psychogenic depression, Masked depression, Menopausal depressions), Depressive neurosis, Psychosomatic affections accompanied by anxiety and apathy, Dysphoria and depression in alcoholics and drug-addicts.

DOSAGE AND ADMINISTRATION
Adults: Usually 2 tablets daily (morning and noon). In severe cases the morning dose may be increased to 2 tablets.
Elderly patients: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet in the morning. In cases of insomnia or severe restlessness additional treatment with sedative in the acute phase is recommended.

SIDE EFFECT
In the recommended doses side-effects are rare. These could be transient restlessness and insomnia.

PRECAUTION
If previously the patient has been treated with tranquilizers with sedative effect these should be withdrawn gradually.

CONTRAINDICATION
The immediate recovery phase after myocardial infarction. Defects in bundle-branch conduction. Untreated narrow angle glaucoma. Acute alcohol, barbiturate and opiate intoxications. Flupentixol Melitracen should not be given to patients who have received a MAO-inhibitor within two weeks. Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.

USE IN PREGNANCY AND LACTATION
Flupentixol-Melitracen should preferably not be given during pregnancy and lactation.

DRUG INTERACTIONS
Flupentixol + Melitracen may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crisis. Neuroleptics and thymoleptics reduce the antihypertensive effect of Guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

OVERDOSAGE
Symptoms: In cases of overdosage the symptoms of intoxications by Melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Treatment: Symptomatic and supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.

STORAGE
Store tablet and powder for suspension at or below 30°C. Protect from light & moisture. Keep out of the reach of children.

PACKAGING
MELIT® tablet: Each box contains 50 tablets in blister pack.