BNF 78 Attention deficit hyperactivity disorder 347
l INTERACTIONS → Appendix 1: atomoxetine
(in adults). gastrointestinal discomfort. genital pain (rare
in children). headaches . hyperhidrosis (uncommon in
children). menstrual cycle irregularities (in adults). mood
altered . mydriasis (in children). nausea . palpitations
(uncommon in children). prostatitis (in adults). sensation
abnormal (uncommon in children). sexual dysfunction
(rare in children). skin reactions . sleep disorders .taste
altered (in adults).thirst (in adults).tremor (uncommon
▶ Uncommon Behaviour abnormal . chest pain (very common
coldness (in adults). QT interval prolongation . suicidal
behaviour. syncope .tic (very common in children). vision
▶ Frequency not known Sudden cardiac death
l PREGNANCY Manufacturer advises avoid unless potential
l BREAST FEEDING Avoid-present in milk in animal studies.
Dose adjustments Manufacturer advises halve dose in
moderate impairment and quarter dose in severe
▶ Monitor for appearance or worsening of anxiety,
▶ Pulse, blood pressure, psychiatric symptoms, appetite,
weight and height should be recorded at initiation of
therapy, following each dose adjustment, and at least
Suicidal ideation Following 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
Hepatic impairment Following 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
Medicines for Children leaflet: Atomoxetine for attention deficit
hyperactivity disorder (ADHD) www.medicinesforchildren.org.
uk/atomoxetine-attention-deficit-hyperactivity-disorder-adhd
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (December
2015) that atomoxetine oral solution (Strattera ®) is
accepted for restricted use within NHS Scotland for the
treatment of attention deficit hyperactivity disorder
(ADHD) in children of 6 years and older, in adolescents and
in adults. It is restricted to patients who are unable to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 3
▶ Strattera (Eli Lilly and Company Ltd)
Atomoxetine (as Atomoxetine hydrochloride) 4 mg per
1 ml Strattera 4mg/1ml oral solution sugar-free | 300 ml P £85.00 DT = £85.00
CAUTIONARY AND ADVISORY LABELS 3
▶ Strattera (Eli Lilly and Company Ltd)
Atomoxetine (as Atomoxetine hydrochloride) 10 mg Strattera
10mg capsules | 7 capsule P £13.28 | 28 capsule P £53.09
Atomoxetine (as Atomoxetine hydrochloride) 18 mg Strattera
18mg capsules | 7 capsule P £13.28 | 28 capsule P £53.09
Atomoxetine (as Atomoxetine hydrochloride) 25 mg Strattera
25mg capsules | 7 capsule P £13.28 | 28 capsule P £53.09
Atomoxetine (as Atomoxetine hydrochloride) 40 mg Strattera
40mg capsules | 7 capsule P £13.28 | 28 capsule P £53.09
Atomoxetine (as Atomoxetine hydrochloride) 60 mg Strattera
60mg capsules | 28 capsule P £53.09 DT = £53.09
Atomoxetine (as Atomoxetine hydrochloride) 80 mg Strattera
80mg capsules | 28 capsule P £70.79 DT = £70.79
Atomoxetine (as Atomoxetine hydrochloride) 100 mg Strattera
100mg capsules | 28 capsule P £70.79 DT = £70.79
Methylphenidate hydrochloride 03-Oct-2017
Attention deficit hyperactivity disorder (initiated under
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Child 6–17 years: Initially 5 mg 1–2 times a day,
increased in steps of 5–10 mg daily if required, at
weekly intervals, increased if necessary up to 60 mg
daily in 2–3 divided doses, increased if necessary up to
2.1 mg/kg daily in 2–3 divided doses, the licensed
maximum dose is 60 mg daily in 2–3 doses, higher dose
(up to a maximum of 90 mg daily) under the direction
of a specialist, discontinue if no response after
1 month, if effect wears off in evening (with rebound
hyperactivity) a dose at bedtime may be appropriate
(establish need with trial bedtime dose). Treatment
may be started using a modified-release preparation
▶ Adult: Initially 5 mg 2–3 times a day, dose is increased
if necessary at weekly intervals according to response,
increased if necessary up to 100 mg daily in 2–3 divided
doses, if effect wears off in evening (with rebound
hyperactivity) a dose at bedtime may be appropriate
(establish need with trial bedtime dose). Treatment
may be started using a modified-release preparation
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: 10–60 mg daily in divided doses; usual dose
20–30 mg daily in divided doses, dose to be taken
DOSE EQUIVALENCE AND CONVERSION
▶ When switching from immediate-release preparations
to modified-release preparations—consult product
Attention deficit hyperactivity disorder
▶ Child 6–17 years: Initially 18 mg once daily, dose to be
taken in the morning, increased in steps of 18 mg every
week, adjusted according to response; increased if
348 Mental health disorders BNF 78
necessary up to 2.1 mg/kg daily, licensed max. dose is
54 mg once daily, to be increased to higher dose only
under direction of specialist; discontinue if no
response after 1 month; maximum 108 mg per day
▶ Adult: Initially 18 mg once daily, dose to be taken in
the morning; adjusted at weekly intervals according to
response; maximum 108 mg per day
DOSE EQUIVALENCE AND CONVERSION
▶ Total daily dose of 15 mg of standard-release
formulation is considered equivalent to Concerta ® XL
DELMOSART ® PROLONGED-RELEASE TABLET
Attention deficit hyperactivity disorder (under expert
▶ Child 6–17 years: Initially 18 mg once daily, dose to be
taken in the morning, then increased in steps of 18 mg
every week if required, discontinue if no response
after 1 month; maximum 54 mg per day
▶ Adult: Initially 18 mg once daily, dose to be taken in
the morning, then increased in steps of 18 mg every
week if required, discontinue if no response after
1 month; maximum 54 mg per day
DOSE EQUIVALENCE AND CONVERSION
▶ Total daily dose of 15 mg of standard-release
formulation is considered equivalent to Delmosart ®
Attention deficit hyperactivity disorder
▶ Child 6–17 years: Initially 10 mg once daily, dose to be
taken in the morning before breakfast; increased
gradually at weekly intervals if necessary; increased if
necessary up to 2.1 mg/kg daily, licensed max. dose is
60 mg daily, to be increased to higher dose only under
direction of specialist; discontinue if no response after
1 month; maximum 90 mg per day
▶ Adult: Initially 10 mg once daily, dose to be taken in
the morning before breakfast; increased gradually at
weekly intervals if necessary; maximum 100 mg per day
Attention deficit hyperactivity disorder
▶ Child 6–17 years: Initially 10 mg once daily, dose to be
taken in the morning with breakfast; adjusted at
weekly intervals according to response; increased if
necessary up to 2.1 mg/kg daily, licensed max. dose is
60 mg daily, to be increased to higher dose only under
direction of specialist; discontinue if no response after
1 month; maximum 90 mg per day
▶ Adult: Initially 10 mg once daily, dose to be taken in
the morning with breakfast; adjusted at weekly
intervals according to response; maximum 100 mg per
Attention deficit hyperactivity disorder (under expert
▶ Child 6–17 years: Initially 18 mg once daily, dose to be
taken in the morning, increased in steps of 18 mg every
week, adjusted according to response, discontinue if no
response after 1 month; maximum 54 mg per day
▶ Adult: Initially 18 mg once daily, dose to be taken in
the morning, increased in steps of 18 mg every week,
adjusted according to response, discontinue if no
response after 1 month; maximum 54 mg per day
DOSE EQUIVALENCE AND CONVERSION
▶ Total daily dose of 15 mg of standard-release
formulation is considered equivalent to Xaggitin ® XL
l UNLICENSED USE Doses over 60 mg daily not licensed;
doses of Concerta XL over 54 mg daily not licensed.
Not licensed for use in narcolepsy. Not licensed for use in
adults for attention deficit hyperactivity disorder.
l CAUTIONS Agitation . alcohol dependence . anxiety . drug
dependence . epilepsy (discontinue if increased seizure
frequency). family history of Tourette syndrome . susceptibility to angle-closure glaucoma .tics
CONCERTA ® XL, DELMOSART ® PROLONGED-RELEASE
TABLET Dysphagia (dose form not appropriate).restricted
gastro-intestinal lumen (dose form not appropriate)
XAGGITIN ® XL Dysphagia (dose form not appropriate)
l INTERACTIONS → Appendix 1: methylphenidate
▶ Common or very common Alopecia . anxiety . appetite
mouth . fever. gastrointestinal discomfort. growth
cardiac death .thinking abnormal .thrombocytopenia
l PREGNANCY Limited experience—avoid unless potential
l BREAST FEEDING Limited information available—avoid.
▶ Monitor for psychiatric disorders.
▶ Pulse, blood pressure, psychiatric symptoms, appetite,
weight and height should be recorded at initiation of
therapy, following each dose adjustment, and at least
l TREATMENT CESSATION Avoid abrupt withdrawal.
l DIRECTIONS FOR ADMINISTRATION
MEDIKINET ® XL Contents of capsule can be sprinkled on a
tablespoon of apple sauce or yoghurt (then swallowed
EQUASYM ® XL Contents of capsule can be sprinkled on a
tablespoon of apple sauce (then swallowed immediately
l PRESCRIBING AND DISPENSING INFORMATION Different
versions of modified-release preparations may not have
the same clinical effect. To avoid confusion between these
different formulations of methylphenidate, prescribers
should specify the brand to be dispensed.
CONCERTA ® XL Consists of an immediate-release
component (22% of the dose) and a modified-release
BNF 78 Attention deficit hyperactivity disorder 349
MEDIKINET ® XL Consists of an immediate-release
component (50% of the dose) and a modified-release
EQUASYM ® XL Consists of an immediate-release
component (30% of the dose) and a modified-release
Medicines for Children leaflet: Methylphenidate for attention
deficit hyperactivity disorder (ADHD) www.medicinesforchildren.
org.uk/methylphenidate-attention-deficit-hyperactivitydisorder-adhd
Driving and skilled tasks Drugs and Driving Prescribers
and other healthcare professionals should advise patients
if treatment is likely to affect their ability to perform
skilled tasks (e.g. driving). This applies especially to drugs
with sedative effects; patients should be warned that these
effects are increased by alcohol. General information
about a patient’s fitness to drive is available from the
Driver and Vehicle Licensing Agency at www.dvla.gov.uk.
2015 legislation regarding driving whilst taking certain
drugs, may also apply to methylphenidate, see Drugs and
driving under Guidance on prescribing p. 1.
CONCERTA ® XL Tablet membrane may pass through
gastro-intestinal tract unchanged.
DELMOSART ® PROLONGED-RELEASE TABLET Manufacturer
advises tablet membrane may pass through gastrointestinal tract unchanged.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 25
▶ Concerta XL (Janssen-Cilag Ltd)
Methylphenidate hydrochloride 18 mg Concerta XL 18mg tablets |
30 tablet P £31.19 DT = £31.19b
Methylphenidate hydrochloride 27 mg Concerta XL 27mg tablets | 30 tablet P £36.81 DT = £36.81b
Methylphenidate hydrochloride 36 mg Concerta XL 36mg tablets
| 30 tablet P £42.45 DT = £42.45b
Methylphenidate hydrochloride 54 mg Concerta XL 54mg tablets
| 30 tablet P £73.62 DT = £36.80b ▶ Delmosart (Actavis UK Ltd)
Methylphenidate hydrochloride 18 mg Xaggitin XL 18mg tablets | 30 tablet P £15.58 DT = £31.19b
Methylphenidate hydrochloride 27 mg Xaggitin XL 27mg tablets |
30 tablet P £18.40 DT = £36.81b
Methylphenidate hydrochloride 36 mg Xaggitin XL 36mg tablets | 30 tablet P £21.22 DT = £42.45b
Methylphenidate hydrochloride 54 mg Xaggitin XL 54mg tablets | 30 tablet P £36.80 DT = £36.80b
▶ Methylphenidate hydrochloride (Non-proprietary)
Methylphenidate hydrochloride 5 mg Methylphenidate 5mg tablets
| 30 tablet P £3.03 DT = £3.03b
Methylphenidate hydrochloride 10 mg Methylphenidate 10mg
tablets | 30 tablet P £5.29 DT = £3.57b
Methylphenidate hydrochloride 20 mg Methylphenidate 20mg
tablets | 30 tablet P £10.92 DT = £10.92b ▶ Medikinet (Flynn Pharma Ltd)
Methylphenidate hydrochloride 5 mg Medikinet 5mg tablets |
Methylphenidate hydrochloride 10 mg Medikinet 10mg tablets | 30 tablet P £5.49 DT = £3.57b
Methylphenidate hydrochloride 20 mg Medikinet 20mg tablets | 30 tablet P £10.92 DT = £10.92b
▶ Ritalin (Novartis Pharmaceuticals UK Ltd)
Methylphenidate hydrochloride 5 mg Tranquilyn 5mg tablets | 30 tablet P £3.03 DT = £3.03b
Methylphenidate hydrochloride 10 mg Tranquilyn 10mg tablets | 30 tablet P £4.27 DT = £3.57b
Methylphenidate hydrochloride 20 mg Tranquilyn 20mg tablets | 30 tablet P £10.92 DT = £10.92b
CAUTIONARY AND ADVISORY LABELS 25
▶ Equasym XL (Shire Pharmaceuticals Ltd)
Methylphenidate hydrochloride 10 mg Equasym XL 10mg capsules
| 30 capsule P £25.00 DT = £25.00b
Methylphenidate hydrochloride 20 mg Equasym XL 20mg capsules
| 30 capsule P £30.00 DT = £30.00b
Methylphenidate hydrochloride 30 mg Equasym XL 30mg capsules
| 30 capsule P £35.00 DT = £35.00b ▶ Medikinet XL (Flynn Pharma Ltd) A
Methylphenidate hydrochloride 5 mg Medikinet XL 5mg capsules
| 30 capsule P £24.04 DT = £24.04b
Methylphenidate hydrochloride 10 mg Medikinet XL 10mg
capsules | 30 capsule P £24.04 DT = £25.00b
Methylphenidate hydrochloride 20 mg Medikinet XL 20mg
capsules | 30 capsule P £28.86 DT = £30.00b
Methylphenidate hydrochloride 30 mg Medikinet XL 30mg
capsules | 30 capsule P £33.66 DT = £35.00b
Methylphenidate hydrochloride 40 mg Medikinet XL 40mg
capsules | 30 capsule P £57.72 DT = £57.72b
Methylphenidate hydrochloride 50 mg Medikinet XL 50mg
capsules | 30 capsule P £62.52 DT = £62.52b
Methylphenidate hydrochloride 60 mg Medikinet XL 60mg
capsules | 30 capsule P £67.32 DT = £67.32b
CNS STIMULANTS › CENTRALLY ACTING
SYMPATHOMIMETICS › AMFETAMINES
▶ Adult: Initially 10 mg daily in divided doses, increased
in steps of 10 mg every week, maintenance dose to be
given in 2–4 divided doses; maximum 60 mg per day
▶ Elderly: Initially 5 mg daily in divided doses, increased
in steps of 5 mg every week, maintenance dose to be
given in 2–4 divided doses; maximum 60 mg per day
Refractory attention deficit hyperactivity disorder
(initiated under specialist supervision)
▶ Child 6–17 years: Initially 2.5 mg 2–3 times a day,
increased in steps of 5 mg once weekly if required;,
usual maximum 1 mg/kg daily, up to 20 mg daily (40 mg
daily has been required in some children);
maintenance dose to be given in 2–4 divided doses
▶ Adult: Initially 5 mg twice daily, dose is increased at
weekly intervals according to response, maintenance
dose to be given in 2–4 divided doses; maximum 60 mg
l UNLICENSED USE Not licensed for use in adults for
refractory attention deficit hyperactivity disorder.
l CONTRA-INDICATIONS Advanced arteriosclerosis (in
adults). agitated states . cardiovascular disease . history of
hypertension . structural cardiac abnormalities
l CAUTIONS Anorexia . bipolar disorder. history of epilepsy
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