) abrupt withdrawal of phenelzine should be avoided where possible. Phenelzine may cause excessive stimulation in schizophrenic patients; in manic- depressive states it may result in a swing from a depressive to a manic phase. Caution should be exercised if the patient undergoes concurrent electroconvulsive therapy (ECT).
Excipients:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 5 Interaction with other medicinal products and other forms of interaction Patients should be warned against self medication, particularly cold cures, cough cures, hay fever medications, anti-appetite medicines, weight-reducing preparations and “pep” pills and about potential food interactions.
Patients under treatment with this medicine should avoid high protein food that has undergone breakdown by ageing, fermentation, pickling, smoking or bacterial contamination. Patients should avoid cooked or plain cheese, Oxo, Bovril, Marmite, brewer’s yeast, etc.
during treatment and up to 14 days after ceasing treatment. ), liver, yoghurt, broad bean pods, fermented soya bean extract, and excessive amounts of chocolate may also present a hazard. Patients should not consume alcoholic drink or non-alcoholic beers, lagers and wines and excessive amounts of tea and coffee should be avoided.
Where a reaction between phenelzine and certain foodstuffs occurs the intensity of the reaction is usually related to the tyramine content of the food. The reaction is now well recognised and serious hypertensive episodes are extremely rare.
Should such a reaction occur, the hypertension should be controlled promptly by slow administration of phentolamine 5mg to 10mg IV repeated if necessary. Care should be taken to administer this drug slowly to avoid an excessive hypotensive effect.
Phenelzine may also potentiate the effects of alcohol. Phenelzine may potentiate the action of pethidine, morphine, adrenaline, amphetamines and other sympathomimetic amines such as fenfluramine, ephedrine, phenylpropanolamine, dopamine and levodopa (see also Contraindications).
Phenelzine may also potentiate the effects of antihypertensives, hypoglycaemic agents, sympathomimetics, anti-Parkinson drugs, antimuscarinics, local anaesthetics and CNS depressants, including barbiturates. It is suggested that MAOIs are not administered at the same time as, or within 14 days of, treatment with amfebutamone (bupropion) or 5HT1 agonists.
It is suggested that MAOIs are not administered at the same time as anti-epileptics, altretamine, doxapram, tetrabenazine, oxypertine or clozapine. The combination of MAOIs and tryptophan has been reported to cause behavioural and neurological symptoms.
6 Fertility, pregnancy and lactation Pregnancy Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons. There is no evidence as to drug safety in human pregnancy nor is there evidence from animal work that it is free from hazard.
Breastfeeding It is not known if phenelzine is excreted in breast milk. Because of the potential for serious adverse effects to the infant, a decision should be made whether to discontinue the drug or not to breast-feed. 7 Effects on ability to drive and use machines Phenelzine may cause drowsiness or blurred vision, and may affect the ability to drive and operate machinery.
8 Undesirable effects Side-effects tend to be mild or moderate in severity, often subsiding as treatment continues, and can be minimised by adjusting dosage; rarely is it necessary to discontinue phenelzine. The most important reaction associated with this medicine is the occurrence of hypertensive crises, which have been associated with intracranial bleeding and have sometimes been fatal.
4). The undesirable effects reported with phenelzine during clinical trials and post- marketing surveillance are shown in the table below. They are listed by System- Organ Class (SOC) and in order of frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 1 Frequency of adverse event SOC Frequency Event Blood and lymphatic system disorders Uncommon Purpura, blood disorder Immune system disorders Uncommon Lupus-like syndrome Endocrine disorders Uncommon Hypernatraemia Metabolism and nutrition disorders Very rare Hypermetabolism Common Insomnia, anorgasmia Uncommon Nervousness, euphoria, abnormal behaviour, feeling jittery, confusion, hallucinations Very rarely Ataxia, shock-like coma, toxic delirium, neuroleptic malignant syndrome (occasionally fatal), manic reaction, acute anxiety reaction, precipitation of schizophrenia Psychiatric disorders Unknown Suicidal ideation, suicidal behaviour Common Dizziness, drowsinessNervous system disorders Uncommon Headache, paraesthesia, convulsion, neuropathy peripheral, repetitive speech Common Blurred visionEye disorders Uncommon Glaucoma, nystagmus Uncommon ArrhythmiasCardiac disorders Very rare Cardiovascular depression1 Common Postural hypotensionVascular disorders Unknown Hypertension Respiratory, thoracic and mediastinal disorders Very rare Respiratory depression1 Common Nausea, vomiting, dryness of the mouth, constipation Gastrointestinal disorders Uncommon Increased appetite, increased weight Common Elevated serum transaminases Uncommon Elevated liver enzymes Hepatobiliary disorders Very rare Fatal progressive necrotising hepatocellular damage, reversible jaundice Common Oedema Uncommon […]