Drugs List

Therapeutic Indications

Uses

Depression - severe
Treatment of social phobia

Contraindications

Children under 18 years
Within 5 weeks of discontinuing fluoxetine or 2 weeks of other SSRIs
Within 7 days of discontinuing safinamide
Confusional states
Galactosaemia
Phaeochromocytoma
Schizophrenia

Precautions and Warnings

Suicidal ideation
Bipolar disorder
Breastfeeding
Glucose-galactose malabsorption syndrome
Lactose intolerance
Porphyria
Predominant excitation or agitation
Pregnancy
Severe hepatic impairment
Thyrotoxicosis

Patients at risk of suicide should be closely supervised
Reduce dose in patients with severe hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Contains polyethylene glycol
Breastfeeding: Monitor infant for systemic effects of treating the mother
Treatment of depression - monitor initially; may take 2-4 weeks to respond
Advise patients/carers to seek medical advice if suicidal intent develops
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
Advise patient against self medication, particularly cold remedies
Advise patient against consuming large amounts of tyramine rich foods

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

Other psychiatric conditions for which moclobemide is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

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.

Caution should be exercised in patients with thyrotoxicosis as a hypertensive reaction may be precipitated.

Patients with excitation or agitation as predominant features should only be treated with moclobemide if used in combination with a sedative. The sedative should only be used for a maximum of 2 to 3 weeks.

Manic episodes can be provoked in bipolar disorders.

Pregnancy and Lactation

Pregnancy

Use moclobemide with caution in pregnancy.

Moclobemide is not recommended during pregnancy due to limited data and potential interactions with other medications and some tyramine-rich foods.

Moclobemide may exacerbate hypertension, which in turn can alter placental blood flow, leading to serious consequences for foetal growth and development. It may also interfere with drugs used at delivery and should be avoided unless all other treatments have failed. However, if a patient is stable on moclobemide, it should not be withdrawn or changed to another antidepressant as this may adversely affect her health. The patient should receive regular psychiatric and obstetric care in order to diagnose a relapse or complication with the pregnancy as quickly as possible.

Exposure within the first three months is not an indication for termination of the pregnancy, though fetal ultrasonography should be used to monitor development. Neonate adaption disorders may be prevented by dose reduction or interruption immediately preceding delivery, upon discussion with the patient, and providing the clinical course allows it, but the pre-pregnancy dose must be reinitiated immediately after delivery to avoid relapse. If moclobemide is used up to delivery, the neonate should be observed for withdrawal symptoms for at least two days after. (Schaefer et al, 2007)

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 moclobemide with caution in pregnancy.

Use of moclobemide during breastfeeding is tolerable if compellingly indicated, though the drugs of choice are tricyclic antidepressants and SSRIs (Schaefer et al, 2007).

Studies have shown that the minimal amount of moclobemide that passes into breast milk is unlikely to pose a risk for the infant, and no adverse effects in the infants were noted. Moclobemide has a short half life, which makes accumulation in the milk unlikely.

Where possible, moclobemide should be taken as a single dose before the baby's longest sleep period, and the infant breastfed immediately before the dose is taken, avoiding the peak levels of 1-3 hours after the dose. Infants should be monitored for drowsiness and other behavioural changes.

Major route of metabolism is via the liver - avoid exposure in infants with significantly compromised liver function.

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
Confusion
Constipation
Diarrhoea
Dizziness
Dry mouth
Flushing
Galactorrhoea
Headache
Hyponatraemia
Increases in hepatic enzymes
Irritability
Nausea
Oedema
Paraesthesia
Pruritus
Rash
Restlessness
Serotonin syndrome
Skin reactions
Sleep disturbances
Suicidal tendencies
Urticaria
Visual disturbances
Vomiting

Presentation

Tablets containing moclobemide

Drugs List

Therapeutic Indications

Uses

Depression - severe
Treatment of social phobia

Dosage

Adults

Elderly

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Within 5 weeks of discontinuing fluoxetine or 2 weeks of other SSRIs
Within 7 days of discontinuing safinamide
Confusional states
Galactosaemia
Phaeochromocytoma
Schizophrenia

Precautions and Warnings

Suicidal ideation
Bipolar disorder
Breastfeeding
Glucose-galactose malabsorption syndrome
Lactose intolerance
Porphyria
Predominant excitation or agitation
Pregnancy
Severe hepatic impairment
Thyrotoxicosis

Patients at risk of suicide should be closely supervised
Reduce dose in patients with severe hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Contains polyethylene glycol
Breastfeeding: Monitor infant for systemic effects of treating the mother
Treatment of depression - monitor initially; may take 2-4 weeks to respond
Advise patients/carers to seek medical advice if suicidal intent develops
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
Advise patient against self medication, particularly cold remedies
Advise patient against consuming large amounts of tyramine rich foods

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

Other psychiatric conditions for which moclobemide is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

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.

Caution should be exercised in patients with thyrotoxicosis as a hypertensive reaction may be precipitated.

Patients with excitation or agitation as predominant features should only be treated with moclobemide if used in combination with a sedative. The sedative should only be used for a maximum of 2 to 3 weeks.

Manic episodes can be provoked in bipolar disorders.

Pregnancy and Lactation

Pregnancy

Use moclobemide with caution in pregnancy.

Moclobemide is not recommended during pregnancy due to limited data and potential interactions with other medications and some tyramine-rich foods.

Moclobemide may exacerbate hypertension, which in turn can alter placental blood flow, leading to serious consequences for foetal growth and development. It may also interfere with drugs used at delivery and should be avoided unless all other treatments have failed. However, if a patient is stable on moclobemide, it should not be withdrawn or changed to another antidepressant as this may adversely affect her health. The patient should receive regular psychiatric and obstetric care in order to diagnose a relapse or complication with the pregnancy as quickly as possible.

Exposure within the first three months is not an indication for termination of the pregnancy, though fetal ultrasonography should be used to monitor development. Neonate adaption disorders may be prevented by dose reduction or interruption immediately preceding delivery, upon discussion with the patient, and providing the clinical course allows it, but the pre-pregnancy dose must be reinitiated immediately after delivery to avoid relapse. If moclobemide is used up to delivery, the neonate should be observed for withdrawal symptoms for at least two days after. (Schaefer et al, 2007)

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 moclobemide with caution in pregnancy.

Use of moclobemide during breastfeeding is tolerable if compellingly indicated, though the drugs of choice are tricyclic antidepressants and SSRIs (Schaefer et al, 2007).

Studies have shown that the minimal amount of moclobemide that passes into breast milk is unlikely to pose a risk for the infant, and no adverse effects in the infants were noted. Moclobemide has a short half life, which makes accumulation in the milk unlikely.

Where possible, moclobemide should be taken as a single dose before the baby's longest sleep period, and the infant breastfed immediately before the dose is taken, avoiding the peak levels of 1-3 hours after the dose. Infants should be monitored for drowsiness and other behavioural changes.

Major route of metabolism is via the liver - avoid exposure in infants with significantly compromised liver function.

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
Confusion
Constipation
Diarrhoea
Dizziness
Dry mouth
Flushing
Galactorrhoea
Headache
Hyponatraemia
Increases in hepatic enzymes
Irritability
Nausea
Oedema
Paraesthesia
Pruritus
Rash
Restlessness
Serotonin syndrome
Skin reactions
Sleep disturbances
Suicidal tendencies
Urticaria
Visual disturbances
Vomiting

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: August 2015

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.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 12 August 2015.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Manerix 150 mg tablets. Meda Pharmaceuticals. Revised March 2015.

Summary of Product Characteristics: Manerix 300 mg tablets. Meda Pharmaceuticals. Revised March 2015.

MHRA 4th February 2008
Available at: https://www.mhra.gov.uk
Last accessed: 12 August 2015

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Moclobemide Last revised: 07 September 2013
Last accessed: 12 August 2015

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 22 March 2014
Last accessed: 12 August 2015