▶ Tics and Tourette syndrome Discontinue use if tics occur.
▶ Growth restriction in children Monitor height and weight as
growth restriction may occur during prolonged therapy
(drug-free periods may allow catch-up in growth but
withdraw slowly to avoid inducing depression or renewed
l INTERACTIONS → Appendix 1: amfetamines
abnormal . depression . dry mouth . headache . mood
retardation . hallucination . hepatic coma . hepatic
tendencies .thrombocytopenia .tic (in those at risk). vasculitis cerebral . vision disorders
disorder.reflexes increased .rhabdomyolysis . sexual
dysfunction . sudden death .taste altered .tremor
Overdose Amfetamines cause wakefulness, excessive
activity, paranoia, hallucinations, and hypertension
followed by exhaustion, convulsions, hyperthermia, and
coma. See Stimulants under Emergency treatment of
l PREGNANCY Avoid (retrospective evidence of uncertain
significance suggesting possible embryotoxicity).
l BREAST FEEDING Significant amount in milk—avoid.
l RENAL IMPAIRMENT Use with caution.
▶ Monitor for aggressive behaviour or hostility during initial
▶ 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
▶ In children Tablets can be halved.
l PRESCRIBING AND DISPENSING INFORMATION Data on
safety and efficacy of long-term use not complete.
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.
For information on 2015 legislation regarding driving
whilst taking certain controlled drugs, including
amfetamines, see Drugs and driving under Guidance on
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: modified-release
capsule, oral suspension, oral solution
▶ Dexamfetamine sulfate (Non-proprietary)
Dexamfetamine sulfate 1 mg per 1 ml Dexamfetamine 5mg/5ml
oral solution sugar free sugar-free | 150 ml P £29.44–£34.35b
sugar-free | 500 ml P £114.49 DT = £114.49b
▶ Dexedrine Spansules (Imported (United States))
Dexamfetamine sulfate 5 mg Dexedrine 5mg Spansules | 100 capsule P sb
Dexamfetamine sulfate 10 mg Dexedrine 10mg Spansules | 100 capsule P sb
Dexamfetamine sulfate 15 mg Dexedrine 15mg Spansules | 100 capsule P sb
▶ Dexamfetamine sulfate (Non-proprietary)
Dexamfetamine sulfate 5 mg Amfexa 5mg tablets | 30 tablet P £19.89b
Dexamfetamine sulfate 10 mg Amfexa 10mg tablets | 30 tablet P £39.78 DT = £39.78b
Dexamfetamine sulfate 20 mg Amfexa 20mg tablets | 30 tablet P £79.56 DT = £79.56b
Lisdexamfetamine mesilate 23-Jan-2018
l DRUG ACTION Lisdexamfetamine is a prodrug of
Attention deficit hyperactivity disorder (initiated by a
▶ Child 6–17 years: Initially 30 mg once daily, alternatively
initially 20 mg once daily, increased in steps of
10–20 mg every week if required, dose to be taken in
the morning, discontinue if response insufficient after
1 month; maximum 70 mg per day
▶ Adult: Initially 30 mg once daily, increased in steps of
20 mg every week if required, dose to be taken in the
morning, discontinue if response insufficient after
1 month; maximum 70 mg per day
l CONTRA-INDICATIONS Advanced arteriosclerosis . agitated
states . hyperthyroidism . moderate hypertension . severe
hypertension . symptomatic cardiovascular disease
l CAUTIONS Bipolar disorder. history of cardiovascular
disease . history of substance abuse . may lower seizure
threshold (discontinue if seizures occur). psychotic
disorders . susceptibility to angle-closure glaucoma .tics . Tourette syndrome
▶ Cardiovascular disease Manufacturer advises caution in
patients with underlying conditions that might be
compromised by increases in blood pressure or heart rate;
l INTERACTIONS → Appendix 1: amfetamines
children). insomnia . mood altered . movement disorders
(uncommon in children). nausea . palpitations . sexual
dysfunction (uncommon in children).tachycardia .tremor . weight decreased
▶ Uncommon Depression (very common in children). drowsiness (very common in children). fever (very
BNF 78 Attention deficit hyperactivity disorder 351
common in children). logorrhea . psychiatric disorders
(very common in children). skin reactions (very common
in children).taste altered . vision blurred . vomiting (very
▶ Frequency not known Angioedema . cardiomyopathy
(uncommon in children). drug dependence . hallucination
(uncommon in children). hepatitis allergic . mydriasis
(uncommon in children). psychotic disorder. Raynaud’s
phenomenon (uncommon in children). seizure . StevensJohnson syndrome
Overdose Amfetamines cause wakefulness, excessive
activity, paranoia, hallucinations, and hypertension
followed by exhaustion, convulsions, hyperthermia, and
coma. See Stimulants under Emergency treatment of
l PREGNANCY Manufacturer advises use only if potential
l BREAST FEEDING Manufacturer advises avoid—present in
Dose adjustments Manufacturer advises max. dose 50 mg
▶ Manufacturer advises monitor for aggressive behaviour or
hostility during initial treatment.
▶ Manufacturer advises monitor pulse, blood pressure, and
for psychiatric symptoms before treatment initiation,
following each dose adjustment, and at least every
6 months thereafter. Monitor weight in adults before
treatment initiation and during treatment; in children,
height and weight should be recorded before treatment
initiation, and height, weight and appetite monitored at
least every 6 months during treatment.
l TREATMENT CESSATION Avoid abrupt withdrawal.
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
swallow whole or mix contents of capsule with soft food
such as yoghurt or in a glass of water or orange juice;
contents should be dispersed completely and consumed
l PATIENT AND CARER ADVICE Patients and carers should be
counselled on the administration of capsules.
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.
For information on 2015 legislation regarding driving
whilst taking certain controlled drugs, including
amfetamines, see Drugs and driving under Guidance on
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (May 2013)
that lisdexamfetamine dimesylate (Elvanse ®) is accepted
for use within NHS Scotland as part of a comprehensive
treatment programme for attention deficit hyperactivity
disorder (ADHD) in children aged 6 years and over when
response to previous methylphenidate treatment is
considered clinically inadequate.
▶ In adults The Scottish Medicines Consortium has advised
(September 2015) that lisdexamfetamine dimesylate
(Elvanse Adult ®) is accepted for use within NHS Scotland
as part of a comprehensive treatment programme for
attention deficit hyperactivity disorder (ADHD) in adults.
Based on clinical judgment, patients should have ADHD of
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(December 2013) that lisdexamfetamine dimesylate
(Elvanse ®) is recommended as an option for use within
NHS Wales as part of a comprehensive treatment
programme for attention deficit hyperactivity disorder
(ADHD) in children aged six years and over when response
to previous methylphenidate treatment is considered
clinically inadequate. Treatment must be under the
supervision of a specialist in childhood and/or adolescent
▶ In adults The All Wales Medicines Strategy Group has
advised (October 2015) that lisdexamfetamine dimesylate
(Elvanse Adult ®) is recommended as an option for use
within NHS Wales as part of a comprehensive treatment
programme for attention deficit hyperactivity disorder
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 3, 25
▶ Elvanse (Shire Pharmaceuticals Ltd) A
Lisdexamfetamine dimesylate 20 mg Elvanse 20mg capsules |
28 capsule P £54.62 DT = £54.62b
Lisdexamfetamine dimesylate 30 mg Elvanse Adult 30mg capsules
| 28 capsule P £58.24 DT = £58.24b Elvanse 30mg capsules | 28 capsule P £58.24 DT = £58.24b
Lisdexamfetamine dimesylate 40 mg Elvanse 40mg capsules | 28 capsule P £62.82 DT = £62.82b
Lisdexamfetamine dimesylate 50 mg Elvanse Adult 50mg capsules
| 28 capsule P £68.60 DT = £68.60b Elvanse 50mg capsules | 28 capsule P £68.60 DT = £68.60b
Lisdexamfetamine dimesylate 60 mg Elvanse 60mg capsules | 28 capsule P £75.18 DT = £75.18b
SYMPATHOMIMETICS › ALPHA2-ADRENOCEPTOR
Attention deficit hyperactivity disorder in children for
whom stimulants are not suitable, not tolerated or
ineffective (initiated under specialist supervision)
▶ Child 6–12 years (body-weight 25 kg and above): Initially
1 mg once daily; adjusted in steps of 1 mg every week if
necessary and if tolerated; maintenance
0.05–0.12 mg/kg once daily (max. per dose 4 mg), for
optimal weight-adjusted dose titrations, consult
▶ Child 13–17 years (body-weight 34–41.4 kg): Initially 1 mg
once daily; adjusted in steps of 1 mg every week if
necessary and if tolerated; maintenance
0.05–0.12 mg/kg once daily (max. per dose 4 mg), for
optimal weight-adjusted dose titrations, consult
▶ Child 13–17 years (body-weight 41.5–49.4 kg): Initially
1 mg once daily; adjusted in steps of 1 mg every week if
necessary and if tolerated; maintenance
0.05–0.12 mg/kg once daily (max. per dose 5 mg), for
optimal weight-adjusted dose titrations, consult
▶ Child 13–17 years (body-weight 49.5–58.4 kg): Initially
1 mg once daily; adjusted in steps of 1 mg every week if
necessary and if tolerated; maintenance
0.05–0.12 mg/kg once daily (max. per dose 6 mg), for
352 Mental health disorders BNF 78
optimal weight-adjusted dose titrations, consult
▶ Child 13–17 years (body-weight 58.5 kg and above): Initially
1 mg once daily; adjusted in steps of 1 mg every week if
necessary and if tolerated; maintenance
0.05–0.12 mg/kg once daily (max. per dose 7 mg), for
optimal weight-adjusted dose titrations, consult
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises reduce dose by half with
concurrent use of moderate and potent inhibitors of
▶ Manufacturer advises increase dose up to max. 7 mg
daily with concurrent use of potent inducers of
CYP3A4—no specific recommendation made for
l CAUTIONS Bradycardia (risk of torsade de pointes). heart
block (risk of torsade de pointes). history of cardiovascular
disease . history of QT-interval prolongation . hypokalaemia (risk of torsade de pointes)
l INTERACTIONS → Appendix 1: guanfacine
▶ Rare or very rare Hypertension . hypertensive
▶ Frequency not known Erectile dysfunction
SIDE-EFFECTS, FURTHER INFORMATION Somnolence and
sedation may occur, predominantly during the first 2-
3 weeks of treatment and with dose increases;
manufacturer advises to consider dose reduction or
discontinuation of treatment if symptoms are clinically
Overdose Features may include hypotension, initial
hypertension, bradycardia, lethargy, and respiratory
depression. Manufacturer advises that patients who
develop lethargy should be observed for development of
more serious toxicity for up to 24 hours.
l CONCEPTION AND CONTRACEPTION Manufacturer
recommends effective contraception in females of
l PREGNANCY Manufacturer advises avoid—toxicity in
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution
(pharmacokinetics have not been assessed in paediatric
patients with hepatic impairment).
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