Lisdexamfetamine Dimesylate

Class: Amphetamines
VA Class: CN801
Chemical Name: (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethly] hexanamide dimethanesulfonate
Molecular Formula: C15H25N3O (CH4O3S)2
CAS Number: 608137-32-2
Brands: Vyvanse

Warning(s)

  • Abuse Potential
  • Amphetamines have a high potential for abuse.1

  • Administration of amphetamines for prolonged periods of time may lead to drug dependence.1

  • Particular attention should be paid to the possibility of individuals obtaining amphetamines for nontherapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.1

  • The possibility that family members may abuse the patient’s medication should be considered.5

  • Sudden Death and Serious Cardiovascular Events
  • Possible sudden death and serious cardiovascular events, particularly in individuals who abuse amphetamines.1 6 9 (See Sudden Death and Serious Cardiovascular Events under Cautions.)

Introduction

Prodrug of dextroamphetamine; noncatechol, sympathomimetic amine with CNS-stimulating activity.1 8 28

Uses for Lisdexamfetamine Dimesylate

Attention Deficit Hyperactivity Disorder

Used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention deficit hyperactivity disorder (ADHD) (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction).1 3 6 7 8 28

Safety and efficacy established in children 6–12 years of age who met criteria for ADHD (combined type or predominantly hyperactive-impulsive type) and also in adults who met criteria for ADHD.1 2 3 4 29 30

Slideshow: Does Your Child Have ADHD? Recognizing Signs & Treatment Options

Almost all studies comparing behavioral therapy versus stimulants alone have shown a much stronger therapeutic effect from stimulants than from behavioral therapy, and stimulants (e.g., amphetamines, methylphenidate) remain the drugs of choice for the management of ADHD.5 6 7 10 11 12 13 14 15 16 17 18 19 20

Drug therapy is not indicated in all patients with ADHD, and such therapy should be considered only after a complete evaluation including medical history has been performed.1 6 17 18

Use should depend on age, adequate diagnosis (based on medical, special psychological, educational, and social resources), and the clinician’s assessment of the severity, duration, and frequency of symptoms and should not depend solely on one or more behavioral characteristics.1 5 6 17

Lisdexamfetamine Dimesylate Dosage and Administration

Administration

Oral Administration

Administer once daily in the morning without regard to meals.1 Because of potential for insomnia, avoid administering in the afternoon.1 28 30

Capsule may be swallowed whole or may be opened and the entire contents dissolved in water immediately prior to administration; resulting solution should not be stored for use at a later time.1 28

Do not subdivide capsule contents; do not administer a dose less than the entire contents of one capsule.1

Dosage

Available as lisdexamfetamine dimesylate; dosage expressed in terms of the salt.1

Adjust dosage according to individual response and tolerance; the smallest dose required to produce the desired response should always be used.1 6 30

When possible, therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.1 6

Pediatric Patients

Attention Deficit Hyperactivity Disorder
Oral

Children 6–12 years of age: Initially, 30 mg once daily (as initial treatment for ADHD or in patients being switched to lisdexamfetamine from other drugs); dosage may be adjusted in 10- or 20-mg increments at weekly intervals; maximum 70 mg daily.1 28 30

If the initial 30-mg daily dosage is not tolerated, dosage may be decreased to 20 mg daily.27

Adults

Attention Deficit Hyperactivity Disorder
Oral

Initially, 30 mg once daily (as initial treatment for ADHD or in patients being switched to lisdexamfetamine from other drugs); dosage may be adjusted in 10- or 20-mg increments at weekly intervals; maximum 70 mg daily.1 28

If the initial 30-mg daily dosage is not tolerated, dosage may be decreased to 20 mg daily.27

Prescribing Limits

Pediatric Patients

Attention Deficit Hyperactivity Disorder
Oral

Children 6–12 years of age: Maximum 70 mg daily.1

Long-term use (i.e., >4 weeks) has not been studied systematically.1 If used for long-term therapy, periodically reevaluate the usefulness of the drug.1

Adults

Attention Deficit Hyperactivity Disorder
Oral

Maximum 70 mg daily.1

Long-term use (i.e., >4 weeks) has not been studied systematically.1 If used for long-term therapy, periodically reevaluate the usefulness of the drug.1

Special Populations

No special population dosage recommendations at this time.1

Cautions for Lisdexamfetamine Dimesylate

Contraindications

  • Contraindicated in patients with advanced arteriosclerosis,1 5 28 symptomatic cardiovascular disease,1 5 28 moderate to severe hypertension,1 5 28 hyperthyroidism,1 5 28 known hypersensitivity or idiosyncrasy to sympathomimetic amines,1 5 glaucoma,1 5 28 or a history of drug abuse;1 5 28 within 14 days of MAO inhibitor therapy;1 5 28 and in agitated patients.1 28

  • Although amphetamines generally should not be used in patients with a history of drug abuse,1 5 some experts state that this is not an absolute contraindication, provided the patient can be monitored more carefully than would otherwise be indicated.5

Warnings/Precautions

Warnings

Sudden Death and Serious Cardiovascular Events

Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of stimulants; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drugs.1 9

Epidemiologic data suggest a possible association between use of stimulants and sudden unexplained death in healthy children and adolescents.31 32 33 FDA unable to conclude that these data affect evaluation of overall risk and benefit of stimulants used to treat ADHD in children and adolescents.31 FDA is conducting an ongoing safety review of amphetamines and other stimulants to evaluate possible link between use of these agents and sudden death in children.31 32 33 Pediatric patients with ADHD and their parents should avoid discontinuing the child’s use of such stimulants before consulting a clinician.31

Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).1 5 6

In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.1 6 8 9 (See Contraindications under Cautions.)

Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.1 28

Other Warnings and Precautions

Least amount of lisdexamfetamine feasible should be prescribed or dispensed at one time in order to minimize possible overdosage.1

Effects on BP and Heart Rate

Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur.1 28 Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.1

Caution advised in patients with underlying medical conditions that might be affected by increases in BP or heart rate (e.g., hypertension, heart failure, recent MI, ventricular arrhythmia).1

Exacerbation or Precipitation of Psychotic Symptoms

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.1 5

Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.1 6 If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1 6

Precipitation of Manic Symptoms

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.1 Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).1

Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.1 If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1

Aggression

Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.1 No systematic evidence that stimulants cause these adverse effects; however, monitor patients beginning treatment for ADHD for onset or worsening of aggressive behavior or hostility.1 6

Growth Suppression

Long-term (i.e., >12 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 6 Dose-related weight loss reported in children during 4 weeks of therapy with lisdexamfetamine.1

Manufacturer recommends monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.1 6 28 However, AAP states that studies of stimulants in children found little or no decrease in expected height, with any decrease in growth early in treatment being compensated for later on.7

Seizures

Possible lowering of seizure threshold in patients with history of seizures, in those with prior EEG abnormalities but no history of seizures, and, very rarely, in those without history of seizures and with no prior evidence of EEG abnormalities.1 28 If seizures occur, discontinue therapy.1

Visual Effects

Visual disturbances (e.g., difficulty with accommodation, blurred vision) reported with stimulants.1 28

Tics

Amphetamines reported to exacerbate motor and phonic tics and Tourette’s syndrome.1 However, a history of tics or their development during therapy is not an absolute contraindication to continued use.1 5 7 Nevertheless, evaluate for presence of tics and Tourette’s syndrome in children and their families prior to initiating stimulant therapy.1

Other CNS Effects

Amphetamines may impair the ability to engage in potentially hazardous activities (e.g., operating machinery or vehicles).1

Specific Populations

Pregnancy

Category C.1 25

Risk of prematurity, low birth weight, and withdrawal symptoms (e.g., dysphoria, lassitude, agitation) in infants born to dependent women.1 25

Lactation

Distributed into milk; discontinue nursing or the drug.1 25

Pediatric Use

Safety and efficacy of lisdexamfetamine not established in children 3–5 years of age.1 Amphetamines not recommended for ADHD in children <3 years of age.1 5 6 Not studied to date in adolescents.1

Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.1 (See Warnings under Cautions.)

Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.1 Epidemiologic data also suggest a possible association between use of stimulants and sudden death in healthy children and adolescents.31 32 33 (See Sudden Death and Serious Cardiovascular Events under Cautions.)

Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 (See Growth Suppression under Cautions.)

Geriatric Use

Lisdexamfetamine has not been studied in this population.1

Hepatic Impairment

Not specifically studied in hepatic impairment.27

Renal Impairment

Not specifically studied in renal impairment.27

Common Adverse Effects

Children 6–12 years of age: Decreased appetite,1 6 28 29 30 insomnia,1 6 28 29 30 upper abdominal pain,1 28 30 irritability,1 6 28 30 vomiting, 1 28 weight loss,1 6 28 30 nausea,1 28 dry mouth,1 28 dizziness,1 28 30 affect lability,1 rash,1 tic,1 pyrexia,1 somnolence.1

Adults: Decreased appetite,1 insomnia,1 dry mouth,1 diarrhea,1 nausea,1 anxiety,1 anorexia,1 jitteriness,1 increased BP,1 agitation,1 restlessness,1 hyperHIDrosis,1 increased heart rate,1 tremor,1 dyspnea.1

Interactions for Lisdexamfetamine Dimesylate

Active metabolite (dextroamphetamine) inhibits MAO.1

Lisdexamfetamine is not metabolized by CYP isoenzymes.1 In vitro studies suggest only minor inhibition of CYP isoenzymes 1A2, 2D6, and 3A4 by amphetamine and/or its metabolites.1

Specific Drugs, Tests, and Foods

Drug, Test, or Food

Interaction

Comments

Acidifying agents, urinary (ammonium chloride, sodium acid phosphate, cranberry juice)

Increased urinary excretion and decreased serum concentrations and efficacy of amphetamines1 8

Adrenergic blockers

Potential inhibition of adrenergic blockade1

Alkalinizing agents (carbonic anhydrase inhibitors, sodium bicarbonate)

Decreased urinary excretion of amphetamines8

Antidepressants, tricyclic (desipramine, protriptyline)

Enhanced activity of tricyclic antidepressants; desipramine or protriptyline cause striking and sustained increases in the concentration of dextroamphetamine in the brain; cardiovascular effects can be potentiated1

Antihistamines

Amphetamines may counteract the sedative effects of antihistamines1

Antihypertensives

Amphetamines may antagonize the hypotensive effects of antihypertensives1

Chlorpromazine

Chlorpromazine inhibits the central stimulant effects of amphetamines by blocking dopamine and norepinephrine receptors1

Can be used to treat amphetamine poisoning1

Ethosuximide

Intestinal absorption of ethosuximide may be delayed1

Haloperidol

Haloperidol inhibits the central stimulant effects of amphetamines by blocking dopamine receptors1

Lithium carbonate

Lithium may inhibit the anorectic and stimulatory effects of amphetamine1

MAO inhibitors

MAO inhibitors slow the metabolism of amphetamines, increasing their effect on the release of norepinephrine and other monoamines leading to headaches and other signs of hypertensive crisis1

Toxic neurologic effects, hypertensive crisis, and malignant hyperpyrexia can occur, sometimes with fatal results1

Amphetamines contraindicated in patients currently or recently (within 14 days) receiving MAO inhibitor1

Meperidine

Amphetamines potentiate the analgesic effect of meperidine1

Methenamine

Acidifying agents used with methenamine increase urinary excretion and decrease efficacy of amphetamines1

Norepinephrine

Amphetamines enhance the adrenergic effects of norepinephrine1

Phenobarbital

Amphetamines may delay absorption of phenobarbital; concomitant use may produce a synergistic anticonvulsant action1

Phenytoin

Amphetamines may delay absorption of phenytoin; concomitant use may produce a synergistic anticonvulsant action1

Propoxyphene

In propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur1

Sympathomimetic agents

Enhanced activity of sympathomimetic agents1

Use with caution1

Test, plasma corticosteroids

Elevated plasma corticosteroid concentrations; this increase is greatest in the evening1

Test, urinary steroids

Possible interference with urinary steroid determinations1

Veratrum alkaloids

Amphetamines inhibit the hypotensive effect of veratrum1

Lisdexamfetamine Dimesylate Pharmacokinetics

Absorption

Bioavailability

Lisdexamfetamine (a prodrug of dextroamphetamine) is rapidly absorbed from the GI tract.1 28 Peak plasma concentrations of lisdexamfetamine occur in approximately 1 hour; concentrations are low and transient; nonquantifiable by 8 hours after administration.1 Peak plasma concentrations of dextroamphetamine occur in approximately 3.5–3.7 hours.1 3 30

Onset

Occurs within 2 hours after oral administration.3

Duration

Approximately 10–12 hours.1 8 27

Food

Food (high-fat meal) delays time to peak plasma concentration of dextroamphetamine by about 1 hour but does not affect magnitude of peak plasma concentration or AUC of dextroamphetamine.1

Distribution

Extent

Amphetamines readily cross the blood-brain barrier and are distributed into most body tissues.26

Amphetamines are distributed into milk in concentrations 3–7 times maternal blood concentrations.21 25

Elimination

Metabolism

Lisdexamfetamine (a prodrug of dextroamphetamine) is converted to l-lysine and dextroamphetamine by first-pass intestinal and/or hepatic metabolism.1

Lisdexamfetamine is not metabolized by CYP isoenzymes.1

Elimination Route

Excreted principally in urine.1 Approximately 96% of a 70-mg radiolabeled oral dose of lisdexamfetamine was recovered in urine; parent drug accounted for about 2% of the recovered radioactivity.1

Changes in urinary pH may alter excretion of amphetamines.1 (See Specific Drugs, Tests, and Foods under Interactions.)

Half-life

Lisdexamfetamine: <1 hour;1 8 dextroamphetamine: 9.4–13 hours.3 8 30

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).1

Actions

  • Amphetamines are sympathomimetic amines with CNS stimulant activity.1 23

  • Lisdexamfetamine is a prodrug of dextroamphetamine; dextroamphetamine may block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneural space.1 23 28 30

  • Pharmacologic actions of amphetamines are qualitatively similar to those of ephedrine and include CNS and respiratory stimulation and sympathomimetic activity including pressor response, bronchodilation, and contraction of the urinary bladder sphincter.23 24

  • Theories of dysfunction in ADHD focus on the prefrontal cortex, which controls many executive functions (e.g., planning, impulse control).5 Stimulants have putative effects on central dopamine and norepinephrine pathways that are crucial in frontal lobe function.5

  • Produces an anorexigenic effect, leading to loss of weight.1 5 23 No primary effect on appetite has been demonstrated in humans and it has been postulated that anorexigenic effects are secondary to increased sympathetic activity resulting from release of norepinephrine and dopamine.22

Advice to Patients

  • Provide patient or caregiver with a copy of the manufacturer’s patient information (medication guide); discuss and answer questions about its contents as needed.1 Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.1

  • Advise parents with concerns about long-term effects (e.g., effects on weight) and the need for continued therapy that drug holidays can be considered in consultation with the patient’s clinician.5 6 7 However, the benefits versus risks of such interruptions in therapy have not been established.7

  • Question about possible substance abuse, including in other family members (since they may abuse the patient’s medication supply).1

  • Advise to take drug in the morning to minimize insomnia.1

  • Advise that appetite suppression may occur.1 5 Giving the morning dose with a meal and providing a high-caloric drink or snack late in the evening when the stimulant effects have subsided may be helpful.5

  • Advise to inform clinician immediately if adverse cardiovascular (e.g., chest pain, shortness of breath, fainting) or psychiatric effects (e.g., hallucinations, delusional thinking, mania) occur.1

  • Instruct about the potential for amphetamines to impair patient’s ability to perform potentially hazardous activities, such as driving or operating heavy machinery.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses/conditions (e.g., cardiac/cardiovascular disease, thyroid disease, glaucoma, suicidal ideation or behaviors, mental/psychiatric disorder, seizures).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.1

Lisdexamfetamine Dimesylate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

20 mg

Vyvanse (C-II)

Shire

30 mg

Vyvanse (C-II)

Shire

40 mg

Vyvanse (C-II)

Shire

50 mg

Vyvanse (C-II)

Shire

60 mg

Vyvanse (C-II)

Shire

70 mg

Vyvanse (C-II)

Shire

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Vyvanse 20MG Capsules (SHIRE US INC.): 20/$125.99 or 30/$177.98

Vyvanse 30MG Capsules (SHIRE US INC.): 20/$126.99 or 30/$189.97

Vyvanse 40MG Capsules (SHIRE US INC.): 20/$113.99 or 30/$170.97

Vyvanse 50MG Capsules (SHIRE US INC.): 20/$118.57 or 30/$171.45

Vyvanse 60MG Capsules (SHIRE US INC.): 20/$117.70 or 30/$176.56

Vyvanse 70MG Capsules (SHIRE US INC.): 20/$117.98 or 30/$171.45

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Shire US Inc. Vyvanse (lisdexamfetamine dimesylate) capsules prescribing information. Wayne, PA; 2008 Apr.

2. Biederman J, Krishnan S, Zhang Y et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007; 29:450-63. [PubMed 17577466]

3. Shire US Inc., Wayne, PA: Personal communication.

4. Biederman J, Boellner SW, Childress A et al. Improvements in symptoms of attention-deficit/hyperactivity disorder in school-aged children with lisdexamfetamine (NRP-104) and mixed amphetamine salts, extended-release versus placebo. Poster presented at 159th annual meeting of the American Psychiatric Association. Toronto, Canada: 2006 May 24.

5. American Academy of Child and Adolescent Psychiatry. Practice parameter for the use of stimulant medications in the treatment of children, adolescents and adults. Washington, DC; 2001. From the AACAP website. Accessed 2007 Aug 15.

6. American Academy of Child and Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with attention deficit hyperactivity disorder. Washington, DC; 2007. From the AACAP website. Accessed 2007 Aug 15.

7. American Academy of Pediatrics Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical treatment guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001; 108:1033-44. [IDIS 470916] [PubMed 11581465]

8. Anon. Lisdexamfetamine dimesylate (Vyvanse) for ADHD. Med Lett Drugs Ther. 2007; 49:58-9.

9. US Food and Drug Administration. Adderall and Adderall XR (amphetamine): sudden death in children. Rockville, MD; 2005 Feb 9. Alert for Healthcare Professionals.

10. National Institutes of Health Office of Medical Applications of Research. NIH Consensus statement: diagnosis and treatment of attention deficit hyperactivity disorder. 1998; 16(Nov 16-18): in press. From NIH web site [1998 Nov 19]).

11. Swanson JM, Sergeant JA, Taylor E et al. Attention-deficit hyperactivity disorder and hyperkinetic disorder. Lancet. 1998; 351:429-33. [IDIS 403568] [PubMed 9482319]

12. Goldman LS, Genel M, Bexman RJ et al for the Council on Scientific Affairs et al. Diagnosis and treatment of attention-deficit/hyperactivity disorder in children and adolescents. JAMA. 1998; 279:1100-7. [IDIS 402940] [PubMed 9546570]

13. Shaffer D. Attention deficit hyperactivity disorder in adults. Am J Psychiatry. 1994; 151:633-8. [PubMed 7909410]

14. Spencer T, Biederman J, Wilens TE et al. Adults with attention-deficit/hyperactivity disorder: a controversial diagnosis. J Clin Psychiatry. 1998; 59(Suupl 7):59-68. [IDIS 409837] [PubMed 9680054]

15. Popper CW. Antidepressants in the treatment of attention-deficit/hyperactivity disorder. J Clin Psychiatry. 1997; 58(Suppl 14):14-29. [IDIS 398614] [PubMed 9418743]

16. Smith BH, Pelham WE, Gnagy E et al. Equivalent effects of stimulant treatment for attention-deficit hyperactivity disorder during childhood and adolescence. J Am Acad Child Adolesc Psychiatry. 1998; 37:314-21. [IDIS 402147] [PubMed 9519637]

17. The MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999; 56:1073-86. [IDIS 440533] [PubMed 10591283]

18. Taylor E. Development of clinical services for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999; 56:10979.

19. The MTA Cooperative Group. Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder. Arch Intern Med. 1999; 56:1088-96.

20. Pliszka SR, Greenhill LL, Crismon ML et al. The Texas Children’s Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part I. J Am Acad Child Adolesc Psychiatry. 2000; 39:908-19. [IDIS 449214] [PubMed 10892234]

21. Drugs used in obesity. In: Drug evaluations subscription. Chicago, IL: American Medical Association; III/PSY-6:1-16, Winter 1992.

22. Littner M, Johnson SF, McCall WV et al for the American Academy of Sleep Medicine Standards of Practice Committee. Practice parameters for the treatment of narcolepsy: an update for 2000. Sleep. 2001; 24:451-66. [PubMed 11403530]

23. Westfall TC, Westfall DP. Adrenergic agonists and antagonists. In: Brunton LL, Lazo JS, Parker KL, eds.Goodman and Gilman’s the pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill; 2005:237-95.

24. GlaxoSmithKline. Dexedrine (dextroamphetamine sulfate) extended-release capsules and tablets prescribing information. Research Triangle Park, NC; 2007 Mar.

25. Amphetamine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:74-80.

26. Weiner N. Norepinephrine, epinephrine, and the sympathomimetic amines. In: Gilman AG, Goodman LS, Rall TW et al, eds.Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan; 1985:145-80.

27. Shire Pharmaceuticals, Wayne, PA: Personal communication.

28. Hussar DA. New drugs: aliskiren hemifumarate, lisdexamfetamine dimesylate, and lapatinib. J Am Pharm Assoc. 2007; 47:425-6, 428-30.

29. Biederman J, Boellner SW, Childress A et al. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007; 62:970-6. [PubMed 17631866]

30. Blick SK, Keating GM. Lisdexamfetamine. Pediatr Drugs. 2007; 9:129-35.

31. Food and Drug Administration. FDA Alert: Information for healthcare professionals: Communication about an ongoing safety review of stimulant medications [dexmethylphenidate (marketed as Focalin, Focalin XR), dextroamphetamine (marketed as Dexedrine, Dexedrine Spansules, Dextrostat, and generics), lisdexamfetamine (marketed as Vyvanse), methamphetamine (marketed as Desoxyn), methylphenidate (marketed as Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, and Ritalin-SR), mixed salts amphetamine (marketed as Adderall and Adderall XR), and pemoline (marketed as Cylert and generics)] used in children with attention-deficit/hyperactivity disorder (ADHD). Rockville, MD; 2009 Jun 23. From the FDA website.

32. Gould MS, Walsh BT, Munfakh JL et al. Sudden death and use of stimulant medications in youths. Am J Psychiatry. 2009; 166:992-1001. [PubMed 19528194]

33. Vitiello B, Towbin K. Stimulant treatment of ADHD and risk of sudden death in children. Am J Psychiatry. 2009; 166:955-7. [PubMed 19528196]

34. US Food and Drug Administration. AHRQ and FDA to collaborate in largest study ever of possible heart risks with ADHD medications. FDA News September 17, 2007. From FDA web site.

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