Drugs List

Therapeutic Indications

Uses

Depressive illness

Contraindications

Children under 18 years
Within 2 weeks of discontinuing MAOIs

Precautions and Warnings

Elderly
Suicidal ideation
Benign prostatic hyperplasia
Bipolar disorder
Breastfeeding
Epileptic disorder
Glaucoma
Hepatic impairment
History of cardiac disorder
History of seizures
Postural hypotension
Pregnancy
Renal impairment - glomerular filtration rate below 20ml/minute
Urinary retention

Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Discontinue treatment if patient develops seizures
Monitor patients with epilepsy while taking this treatment
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
Avoid abrupt withdrawal
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

At the time of writing, there are no clinical data on the exposure to reboxetine during pregnancy. Postmarketing safety data on a limited number of exposed pregnancies indicate no adverse effects on pregnancy or on the health of the foetus/neonate.

The manufacturer advises that reboxetine should only be used in pregnancy if the potential benefits of maternal treatment outweigh the possible risk to the developing foetus. Due to the insufficient experience with reboxetine, Schaefer concludes that it should be avoided during pregnancy where possible. However, use during the first trimester is not an indication for termination, but a detailed foetal ultrasound should be offered. Furthermore, a patient who is stable on reboxetine should not be changed to another medication as this may worsen her health.

If used during pregnancy, neonatal adaption disorders may be prevented by dose reduction or treatment interruption in the days immediately preceding delivery. The pre-pregnancy dosage should then be started again immediately after birth in order to prevent relapse.

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 14-17 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 ).

Animal data - No direct or indirect harmful effects demonstrated.

Effects on foetus - Possibly withdrawal symptoms if used during third trimester.

Other information - Other antidepressants may be preferred as there is more information available. However, a pregnant mother stable on reboxetine should not be switched.

Lactation

The manufacturer advise that this medication is not recomended during lactation.

Reboxetine is excreted in breast milk, and the effect on the infant is unknown. However the amount transferred into the milk is anticipated to be very low, and hence the manufacturer concludes that the use of reboxetine during breastfeeding may be considered if the potential benefits outweigh the risk for the infant. Also Schaefer notes that whenever possible, drugs of choice among the tricyclic antidepressants or selective serotonin reuptake inhibitors should be used in preference, as there is more information available on these.

If reboxetine is used during breastfeeding, in cases of neonatal symptoms potentially associated with drug therapy, a paediatrician and teratology information centre should be contacted, with a view to measuring the drug values in the infant's serum, using supplementary formula feeding, weaning or changing therapy.

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

Aggression
Agitation
Akathisia
Allergic dermatitis
Anorexia
Anxiety
Chills
Cold extremities
Constipation
Decreased appetite
Delayed ejaculation
Disturbances in accommodation
Dizziness
Dry mouth
Dysgeusia
Dysuria
Ejaculatory pain
Erectile dysfunction
Glaucoma (closed angle)
Hallucinations
Headache
Hypertension
Hyponatraemia
Hypotension
Impotence
Increased heart rate
Insomnia
Irritability
Mydriasis
Nausea
Palpitations
Paraesthesia
Postural hypotension
Rash
Raynaud's phenomenon
Reduced plasma potassium levels
Sensation of incomplete bladder emptying
Suicidal tendencies
Sweating
Tachycardia
Testicular pain
Urinary hesitancy
Urinary retention
Urinary tract infections
Vasodilatation
Vasodilation
Vertigo
Vomiting

Presentation

Tablets containing reboxetine

Drugs List

Therapeutic Indications

Uses

Depressive illness

Dosage

Adults

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Within 2 weeks of discontinuing MAOIs

Precautions and Warnings

Elderly
Suicidal ideation
Benign prostatic hyperplasia
Bipolar disorder
Breastfeeding
Epileptic disorder
Glaucoma
Hepatic impairment
History of cardiac disorder
History of seizures
Postural hypotension
Pregnancy
Renal impairment - glomerular filtration rate below 20ml/minute
Urinary retention

Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Discontinue treatment if patient develops seizures
Monitor patients with epilepsy while taking this treatment
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
Avoid abrupt withdrawal
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

At the time of writing, there are no clinical data on the exposure to reboxetine during pregnancy. Postmarketing safety data on a limited number of exposed pregnancies indicate no adverse effects on pregnancy or on the health of the foetus/neonate.

The manufacturer advises that reboxetine should only be used in pregnancy if the potential benefits of maternal treatment outweigh the possible risk to the developing foetus. Due to the insufficient experience with reboxetine, Schaefer concludes that it should be avoided during pregnancy where possible. However, use during the first trimester is not an indication for termination, but a detailed foetal ultrasound should be offered. Furthermore, a patient who is stable on reboxetine should not be changed to another medication as this may worsen her health.

If used during pregnancy, neonatal adaption disorders may be prevented by dose reduction or treatment interruption in the days immediately preceding delivery. The pre-pregnancy dosage should then be started again immediately after birth in order to prevent relapse.

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 14-17 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 ).

Animal data - No direct or indirect harmful effects demonstrated.

Effects on foetus - Possibly withdrawal symptoms if used during third trimester.

Other information - Other antidepressants may be preferred as there is more information available. However, a pregnant mother stable on reboxetine should not be switched.

Lactation

The manufacturer advise that this medication is not recomended during lactation.

Reboxetine is excreted in breast milk, and the effect on the infant is unknown. However the amount transferred into the milk is anticipated to be very low, and hence the manufacturer concludes that the use of reboxetine during breastfeeding may be considered if the potential benefits outweigh the risk for the infant. Also Schaefer notes that whenever possible, drugs of choice among the tricyclic antidepressants or selective serotonin reuptake inhibitors should be used in preference, as there is more information available on these.

If reboxetine is used during breastfeeding, in cases of neonatal symptoms potentially associated with drug therapy, a paediatrician and teratology information centre should be contacted, with a view to measuring the drug values in the infant's serum, using supplementary formula feeding, weaning or changing therapy.

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 of patients 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.

Advise patients not to drive or operate machinery if their judgement is impaired.

Advise patients not to take St John's wort concurrently.

Side Effects

Aggression
Agitation
Akathisia
Allergic dermatitis
Anorexia
Anxiety
Chills
Cold extremities
Constipation
Decreased appetite
Delayed ejaculation
Disturbances in accommodation
Dizziness
Dry mouth
Dysgeusia
Dysuria
Ejaculatory pain
Erectile dysfunction
Glaucoma (closed angle)
Hallucinations
Headache
Hypertension
Hyponatraemia
Hypotension
Impotence
Increased heart rate
Insomnia
Irritability
Mydriasis
Nausea
Palpitations
Paraesthesia
Postural hypotension
Rash
Raynaud's phenomenon
Reduced plasma potassium levels
Sensation of incomplete bladder emptying
Suicidal tendencies
Sweating
Tachycardia
Testicular pain
Urinary hesitancy
Urinary retention
Urinary tract infections
Vasodilatation
Vasodilation
Vertigo
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: July 2013

Reference Sources

British National Formulary, 65th Edition (2013) Pharmaceutical Press, London.

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

Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Edronax 4mg tablets. Pharmacia Ltd. Revised June 2013

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

MHRA 4th February 2008
https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
Last accessed 12th July 2013