ISOCARBOXAZID

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.

In general, Isocarboxazid is well tolerated by the majority of patients. Side-effects, if they occur, are those common to the group of monoamine oxidase inhibitors. The most frequently reported have been orthostatic hypotension, associated in some patients with disturbances in cardiac rhythm, peripheral oedema, complaints of dizziness, dryness of the mouth, nausea and vomiting, constipation, blurred vision, insomnia, drowsiness, weakness and fatigue.

These side-effects can usually be controlled by dosage reduction. There have been infrequent reports of mild headaches, sweating, paraesthesiae, peripheral neuritis, hyperreflexia, agitation, overactivity, muscle tremor, confusion and other behavioural changes, difficulty in micturition, impairment of erection and ejaculation, and skin rashes.

Although rare, blood dyscrasias (purpura, granulocytopenia) have been reported. Response to Isocarboxazid may be accompanied by increased appetite and weight gain. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card Scheme in the Google Play or Apple App Store.

Some monoamine oxidase inhibitors have occasionally caused hepatic complications and jaundice in patients, therefore regular monitoring of liver function should be carried out during Isocarboxazid therapy. If there is any evidence of a hepatotoxic reaction, the drug should be withdrawn immediately.

The drug should be used cautiously in patients with impaired renal function, to prevent accumulation taking place, and also in the elderly or debilitated and those with cardiovascular disease, diabetes or blood dyscrasias. In restless or agitated patients, Isocarboxazid may precipitate states of excessive excitement.

Isocarboxazid appears to have varying effects in epileptic patients; while some have a decrease in frequency of seizures, others have more seizures. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.

It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Isocarboxazid is contra-indicated in patients with any impairment of hepatic function, cerebrovascular disorders or severe cardiovascular disease, and in those with actual or suspected phaeochromocytoma.

Selective serotonin reuptake inhibitors (SSRIs):

Cases of serious and sometimes fatal reactions (serotonin syndrome) have been reported in patients receiving monoamine oxidase inhibitors (MAOIs) in combination with SSRIs, and in patients who have recently discontinued an SSRI and have been started on a MAOI.

Treatment with SSRIs should only be started 2 weeks after discontinuation of Isocarboxazid. Conversely, treatment with Isocarboxazid should not be started until at least a week after stopping a SSRI or related anti-depressant (at least 5 weeks for fluoxetine).

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