Modified-release capsule
CAUTIONARY AND ADVISORY LABELS 25
▶Equasym XL(Shire Pharmaceuticals Ltd)
Methylphenidate hydrochloride 10 mgEquasym XL 10 mg capsules
| 30 capsuleP£ 25. 00 DT = £ 25. 00 b
Methylphenidate hydrochloride 20 mgEquasym XL 20 mg capsules
| 30 capsuleP£ 30. 00 DT = £ 30. 00 b
Methylphenidate hydrochloride 30 mgEquasym XL 30 mg capsules
| 30 capsuleP£ 35. 00 DT = £ 35. 00 b
▶Medikinet XL(Flynn Pharma Ltd)
Methylphenidate hydrochloride 5 mgMedikinet XL 5 mg capsules
| 30 capsuleP£ 24. 04 b
Methylphenidate hydrochloride 10 mgMedikinet XL 10 mg
capsules| 30 capsuleP£ 24. 04 DT = £ 25. 00 b
Methylphenidate hydrochloride 20 mgMedikinet XL 20 mg
capsules| 30 capsuleP£ 28. 86 DT = £ 30. 00 b
Methylphenidate hydrochloride 30 mgMedikinet XL 30 mg
capsules| 30 capsuleP£ 33. 66 DT = £ 35. 00 b
Methylphenidate hydrochloride 40 mgMedikinet XL 40 mg
capsules| 30 capsuleP£ 57. 72 DT = £ 57. 72 b
Methylphenidate hydrochloride 50 mgMedikinet XL 50 mg
capsules| 30 capsuleP£ 62. 52 b
Methylphenidate hydrochloride 60 mgMedikinet XL 60 mg
capsules| 30 capsuleP£ 67. 32 bCNS STIMULANTS›CENTRALLY ACTING
SYMPATHOMIMETICS›AMFETAMINES
Dexamfetamine sulfate
(Dexamphetamine sulfate)
lINDICATIONS AND DOSE
Refractory attention deficit hyperactivity disorder
(initiated under specialist supervision)
▶BY MOUTH
▶Child 6–17 years:Initially 2. 5 mg 2 – 3 times a day,
increased in steps of 5 mg once weekly if required,
increased if necessary up to 1 mg/kg daily,
maintenance dose to be given in 2 – 4 divided doses, up
to 20 mg daily ( 40 mg daily has been required in some
children)lCONTRA-INDICATIONSAgitated states.cardiovascular
disease.history of alcohol abuse.history of drug abuse.
hyperexcitability.hyperthyroidism.moderate
hypertension.severe hypertension.structural cardiac
abnormalities
lCAUTIONSAnorexia.bipolar disorder.history of epilepsy
(discontinue if seizures occur).mild hypertension.
psychosis.susceptibility to angle-closure glaucoma.tics.
Tourette syndrome
CAUTIONS, FURTHER INFORMATION
▶Tics and Tourette syndromeDiscontinue use if tics occur.
▶Growth restriction in childrenMonitor 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
hyperactivity).
lINTERACTIONS→Appendix 1 : amfetamines
lSIDE-EFFECTS
▶Common or very commonAbdominal pain.anxiety.
appetite decreased.arrhythmias.arthralgia.behaviour
abnormal.depression.dry mouth.headache.mood
altered.movement disorders.muscle cramps.nausea.
palpitations.poor weight gain.sleep disorders.vertigo.
vomiting.weight decreased
▶Rare or very rareAnaemia.angina pectoris.cardiac arrest
.cerebrovascular insufficiency.fatigue.growth
retardation.hallucination.hepatic coma.hepatic
function abnormal.intracranial haemorrhage.leucopenia
.mydriasis.psychosis.seizure.skin reactions.suicidal
tendencies.thrombocytopenia.tic (in those at risk).
vasculitis cerebral.vision disorders
▶Frequency not knownAcidosis.alopecia.cardiomyopathy.
chest pain.circulatory collapse.colitis ischaemic.
concentration impaired.confusion.diarrhoea.dizziness.
drug dependence.drug tolerance.hyperhidrosis.
hypermetabolism.hyperpyrexia.kidney injury.
myocardial infarction.neuroleptic malignant syndrome.
obsessive-compulsive 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
poisoning p. 832.
lPREGNANCYAvoid (retrospective evidence of uncertain
significance suggesting possible embryotoxicity).
lBREAST FEEDINGSignificant amount in milk—avoid.
lRENAL IMPAIRMENTUse with caution.
lMONITORING REQUIREMENTS
▶Monitor growth in children.
▶Monitor for aggressive behaviour or hostility during initial
treatment.
▶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.
lTREATMENT CESSATIONAvoid abrupt withdrawal.
lDIRECTIONS FOR ADMINISTRATIONTablets can be halved.
lPRESCRIBING AND DISPENSING INFORMATIONData on
safety and efficacy of long-term use not complete.
lPATIENT AND CARER ADVICE
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
NICE decisions
▶Methylphenidate, atomoxetine and dexamfetamine for
attention deficit hyperactivity disorder (ADHD) (March 2006 )
NICE TA98
Dexamfetamine is recommended, within its licensed
indications, as an option for the management of ADHD in
children and adolescents.
http://www.nice.org.uk/TA98lMEDICINAL 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
Oral solution
▶Dexamfetamine sulfate (Non-proprietary)
Dexamfetamine sulfate 1 mg per 1 mlDexamfetamine 5 mg/ 5 ml
oral solution sugar free sugar-free| 150 mlP£ 29. 44 – £ 34. 35 b
sugar-free| 500 mlP£ 114. 49 DT = £ 114. 49 b
Modified-release capsule
▶Dexedrine Spansules(Imported (United States))
Dexamfetamine sulfate 5 mgDexedrine 5 mg Spansules|
100 capsulePsb
Dexamfetamine sulfate 10 mgDexedrine 10 mg Spansules|
100 capsulePsb
Dexamfetamine sulfate 15 mgDexedrine 15 mg Spansules|
100 capsulePsbBNFC 2018 – 2019 Attention deficit hyperactivity disorder 229
Nervous system4