Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom
Phenelzine is a monoamine oxidase inhibitor (MAOI). It has been found to be effective in depressed patients clinically characterised as ‘atypical’, ‘non endogenous’, ‘neurotic’ or where treatment with other antidepressants has failed. These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features.
Oral administration.
One 15mg tablet three times a day. A response is usually seen within the first week. If no response is evident after two weeks, the dosage may be increased to a maximum of one 15mg tablet four times a day. Doses of up to two 15mg tablets three times a day may be used in hospitals. The effectiveness of the drug may not become apparent in less than 4 weeks therapy. After a satisfactory response has been achieved, the dosage may be reduced very gradually to a suitable maintenance level. This may be as low as one 15mg tablet every other day.
As for adults.
Postural hypotension may be an unwanted effect of MAOIs in the elderly. Elderly patients as a group tend to receive multiple drug therapies and the possibility of increased risk of drug interactions should be borne in mind. Nardil should only be used with great caution in elderly patients.
Despite these problems, MAOIs (including Nardil) have been found to be useful in the treatment of depression in the elderly.
Nardil is not indicated for children under 16 years of age.
Signs and symptoms may be absent or minimal during the initial 12-hour period following ingestion and may develop slowly thereafter, reaching a maximum in 24 to 48 hours. Death has been reported following overdosage, therefore immediate hospitalisation with continuous patient observation and monitoring throughout this period is essential.
Large doses may produce hypomania, euphoria, followed by coma with hypotension, or acute hypertension sometimes with subarachnoid haemorrhage. In a few cases extra-pyramidal symptoms have been recorded.
Other symptoms may be: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonos, rigidity, convulsions, rapid and irregular pulse, precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis and cool, clammy skin.
Gastric lavage with instillation of charcoal slurry may be helpful in early poisoning (tablets dissolve slowly in stomach).
Absolute bed rest, raise feet in hypotension. Vasopressors are best avoided. Hypertension should be urgently controlled with phentolamine IV. Avoid hypnotics, such as morphine, pethidine, barbiturates. Body temperature should be monitored, and fever managed by cooling.
Use intravenous therapy to maintain fluid and electrolyte balance and use a slow IV injection of diazepam for any CNS stimulation. In deep coma and severe hypotension hydrocortisone by injection may be tried.
There is no specific antidote for Nardil. Haemodialysis, peritoneal dialysis and charcoal haemoperfusion may be of value in massive overdosage, but sufficient data are not available to recommend their routine use in these cases.
18 months.
Store between 2°C to 8°C in a refrigerator, unless unavoidable for short periods.
White, high density polyethylene bottle fitted with a white, high density, polyethylene child resistant, tamper evident cap with expanded polyethylene liner, containing 100 tablets.
No special requirements.
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