SECTION 6: TREATMENT OF ADHD

Formulary and Prescribing Guidelines

SECTION 6: TREATMENT OF ADHD

Section 6. Treatment of ADHD

2 Approved Medicines Management Group March 2016

6.1 Introduction

Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological condition. The core symptoms are hyperactivity, impulsivity and inattention which may lead to educational and behavioural difficulties. The condition is often associated with learning difficulties, communication and motor co-ordination problems. Stimulant and other medications are recognised as part of the multi-modal management approach and help to improve concentration, reduce impulsivity and reduce hyperactivity.

The following guidelines provide information about the medications and outline the responsibilities of the primary and secondary care teams in prescribing. This guidance is not intended to be prescriptive and should be amended to the individual client and their circumstances. National Institute for Health and Clinical Excellence (NICE) guidelines, September 2008, have recommended that Methylphenidate immediate (standard) release, methylphenidate slow- release, dexamfetamine and atomoxetine may be used as part of a comprehensive treatment programme in the management of persistent ADHD1.

This includes advice and support for family and teachers in addition to specific psychological treatments for patients (such as behavioural therapy). It is worth noting that whilst these wider services are desirable, any shortfall in provision should not be used as a reason for delaying the appropriate use of medication. Treatment and care should take into account the individual’s needs and preferences. Good communication across all parties involved is essential for a treatment plan to be successful.

6.2 Treatment choice

Medication for pre-school children is not recommended. Parents should be offered group-based parent-training/education programmes as first line treatment1. In school-age children (6-11) and young people/adolescents (12-18) with moderate ADHD, drug treatment should be reserved for circumstances when non-pharmacological interventions or programmes have failed or have been refused. Drug treatment may be used as first line treatment in school age children and young adults with severe ADHD. This should be offered alongside group based parent-training/education programmes. Seek additional resource (e.g. ICD-10) for classification criteria.

ADHD frequently presents with other psychiatric conditions such as conduct disorder, oppositional defiant disorder, depression, anxiety disorders, tics and tourettes syndrome. These need to be identified during the initial assessment and appropriate management strategies offered which may include other medication. Many patients with ADHD (particularly during early adolescence) do not like taking regular medication and sometimes feel this is a punishment for their perceived disruptive behaviour. During this time professionals need to give a clear and consistent message to the patient (and family) about the progress the client is making. Using simple drug regimens, for example, once daily modified release doses may be useful to support adherence in such circumstances.

6.3 NICE Clinical Guidelines – CHILDREN AND YOUNG PEOPLE

NICE CG72, September 2008. Attention Deficit Hyperactivity Disorder: diagnosis and

management of ADHD in children, young people and adults1

Drug treatment in children and young people should be based on a comprehensive assessment and always form part of a tailored treatment plan that includes psychological, behavioural and educational interventions.

http://guidance.nice.org.uk/CG72




Drug treatment should (in children and adolescents) only be started by a healthcare professional with expertise in ADHD and involve:

Full mental health and social assessment, including risk assessment for substance misuse and drug diversion

Evaluation (and documentation) of family history of serious cardiac disease including sudden death in young family members. An ECG should be carried out if there is family history of serious cardiac disease and/or sudden cardiac death in a young member

Full medical history and physical examination, including:

o Cardiac examination including heart rate and blood pressure plotted on a centile chart and assessment of history of exercise syncope, undue breathlessness, and any other cardiovascular symptoms. An ECG should be carried out if there is a past medical history of serious cardiac disease and/or abnormal findings on cardiac examination.

o Height and weight plotted on a growth chart

Methylphenidate, atomoxetine, dexamfetamine, lisdexamfetamine and guanfacine are recommended, within their licensed indications as options for the management of ADHD. Co- morbidities, adverse effects, compliance issues and service user or their carer’s preference should all be taken into consideration when deciding a drug treatment. If there is a choice of more than one drug, consider the one of lowest acquisition cost.

When the decision has been taken to treat a child or adolescent with medication, consider;

1. Methylphenidate:

o For ADHD without significant co-morbidity (with the exception of co-morbid conduct disorder)

o Immediate release preparations if more flexible dosing is required or during initial titration to determine correct dosing levels

o Modified release preparations for convenience, improving adherence, reducing stigma, and reducing problems associated with storing and administering controlled drugs in schools

2. Atomoxetine:

o When tics, tourettes syndrome, anxiety disorders, stimulant misuse or risk of stimulant diversion are present

o If methylphenidate has been tried and was ineffective at the maximum tolerated dose, or the child or adolescent is intolerant to low or moderate doses of methylphenidate

o Monitor children and adolescents for agitation, irritability, suicidal thinking, and unusual changes in behaviour



(including self-harming); particularly during the initial months of treatment, or after a dose change

o Highlight to parents/carers about the potential for suicidal thinking and self-harm, and, rarely liver damage (presenting as abdominal pain, dark urine, jaundice, and unexplained nausea).

o Monitor for symptoms of cardiac disease. Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders5.

3. Dexamfetamine:

o When symptoms are unresponsive to maximum tolerated doses of methylphenidate or atomoxetine

4. Lisdexamfetamine (currently formulary but not included in CG72)

o Children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate

o Lisdexamfetamine is rapidly absorbed from the gastrointestinal tract and hydrolysed primarily by red blood cells to dexamfetamine, which is responsible for the drug's activity as a once daily formulation

5. Guanfacine prolonged-release is a non-stimulant treatment for Children and young people aged 6-17 years old for whom

stimulants are not suitable, not tolerated or have been shown to be ineffective

In children and adolescents, parents and teachers should record symptoms (e.g. Conner’s 10-item scale), and side-effects at each dose change.

If there is no response to methylphenidate, atomoxetine or dexamfetamine, treat further only after referral to tertiary services. Further treatment may include unlicensed drugs (for ADHD) such as bupropion, clonidine (necessitates pre-treatment cardiovascular examination and ECG), modafinil, and imipramine

Continue treatment for as long as it is effective. Review at least annually in children and adolescents. This review should include:

o Clinical need, benefits and side effects

o The views of the person with ADHD, and those of the parents/carers, as appropriate

o The effect of missed doses, planned dose reductions and brief periods of no treatment

o The preferred pattern of drug use.

Do not use antipsychotics for ADHD in children and adolescents.



6.3.1 Initiation and Titration of Methylphenidate, Atomoxetine,Dexamfetamine,

Lisdexamphetamine and Guanfacine in children (6- 11 years) and

adolescents (12 – 18 years)1,3

The first line drug of choice should be methylphenidate standard release if all

three drugs are considered appropriate, as modified release methylphenidate,

dexamphetamine and atomoxetine all have higher acquisitions costs.

See Annex 1 for a side effect profile and contra-indications for the drugs below.

(This list is by no means exhaustive and readers are always advised to consult

other sources for a comprehensive profile of a drug)

See Annex 2 for monitoring and intervention required for side effects of named

drugs as recommended by NICE CG 72, September 2008.

Drug3 Brand

3 Titration & Dosing regime

3

M

E

T

H

Y

L

P

H

E

N

I

D

A

T

E

Methylphenidate

standard release

(1st

line)

5,10, 20 mg Tabs

Max. 60mg daily

Medikinet XL

10, 20 30, 40 mg Caps

Modified release

Max. 60mg daily

(50% immediate

release)

Equasym XL

10, 20, 30 mg Caps

Modified release

Max. 60mg daily

(30% immediate

release)

Concerta XL

18, 27, 36 mg Tabs

Modified release

Max 54mg daily

(22% immediate

release)

Controlled Drug

Initial treatment should begin with low doses of immediate release or if necessary M/R preparations consistent with starting doses in the BNF, 5mg 1-2 times daily, increasing at weekly intervals by 5-10mg daily. If both Equasym XL and Concerta XL are considered appropriate, the preparation of lowest acquisition cost should be selected (Equasym XL)

The dose should be titrated against symptoms (Conners 10-item scale) and side effects over 4–6 weeks until dose optimisation is achieved. Review progress regularly (for example, by weekly telephone contact or at each dose change).

Dose titration should be slower if tics or seizures are present.

Consider dose reduction if side effects become troublesome

Modified-release preparations should be given as a single dose in the morning. Equasym capsule contents can be sprinkled on a tablespoon of apple sauce and swallowed immediately. Immediate-release preparations may be given in two or three divided doses

If there has been a poor response to Methylphenidate, and in consultation with a tertiary or regional centre, consider gradually increasing the dose at weekly intervals to 0.7 mg/kg up to three times a day or a total daily dose of 2.1 mg/kg/day (up to a total maximum of 90 mg/day) [unlicensed]

Methylphenidate (standard release) 15mg = 18mg

Concerta XL



Drug3 Brand


3

A

T

O

M

O

X

E

T

I

N

E

Strattera

10, 18, 25, 40, 60, 80,

100mg Caps

Max dose

For those weighing up to 70 kg, the total starting dose should be approximately 0.5 mg/kg/day. This initial dose should be maintained for a minimum of 7 days prior to upward dose titration. The recommended maintenance dose is approximately 1.2mg/kg/day. Dose titration should be slower if seizures are present.

For those weighing more than 70 kg, the initial total dose should be 40 mg/day. This initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is 80mg/day.

Offer as a single daily dose or as two divided doses with last dose no later than early evening.

If there has been a poor response to atomoxetine, and in consultation with a tertiary or regional centre, consider increasing the dose to 1.8 mg/kg/day (up to a total maximum of 120 mg per day). [unlicensed]

D

E

X

A

M

F

E

T

A

M

I

N

E

Dexamfetamine

5mg Tabs

Dexedrine

5mg Tabs

Tablets scored

Controlled drug

Initial treatment should begin with low doses consistent with starting doses in the BNF, i.e. 5-10mg daily, increasing as required at weekly intervals of 5mg daily to a maximum of 20 mg/day, but doses of up to 40mg/day may be occasionally required

The dose should be titrated against symptoms and side effects over 4–6 weeks. Review progress regularly (for example, by weekly telephone contact or at each dose change). Dose titration should be slower if tics or seizures are present

Maintenance dose can be given in 2-4 divided doses

L

I

S

D

E

X

A

M

F

E

T

A

M

I

N

E

Elvanse 30mg, 50mg, 70mg

Capsules

Controlled drug

This medicinal product is subject to additional monitoring – see BNF

30mg lisdexamfetamine = 8.9mg of dexamfetamine. 50mg=14.8mg and 70mg=20.8mg

The starting dose is 30 mg taken once daily in the morning (For all patients, either starting treatment for ADHD or switching from another medication)

The dose maybe increased by 20 mg increments, at approximately weekly intervals

The maximum recommended dose is 70 mg/day; higher doses have not been studied.

Elvanse may be taken with or without food.

Elvanse may be swallowed whole, or the capsule may be opened and the entire contents dissolved in a glass of water



Drug3 Brand


3

G

U

A

N

F

A

C

I

N

E

Intuniv 1mg,2mg,3mg,4mg Prolonged-release

tablets

The starting dose is 1mg/day, irrespective of age and weight

The dose is then increased by 1mg/day each week, to a maximum dose that depends on age and weight

For a child aged 6-12 and weighing 25kg or more, the maximum dose is 4mg

For an adolescent aged 13-17, the maximum dose is as follows:

o 31-41.4kg – 4mg once per day o 41.4-49.4kg – 5mg once per day o 49.5-58.4kg – 6mg once per day o 58.5kg and above – 7mg once per day

As one of the side effects is somnolence it is recommended that the dose be given in the evening.

6.4 NICE Clinical Guidelines – ADULTS

NICE CG72, September 2008. Attention Deficit Hyperactivity Disorder: diagnosis and

management of ADHD in children, young people and adults1

Drug treatment should be first-line treatment unless the patient prefers psychological treatment and be commenced by practitioners competent in the management of ADHD. Drug treatment should remain part of a comprehensive treatment programme addressing psychological, behavioural and educational or occupational needs.

Pre-drug treatment assessment should include:

Full mental health and social assessment, including risk assessment for substance misuse and drug diversion

Full medical history and physical examination, including:

o Cardiac examination including heart rate and blood pressure plotted on a centile chart

o Assessment of history of exercise syncope, undue breathlessness, and any other cardiovascular symptoms

o ECG, if there is a past medical history of serious cardiac disease and/or abnormal findings on cardiac examination. An ECG should be carried out if there is family history of serious cardiac disease and/or sudden cardiac death in a young member of the family.

o Weight.

Methylphenidate should normally be tried first. Consider atomoxetine or dexamfetamine if symptoms do not respond to methylphenidate or the person is intolerant to it after an adequate trial (usually about 6 weeks). Caution should be exercised if prescribing





dexamfetamine to people at risk of stimulant misuse or diversion. Consider atomoxetine as first-line treatment if there are concerns about drug misuse and diversion.

Adults who take atomoxetine should be monitored for (and warned about) agitation, irritability, suicidal thinking, and unusual changes in behaviour (including self-harming) particularly during the initial months of treatment, or after a dose change. Adults taking atomoxetine should also be warned about unexplained nausea, abdominal cramping, dark urine, and jaundice (due to rare reports of liver damage). Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders5. Cardiovascular status should be regularly monitored

Drug treatment for people who misuse substances should only be prescribed by healthcare professionals with expertise in managing both ADHD and substance misuse. For adults with ADHD and drug or alcohol addiction disorders, there should be close liaison between the professional treating the ADHD and an addiction specialist.

Dose titration should be slower if the patient has a history of tics or seizures.

Continue treatment for as long as it is effective and necessary. Review at least annually.

Do not use antipsychotics for ADHD in adults.

6.4.1 Initiation and Titration of Methylphenidate, Atomoxetine and Dexamfetamine

in ADULTS1. Guanfacine is not licensed for the treatment of adults

See Annex 1 for a side effect profile and contra-indications for the drugs below.

(This list is by no means exhaustive and readers are always advised to consult

other sources for a comprehensive profile of a drug)

See Annex 2 for monitoring and intervention required for side effects of named

drugs as recommended by NICE CG 72, September 2008



Drug3 Brand


3

M

E

T

H

Y

L

P

H

E

N

I

D

A

T

E

Methylphenidate

standard release

5,10, 20mg Tabs

(1st

line)

Equasym XL

10, 20, 30 mg Caps

Modified release

(30% IR)

Medikinet XL

10, 20, 30, 40mg Caps

Modified release

(50% IR)

Concerta XL

18, 27, 36 mg Tabs

Modified release

(22% IR)

Controlled drug

Begin with low doses (5 mg three times daily for immediate-release preparations or the equivalent modified-release dose).

Increase the dose according to response (and side-effects) up to a maximum of 100 mg/day (over 4-6 weeks)

Offer immediate-release preparations up to four times a day

Modified- release preparations may increase adherence and be preferred if there is concern about misuse or diversion. Normally offer these once daily, but no more than twice daily. If both Equasym XL and Concerta XL are considered appropriate, the preparation of lowest acquisition cost should be selected (Equasym XL)

Methylphenidate (standard release) 15mg = 18mg

Concerta XL

Unlicensed use

A

T

O

M

O

X

E

T

I

N

E

Strattera

10, 18, 25, 40, 60, 80,

100mg Caps

Up to 70 kg body weight: use a total starting dose of approximately 0.5 mg/kg/day, then gradually increase dose after 7 days according to response to approximately 1.2 mg/kg/day.

Over 70 kg body weight: use a total starting dose of 40 mg/day, then gradually increase dose after 7 days according to response up to a maximum maintenance dose of 100 mg/day.

The usual maintenance dose is 80 mg-100 mg/day which can be offered in divided doses. Trial this dose for 6 weeks to determine efficacy. If there has been a poor response to atomoxetine, and in consultation with a tertiary or regional centre, consider: increasing the dose to 1.8 mg/kg/day (up to a total maximum of 120 mg per day). (unlicensed)

D

E

X

A

M

F

E

T

A

M

I

N

E

Dexamfetamine

5mg Tabs

Dexedrine

5mg Tabs

Tablets scored

Controlled drug

Begin with low doses (5 mg twice daily). Increase dose according to response (and side-effects) up to a maximum of 60 mg/day (over 4-6 weeks).

Offer divided doses, usually between two and four times daily

Unlicensed use



Drug3 Brand


3

L

I

S

D

E

X

A

M

F

E

T

A

M

I

N

E

Elvanse 30mg, 50mg, 70mg

Capsules

Controlled drug

This medicinal product is

subject to additional

monitoring – see bnf

30mg lisdexamfetamine = 8.9mg of dexamfetamine. 50mg=14.8mg and 70mg=20.8mg

The starting dose is 30 mg taken once daily in the morning (For all patients, either starting treatment for ADHD or switching from another medication)

The dose maybe increased by 20 mg increments, at approximately weekly intervals

The maximum recommended dose is 70 mg/day; higher doses have not been studied.

Elvanse may be taken with or without food.

Elvanse may be swallowed whole, or the capsule may be opened and the entire contents dissolved in a glass of water

Unlicensed use

References

1. NICE CG 72, September 2008 (last modified march 2013). Attention Deficit

Hyperactivity Disorder Diagnosis and management of ADHD in children, young people

and adults

http://guidance.nice.org.uk/CG72 (Accessed Dec 2015)

2. Summary of Product Characteristics (for individual drugs):

http://www.medicines.org.uk/emc/ (Accessed May 2016)

3. BNF: 70th current edition, Sep 2015

4. South London & Maudsley NHS Foundation Trust Prescribing Guidelines 12th edition,

Wiley Blackwell, 2015

5. MHRA drug safety alert, December 2011

6. Nice Evidence summary, new medicine: Attention deficit hyperactivity disorderin

children and young people: guanfacine prolonged-release.

https://www.nice.org.uk/advice/esnm70


http://www.medicines.org.uk/emc/



Annex 1

Side-Effects and Contra-indications of Methylphenidate, Atomoxetine and Dexamfetamine1

Drug Side effects/cautions Contra-indications

M

E

T

H

Y

L

P

H

E

N

I

D

A

T

E

Can lower seizure threshold, and thus patients who develop seizures should have therapy with Methylphenidate stopped

Decreased appetite is common. Can cause moderately reduced weight gain, and growth retardation-thus height, weight and appetite should be recorded every 6 months

Because of potential for abuse, misuse and diversion, patients should be monitored with respect to tolerance, psychological dependence and even frank psychosis

Can generate new or exacerbate pre-existing psychotic or manic symptoms (thus necessitating consideration of withdrawal). Additionally, can worsen or generate new episodes of aggression, hostility, suicidal tendency, anxiety, agitation or tension-thus, as before, monitoring of psychiatric symptoms should be carried out with every dose adjustment, every 6 months or at every visit.

Is associated with emergence/worsening of verbal/motor tics, and worsening of Tourette’s syndrome. Patients should be monitored for emergence/worsening of these symptoms at every dose increase & every 6 months (or at every visit)

Methylphenidate may cause an increase in systolic and diastolic BP of over 10 mmHg, relative to controls

o Caution is thus indicated in patients whose underlying medical conditions may be compromised by increase(s) in BP/HR. Cardiovascular status, BP and HR should be monitored and recorded at each dose adjustment and then at least every 6 months

o Sudden death has been reported in association with use of stimulants and, thus, are not recommended in children/adolescents with cardiac structural abnormalities

o Additionally, monitor for signs of cerebral ischemia such as severe headache, numbness, weakness, paralysis, and impairment of co-ordination, vision, speech, language or memory and if present, terminate therapy with methylphenidate.

(This is not an exhaustive list - consult SPC/BNF/cBNF for further information)

Known sensitivity to methylphenidate or any of the excipients in methylphenidate tablets

Glaucoma

Phaechromocytoma

Concurrent treatment with an irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing an MAOI

Hyperthyroidism

Anorexia nervosa/anorexic disorders

High risk substance abuse patients (not a contra-indication in current SPC)

Diagnosis or history of severe depression, suicidal tendencies, mania, or schizophrenia

Diagnosis or history of severe and episodic (Type 1) Bipolar (affective) disorder (that is not well controlled)

Unless specialist cardiac advice has been obtained pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)

Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke.





A

T

O

M

O

X

E

T

I

N

E

There have been reports of sudden cardiac death in patients on atomoxetine, and, thus, should be used with caution in patients with structural cardiac abnormalities, and only after cardiac consultation

Atomoxetine is associated with an increase in HR and BP, and thus should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. Use with extreme caution in patients who have prolonged QTc interval (acquired or congenital). The use of atomoxetine in combination with drugs which can prolong the QTc interval should be undertaken with extreme caution. Patients who develop symptoms of suggestive of cardiac disease during treatment should undergo specialist investigation

Can lower seizure threshold and should be stopped in patients who develop new seizures.

As for other drugs in ADHD, weight and height (and appetite) should be regularly monitored and recorded

As for other drugs in ADHD, atomoxetine can worsen or cause emergence of psychosis, mania, aggression, hostility or emotional lability. Monitoring for emergence of suicidal ideation and suicide attempts is a special monitoring requirement for atomoxetine

Can cause liver injury – and thus should be stopped (and not re-started) in patients with elevated liver enzymes, and raised bilirubin with jaundice.


Hypersensitivity to atomoxetine or to any of the excipients.

Atomoxetine should not be used in patients with narrow-angle glaucoma, as in clinical trials the use of atomoxetine was associated with an increased incidence of mydriasis.

Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOIs). Atomoxetine should not be used within a minimum of 2 weeks after discontinuing therapy with a MAOI. Treatment with a MAOI should not be initiated within 2 weeks after discontinuing atomoxetine.

Should not be used in patients with severe cardiovascular or cerebrovascular disorders whose condition would be expected to deteriorate if they experience increases in blood pressure or heart rate that could be clinically important. Examples of these severe disorders can be found in the SPC


D

E

X

A

M

F

E

T

A

M

I

N

E

Epilepsy

Can cause growth retardation – therefore, as for atomoxetine, must monitor weight and height. Should actual growth lag behind expected – drug treatment should interrupted temporarily. Use with caution in anorexia

Can worsen pre-existing psychotic disorder, and can induce mixed or manic episode(s) in bipolar patients

Additionally, has been associated with precipitating psychotic or manic symptoms in patients without prior history. As for atomoxetine and methylphenidate – monitor for emergence or exacerbation of aggression or hostility

Mild hypertension


Hypersensitivity to dexamfetamine and other amphetamine derivatives

Gilles de la Tourette syndrome (and if tics emerge, discontinue treatment)

Concurrent treatment (and for 14 after) treatment with an MAOI

Pregnancy

Hyperthyroidism

Hyper-excitability; History of drug or alcohol abuse

Glaucoma

Moderate/severe hypertension, structural cardiac abnormalities, arteriosclerosis.





L

I

S

D

E

X

A

M

F

E

T

A

M

I

N

E

Anorexia;

history of cardiovascular disease or abnormalities;

psychosis or bipolar disorder; monitor for aggressive behavior or hostility during initial treatment;

history of drug or alcohol abuse;

may lower seizure threshold (discontinue if seizures occur);

tics and Tourette syndrome (use with caution)—discontinue if tics occur;

monitor growth in children;

susceptibility to angle-closure glaucoma;

avoid abrupt withdrawal;

acute porphyria; use with caution in renal impairment;

Lisdexamfetamine can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision. These could have a moderate influence on the ability to drive and use machines. Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.

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 hyperactivity);


Symptomatic cardiovascular disease including moderate to severe hypertension and advanced arteriosclerosis,

hyper excitability or agitated states,

hyperthyroidism

thyrotoxicosis

Glaucoma

Concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days of MAOI treatment (risk of hypertensive crisis).

Lisdexamfetamine (Elvanse®) has black triangle status, which means that all suspected adverse reactions (including those considered not to be serious and where the causal link is uncertain) should be reported to the MHRA.


G

U

A

N

F

A

C

I

N

E

Guanfacine can cause syncope,hypotension, btadycardia, somnolence, sedation, weight gain and Qt interval prolongation

Blood pressure and pulse may increase following discontinuation of Guanfacine. Monitoring and tapering of the dose during withdrawal is recommended.


Hypersensitivity to Guanfacine or any of the excipents.

Consult SPC/BNF/cBNF for further information



Annex 2

Monitoring and intervention IN CHILDREN, ADOLESCENTS and ADULTS

1 (see over for Guanfacine)

Monitoring and intervention Methylph-

enidate

Atomoxe-

tine

Dexamfe-

tamine

Lisdexam-

fetamine

HEIGHT & WEIGHT

Measure height at baseline then every 6 months &

record each observation on a growth chart. Should

height be adversely affected, consider ‘drug holiday’ to

allow catch up. Measure (and record on growth chart)

weight at baseline 3 & 6 months after initiation, & then

every 6 months in conjunction with height. If weight loss

occurs, obtain dietary advice & give medication with or

after food, rather than before meals.

Child

Adolescent

Adults

(weight only)

Child

Adolescent

Adults

(weight only)

Child

Adolescent

Adults

(weight only)

Child

Adolescent

Adults

(weight only)

CARDIAC FUNCTION, PULSE & BP

Measure BP & pulse (and record on a centile chart) at

baseline. Repeat before and after each dose increment

during titration. Thereafter record these parameters

every 6 months. Assess cardiac function concurrently.

Sustained resting tachycardia, arrhythmia or systolic

blood pressure greater than the 95th

percentile (or a

clinically significant increase) measured on two

occasions should prompt dose reduction & referral to a

paediatrician or physician.

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

REPRODUCTIVE SYS., & SEXUAL FUNCTION

NICE guidance recommends that patients on

atomoxetine be monitored for dysmenorrhoea, erectile

and ejaculatory dysfunction.

-

Adolescent

Adults

-

-

SEIZURE

All 4 have the potential to lower convulsive threshold, but

should a seizure (de novo) or exacerbation of

established epilepsy occur, NICE recommends that

dexamfetamine be considered and methylphenidate or

atomoxetine (if taking) be discontinued immediately.

Child

Adolescent

Child

Adolescent

Child

Adolescent

Child

Adolescent

TICS

Consider whether tics are stimulant-related, & whether

tic-related impairment outweighs the benefits of ADHD

treatment. If stimulant related, reduce the dose or stop

drug treatment or consider using atomoxetine instead.

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

PSYCHOTIC SYMPTOMS (delusions &

hallucinations)

Withdraw stimulant if believed to be related, carry out a

full psychiatric assessment & consider using

atomoxetine.

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

ANXIETY (INCLUDING PANIC)

Where symptoms are precipitated by stimulants,

particularly in children & young people with a history of

coexisting anxiety, use lower doses of the stimulant

and/or combine with an antidepressant used to treat

anxiety. Switching to atomoxetine may be effective.

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

Child

Adolescent

Adults

AGITATION, IRRITABILITY & SELF-HARM

Patients on atomoxetine should be monitored for

increase in suicidal thoughts & acts of self –harm,

especially in the first weeks of therapy.

Child

Adolescent

Child

Adolescent

Child

Adolescent

Child

Adolescent

Although NICE CG72 recommends routine cardiac monitoring

every 3 months, the MMG has taken the decision that 6

monthly checks are satisfactory based on SPCs, the cBNF and

clinical opinion unless specifically required.



Adults Adults Adults Adults

DRUG MISUSE AND DIVERSION

If problematic, consider switching to MR methylphenidate

or atomoxetine

Child

Adolescent

-

Child

Adolescent

Child

Adolescent

Monitoring of Guanfacine

Prior to starting treatment with guanfacine, cardiovascular status should be assessed to

identify patients at increased risk of hypotension, bradycardia, and QT-prolongation or risk

of arrythmia. This includes heart rate, blood pressure and family history of sudden cardiac

or unexplained death.

Monitoring of heart rate and blood pressure should continue on a weekly basis during dose

titration and stabilisation and at least every 3 months for the first year of treatment. Six

monthly monitoring should follow thereafter with more frequent monitoring after dose

adjustment.

Weight , height and BMI should be monitored prior to starting treatment, every 3 months

for the first year and every 6 months thereafter with more frequent monitoring after dose

adjustment.

SECTION 6: TREATMENT OF ADHD

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Transcript of SECTION 6: TREATMENT OF ADHD