Modified-release methylphenidate hydrochloride p. 227
preparations are preferred in children because of their
pharmacokinetic profile, convenience, improved adherence,
lack of need to be taken at school (and associated problems
with storing and administering controlled drugs in school).
Immediate-release preparations can be given when more
flexible dosing regimens are required or during initial dose
titration.
When starting drug treatment, children should be
monitored for side-effects. In particular, those treated with
atomoxetine below should be closely observed for agitation,
irritability, suicidal thinking and self-harming behaviour,
and unusual changes in behaviour, particularly during the
initial months of treatment, or after a change in dose.
Parents or carers should also be warned about the potential
for liver damage in rare cases with atomoxetine below.h
Limited evidence has shown benefit from treatment with
lisdexamfetamine mesilate p. 230 in reducing ADHD
symptoms in children aged 6 years and over—it is licensed
for use when the response to previous methylphenidate
hydrochloride p. 227 treatment is considered clinically
inadequate. In addition, limited evidence has shown the
effectiveness of guanfacine p. 231 in reducing ADHD
symptoms in children aged 6 years and over—it is licensed
for use in children for whom stimulants are not suitable, not
tolerated or have been shown to be ineffective.
Poor response to treatment
gIf there has been a poor response to parent-
training/education programmes, psychological treatment
and drug treatment with methylphenidate hydrochloride
p. 227 and atomoxetine below, a comprehensive review is
required. Further options for treatment include higher doses
of methylphenidate hydrochloride or atomoxetine;
switching to dexamfetamine sulfate p. 229 ; further or
alternative psychological treatments; or referral to regional
specialists for alternative drug treatment (such as bupropion
hydrochloride, clonidine hydrochloride p. 102 , modafinil, or
imipramine hydrochloride p. 240 [unlicensed indications]).
Following an adequate response, drug treatment for ADHD
should be continued for as long as it is clinically effective.
Treatment should be reviewed annually.hUseful Resources
Attention deficit hyperactivity disorder: diagnosis and
management. National Institute for Health and Care
Excellence. Clinical guideline 72. September 2008 (updated
February 2016 ).
http://www.nice.org.uk/guidance/CG 72CNS STIMULANTS›CENTRALLY ACTING
SYMPATHOMIMETICSAtomoxetine 28-Sep-2016
lINDICATIONS AND DOSE
Attention deficit hyperactivity disorder (initiated by a
specialist)
▶BY MOUTH
▶Child 6–17 years (body-weight up to 70 kg):Initially
500 micrograms/kg daily for 7 days, dose is increased
according to response; maintenance 1. 2 mg/kg daily,
total daily dose may be given either as a single dose in
the morning or in 2 divided doses with last dose no
later than early evening, high daily doses to be given
under the direction of a specialist; maximum 1. 8 mg/kg
per day; maximum 120 mg per day
▶Child 6–17 years (body-weight 70 kg and above):Initially
40 mg daily for 7 days, dose is increased according to
response; maintenance 80 mg daily, total daily dose
may be given either as a single dose in the morning or
in 2 divided doses with last dose no later than earlyevening, high daily doses to be given under the
direction of a specialist; maximum 120 mg per daylUNLICENSED USEAtomoxetine doses in BNF may differ
from those in product literature. Doses above 100 mg daily
not licensed.
lCONTRA-INDICATIONSPhaeochromocytoma.severe
cardiovascular disease.severe cerebrovascular disease
lCAUTIONSQT-interval prolongation.aggressive
behaviour.cardiovascular disease.cerebrovascular
disease.emotional lability.history of seizures.hostility.
hypertension.mania.psychosis.structural cardiac
abnormalities.susceptibility to angle-closure glaucoma.
tachycardia
lINTERACTIONS→Appendix 1 : atomoxetine
lSIDE-EFFECTS
▶Common or very commonAnxiety.appetite decreased.
asthenia.chest pain.constipation.depression.dizziness.
drowsiness.gastrointestinal discomfort.headaches.
insomnia.mood altered.mydriasis.nausea.skin
reactions.tic.vomiting.weight decreased
▶UncommonBehaviour abnormal.dyspnoea.hallucination
.hyperhidrosis.hypersensitivity.palpitations.psychosis.
QT interval prolongation.seizure.sensation abnormal.
sinus tachycardia.suicidal behaviour.syncope.tremor.
vision blurred
▶Rare or very rareGenital pain.hepatic disorders.priapism
.Raynaud’s phenomenon.urinary disorders
▶Frequency not knownSudden cardiac death
lPREGNANCYManufacturer advises avoid unless potential
benefit outweighs risk.
lBREAST FEEDINGAvoid-present in milk inanimalstudies.
lHEPATIC IMPAIRMENT
Dose adjustmentsHalve dose in moderate impairment.
Quarter dose in severe impairment.
lMONITORING REQUIREMENTS
▶Monitor for appearance or worsening of anxiety,
depression or tics.
▶Pulse, blood pressure, psychiatric symptoms, appetite,
weight and height should be recorded at initiation of
therapy, following each dose adjustment, and at least
every 6 months thereafter.
lPATIENT AND CARER ADVICE
Suicidal ideationFollowing reports of suicidal thoughts and
behaviour, patients and their carers should be informed
about the risk and told to report clinical worsening,
suicidal thoughts or behaviour, irritability, agitation, or
depression.
Hepatic impairmentFollowing rare reports of hepatic
disorders, patients and carers should be advised of the risk
and be told how to recognise symptoms; prompt medical
attention should be sought in case of abdominal pain,
unexplained nausea, malaise, darkening of the urine, or
jaundice.
Medicines for Children leaflet: Atomoxetine for attention deficit
hyperactivity disorder (ADHD)www.medicinesforchildren.org.
uk/atomoxetine-attention-deficit-hyperactivity-disorder-adhd
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Methylphenidate, atomoxetine and dexamfetamine for
attention deficit hyperactivity disorder (ADHD) (March 2006 )
NICE TA98
Atomoxetine is recommended, within its licensed
indications, as an option for the management of ADHD in
children and adolescents.
http://www.nice.org.uk/TA98
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (December
2015 ) that atomoxetine oral solution (Strattera®)is226 Mental health disorders BNFC 2018 – 2019
Nervous system4