Criteria for Outpatient Use Guidelines

The information contained at this site and available for download is for the convenience of the public. Some documents are made available in specific file formats to respond to specific requests.

The Texas Health and Human Services Commission is not responsible for any errors in transmission or any errors or omissions in the documents.

[Developed, October 2007; revised, July 2008; March 2011; April 2011; May 2011]

Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with [*].

Printable version (PDF)

1.* Dosage

Adults
The maximum adult recommended doses for available psychostimulants used in ADD/ADHD management are summarized in Table 1.

Table 1
Maximum Recommended Adult Dosages for ADHD Medication

Drug	Maximum Daily Dose
STIMULANTS: Amphetamine salts (mixed)* Adderall®, generic (tablet) 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg	40 mg
STIMULANTS: Amphetamine salts (mixed)* Adderall XR®, generic (extended-release capsule) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg	20 mg
STIMULANTS: Dexmethylphenidate Focalin®, generic (tablets) 2.5 mg, 5 mg, 10 mg	20 mg
STIMULANTS: Dexmethylphenidate Focalin®XR (extended-release tablets) 5mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg	40 mg
STIMULANTS: Lisdexamfetamine Vyvanse® (capsules) 20 mg, 30 mg. 40 mg, 50 mg, 60 mg, 70 mg	70 mg
STIMULANTS: Methamphetamine: Desoxyn®, generic (tablet) 5 mg	25 mg/day
STIMULANTS: Methylphenidate Immediate-Release: generic (tablet) 5 mg, 10 mg, 20 mg	60 mg/day
Ritalin®, generic (tablet) 5 mg, 10 mg, 20 mg	60 mg/day
STIMULANTS:Methylphenidate Extended-Release: Concerta® (extended release tablet) 18 mg, 27 mg, 36 mg, 54 mg	72 mg/day
Metadate® CD (extended-release capsule) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg	60 mg/day
Metadate® ER, generic(extended release tablet) 10 mg, 20 mg	60 mg/day
Methylin® ER, generic (extended release tablet) 10 mg, 20 mg (generic for 20 mg only)	60 mg/day
Ritalin® LA (extended-release capsule) 10 mg, 20 mg, 30 mg, 40 mg	60 mg/day
Ritalin-SR®, generic (sustained release tablet) 20 mg	60 mg/day
NON-STIMULANTS: Non-Stimulants (Selective Norepinephrine Reuptake Inhibitors) Atomoxetine Strattera® (tablets) 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg	100 mg

* Mixed amphetamine salts are a 1:1:1:1 combination of dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate and amphetamine sulfate.

Pediatrics
Many ADHD medications are FDA-approved for use in pediatric patients. Table 2 summarizes pediatric ADD/ADHD recommended daily doses based upon patient-specific characteristics including age and weight.

Table 2
Pediatric (Child and Adolescent) Dosages for ADHD Medications

Drug	Age of patient	Maximum Daily Dose
STIMULANTS: Amphetamine salts (mixed)* Adderall®, generic (tablet) 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg	3-5 years of age	40 mg/day
STIMULANTS: Amphetamine salts (mixed)* Adderall®, generic (tablet) 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg	6-13 years of age	40 mg/day
STIMULANTS: Amphetamine salts (mixed)* Adderall®XR, generic (extended-release capsule) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg	6-12 years of age	30 mg/day
STIMULANTS: Amphetamine salts (mixed)* Adderall®XR, generic (extended-release capsule) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg	13-17 years of age	20 mg/day
STIMULANTS: Dexmethylphenidate: Focalin®, generic (tablets) 2.5 mg, 5 mg, 10 mg	6-17 years of age	20 mg/day
STIMULANTS: Dexmethylphenidate: Focalin®XR (extended-release tablets) 5mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg	6-17 years of age	30 mg/day
STIMULANTS: Dextroamphetamine: generic (tablets) 5 mg, 10 mg; ProCentra® (oral solution) 5 mg/5 ml	> 3-16 years of age	40 mg/day
STIMULANTS: Dextroamphetamine: Dexedrine®Spansules, generic (extended-release capsules) 5 mg, 10 mg, 15 mg	6-16 years of age	40 mg/day
STIMULANTS: Lisdexamfetamine: Vyvanase™ (capsules) 20 mg, 30 mg. 40 mg, 50 mg, 60 mg, 70 mg	6-17 years of age	70 mg/day
STIMULANTS: Methamphetamine: Desoxyn®, generic (tablet) 5 mg	> 6 years of age	25 mg/day
STIMULANTS: Methylphenidate Immediate-Release generic (tablet) 5 mg, 10 mg, 20 mg	> 6 years of age	60 mg/day
STIMULANTS: Methylphenidate Immediate-Release Ritalin®, generic (tablet) 5 mg, 10 mg, 20 mg	> 6 years of age	60 mg/day
STIMULANTS: Methylphenidate Extended-Release: Concerta® (extended release tablet) 18 mg, 27 mg, 36 mg, 54 mg	6-12 years of age	54 mg/day
STIMULANTS: Methylphenidate Extended-Release: Concerta® (extended release tablet) 18 mg, 27 mg, 36 mg, 54 mg	13-17 years of age	72 mg/day (max: 2 mg/kg/day)
STIMULANTS: Methylphenidate Extended-Release Metadate® CD (extended-release capsule) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg	> 6 years of age	60 mg/day
STIMULANTS: Methylphenidate Extended-Release Metadate® ER, generic(extended release tablet) 10 mg, 20 mg (generic for 20 mg only)	> 6 years of age	60 mg/day
STIMULANTS: Methylphenidate Extended-Release Methylin® ER, generic(extended release tablet) 10 mg, 20 mg (generic for 20 mg only)	> 6 years of age	60 mg/day
STIMULANTS: Methylphenidate Extended-Release Ritalin® LA (extended-release capsule) 10 mg, 20 mg, 30 mg, 40 mg	> 6 years of age	60 mg/day
STIMULANTS: Methylphenidate Extended-Release Ritalin-SR®, generic (sustained release tablet) 20 mg	> 6 years of age	60 mg/day
STIMULANTS: Methylphenidate Transdermal System: Daytrana™ (transdermal patch) 10 mg/9h, 15 mg/9h, 20 mg/9h, 30 mg/ 9h	6-17 years of age	30 mg/9 hours/day
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITORS - NON-STIMULANTS Non-Stimulants (Selective Norepinephrine Reuptake Inhibitors): Atomoxetine Strattera® (capsules) 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg 100 mg	6-17 years of age (< 70 kg)	1.4 mg/kg/day up to 100 mg/day
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITORS - NON-STIMULANTS: Atomoxetine Strattera® (capsules) 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg 100 mg	6-17 years of age (> 70 kg)	100 mg/day
SELECTIVE ALPHA2A-ADRENERGIC RECEPTOR AGONISTS - NON-STIMULANTS: (Alpha2A-Adrenergic Receptor Agonists): Guanfacine Intuniv® (extended-release tablet) 1 mg, 2 mg, 3 mg, 4 mg	6-17 years of age	4 mg/day

* Mixed amphetamine salts are a 1:1:1:1 combination of dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate and amphetamine sulfate

2. Duration of Therapy

Attention-deficit/hyperactivity disorder (ADHD) is defined in DSM-IV as a behavioral disorder of childhood onset characterized by symptoms of inattentiveness and hyperactivity-impulsivity.   While many of the approved medications improve inattention, hyperactivity, and impulsivity in up to 70-96% of patients, symptoms may persist lifelong with less pronounced hyperactivity.  Therefore, treatment often lasts well into adulthood, and ADHD is considered a chronic disorder.

3.* Duplicative Therapy

The use of two or more psychostimulants concurrently for ADD/ADHD management is not justified.  Additional therapeutic benefit is not realized when ADHD medications are used in combination.  Additionally, guanfacine extended-release tablets should not be prescribed concurrently with other guanfacine-containing products due to increased risks of additive pharmacologic/adverse effects, including hypotension.  Patient profiles documenting receipt of multiple ADHD medications or multiple guanfacine-containing products will be reviewed.

4.* Drug-Drug Interactions

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions.Drug-drug interactions considered clinically significant for ADD/ADHD medications are summarized in Table 3.  Only those drug-drug interactions identified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed:

Table 3 : Drug-Drug Interactions for ADD/ADHD Medications

TARGET DRUG	INTERACTING DRUG	INTERACTION	RECOMMENDATION	CLINICAL SIGNIFICANCE*+
amphetamines, amphetamine-related compounds, dexmethylphenidate, methylphenidate	antihypertensive agents	combined administration decreases hypotensive effect of antihypertensive agents	closely monitor blood pressure and adjust antihypertensive therapy doses as necessary	2- major (CP)
amphetamines, amphetamine-related compounds, dexmethylphenidate, methylphenidate	monoamine oxidase inhibitors (MAOIs)	combined administration increases risk of enhanced vasopressor effects and hypertensive crisis due to increased norepinephrine availability; amphetamines, dexmethylphenidate, and methylphenidate potentiate  catecholamine neurotransmitter effects, while MAOIS block catecholamine degradation and increase norepinephrine levels at nerve receptor sites	concurrent administration as well as amphetamine, dexmethylphenidate, or methylphenidate administration within 14 days of MAOI use is contraindicated	contraindicated (DrugReax) 1-severe (CP) 1 (DIF)
amphetamines, amphetamine-related compounds	SSRIs, SNRIs	combined administration may produce additive pharmacologic effects and  increase risk of serotonin syndrome as amphetamines may stimulate serotonin release in central nervous system (CNS)	administer cautiously together and observe for signs/symptoms of serotonin syndrome; discontinue therapy and treat as necessary if serotonin syndrome develops	major (DrugReax) 2-major (CP) 2 (DIF)
amphetamines, amphetamine-related compounds	TCAs	adjunctive administration may potentiate amphetamine pharmacologic/adverse effects including hypertension, other cardiac effects, and  CNS stimulation due to additive effects on norepinephrine release/activity	administer combination cautiously; observe for increased adverse effects	moderate (DrugReax) 2-major (CP)
atomoxetine	albuterol	combined administration may produce increased heart rate, blood pressure due to unknown mechanism	administer combination cautiously; monitor blood pressure and heart rate	major (DrugReax) 3-moderate (CP)
atomoxetine	CYP2D6 inhibitors (e.g., amiodarone, fluoxetine, venlafaxine)	combined administration may increase atomoxetine serum levels and potentiate pharmacologic/adverse effects as atomoxetine metabolized by CYP2D6	closely monitor patients administered this drug combination, monitor for adverse effects; adjust atomoxetine doses as needed	moderate (DrugReax) 2-major (CP) 2 (DIF)
atomoxetine	MAOIs	simultaneous administration may result in additive serotonergic effects and increased risk of serotonin syndrome as atomoxetine inhibits serotonin reuptake and MAOIs inhibit catecholamine breakdown	concomitant administration as well as atomoxetine administration within 14 days of MAOI use contraindicated	contraindicated (DrugReax) 1-severe (CP) 1 (DIF)
dexmethylphenidate, methylphenidate	select anticonvulsants (e.g., phenobarbital, phenytoin, primidone)	adjunctive administration may increase serum anticonvulsant levels of select anticonvulsants due to unknown mechanism; dexmethylphenidate,  methylphenidate may also lower seizure threshold	monitor serum anticonvulsant levels closely and monitor patients for increased adverse effects; adjust anticonvulsant doses as needed; also monitor seizure frequency	moderate (DrugReax) 2-major, 3-moderate (CP) 4 (DIF)
dexmethylphenidate, methylphenidate	warfarin	coadministration may increased warfarin serum levels and enhance pharmacologic/adverse effects, including bleeding	closely monitor INR with combined therapy and adjust warfarin doses as necessary	moderate (DrugReax) 3-moderate (CP)
guanfacine	antihypertensive agents	combined administration may result in additive hypotensive effects	closely monitor blood pressure and adjust doses as necessary	3-moderate (CP)
guanfacine	CNS depressants	combined administration may result in additive pharmacologic (sedative) effects	administer cautiously together	3-moderate (CP)
guanfacine	strong CYP3A4 inhibitors (e.g., ketoconazole)	adjunctive administration may result in increased guanfacine concentrations and the potential for enhanced pharmacologic/adverse effects as guanfacine is metabolized by CYP3A4	administer cautiously together and monitor for increased pharmacologic effects (e.g., hypotension, bradycardia, sedation)	unknown
guanfacine	CYP3A4 inducers (e.g., rifampin, phenytoin)	concurrent administration had reduced guanfacine AUC by 70% and may result in decreased guanfacine serum levels and reduced pharmacologic/clinical effects as guanfacine is metabolized by CYP3A4	monitor for loss of guanfacine clinical effects; increased guanfacine doses may be necessary	3-moderate (CP)
guanfacine	valproic acid (VA)	combined administration may result in increased VA serum levels, potentially due to competition for glucuronidation metabolic pathway	monitor for additive CNS effects; VA dosage adjustments may be required	unknown
methylphenidate	carbamazepine	concomitant administration may result in reduced methylphenidate serum levels and decreased pharmacologic effects due to unknown mechanism; methylphenidate may also lower seizure threshold	closely monitor patient response to methylphenidate therapy and adjust methylphenidate doses as necessary with this drug combination; also monitor seizure frequency	moderate (DrugReax) 2-major (CP) 4 (DIF)

*CP = Clinical Pharmacology
+Drug Interaction Facts

References

1. Methylphenidate oral solution (Methylin®) Package Insert.  Shionogi Pharma, Inc., October 2010.
2. Methylphenidate chewable tablets (Methylin®) Package Insert.  Shionogi Pharma, Inc., October 2010.
3. Methylphenidate extended-release tablets (Metadate ER™) Package Insert.  UCB, Inc., August 2008.
4. Methylphenidate extended-release capsules (Metadate CD®) Package Insert.  UCB, Inc., September 2010.
5. Methylphenidate immediate-release (Methylin®), extended-release (Methylin ER®) Package Insert.  Mallinckrodt Inc., April 2010.
6. Methylphenidate tablets, sustained-release tablets, extended-release capsules (Ritalin®, Ritalin-SR®, Ritalin LA®) Package Insert.  Novartis Pharmaceuticals Corp., December 2010.
7. Lisdexamfetamine (Vyvanse®) Package Insert.  Shire US Inc., November 2010.
8. Dextroamphetamine sustained-release capsules (Dexedrine® Spansules®) Package Insert.  Amedra Pharmaceuticals, LLC, December 2010.
9. Dextroamphetamine oral solution (ProCentra®) Package Insert.  FSC Laboratories, June 2010.
10. Amphetamine mixed salts extended-release (Adderall XR®) Package Insert.  Shire US Inc., November 2010.
11. Amphetamine mixed salts tablets Package Insert.  Core Pharma LLC, November 2010.
12. Atomoxetine (Strattera®) Package Insert. Eli Lilly and Company, March 2011.
13. Dexmethylphenidate extended-release capsules (Focalin® XR) Package Insert.  Novartis, November 2010.
14. Methylphenidate transdermal system (Daytrana®) Package Insert.  Noven Pharmaceuticals, Inc., November 2010.
15. DRUGDEX® System (electronic version). Thomson Reuters (Healthcare) Inc., Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com.libproxy.uthscsa.edu.   Accessed March 17th, 2011.
16. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc; 2011. Available at: http://www.clinicalpharmacology.com. Accessed March 17th, 2011.
17. Drug Facts and Comparisons.  Clin-eguide [database online].  St. Louis, MO:  Wolters Kluwer Health, Inc; 2011.  Available at:  http://clineguide.com.  Accessed March 17th, 2011.
18. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision. Washington DC, American Psychiatric Press, 2000:39-134.
19. Greydanus DE, Pratt HD, Patel DR.  Attention deficit hyperactivity disorder across the lifespan: the child, adolescent, and adult.  Disease-A-Month. 2007;53:70-131.
20. Harpin VA. Medication options when treating children and adolescents with ADHD: interpreting the NICE guidance 2006.  Arch Dis Child Educ Pract Ed.  2008;93:58-65.
21. Pliska S, for the AACAP Work Group on Quality Issues.  Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder.  J Am Acad Child Adolesc Psychiatry. 2007;46:894-921.
22. Moss SB, Nair R, Vallarino A, Wang S.  Attention deficit/hyperactivity disorder in adults.  Prim Care.  2007;34:445-73.
23. American Academy of Pediatrics. Clinical practice guideline: Treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108:1033-44.
24. Pliska SR, Crismon ML, Hughes CW, et al, for the Texas Consensus Conference Panel on Pharmacotherapy of Childhood Attention Deficit Hyperactivity Disorder.  The Texas Children’s Medication Algorithm Project:  revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(6):642-57.
25. Rader R, McCauley L, Callen EC. Current strategies in the diagnosis and treatment of childhood attention-deficit/hyperactivity disorder.  Am Fam Physician.  2009;79(8):657-65.
26. Dopheide JA, Pliszka SR. Attention-deficit-hyperactivity disorder: an update.  Pharmacotherapy.  2009;29(6):656-79.
27. Drug interaction facts.  Clin-eguide [database online].  St. Louis, MO:  Wolters Kluwer Health, Inc; 2011.  Available at:  http://clineguide.com.  Accessed March 18th, 2011.
28. DRUG-REAX® System (electronic version). Thomson Reuters (Healthcare) Inc., Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com.libproxy.uthscsa.edu.  Accessed March 18th, 2011.
29. Guanfacine extended-release tablets (Intuniv®) Package Insert.  Shire Pharmaceuticals Inc., March 2011.

Prepared by: Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin.