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Transcript
SCHEDULE II:
ATTENTION-DEFICIT / HYPERACTIVITY
DISORDER
(ADHD)
Sara J.D. Bork, PharmD, MBA
April 14th, 2016
PHARMACY
DISCLOSURES
• Speaker Disclosures
• Sara Bork does not have any actual or potential conflicts of
interest in relation to this program
• Editorial advisors and ACPE administrator disclosures
• No actual or potential conflicts of interest in relation to
this program are reported.
PHARMACY
OBJECTIVES
• Compare characteristics of Attention-Deficit/Hyperactivity Disorder
in children, adolescents and adults
• Provide an overview of the current American Academy of Pediatrics
Clinical Practice Guideline for the Diagnosis, Evaluation, and
Treatment of Attention-Deficit/Hyperactivity Disorder in Children
and Adolescents and application in select clinical practice scenarios
• Differentiate pharmacologic treatment options for AttentionDeficit/Hyperactivity Disorder in children, adolescents and adults
PHARMACY
IN PREPARATION FOR TODAY…
•
•
•
•
•
Define Attention Deficit / Hyperactivity Disorders (ADHD)
Prevalence of ADHD
Differentiation of child, adolescent and adult ADHD
AAP Practice Guidelines
Medication Treatment
•
•
•
•
•
•
•
PHARMACY
Methylphenidate
Dextroamphetamine
Dexmethylphenidate
Lisdexamfetamine
Atomoxetine
Clonidine
Guanfacine
ATTENTION-DEFICIT / HYPERACTIVITY
DISORDER (ADHD)
PHARMACY
ADHD
Attention-deficit / hyperactivity disorder (ADHD) is
a disorder that manifests with persistent symptoms
of inattention and/or hyperactivity-impulsivity.
These symptoms affect academic, occupational,
and social functioning.
PHARMACY
DSM-IV-TR. 4th Edition, 2000.
TIMELINE
PHARMACY
CDC. ADHD: Data & Statistics.
http://www.cdc.gov/ncbddd/adhd/data.html
PREVALENCE OF ADHD
• ADHD in children 5 – 17 years: 9%
• ADHD in children 12 – 17 years: 3 million children
• Males 12.3%: Females 5.5%
• Studies of ADHD in childhood suggest persistence of
ADHD
• Into adolescence: 75%
• Into adulthood: 50%
PHARMACY
Curr Opin Pediatr 2014;26:119-129.
PREVALENCE OF ADHD DIAGNOSIS
PHARMACY
CDC. ADHD: Data & Statistics.
http://www.cdc.gov/ncbddd/adhd/data.html
PREVALENCE OF ADHD TREATMENT
PHARMACY
CDC. ADHD: Data & Statistics.
http://www.cdc.gov/ncbddd/adhd/data.html
ADHD IN TEXAS
PHARMACY
CDC. ADHD: Data & Statistics.
http://www.cdc.gov/ncbddd/adhd/data.html
ADHD IN TEXAS
PHARMACY
CDC. ADHD: Data & Statistics.
http://www.cdc.gov/ncbddd/adhd/data.html
PHARMACY
N Engl J Med 2014;370(9):838-846.
PHARMACY
N Engl J Med 2013;369(20):1935-1944.
AAP PRACTICE GUIDELINES
1. The primary care clinician should initiate an
evaluation for ADHD for any child 4 through 18 years
of age who presents with academic or behavioral
problems and symptoms of inattention, hyperactivity,
or impulsivity (quality of evidence B/strong
recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
PHARMACY
Pediatrics 2011;128(5):SI1-SI21.
ASSESSMENT OF ADHD
PHARMACY
J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
AAP PRACTICE GUIDELINES
2. To make a diagnosis of ADHD, the primary care clinician
should determine that Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition criteria have been met
(including documentation of impairment in more than 1
major setting); information should be obtained primarily from
reports from parents or guardians, teachers, and other school
and mental health clinicians involved in the child’s care. The
primary care clinician should also rule out any alternative
cause (quality of evidence B/strong recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
PHARMACY
N Engl J Med 2014;370(9):838-846.
INATTENTION
PHARMACY
N Engl J Med 2013;369(20):1935-1944.
HYPERACTIVITY / IMPULSIVITY
PHARMACY
N Engl J Med 2013;369(20):1935-1944.
SYMPTOMS OF ADHD
PHARMACY
Pediatrics 2011;128(5):SI1-SI21.
DIAGNOSIS
• Combined presentation
• Both inattention and hyperactivity / impulsivity criteria have been
present for the past 6 months
• Predominantly inattentive presentation
• Inattention criteria are met but criteria for hyperactivity and
impulsivity are not met
• Predominantly hyperactive and impulsive presentation
• Hyperactivity / impulsivity criteria are met and criteria for inattention
are not met
PHARMACY
N Engl J Med 2013;369(20):1935-1944.
AAP PRACTICE GUIDELINES
3. In the evaluation of a child for ADHD, the primary
care clinician should include assessment for other
conditions that might coexist with ADHD, including
emotional or behavioral (e.g., anxiety, depressive,
oppositional defiant, and conduct disorders),
developmental (e.g., learning and language disorders
or other neurodevelopmental disorders), and physical
(e.g., tics, sleep apnea) conditions (quality of
evidence B/strong recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
Relationship
Issues
Oppositional
Defiant
Disorder
(ODD)
Conduct
Disorder
(CD)
Tic Disorder
Insomnia
COMORBIDITIES OF ADHD
Autism
Anxiety
Learning
Disorders
PHARMACY
Depression
Increased
Injuries
Bipolar
Disorder
Substance
Abuse
CDC. ADHD: Other Concerns and Conditions.
http://www.cdc.gov/ncbddd/adhd/conditions.html
AAP PRACTICE GUIDELINES
4. The primary care clinician should recognize ADHD as
a chronic condition and, therefore, consider children
and adolescents with ADHD as children and youth
with special health care needs. Management of
children and youth with special health care needs
should follow the principles of the chronic care model
and the medical home (quality of evidence B/strong
recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
PHARMACY
Pediatrics 2011;128(5):SI1-SI21.
AAP PRACTICE GUIDELINES
5. Recommendations for treatment of children and
youth with ADHD vary depending on the patient’s
age:
a. For preschool-aged children (4–5 years of age), the primary care clinician
should prescribe evidence-based parent- and/or teacher-administered
behavior therapy as the first line of treatment (quality of evidence
A/strong recommendation)
PHARMACY
Pediatrics 2011;128(5):1007-1022.
AAP PRACTICE GUIDELINES
5. Recommendations for treatment of children and
youth with ADHD vary depending on the patient’s
age:
a. And may prescribe methylphenidate if the behavior interventions do not
provide significant improvement and there is moderate-to severe
continuing disturbance in the child’s function. In areas where evidencebased behavioral treatments are not available, the clinician needs to
weigh the risks of starting medication at an early age against the harm of
delaying diagnosis and treatment (quality of evidence
B/recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
AAP PRACTICE GUIDELINES
5. Recommendations for treatment of children and
youth with ADHD vary depending on the patient’s
age:
b.
For elementary school–aged children (6–11 years of age), the
primary care clinician should prescribe US Food and Drug
Administration–approved medications for ADHD (quality of
evidence A/strong recommendation) and/or evidence-based
parent and/or teacher-administered behavior therapy as
treatment for ADHD, preferably both (quality of evidence
B/strong recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
AAP PRACTICE GUIDELINES
5. Recommendations for treatment of children and
youth with ADHD vary depending on the patient’s
age:
b. The evidence is particularly strong for stimulant
medications and sufficient but less strong for atomoxetine,
extended-release guanfacine, and extended-release
clonidine (in that order) (quality of evidence A/strong
recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
AAP PRACTICE GUIDELINES
5. Recommendations for treatment of children and
youth with ADHD vary depending on the patient’s
age:
c. For adolescents (12–18 years of age), the primary care
clinician should prescribe Food and Drug Administration–
approved medications for ADHD with the assent of the
adolescent (quality of evidence A/strong recommendation)
and may prescribe behavior therapy as treatment for ADHD
(quality of evidence C/recommendation), preferably both.
PHARMACY
Pediatrics 2011;128(5):1007-1022.
NONPHARMACOLOGIC OPTIONS
• AAP guidelines recommend Behavioral Modification
Training (BMT) as first line for children 4-6 years
• Combination of behavioral therapies with medication
is considered most effective therapy for children > 6
years
PHARMACY
Pediatrics 2011;128(5):1007-1022.
PHARMACY
N Engl J Med 2014;370(9):838-846.
BEHAVIORAL PARENT TRAINING
• 10-20 weekly sessions (1 to 2 hours) during which time parents:
1.
are given information about the nature of ADHD
2.
learn to attend more carefully to their child’s misbehavior and to when their
child complies
3.
establish a home token economy
4.
use time out effectively
5.
manage noncompliant behaviors in public settings
6.
use a daily school report card
7.
anticipate future misconduct
PHARMACY
J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-928.
BEHAVIORAL THERAPY: AT HOME
•
•
•
•
•
•
•
•
Create a routine
Get organized
Avoid distractions
Limit choices
Change your interactions with your child
Use goals and rewards
Discipline effectively
Help your child discover a talent
Patient &
Family
PHARMACY
CDC. ADHD: Treatment.
http://www.cdc.gov/ncbddd/adhd/treatment.html
BEHAVIORAL THERAPY:
IN THE CLASSROOM
•
•
•
•
•
Use a homework folder for communications
Make assignments clear
Give positive reinforcement
Be sensitive to self-esteem issues
Involve the school counselor or psychologist
Patient &
Family
School
PHARMACY
CDC. ADHD: Treatment.
http://www.cdc.gov/ncbddd/adhd/treatment.html
BEHAVIORAL THERAPY: TECHNIQUES
PHARMACY
Pediatrics 2001:108(4);1033-1044.
GUIDELINES FOR TREATMENT
• The Texas Children's Medication Algorithm Project
Patient &
Family
Revision of the algorithm for pharmacotherapy of
attention-deficit/hyperactivity disorder. (2006)
School
• American Academy of Child Adolescent Psychiatry (2007)
Health Care
Professional
• American Academy of Pediatrics (2011)
All recommend a stimulant as first line
PHARMACY
J Am Acad Child Adolesc Psychiatry. 2006;45(6):642-57.
J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-928.
Pediatrics 2011;128(5):1007-1022.
PHARMACY
Ann Pharmacother. 2014;48(2):209-25.
TEXAS CMAP ALGORITHM: COMORBIDITIES
PHARMACY
J Am Acad Child Adolesc Psychiatry. 2006 Jun;45(6):642-57.
TREATMENT
PHARMACY
TREATMENT: INDIVIDUALIZE THERAPY
•
•
•
Psychoeducation
•
Education on signs and symptoms of ADHD
•
Education on the misconceptions about ADHD and its treatment
Psychotherapy
•
Behavioral parent therapy
•
Behavioral classroom management
•
Behavioral peer interventions
Medications
•
Stimulants
•
Non-Stimulants
PHARMACY
N Engl J Med 2014;370(9):838-846.
GOALS OF TREATMENT
• Ensure safety of the patient
• Develop a therapeutic relationship
• Change the patient’s behavior / symptoms
•
•
•
•
•
•
Improve written and verbal communication
Improve academic performance
Decrease disruptive behaviors
Improve self-esteem
Reduce requirement of supervision
Enhance safety
PHARMACY
Ped in Review. 2003:24(3);92-98.
AAP PRACTICE GUIDELINES
6. The primary care clinician should titrate doses of
medication for ADHD to achieve maximum
benefit with minimum adverse effects (quality of
evidence B/strong recommendation).
PHARMACY
Pediatrics 2011;128(5):1007-1022.
PHARMACOLOGIC TREATMENT
PHARMACY
TREATMENT PIPELINE
1930-40’s
1950’s
1970’s
1980’s
1990’s
2000’s
Benzedrine and desoxyn become first agents
Introduction of methylphenidate or amphetamine
Introduction of pemoline (Cylert®) and dextroamphetamine (Dexedrine®)
Sustained release methylphenidate
Multiple formulations of methylphenidate become available (Methadate ER®,
Concerta®, and Methylin ER®)
More formulations of methylphenidate become available (Focalin®, Adderall
XR®, Methadate CD®, Ritalin LA®, Methylin®, Focalin XR®, Daytrana®) as well
as lisdexamfetamine (Vyvanse®)
Release of non-stimulants atomoxetine (Strattera®), guanfacine (Intuniv®),
and clonidine (Kapway®)
PHARMACY
CDC. ADHD: Data & Statistics.
http://www.cdc.gov/ncbddd/adhd/data.html
PHARMACY
Pediatrics 2011;128(5):SI1-SI21.
PHARMACY
N Engl J Med 2014;370(9):838-846.
STIMULANTS
Mechanism of Action (MOA)
• Inhibit the reuptake of dopamine (DA) and norepinephrine (NE)
• Inhibit monoamine oxidase, which is responsible for metabolizing
DA and NE (amphetamine > methylphenidate)
• Amphetamine: Releases stored neurotransmitters at the
presynaptic terminal
PHARMACY
Ann Pharmacother. 2014;48(2):209-25.
STIMULANTS
Medication
Dose
Duration of Effect
Concerta®
18 mg/DAY (MAX: 72 mg)
12 hours
Methylin®
5 mg two to three times a day (MAX: 60 mg)
3-5 hours
Daytrana®
10 mg (apply for 9 hours) (MAX: 30 mg)
11-12 hours
Ritalin®
5 mg two to three times a day (MAX: 60 mg)
3-5 hours
Ritalin LA®
20 mg/DAY (MAX: 60 mg)
6-8 hours
Ritalin SR®
20 mg once to twice daily (MAX: 60 mg)
2-6 hours
Metadate CD®
20 mg/DAY (MAX: 60 mg)
6-8 hours
Quillivant XR®
20 mg/DAY (MAX: 60 mg)
12 hours
Focalin®
2.5 mg twice daily (MAX: 60 mg)
3-5 hours
Focalin
XR®
PHARMACY
5 mg/DAY (MAX: 20 mg)
8-12 hours
Methylphenidate
Dexmethylphenidate
DSM-IV-TR. 4th Edition, 2000.
STIMULANTS
Medication
Dose
Duration of Effect
Adderall®
2.5-5 mg once to twice daily (MAX: 40 mg)
6 hours
Adderall XR®
5 mg/DAY (MAX: 40 mg)
10 hours
Dexedrine®
2.5 mg two to three times a day (MAX: 40
mg)
4-6 hours
Dexedrine Spansule®
5 mg once to twice daily (MAX: 40 mg)
>6 hours
Lisdexamfetamine
(Vyvanse®)
20 mg/DAY (MAX: 70 mg)
10-12 hours
Mixed amphetamine salts
Dextroamphetamine
Side effects:
•
Headache, abdominal pain, decreased appetite, delayed onset of sleep
PHARMACY
DSM-IV-TR. 4th Edition, 2000.
METHYLPHENIDATE
PHARMACY
IMMEDIATE RELEASE
• Ritalin IR®, Methylin®
•
Initial dose: 2.5-5 mg/DAY (MAX: 60 mg/DAY)
•
Peak: ~2 hours with a duration: 3-6 hours
•
Divide doses 2-3 times/DAY (breakfast, lunch)
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
SUSTAINED-RELEASE
• Ritalin SR®, Metadate ER®, Methylin ER®
•
Initial dosing should be with Immediate Release formulations
•
Switch to equivalent dosing (IR = SR)
•
SR Peak: 4-7 hours with duration: 8 hours
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
SUSTAINED-RELEASE (BI-PHASIC)
• Ritalin LA®, Metadate CD®
•
•
Biphasic release simulates twice daily dosing
•
1st peak = ~2 hours
•
2nd peak = 6 hours
Duration: ~ 8 hours
•
IR:ER
•
Metadate CD® = 30:70
•
Ritalin LA® = 50:50
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
EXTENDED-RELEASE SUSPENSION
• Quillivant XR®
•
Powder suspension for reconstitution
•
Shake well
•
Room temperature (4 months)
•
Final Concentration = 25 mg/5 mL
•
Peak: ~4 hours
•
IR:ER (20:80)
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
OSMOTIC CONTROLLED-RELEASE ORAL
DELIVERY SYSTEM
• Concerta®
•
•
Dosing: 18-72 mg/DAY
Tri-phasic release stimulates
three times daily dosing
• 1st peak = 1-2 hours
• Slow increase over next 3-4 hours
• Time to peak: 6-8 hours
• Slow decline
•
Duration: 12 hours
•
Adjust doses weekly
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
OSMOTIC CONTROLLED-RELEASE ORAL
DELIVERY SYSTEM
PHARMACY
Tablet Dose
Initial Dose
Extended Dose
18 mg
4 mg
14 mg
27 mg
6 mg
21 mg
36 mg
8 mg
28 mg
54 mg
12 mg
42 mg
72 mg
16 mg
56 mg
DOSE CONVERSIONS: METHYLPHENIDATE
Immediate Release
Sustained Release
OROS
5 mg two to three times a day
20 mg once daily
18 mg once daily
10 mg two to three times a day
40 mg once daily
36 mg once daily
15 mg two to three times a day
60 mg once daily
54 mg once daily
20 mg three times a day
72 mg once daily
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
TRANSDERMAL PATCH
• Daytrana®
• Dosage Forms: 10, 15, 20, and 30 mg
• Apply patch for 9 hours
• Onset: ~2 hours
• Peak: 7.5-10.5 hours
• Residual effects: 3 hours after removal
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
TRANSDERMAL PATCH APPLICATION
• Alternate hip daily
•
•
Avoid waist line
Try rotating areas
• Clean, dry, non-oily, intact skin
•
Apply pressure for 30 seconds
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
TRANSDERMAL CONVERSIONS
Methylphenidate Patch
Drug Delivery Rate
(mg/hr)
Methylphenidate PO
Equivalent (mg/DAY)
10
1.1
15
15
1.65
22.5
20
2.2
30
30
3.3
45
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
DEXMETHYLPHENIDATE
PHARMACY
DEXMETHYLPHENIDATE
• Focalin IR®
•
2.5 mg twice daily (MAX: 60 mg)
• Dosage may be adjusted in increments of 2.5-5 mg at weekly intervals
(MAX dose: 20 mg/DAY)
•
Doses should be taken at least 4 hours apart
•
Peak: 1-1.5 hours
•
Duration: 6 hours
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
DEXMETHYLPHENIDATE
•Focalin XR®
•
5 mg/DAY (MAX: 40 mg)
• Dosage may be adjusted in increments of 5 mg/DAY at weekly intervals (MAX dose:
30 mg/Day)
•
•
•
•
Onset of Action: ~0.5 hours
Peak:
st
• 1 : 1.5 hours (1-4 hours)
nd: 6.5 hours (4.5-7 hours)
• 2
Duration: 12 hours
Biphasic release
• IR:ER = 50:50
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
DEXMETHYLPHENIDATE: CONVERSIONS
•
•
Conversion to dexmethylphenidate from methylphenidate
•
Immediate release: Initial: Half the total daily dose of racemic methylphenidate (maximum
dexmethylphenidate dose: 20 mg/day)
•
Extended release: Initial: Half the total daily dose of racemic methylphenidate (maximum
dexmethylphenidate dose: 40 mg/day)
Conversion from dexmethylphenidate immediate release to dexmethylphenidate extended
release
•
•
When changing from Focalin® tablets to Focalin® XR capsules, patients may be switched to the same
daily dose using Focalin® XR (maximum dose: 40 mg/day)
Dose reductions and discontinuation
•
Reduce dose or discontinue in patients with paradoxical aggravation of symptoms. Discontinue if no
improvement is seen after one month of treatment.
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
DEXTROAMPHETAMINE
PHARMACY
DEXTROAMPHETAMINE
• Dexedrine®
• Dexedrine Spansules (SR)®
•
5 mg/DAY (MAX: 20 mg)
•
5 mg once daily (MAX: 15 mg)
•
Duration: 4-6 hours
•
Duration: 6-10 hours
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
LISDEXAMFETAMINE
• Vyvanse®
•
Amphetamine pro-drug
•
Less potential for abuse
•
Dose: 20-70 mg/DAY
•
Duration: 8-12 hours
•
Capsules can be opened,
dissolved in water and
taken immediately
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
MIXED AMPHETAMINE SALTS
PHARMACY
MIXED AMPHETAMINE SALTS
• Adderall®
• Adderall XR®
•
3-5 years: 2.5 mg once daily
•
10 mg/DAY (MAX: 30 mg)
•
>6 years: 5-10 mg once daily
•
Duration: 10-12 hours
•
Biphasic release
(MAX: 40 mg)
•
Duration: 4-6 hours
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
CONTRAINDICATIONS AND
PRECAUTIONS FOR STIMULANTS
• Anxiety
• Seizure disorders
• Motor tics
• EEG abnormalities
• MAO inhibitors
• Cardiac abnormalities (or
family history)
• History of drug abuse
• History of psychosis
• Glaucoma
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
STIMULANTS: CLINICAL PEARLS
•
Drug holidays: Periodic discontinuation
•
•
•
•
•
•
Assess the patient's requirements
Decrease tolerance
Limit suppression of linear growth and weight
Some patients may require 3 doses/DAY for treatment of ADHD
Concerta® is OROS of methylphenidate
Some products contain a mixture of immediate release and extended release
beads
•
•
Metadate CD® is designed to release 30% of the dose immediately and 70% over an extended period
Ritalin LA® is designed to release 50% of the dose immediately and 50% delayed release over time
• This is also enteric coated
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
STIMULANTS
VS. NONSTIMULANTS
Highly
Effective
Non-Scheduled
• Rapid onset
PHARMACY
Schedule II
Not as effective
• Side effects
• Titration
required
• Delayed onset
• Side effects
• Titration required
NONSTIMULANT MEDICATIONS FOR ADHD
• Atomoxetine (Strattera®)
• Clonidine ER tablets (Kapvay®)
• Guanfacine ER tablets (Intuniv®)
• Other non-FDA approved, off-label therapies:
•
Bupropion
•
Venlafaxine
•
TCAs
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
ATOMOXETINE
•
Norepinephrine reuptake inhibitor
•
Onset of effect: 2-4 weeks
•
Side effects
•
•
•
N/V, anorexia, increased BP/HR, constipation, sedation, rare hepatotoxicity (bolded warning)
Once daily WEIGHT-BASED dosing
•
0.5-1.4 mg/kg/DAY up to 70 kg (Target dose of 1.2-1.4 mg/kg/DAY is recommended)
•
Start with lower dose (0.5 mg/kg/DAY) for one week and titrate up, monitoring side effects
Better tolerated dosing when given with dinner, may decrease GI upset and
daytime sedation
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
FDA: THE BOXED WARNING
Pediatric: [U.S. Boxed Warning]: Use with caution in pediatric
patients; may be an increased risk of suicidal ideation. Closely
monitor for clinical worsening, suicidality, or unusual changes in
behavior; especially during the initial few months of a course of
drug therapy, or at times of dose changes, either increases or
decreases. The family or caregiver should be instructed to closely
observe the patient and communicate condition with healthcare
provider. Growth should be monitored during treatment. Height
and weight gain may be reduced during the first 9 to 12 months of
treatment, but should recover by 3 years of therapy.
PHARMACY
FDA: THE BOXED WARNING
• Tell your child or teenager’s doctor if your child or teenager (or
there is a family history of):
•
•
Has bipolar illness (manic-depressive illness)
Had suicide thoughts or actions before starting STRATTERA®
• The chance for suicidal thoughts and actions may be higher:
•
•
Early during STRATTERA® treatment
During dose adjustments
• Prevent suicidal thoughts and action in your child or teenager by:
•
•
PHARMACY
Paying close attention to your child or teenager’s moods, behaviors,
thoughts, and feelings during STRATTERA® treatment
Keeping all follow-up visits with your child or teenager’s doctor as
scheduled
FDA: THE BOXED WARNING
Watch for the following signs in your child or teenager during
STRATTERA® treatment:
•
•
•
•
•
•
Anxiety
Agitation
Panic attacks
Trouble sleeping
Irritability
Hostility
PHARMACY
•
•
•
•
•
•
Aggressiveness
Impulsivity
Restlessness
Mania
Depression
Suicidal thoughts
CLONIDINE / GUANFACINE
• Alpha-adrenergic agonists
• Extended release formulations
•
Approved as monotherapy or as adjunctive therapy in ADHD
• Immediate release formulations
•
Not FDA approved, but see them used
• Clinically useful for treating tics, hypertension, sleep problems, aggression,
self-injurious behavior
• More effective for impulsivity and hyperactivity than for inattentiveness
symptoms
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
CLONIDINE
• Dosing
•
•
•
Initial dose: 0.1 mg at bedtime
Adjust daily dose in increments of 0.1 mg/DAY at weekly intervals
until desired response
Doses should be taken twice a day with either an equal or higher
Total Daily Dose
Morning Dose
split dosage given at bedtime
0.1 mg/day
Bedtime Dose
0.1 mg
0.2 mg/day
0.1 mg
0.1 mg
0.3 mg/day
0.1 mg
0.2 mg
0.4 mg/day
0.2 mg
0.2 mg
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
GUANFACINE
• Dosing
•
Once daily, either in the morning or evening at approximately the same time each
day
•
Initial dose: 1 mg/DAY
•
Adjust dose in increments of no more than 1 mg/DAY at weekly intervals
•
Maintenance dose: 1-4 mg/DAY depending on clinical response and tolerability
•
Clinical improvements: Target dose of 0.05-0.08 mg/kg/DAY, if well tolerated,
titrate up to 0.12 mg/kg/DAY for max benefit
PHARMACY
Drug Information Handbook, Lexi-Comp. 23rd Edition. 2015.
PHARMACY
Ann Pharmacother. 2014;48(2):209-25.
PHARMACY
N Engl J Med 2014;370(9):838-846.
SUMMARY
What should you ask yourself when treating ADHD?
• Are the medications working?
• Are the medications at appropriate doses?
• Are the medications prescribed correctly?
• Is the patient undergoing psychotherapy?
• Is the patient being compliant?
• Is the patient taking the medications at the correct time?
PHARMACY
PHARMACY
COMMENTS/QUESTIONS?
PHARMACY