SCP
3
SHARED CARE PROTOCOL
Atomoxetine
Clinical Indication: Attention Deficit Hyperactivity Disorder (ADHD)
in children and adolescents (aged 6 to 18)
Version 1: May 2014
due for review: April 2016
Introduction
Attention-Deficit Hyperactivity Disorder (ADHD) is diagnosed if the three clinical features -inattention,
over-activity and impulsiveness - have been present from an early age, persist in more than one
situation (e.g. at home and in school) and impair function. The diagnosis must be made following a
comprehensive assessment by an appropriate child psychiatrist and/or a paediatrician with special
interest and training in this field. The assessment and management of this condition has been reviewed
by SIGN Guideline No. 112, October 2009 and NICE Quality Standard 39, July 2013. Drug therapy with
atomoxetine is only one part of the package of care for children with ADHD, which includes behavioural
and educational interventions.
Shared Care
A shared care protocol is used to facilitate the sharing of care and transfer of prescribing. This
would usually take place once the patient’s condition is stable; the patient is demonstrably benefiting
from the treatment and is free from any significant side effects. GPs should only take on the prescribing
when they are confident in the use of the drug, in the context of the protocol. Contingency plans must be
in place to enable the patient to receive the recommended treatment, should the GP decline to
prescribe.
Indication for Therapy
Atomoxetine (Strattera ®) is licensed for children of six years or older as part of a comprehensive
treatment programme for attention-deficit hyperactivity disorder (ADHD). Treatment must be initiated
under the supervision of a child psychiatrist and / or a paediatrician with special interest and training in
this field.
Preparations Available
Atomoxetine (Strattera ®) is available as 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg capsules.
Recommended Dosage and Administration
Child aged 6 years and over and adolescent with body weight up to 70kg, initially 500 mcg/kg daily for 7
days increased according to response to usual maintenance dose of 1.2 mg/kg daily. Doses up to 1.8
mg/kg can be used under specialist advice. (Maximum dose 120 mg daily – unlicensed)
Child and adolescent with body weight over 70kg, initially 40mg daily for 7 days then increased
according to response to usual dose of 80mg – 100mg daily (maximum dose 120mg daily – unlicensed)
Total daily dose may be given either as a single dose in the morning or in two divided doses with the last
dose given no later than early evening, with or without food. It should be swallowed whole.
Dosage must be adjusted in hepatic impairment in accordance with the manufacturers Summary of
Product Characteristics.
Shared Care Responsibilities
Aspects of Care for which the Specialist is responsible
Assessment and diagnosis of children with ADHD
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
Liaising with the GP practice to ensure they are willing to prescribe.
Making suitable arrangements with the patient in the event the practice are not willing to
prescribe.
 To review the patient at 12 months to identify if treatment needs to be continued.
Liaison with GP to agree to share the patient’s care
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Patient monitoring - initially 3 monthly, then 6 monthly in the longer term. This includes height, weight
and blood pressure and pulse.
Discontinuation - advising GP when Atomoxetine should be discontinued for patients receiving the
drug long term. The specialist will provide necessary supervision and support during the drug
discontinuation phase
If Atomoxetine is continued beyond the age of 17 then care should be transferred from CAMHS to
Adult Psychiatric Services as appropriate
Communication to ensure GP is informed of any changes in treatment e.g. patient monitoring, dose
alteration etc
Aspects of Care for which the General Practitioner is responsible



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If unwilling to prescribe the drug, to ask if any colleagues are willing to prescribe. If the
practice is unwilling to prescribe to relay this decision back to the Specialist in a timely
manner for alternative arrangements to be established.
To initiate and prescribe the drug if willing to do so under the instruction from the
Specialist
To establish suitable monitoring as per the above schedule once they take over prescribing
Liaison with the Paediatrician/Psychiatrists regarding any complications of treatment
 Reporting of adverse reactions to Yellow Card Scotland is the responsibility of both the consultant and
GP
 https://yellowcard.mhra.gov.uk/
Adverse Effects
The following adverse effects have been reported:
Insomnia, somnolence, dizziness
Decreased appetite, anorexia, constipation, dyspepsia
Occasional abdominal pain, nausea and vomiting
Headaches, rash, fatigue
Emotional lability, mood swings
Temporary growth retardation may occur during prolonged therapy - monitor height and weight
Changes in blood pressure and heart rate (usually increased)
Drug Interactions
Monoamine oxidase inhibitors (MAOIs).
Fluoxetine, paroxetine, quinidine, terbinafine – may all increase atomoxetine levels.
Salbutamol – action of salbutamol on the cardiovascular system may be potentiated.
Atomoxetine may decrease the effectiveness of anti-hypertensive drugs.
 Drugs that affect noradrenaline – use with caution (venlafaxine, mirtazepine).
 Drugs that lower seizure threshold – use with caution (e.g. TCA’s, SSRIs, tramadol,
neuroleptics).
 QT prolonging drugs (e.g. erythromycin, methadone, mefloquine, TCA’s, lithium, cisapride).
Contra-Indications
Do not use in combination with MAOIs or within 2 weeks of stopping MAOIs
Do not use with severe cardiovascular or cerebrovascular disorders whose conditions
would be expected to deteriorate if they experienced and increase in blood pressure or heart
rate.
Do not use in patients with narrow angle glaucoma.
 Do not use in patients with pheochromocytoma.
 Hypersensitivity to atomoxetine or to any excipients.
Precautions
Suicide related behaviour has been reported. Patients should be monitored for the
appearance or worsening of suicide related behaviour, hostility, irritability, agitation,
depression, psychosis or mania.
 Use with caution in patients with hypertension, tachycardia, cereberovascular or
cardiovascular disease.
 Hepatic effects: Atomoxetine should be discontinued in patients with jaundice or laboratory
evidence of liver injury and should not be restarted. Patients and carers should be advised of
the risks of hepatic disorders , be told how to recognise symptoms and seek prompt medical
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attention in the case of abdominal pain, unexplained nausea, malaise, darkening of urine or
jaundice.
 Seizures are a potential risk therefore Atomoxetine should be introduced with caution in
patients with a history of seizure. Consider discontinuation in any patient developing seizures
or if there is an increase in seizure frequency.
 Reports of QT interval prolongation have been received with patients with atomoxetine.
Atomoxetine should be used with caution in those with congenital or acquired long QT or a
family history of QT prolongation. This risk may be enhanced if atomoxetine is used
concurrently with other drugs that produce QT prolongation, drugs that can cause electrolyte
disturbances and those that inhibit cytochrome P450 2D6 (e.g. fluoxetine, paroxetine,
quinidine, terbinafine).
 Pregnancy.
Please refer to the Current Summary of Product Characteristics (SPC) for full details at
www.medicines.org.uk
Contact Points
Borders CAMHS
Primary Care Prescribing Team
BGH Pharmacy
Dr Diana Leaver, Community Paediatrician
West Lothian ADHD Service
Tel: 01750 23715
Tel: 01896 827708
Tel: 01896 826783
Tel: 01896 826686
Tel: 01506 419666 ext 2734
This information was prepared by the Consultants in the Department of Child and Adolescent Mental Health Service and the Pharmacists at the Royal
Edinburgh Hospital through liaison with the General Practice Prescribing Committee, the Paediatric & Neonatal Drug and Therapeutics Committee, Lothian
University Hospitals Division, and the Hospital and Specialist Services Medicines Committee, NHS Lothian. Used and adapted with permission.
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