Drugs List

Therapeutic Indications

Uses

Depressive illness

Contraindications

Children under 18 years
Concomitant medication consider washout period, see prescribing information
Abnormal liver function test
Breastfeeding
Cerebrovascular disorder
Galactosaemia
Hepatic impairment
Hyperthyroidism
Phaeochromocytoma
Porphyria
Pregnancy
Severe cardiovascular disorder

Precautions and Warnings

Debilitation
Elderly
Electroconvulsive therapy
Suicidal ideation
Cardiovascular disorder
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Haematological disorder
Lactose intolerance
Renal impairment
Severe agitation

Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Monitor blood pressure
Monitor liver function. Withdraw if evidence of hepatotoxic reaction
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
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 foods that interact with MAOIs for 2 weeks after discontinuing drug

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.

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 should be warned to avoid foodstuffs and beverages with a high tyramine content: mature cheeses (including processed cheeses), hydrolysed yeast or meat extracts, alcoholic beverages, particularly heavy red wines, non-alcoholic beers, lagers and wines, and other foods which are not fresh and are fermented, pickled, 'hung', 'matured' or otherwise subject to protein degradation before consumption. Broad bean pods (which contain levodopa) and banana skins may also present a hazard. In extreme cases interactions may result in severe hypertensive episodes. Isocarboxazid should therefore be discontinued immediately upon the occurrence of palpitations or frequent headaches.

Isocarboxazid should be discontinued for at least 2 weeks prior to elective surgery requiring general anaesthesia. The anaesthetist should be warned that a patient is being treated with isocarboxazid, in the event of emergency surgery being necessary.

All patients taking isocarboxazid should be warned against self-medication with proprietary 'cold-cure' preparations and nasal decongestants.

The danger of interaction persists for up to 2 weeks after treatment with isocarboxazid is discontinued.

Consider hyponatraemia in those presenting with drowsiness, confusion or convulsions.

Pregnancy and Lactation

Pregnancy

Isocarboxazid is contraindicated in pregnancy.

The manufacturer recommends not to use isocarboxazid in 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. In addition, the effect of psychotropic drugs on the fine brain structure of the foetus is unknown.

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

Isocarboxazid is contraindicated in breastfeeding.

Since there is no information on the secretion of the drug into breast milk, (though its molecular weight is low enough that excretion into the breast milk is expected) isocarboxazid is contraindicated during lactation.

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
Altered liver function tests
Arrhythmias
Behavioural disturbances
Blood dyscrasias
Blurred vision
Cardiac arrhythmias
Confusion
Constipation
Convulsions
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Ejaculation disorders
Erectile disturbance
Euphoria
Fatigue
Granulocytopenia
Hallucinations
Headache
Hepatocellular necrosis
Hyperactivity
Hyperreflexia
Hypomania
Hyponatraemia
Increased appetite
Insomnia
Jaundice
Leucopenia
Myoclonus
Nausea
Nervousness
Nystagmus
Orthostatic hypotension
Paraesthesia
Peripheral neuritis
Peripheral neuropathy
Peripheral oedema
Psychotic episodes
Purpura
Rash
Sexual disturbances
Suicidal tendencies
Sweating
Tremor
Vomiting
Weakness
Weight gain

Presentation

Tablets containing isocarboxazid

Drugs List

Therapeutic Indications

Uses

Depressive illness

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Concomitant medication consider washout period, see prescribing information
Abnormal liver function test
Breastfeeding
Cerebrovascular disorder
Galactosaemia
Hepatic impairment
Hyperthyroidism
Phaeochromocytoma
Porphyria
Pregnancy
Severe cardiovascular disorder

Precautions and Warnings

Debilitation
Elderly
Electroconvulsive therapy
Suicidal ideation
Cardiovascular disorder
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Haematological disorder
Lactose intolerance
Renal impairment
Severe agitation

Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Monitor blood pressure
Monitor liver function. Withdraw if evidence of hepatotoxic reaction
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
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 foods that interact with MAOIs for 2 weeks after discontinuing drug

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.

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 should be warned to avoid foodstuffs and beverages with a high tyramine content: mature cheeses (including processed cheeses), hydrolysed yeast or meat extracts, alcoholic beverages, particularly heavy red wines, non-alcoholic beers, lagers and wines, and other foods which are not fresh and are fermented, pickled, 'hung', 'matured' or otherwise subject to protein degradation before consumption. Broad bean pods (which contain levodopa) and banana skins may also present a hazard. In extreme cases interactions may result in severe hypertensive episodes. Isocarboxazid should therefore be discontinued immediately upon the occurrence of palpitations or frequent headaches.

Isocarboxazid should be discontinued for at least 2 weeks prior to elective surgery requiring general anaesthesia. The anaesthetist should be warned that a patient is being treated with isocarboxazid, in the event of emergency surgery being necessary.

All patients taking isocarboxazid should be warned against self-medication with proprietary 'cold-cure' preparations and nasal decongestants.

The danger of interaction persists for up to 2 weeks after treatment with isocarboxazid is discontinued.

Consider hyponatraemia in those presenting with drowsiness, confusion or convulsions.

Pregnancy and Lactation

Pregnancy

Isocarboxazid is contraindicated in pregnancy.

The manufacturer recommends not to use isocarboxazid in 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. In addition, the effect of psychotropic drugs on the fine brain structure of the foetus is unknown.

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

Isocarboxazid is contraindicated in breastfeeding.

Since there is no information on the secretion of the drug into breast milk, (though its molecular weight is low enough that excretion into the breast milk is expected) isocarboxazid is contraindicated during lactation.

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

Counselling

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

Patients should be warned to avoid foodstuffs and beverages with a high tyramine content: mature cheeses (including processed cheeses), hydrolysed yeast or meat extracts, alcoholic beverages, particularly heavy red wines, non-alcoholic beers, lagers and wines, and other foods which are not fresh and are fermented, pickled, 'hung', 'matured' or otherwise subject to protein degradation before consumption. Broad bean pods (which contain levodopa) and banana skins may also present a hazard.

Patients should be warned against self-medication with any substance, particularly with 'cold-cure' preparations and nasal decongestants.

Patients should be advised that their ability to drive and operate machinery may be impaired by treatment.

Side Effects

Agitation
Altered liver function tests
Arrhythmias
Behavioural disturbances
Blood dyscrasias
Blurred vision
Cardiac arrhythmias
Confusion
Constipation
Convulsions
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Ejaculation disorders
Erectile disturbance
Euphoria
Fatigue
Granulocytopenia
Hallucinations
Headache
Hepatocellular necrosis
Hyperactivity
Hyperreflexia
Hypomania
Hyponatraemia
Increased appetite
Insomnia
Jaundice
Leucopenia
Myoclonus
Nausea
Nervousness
Nystagmus
Orthostatic hypotension
Paraesthesia
Peripheral neuritis
Peripheral neuropathy
Peripheral oedema
Psychotic episodes
Purpura
Rash
Sexual disturbances
Suicidal tendencies
Sweating
Tremor
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: September 2014

Reference Sources

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 September 04, 2014 .

Summary of Product Characteristics: Isocarboxazid 10 mg tablets. Alliance Pharmaceuticals. Revised November 2011.

MHRA Drug Safety Update February 2008
Available at: https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
Last accessed: September 04, 2014