Dexit Tablet 0.5mg+10mg

Product Information

DEXIT

Dexit®(Flupentixol-Melitracen)

Presentation

Dexit tablet: Pink, round-convex shaped, film coated tablet; each tablet contains Flupentixol Dihydrochloride BP equivalent to

Flupentixol 0.5mg and Melitracen Hydrochloride INN equivalent to Melitracen 10mg.

Indications

Anxiety Ð Depression Ð Apathy. Psychogenic depression, depressive neuroses, masked depression, psychosomatic affections

accompained by anxiety and apathy, menopausal depressions, dysphoria and depression in alcoholics and drug-addicts.

Dosage and administration

Adults: Usually two Flupentixol-Melitracen tablets (two Dexit tablets) daily: morning and noon. In severe cases the morning dose

may be increased to two tablets.

Elderly patients: Daily one Flupentixol-Melitracen tablet (one Dexit tablet) in the morning.

Maintenance dose: Usually one Flupentixol-Melitracen tablet (one Dexit tablet) in the morning. In cases of insomnia or severe

restlessness additional treatment with a sedative in the acute phase is recommended.

Contra-indications, warnings, etc.

Contra-indications: The immediate recovery phase after myocardial infarction. Defects in bundle-branch conduction. Untreated

narrow angle glaucoma. Acute alcohol, barbiturate and opiate intoxications. Melitracen-Flupentixol 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.

Warnings: Flupentixol may initially cause drowsiness. If drowsiness occurs, patients should be warned if driving or operating

machinery.

Precautions: If previously the patients has been treated with tranquilizers with sedative effect these should be withdrawn

gradually.

Drug interactions: It may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of

MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and

similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

Use in pregnancy and lactation: Flupentixol-Melitracen should preferably not be given during pregnancy and lactation.

Use in paediatric patient: Not recommended for children.

Side-effects: In the recommended doses side-effects are rare. These could be transient restlessness, insomnia, dizziness, tremor,

visual disturbances, headache.

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.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Dexit tablet: Cartons containing 50 tablets in blister.