Adelax®

Flupentixol + Melitracen

Prescribing Details



Description

Adelax is a combination preparation of two well known and time tested molecules: 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 exert antidepressant, anxiolytic and activating properties.
Maximum serum concentration is reached in about 4 hours after oral administration of both Flupentixol and 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 pharma-cokinetic properties of the individual compounds.


Uses

No Data


Indications

Adelax is indicated for the treatment of different types of anxiety, depression and apathy. These include:
• Psychogenic depression
• Depressive neuroses
• Masked depression
• Psychosomatic affections accompanied by anxiety apathy
• Menopausal depressions
• Dysphoria and depression in alcoholics and drug addicts
Adelax is also indicated for maintenance in psychogenic depressions and other psychoses.


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 case of insomnia and severe restlessness additional treatment with sedative in the acute phase is recommended.


Use in pregnancy & lactation

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


Geriatric use
No Data

Precautions

If previously the patient has been treated with tranquilizers with sedative effect these should be withdrawn gradually.


Side effects

In the recommended doses side-effects are rare. Restlessness, insomnia, hypomania reported, rarely dizziness, tremor, visual disturbances, headache, hyperprolactinaemia, extrapyramidal symptoms may be observed.


Contraindications

The immediate recovery phase after myocardial infarction. Defects in bundle-branch conduction. Untreated narrow angle glaucoma. Acute alcohol, barbiturate and opiate intoxications. Flupentixol-melitracen combination 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.


Drug interactions

Flupentixol-Melitracen combination 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.


Overdose

Symptoms: In case 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.


Preparation

No Data


Pharmaceutical precautions

Store in a cool dry place. Protect from light


Presentation

Adelax Tablet: Each coated tablet contains Flupentixol 0.5mg as Dihydrochloride BP and Melitracen 10mg as Hydrochloride INN.


Package quantities

Adelax Tablet: Carton of 80 tablets in blister.
Adelax Tablet: Carton of 50 tablets in blister (for Export).