Tablet
▶Dexamfetamine sulfate (Non-proprietary)
Dexamfetamine sulfate 5 mgDexamfetamine 5 mg tablets|
28 tabletP£ 24. 75 DT = £ 24. 13 b
▶Amfexa(Flynn Pharma Ltd)
Dexamfetamine sulfate 5 mgAmfexa 5 mg tablets| 30 tabletP
£ 19. 89 b
Dexamfetamine sulfate 10 mgAmfexa 10 mg tablets|
30 tabletP£ 39. 78 DT = £ 39. 78 b
Dexamfetamine sulfate 20 mgAmfexa 20 mg tablets|
30 tabletP£ 79. 56 bLisdexamfetamine mesilate 23-Jan-2018
lDRUG ACTIONLisdexamfetamine is a prodrug of
dexamfetamine.lINDICATIONS AND DOSE
Attention deficit hyperactivity disorder (initiated by a
specialist)
▶BY MOUTH
▶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 daylCONTRA-INDICATIONSAdvanced arteriosclerosis.agitated
states.hyperthyroidism.moderate hypertension.severe
hypertension.symptomatic cardiovascular disease
lCAUTIONSBipolar 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
CAUTIONS, FURTHER INFORMATION
▶Cardiovascular diseaseManufacturer advises caution in
patients with underlying conditions that might be
compromised by increases in blood pressure or heart rate;
see alsoContra-indications.
lINTERACTIONS→Appendix 1 : amfetamines
lSIDE-EFFECTS
▶Common or very commonAbdominal pain upper.anxiety.
appetite decreased.behaviour abnormal.constipation.
depression.diarrhoea.dizziness.drowsiness.dry mouth.
dyspnoea.fatigue.feeling jittery.fever.headache.
insomnia.mood altered.nausea.palpitations.psychiatric
disorders.skin reactions.tachycardia.tremor.vomiting.
weight decreased
▶UncommonCardiomyopathy.erectile dysfunction.
hallucination.hyperhidrosis.logorrhea.movement
disorders.mydriasis.Raynaud’s phenomenon.taste
altered.vision blurred
▶Frequency not knownAngioedema.drug dependence.
drug tolerance.hepatitis allergic.psychotic disorder.
seizure.Stevens-Johnson syndrome
Overdose Amfetamines cause wakefulness, excessive
activity, paranoia, hallucinations, and hypertension
followed by exhaustion, convulsions, hyperthermia, and
coma. See Stimulants under Emergency treatment of
poisoning p. 832.
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk.
lBREAST FEEDINGManufacturer advises avoid—present in
human milk.
lRENAL IMPAIRMENT
Dose adjustmentsManufacturer advises max. dose 50 mg
daily in severe impairment.
lMONITORING REQUIREMENTS
▶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.
lTREATMENT CESSATIONAvoid abrupt withdrawal.
lDIRECTIONS FOR ADMINISTRATIONManufacturer 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
immediately.
lPATIENT AND CARER ADVICEPatients and carers should be
counselled on the administration of capsules.
Driving and skilled tasksPrescribers 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’sfitness to
drive is available from the Driver and Vehicle Licensing
Agency atwww.dvla.gov.uk.
For information on 2015 legislation regarding driving
whilst taking certain controlled drugs, including
amfetamines, seeDrugs and drivingunder Guidance on
prescribing p. 1.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas 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.
All Wales Medicines Strategy Group (AWMSG) Decisions
TheAll Wales Medicines Strategy Grouphas 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
behavioural disorders.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Capsule
CAUTIONARY AND ADVISORY LABELS3, 25
▶Elvanse(Shire Pharmaceuticals Ltd)A
Lisdexamfetamine dimesylate 20 mgElvanse 20 mg capsules|
28 capsuleP£ 54. 62 DT = £ 54. 62 b
Lisdexamfetamine dimesylate 30 mgElvanse Adult 30 mg capsules
| 28 capsuleP£ 58. 24 DT = £ 58. 24 b
Elvanse 30 mg capsules| 28 capsuleP£ 58. 24 DT = £ 58. 24 b
Lisdexamfetamine dimesylate 40 mgElvanse 40 mg capsules|
28 capsuleP£ 62. 82 DT = £ 62. 82 b
Lisdexamfetamine dimesylate 50 mgElvanse Adult 50 mg capsules
| 28 capsuleP£ 68. 60 DT = £ 68. 60 b
Elvanse 50 mg capsules| 28 capsuleP£ 68. 60 DT = £ 68. 60 b
Lisdexamfetamine dimesylate 60 mgElvanse 60 mg capsules|
28 capsuleP£ 75. 18 DT = £ 75. 18 b
Lisdexamfetamine dimesylate 70 mgElvanse 70 mg capsules|
28 capsuleP£ 83. 16 DT = £ 83. 16 b
Elvanse Adult 70 mg capsules| 28 capsuleP£ 83. 16 DT =
£ 83. 16 b230 Mental health disorders BNFC 2018 – 2019
Nervous system4