Formulary and Prescribing Guidelines SECTION SECTION 6: TREATMENT OF ADHD
Formulary and
Prescribing Guidelines
SECTION SECTION 6: TREATMENT OF ADHD
Section 6. Treatment of ADHD
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Approved Medicines Management Group October 2017
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, published September 2008, last updated February 2016. Attention Deficit
Hyperactivity Disorder: diagnosis and management1
Section 6. Treatment of ADHD
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Advise the family members or carers of children with ADHD that there is no evidence
about the long‑term effectiveness or potential harms of a 'few food' diet for children with
ADHD, and only limited evidence of short‑term benefits.
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.
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
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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.
o Offer Patient and carer advice. Medicines for Children leaflet: Atomoxetine for attention deficit hyperactivity disorder (ADHD)
www.medicinesforchildren.org.uk/atomoxetine-attention-deficit-hyperactivity-disorder-adhd
3. Dexamfetamine:
o When symptoms are unresponsive to maximum tolerated doses of methylphenidate or atomoxetine
o Refer to risk materials as signposted from the SPC for dexamfetamine (http://www.dexamfetamine-guide.co.uk/ )
4. Lisdexamfetamine (currently formulary but not included in NICE 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
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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,
Lisdexamfetamine and Guanfacine in children (6- 11 years) and adolescents
(12 – 18 years)1,2,3
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 monitoring and intervention required for side effects of named
drugs as recommended by NICE CG 72, September 2008.
Drug1,2
3
Brand1,2,3
Titration & Dosing regimen1,2,3
M
E
T
H
Y
L
P
H
E
N
I
D
A
T
E
Methylphenidate
immediate release
(1st
line)
5,10, 20 mg Tabs
Max. 60mg daily in 2-3
divided doses
Medikinet XL
5, 10, 20 30, 40, 50,
60 mg Caps
Modified release
Max. 60mg daily
(50% immediate
release, 50% modified-
release)
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
Section 6. Treatment of ADHD
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Drug1,2
3
Brand1,2,3
Titration & Dosing regimen1,2,3
Equasym XL
10, 20, 30 mg Caps
Modified release
Max. 60mg daily
(30% immediate
release, 70% modified-
release)
Concerta XL
18, 27, 36, 54 mg Tabs
Modified release
Max 54mg daily
(22% immediate
release, 78% modified
release)
Controlled Drug
Other brands are listed
in the BNF
troublesome
Modified-release preparations should be given as a single dose in the morning. Equasym XL and Medikinet XL capsule contents can be sprinkled on a tablespoon of apple sauce (or yoghurt for Medikinet XL) and swallowed immediately without chewing. Immediate-release preparations may be given in two or three divided doses.
Prescribers should specify the brand name of modified release preparations, owing to their different ratios of immediate to modified release components.
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]. 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.
Total daily dose of methylphenidate (standard release) 15mg is considered equivalent to 18mg Concerta XL once daily.
A
T
O
M
O
X
E
T
I
N
E
Strattera
10, 18, 25, 40, 60, 80,
100mg Caps
4mg/1ml oral solution
Max total daily dose
100mg
In children: Doses above
100 mg daily not
licensed.
Atomoxetine doses in
BNF may differ from
those in product
literature.
For those aged 6-17 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 aged 6-17 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]
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Drug1,2
3
Brand1,2,3
Titration & Dosing regimen1,2,3
D
E
X
A
M
F
E
T
A
M
I
N
E
Dexamfetamine
5mg Tabs
Amfexa 5, 10, 20 mg
Tabs (scored).The score
line is only to facilitate
breaking for ease of
swallowing and not to
divide into equal doses.
Dexedrine 5, 10, 15 mg
Spansules (Imported
(United States))
Dexamfetamine
5mg/5ml oral solution
sugar free
Controlled drug
Initial treatment should begin with low doses consistent with starting doses in the SPC, 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, but latest dose should not be taken too late after lunch time to avoid disturbances of sleep.
L
I
S
D
E
X
A
M
F
E
T
A
M
I
N
E
Elvanse 20mg, 30mg, 40mg, 50mg, 60mg, 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 10 to 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.
Swallow whole or mix contents of capsule in yoghurt or a glass of water or orange juice; contents should be dispersed completely and consumed immediately.
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 34 - 41.4kg – 4mg once per day
o 41.5 - 49.4kg – 5mg once per day
o 49.5 - 58.4kg – 6mg once per day
o 58.5kg and above – 7mg once per day
Adolescent subjects must weigh at least 34 kg.
As one of the side effects is somnolence it is
Section 6. Treatment of ADHD
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Drug1,2
3
Brand1,2,3
Titration & Dosing regimen1,2,3
recommended that the dose be given in the evening.
Intuniv® can be administered with or without food, but manufacturer advises avoid administration with high fat meals (may increase absorption).
Manufacturer recommends effective contraception in females of childbearing potential.
Manufacturer advises that patients and carers should inform their prescriber if more than one dose is missed; consider dose re-titration.
Treatment is recommended only for those who are able to swallow the tablet whole without problems.
6.4 NICE Clinical Guidelines – ADULTS
NICE CG72, Published September 2008, updated February 2016. Attention Deficit
Hyperactivity Disorder: diagnosis and management1
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). If a patient is at risk of or showing a tendency towards stimulant misuse or diversion, caution should be exercised if prescribing dexamfetamine. Consider atomoxetine as first-line treatment if there are concerns about drug misuse and diversion.
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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 disorders4. 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 ADULTS1,2,3. Guanfacine is not licensed for the treatment of adults
See Error! Reference source not found. for monitoring and intervention required
for side effects of named drugs as recommended by NICE CG 72, September
2008
Drug1,2,
3
Brand1,2,3
Titration & Dosing regimen1,2,3
M
E
T
H
Y
L
P
H
E
N
I
D
A
T
E
Methylphenidate
immediate release
5,10, 20mg Tabs
(1st
line)
Equasym XL
10, 20, 30 mg Caps
Modified release
(30% immediate release ,
70% modified-release)
Medikinet XL
5, 10, 20, 30, 40, 50, 60
mg Caps
Modified release
(50% immediate release,
50% modified release)
Concerta XL
18, 27, 36, 54 mg Tabs
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) (108mg for Concerta XL)
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)
Prescribers should specify the brand name of modified release preparations, owing to their different ratios of immediate to modified release components.
Methylphenidate (standard release) 15mg = 18mg
Concerta XL
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Drug1,2,
3
Brand1,2,3
Titration & Dosing regimen1,2,3
Modified release
(22% immediate release,
72% modified release)
Max dose 108mg daily
Controlled drug
Other brands are listed
in the BNF
Unlicensed use
A
T
O
M
O
X
E
T
I
N
E
Strattera
10, 18, 25, 40, 60, 80,
100mg Caps
4mg/1ml oral solution
Max total daily dose
100mg
In adults: Dose maximum
of 120 mg not licensed.
Atomoxetine doses in
BNF may differ from
those in product
literature.
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
Amfexa 5, 10, 20 mg
Tabs (scored).
The score line is only to
facilitate breaking for
ease of swallowing and
not to divide into equal
doses.
Dexedrine 5, 10, 15 mg
Spansules (Imported
(United States))
Dexamfetamine
5mg/5ml oral solution
sugar free
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 but latest dose should not be taken too late after lunch time to avoid disturbances of sleep.
Unlicensed use
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Drug1,2,
3
Brand1,2,3
Titration & Dosing regimen1,2,3
L
I
S
D
E
X
A
M
F
E
T
A
M
I
N
E
Elvanse 20mg, 30mg, 40mg, 50mg, 60mg, 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 10 -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.
Swallow whole or mix contents of capsule in yoghurt or a glass of water or orange juice; contents should be dispersed completely and consumed immediately.
Unlicensed use
References
1. NICE CG 72, September 2008 (last updated February 2016). Attention Deficit
Hyperactivity Disorder: Diagnosis and management
http://guidance.nice.org.uk/CG72 (Accessed June 2017)
2. Summary of Product Characteristics (for individual drugs):
http://www.medicines.org.uk/emc/ (Accessed June 2017)
3. BNF: on-line current edition, (accessed June 2017)
4. MHRA drug safety alert, Atomoxetine: effects on heart rate and blood pressure,
25/5/2012
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Annex 1
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
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.
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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
Adults
Child
Adolescent
Adults
Child
Adolescent
Adults
Child
Adolescent
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.