ISOCARBOXAZID Tablets Ref.[9796] Active ingredients: Isocarboxazid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Alliance Pharmaceuticals Ltd, Avonbridge House, 2 Bath Road, Chippenham, Wiltshire, SN15 2BB, UK

Therapeutic indications

For the treatment of the symptoms of depressive illness.

Posology and method of administration

Isocarboxazid Tablets are for oral administration.

Adults

A daily dose of 30mg, in single or divided doses, should be given until improvement is obtained. The maximal effect is only observed after a period varying from 1 – 4 weeks. If no improvement has been seen by 4 weeks, doses up to 60mg may be tried, according to the patient’s tolerance, for no longer than 4 – 6 weeks, provided the patient is closely monitored because of the increased risk of adverse reactions occurring.

Once the optimal effect is achieved, the dose should be reduced to the lowest possible amount sufficient to maintain the improvement. Clinical experience has shown this to be usually 10 – 20mg daily but up to 40mg daily may be required in some cases.

The elderly

The elderly are more likely to experience adverse reactions such as agitation, confusion and postural hypotension. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response.

Children

Isocarboxazid Tablets are not indicated for paediatric use.

Overdose

The primary symptoms of overdosage include dizziness, ataxia and irritability. In acute cases, hypotension or hypertension, tachycardia, pyrexia, psychotic manifestations, convulsions, respiratory depression and coma may occur and continue for 8-14 days before recovery.

Gastric lavage should be performed soon after ingestion and intensive supportive therapy carried out. Sympathomimetic agents should not be given to treat hypotension but plasma expanders may be used in severe cases. Hypertensive crises may be treated by pentolinium or phentolamine, severe shock with hydrocortisone. Diazepam may be used to control convulsions or severe excitement. Dialysis is of value in eliminating the drug in severe cases.

Shelf life

Shelf life: Three years.

Special precautions for storage

The recommended maximum storage temperature is 25°C.

Isocarboxazid Tablets should be stored in well-closed containers.

Nature and contents of container

HDPE bottles with white child resistant caps, containing 56 tablets.

Special precautions for disposal and other handling

None.

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