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PHENELZINE is a brand name for Phenelzine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults One 15 mg 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.
Elderly (over 65 years) 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.
This medicine should only be used with great caution in elderly patients. Despite these problems, MAOIs (including phenelzine) have been found to be useful in the treatment of depression in the elderly. Paediatric population This medicine is not indicated for children under 16 years of age.
Method of administration Oral administration.
) 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.
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.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Phenelzine should be withdrawn two weeks before elective surgery/dentistry. Phenelzine should not be given with cocaine or local anaesthesia containing sympathomimetic vasoconstrictors. The possible combined hypotensive effects of phenelzine and spinal anaesthesia should be kept in mind.
This medicine should be used only with great caution in agitated patients or those who have cardiovascular disease, epilepsy, blood dyscrasias, porphyria or diabetes; and in patients taking diuretics. Blood pressure should be observed frequently to detect any pressor response and therapy discontinued if palpitations or frequent headaches occur.
1. Phenelzine should not be used in patients with phaeochromocytoma, cerebrovascular disease, congestive heart failure, a history of liver disease or with abnormal liver function tests. Phenelzine sulfate should not be administered at the same time as, or within 14 days of, treatment with other MAOIs, buspirone, or dibenzazepine derivative drugs (including tricyclic antidepressant agents, perphenazine or carbamazepine).
In the cases of clomipramine and imipramine, 3 weeks should be left before starting phenelzine therapy. It is recognised that there is some division of consultant opinion with respect to concomitant use of MAOIs and tricyclic antidepressants.
g. venlafaxine) have been combined with MAOIs. Therefore, phenelzine should not be used in combination with these drugs and before initiating phenelzine, a sufficient amount of time must be allowed for clearance of these drugs and their metabolites.
For example, five weeks in the case of fluoxetine and two weeks with paroxetine. Conversely, these drugs should not be started within 14 days of discontinuing phenelzine. Phenelzine should not be used in combination with guanethidine, dextromethorphan, or with CNS depressants such as alcohol and narcotic analgesics.
Death has been reported in patients receiving a single dose of pethidine. Phenelzine is not indicated in the manic phase.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]
Patients should also be closely followed for symptoms of postural hypotension. Hypotensive side effects have occurred in hypertensive as well as normotensive and hypotensive patients. 8 Undesirable Effects) 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’.