Drugs List

Therapeutic Indications

Uses

Depressive illness

Symptoms of depressive illness, especially with phobic symptoms, or where treatment with other types of antidepressants has failed.

Contraindications

Children under 18 years
Concomitant medication consider washout period, see prescribing information
Abnormal liver function test
Cerebrovascular disorder
Congestive cardiac failure
Hepatic impairment
Hereditary fructose intolerance
History of hepatic impairment
Hyperthyroidism
Phaeochromocytoma
Porphyria
Severe cardiovascular disorder

Precautions and Warnings

Electroconvulsive therapy
Patients over 65 years
Suicidal ideation
Breastfeeding
Cardiovascular disorder
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Haematological disorder
History of alcohol abuse
History of drug misuse
Pregnancy
Severe agitation

Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Contains soya or soya derivative
Preparation contains sucrose
Monitor blood pressure
Monitor liver function. Withdraw if evidence of hepatotoxic reaction
Monitor patients undergoing spinal or epidural anaesthesia closely
Tolerance and dependence may occur
Advise patient that postural hypotension may occur
Advise patients/carers to seek medical advice if suicidal intent develops
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
May activate mania or hypomania
May aggravate anxiety and agitation
May cause postural hypotension
Avoid abrupt withdrawal
Discontinue 2 weeks prior to elective surgery
Discontinue if headaches occur
Discontinue if palpitations occur
Discontinue if patient enters a manic phase
Reduce dose in elderly
Advise patient against self medication, particularly cold remedies
Advise patient to avoid alcohol during treatment
Advise patient to avoid non-alcoholic beers, lagers and wines
Advise patient to avoid foods or beverages with a high tyramine content
Avoid excessive intake of tea, coffee or other stimulants
Avoid foods that interact with MAOIs for 2 weeks after discontinuing drug

Monoamine oxidase inhibitors have a great potential for interactions with other drugs. Drug - drug interactions are not covered in this monograph, but can be viewed in the coded data. This data includes information on washout periods of interacting drugs.

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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm

Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.

Discontinue 2 weeks prior to elective surgery requiring general anaesthesia. The anaesthetist should be warned that a patient is being treated with tranylcypromine, in the event of emergency surgery being necessary.

Patients under treatment with tranylcypromine 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. Flavoured textured vegetable protein, hung game, pickled herrings, dry sausage (salami, pepperoni etc), 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.

Pregnancy and Lactation

Pregnancy

Use tranylcypromine with caution in pregnancy.

There is a potential increased risk of neonatal malformations when tranylcypromine is used during pregnancy though little data is available for its use in pregnancy. The manufacture advises against its use in pregnancy unless essential.

Schaefer notes that exposure to MAOIs is not an indication for termination of pregnancy and that detailed foetal ultrasonography may be offered in such cases to control normal development.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use tranylcypromine with caution in breastfeeding.

Highly limited evidence in relation to safety of use in humans so other antidepressants are recommended. Tranylcypromine is excreted into milk in dogs and its molecular weight would indicate its excretion into human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Agitation
Anxiety
Arrhythmias
Ataxia
Blood dyscrasias
Blurred vision
Cardio-respiratory depression
CNS stimulation
Confusion
Constipation
Convulsions
Delayed ejaculation
Diarrhoea
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Euphoria
Extrasystoles
Fatigue
Fever
Flushing
Gastro-intestinal symptoms
Glaucoma
Hallucinations
Headache
Hepatic impairment
Hepatocellular necrosis (progressive)
Hypernatraemia
Hyperreflexia
Hypertensive crisis in some patients (with normal or low blood pressure)
Hypomania
Hyponatraemia
Impotence
Increase in muscle tone
Increased appetite
Increases in hepatic enzymes
Insomnia
Jaundice
Leucopenia
Lupus erythematosus-like syndrome
Mania
Metabolic changes
Mydriasis
Myoclonus
Nausea
Neck pain
Neck stiffness
Nervousness
Neuroleptic malignant syndrome
Nystagmus
Oedema
Oedema of the glottis
Palilalia
Pallor
Paraesthesia
Peripheral neuritis
Peripheral neuropathy
Photophobia
Postural hypotension
Pruritus
Psychotic episodes
Purpura
Rash
Restlessness
Schizophrenia
Sexual disturbances
Sleep disturbances
Speech disturbances
Substernal pain
Suicidal tendencies
Sweating
Tolerance
Tremor
Twitching
Urinary retention
Vomiting
Weakness
Weight gain

Presentation

Tablets containing tranylcypromine

Drugs List

Therapeutic Indications

Uses

Depressive illness

Symptoms of depressive illness, especially with phobic symptoms, or where treatment with other types of antidepressants has failed.

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Concomitant medication consider washout period, see prescribing information
Abnormal liver function test
Cerebrovascular disorder
Congestive cardiac failure
Hepatic impairment
Hereditary fructose intolerance
History of hepatic impairment
Hyperthyroidism
Phaeochromocytoma
Porphyria
Severe cardiovascular disorder

Precautions and Warnings

Electroconvulsive therapy
Patients over 65 years
Suicidal ideation
Breastfeeding
Cardiovascular disorder
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Haematological disorder
History of alcohol abuse
History of drug misuse
Pregnancy
Severe agitation

Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Contains soya or soya derivative
Preparation contains sucrose
Monitor blood pressure
Monitor liver function. Withdraw if evidence of hepatotoxic reaction
Monitor patients undergoing spinal or epidural anaesthesia closely
Tolerance and dependence may occur
Advise patient that postural hypotension may occur
Advise patients/carers to seek medical advice if suicidal intent develops
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
May activate mania or hypomania
May aggravate anxiety and agitation
May cause postural hypotension
Avoid abrupt withdrawal
Discontinue 2 weeks prior to elective surgery
Discontinue if headaches occur
Discontinue if palpitations occur
Discontinue if patient enters a manic phase
Reduce dose in elderly
Advise patient against self medication, particularly cold remedies
Advise patient to avoid alcohol during treatment
Advise patient to avoid non-alcoholic beers, lagers and wines
Advise patient to avoid foods or beverages with a high tyramine content
Avoid excessive intake of tea, coffee or other stimulants
Avoid foods that interact with MAOIs for 2 weeks after discontinuing drug

Monoamine oxidase inhibitors have a great potential for interactions with other drugs. Drug - drug interactions are not covered in this monograph, but can be viewed in the coded data. This data includes information on washout periods of interacting drugs.

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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm

Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.

Discontinue 2 weeks prior to elective surgery requiring general anaesthesia. The anaesthetist should be warned that a patient is being treated with tranylcypromine, in the event of emergency surgery being necessary.

Patients under treatment with tranylcypromine 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. Flavoured textured vegetable protein, hung game, pickled herrings, dry sausage (salami, pepperoni etc), 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.

Pregnancy and Lactation

Pregnancy

Use tranylcypromine with caution in pregnancy.

There is a potential increased risk of neonatal malformations when tranylcypromine is used during pregnancy though little data is available for its use in pregnancy. The manufacture advises against its use in pregnancy unless essential.

Schaefer notes that exposure to MAOIs is not an indication for termination of pregnancy and that detailed foetal ultrasonography may be offered in such cases to control normal development.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use tranylcypromine with caution in breastfeeding.

Highly limited evidence in relation to safety of use in humans so other antidepressants are recommended. Tranylcypromine is excreted into milk in dogs and its molecular weight would indicate its excretion into human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Agitation
Anxiety
Arrhythmias
Ataxia
Blood dyscrasias
Blurred vision
Cardio-respiratory depression
CNS stimulation
Confusion
Constipation
Convulsions
Delayed ejaculation
Diarrhoea
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Euphoria
Extrasystoles
Fatigue
Fever
Flushing
Gastro-intestinal symptoms
Glaucoma
Hallucinations
Headache
Hepatic impairment
Hepatocellular necrosis (progressive)
Hypernatraemia
Hyperreflexia
Hypertensive crisis in some patients (with normal or low blood pressure)
Hypomania
Hyponatraemia
Impotence
Increase in muscle tone
Increased appetite
Increases in hepatic enzymes
Insomnia
Jaundice
Leucopenia
Lupus erythematosus-like syndrome
Mania
Metabolic changes
Mydriasis
Myoclonus
Nausea
Neck pain
Neck stiffness
Nervousness
Neuroleptic malignant syndrome
Nystagmus
Oedema
Oedema of the glottis
Palilalia
Pallor
Paraesthesia
Peripheral neuritis
Peripheral neuropathy
Photophobia
Postural hypotension
Pruritus
Psychotic episodes
Purpura
Rash
Restlessness
Schizophrenia
Sexual disturbances
Sleep disturbances
Speech disturbances
Substernal pain
Suicidal tendencies
Sweating
Tolerance
Tremor
Twitching
Urinary retention
Vomiting
Weakness
Weight gain

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on June 10, 2014

Summary of Product Characteristics: Tranylcypromine 10mg tablets. Amdipharm Mercury. Revised March 2014.

MHRA 4th February 2008
https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
Last accessed: June 10, 2014