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Dormir (Flupentixol & Melitracen)

Composition:

Each film coated tablet contains Flupentixol Dihydrochloride BP equivalent to Flupentixol 0.5 mg and Melitracen Hydrochloride INN equivalent to Melitracen 10 mg.

Description:

Dormir belongs to a group of medicines which work as an anxiolytic and antidepressant. Flupentixol shows anxiolytic effects by blocking dopamine receptors specially D2 receptor and Melitracen, a tricyclic antidepressant (TCA), inhibits norepinephrine and serotonin reuptake thus produces antidepressant effects.

Peak plasma 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:

Dormir is used to treat various types of anxiety, depression and apathy. These include-mild to moderate depression, psychogenic depression, depressive neuroses, personality disorders, psychosomatic affections accompanied by anxiety and apathy, menopausal depressions, dysphoria and depression in alcoholics and drug-addicts.

Dosage and Administration:

Adult: 2 tablets daily: 1 in the morning and 1 at noon. In severe cases the morning dose may be increased to 2 tablets. Elderly patients (above 65 years): 1 tablet in the morning. Maintenance dose: Usually 1 tablet in the morning. Children: Dormir is not recommended for children.

Precaution:

Patient should take Dormir with caution if one have a liver problem and a history of convulsions.

Adverse Effects:

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

Contraindication:

·Allergic to any of the ingredients of the                product.

·Recently have had a heart attack (myocardial    infraction).

· Have disturbances in heart rhythm.

·Have received a MAO-inhibitor within two weeks.

· Untreated narrow angle glaucoma.

· Acute alcohol, barbiturate and opiate intoxications.

· Excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.

Use in Pregnancy and Lactation:

Flupentixol & Melitracen should not be given to pregnant and lactating mother.

Drug Interaction:

Flupentixol plus Melitracen (Dormir) may enhance the response to alcohol, barbiturates and other CNS depressant. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

Overdosage:

Symptoms of over dosage may include:- drowsiness or excitement, unconsciousness, difficulty in breathing, dilated pupils, convulsions, fast heart beats, low blood pressure, weak pulse and fever.
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 system should be instituted. Epinephrine must not be used for such patients. Convulsions may be treated with diazepam and extra pyramidal symptoms with biperiden.

Storage:

Store in a cool and dry place and protect from light.

Packaging:

Dormir Tablet: Each box contains 5x10's tablet in blister pack.

 

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