dextroamphetamine transdermal (Rx)

Brand and Other Names:Xelstrym
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

transdermal system: Schedule II

  • 4.5mg/9hr
  • 9mg/9hr
  • 13.5mg/9hr
  • 18mg/9hr

Attention Deficit Hyperactivity Disorder

Indicated for attention deficit hyperactivity disorder (ADHD)

Apply to application site 2 hr before an effect is needed and remove within 9 hr after application

9 mg/9 hr patch initially; may adjust dose up to 18 mg/9 hr

Titrate dose according to individual clinical response and tolerability

Pharmacological treatment of ADHD may be needed for an extended period

Periodically reevaluate long-term use and adjust dosage as needed

Dosage Modifications

Coadministration with agents that alter urinary pH

  • Alkalinizing agents: Avoid; coadministration may increase amphetamine blood levels
  • Acidifying agents (eg, ascorbic acid): Consider increasing dextroamphetamine dose based on clinical response; coadministration may lower amphetamine blood levels

Coadministration with CYP2D6 inhibitors and/or serotonergic drugs

  • Initiate with lower dose

Renal impairment

  • Severe (GFR 15 to <30 mL/min/1.73 m2): Do not exceed 13.5 mg/9 hr
  • End-stage renal disease (GFR <15 mL/min/1.73 m2): Do not exceed 9 mg/9 hr
  • Dextroamphetamine is not dialyzable

Dosing Considerations

Switching from another medication or any other amphetamine product

  • Discontinue previous treatment, and titrate dextroamphetamine transdermal system using titration schedule
  • Do not substitute for other amphetamine products on a mg-per-mg basis owing to different amphetamine base compositions and differing pharmacokinetic profiles

Before initiating

  • Assess for presence of cardiac disease (eg, perform a careful history, family history of sudden death or ventricular arrhythmia, physical exam)
  • Assess risk of abuse before prescribing, and monitor for signs of abuse and dependence while on therapy
  • Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for use

Dosage Forms & Strengths

transdermal system: Schedule II

  • 4.5mg/9hr
  • 9mg/9hr
  • 13.5mg/9hr
  • 18mg/9hr

Attention Deficit Hyperactivity Disorder

Indicated for attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged ≥6 years

<6 years: Safety and efficacy not established

6-17 years

  • Apply to application site 2 hr before an effect is needed and remove within 9 hr after application
  • Apply 4.5 mg/9 hr patch initially
  • May increase by increments of 4.5 mg/week; not to exceed 18 mg/9 hr
  • Titrate dose according to patient’s clinical response and tolerability
  • Pharmacological treatment of ADHD may be needed for an extended period
  • Periodically reevaluate long-term use and adjust dosage as needed

Dosage Modifications

Coadministration with agents that alter urinary pH

  • Alkalinizing agents: Avoid; coadministration may increase amphetamine blood levels
  • Acidifying agents (eg, ascorbic acid): Consider increasing dextroamphetamine dose based on clinical response; coadministration may lower amphetamine blood levels

Renal impairment

  • Severe (GFR 15 to <30 mL/min/1.73 m2): Do not exceed 13.5 mg/9 hr
  • End-stage renal disease (GFR <15 mL/min/1.73 m2): Do not exceed 9 mg/9 hr
  • Dextroamphetamine is not dialyzable

Dosing Considerations

Limitation of use: Patients with ADHD aged <6 years experienced more long-term weight loss than patients aged ≥6 years

Switching from another medication or any other amphetamine product

  • Discontinue previous treatment, and titrate dextroamphetamine transdermal system using titration schedule
  • Do not substitute for other amphetamine products on a mg-per-mg basis owing to different amphetamine base compositions and differing pharmacokinetic profiles

Before initiating

  • Assess for presence of cardiac disease (eg, perform a careful history, family history of sudden death or ventricular arrhythmia, physical exam)
  • Assess risk of abuse before prescribing, and monitor for signs of abuse and dependence while on therapy
  • Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for use
  • Document height and weight; monitor growth during treatment
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Interactions

Interaction Checker

and dextroamphetamine transdermal

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            Contraindicated (5)

            • isocarboxazid

              isocarboxazid increases effects of dextroamphetamine transdermal by decreasing metabolism. Contraindicated. MAOIs slows amphetamine metabolism, increasing amphetamine?s effect on norepinephrine release and other monoamines from adrenergic nerve endings causing signs of hypertensive crisis. Do not administer dextroamphetamine during or within 14 days following MAOI administration.

            • linezolid

              linezolid increases effects of dextroamphetamine transdermal by decreasing metabolism. Contraindicated. MAOIs slows amphetamine metabolism, increasing amphetamine?s effect on norepinephrine release and other monoamines from adrenergic nerve endings causing signs of hypertensive crisis. Do not administer dextroamphetamine during or within 14 days following MAOI administration.

            • phenelzine

              phenelzine increases effects of dextroamphetamine transdermal by decreasing metabolism. Contraindicated. MAOIs slows amphetamine metabolism, increasing amphetamine?s effect on norepinephrine release and other monoamines from adrenergic nerve endings causing signs of hypertensive crisis. Do not administer dextroamphetamine during or within 14 days following MAOI administration.

            • procarbazine

              procarbazine increases effects of dextroamphetamine transdermal by decreasing metabolism. Contraindicated. MAOIs slows amphetamine metabolism, increasing amphetamine?s effect on norepinephrine release and other monoamines from adrenergic nerve endings causing signs of hypertensive crisis. Do not administer dextroamphetamine during or within 14 days following MAOI administration.

            • tranylcypromine

              tranylcypromine increases effects of dextroamphetamine transdermal by decreasing metabolism. Contraindicated. MAOIs slows amphetamine metabolism, increasing amphetamine?s effect on norepinephrine release and other monoamines from adrenergic nerve endings causing signs of hypertensive crisis. Do not administer dextroamphetamine during or within 14 days following MAOI administration.

            Serious - Use Alternative (2)

            • potassium citrate

              potassium citrate will increase the level or effect of dextroamphetamine transdermal by Other (see comment). Avoid or Use Alternate Drug. Urinary alkalinizing agents can increase blood levels and potentiate the action of amphetamine.

            • potassium citrate/citric acid

              potassium citrate/citric acid will increase the level or effect of dextroamphetamine transdermal by Other (see comment). Avoid or Use Alternate Drug. Urinary alkalinizing agents can increase blood levels and potentiate the action of amphetamine.

            Monitor Closely (62)

            • abiraterone

              abiraterone will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • almotriptan

              almotriptan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • amitriptyline

              amitriptyline will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • amoxapine

              amoxapine will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • ascorbic acid

              ascorbic acid will decrease the level or effect of dextroamphetamine transdermal by Other (see comment). Modify Therapy/Monitor Closely. Urinary acidifying agents can lower blood levels and efficacy of amphetamines. Increase dose of dextroamphetamine transdermal based on clinical response.

            • bupropion

              bupropion will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • buspirone

              buspirone, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • cinacalcet

              cinacalcet will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • citalopram

              citalopram, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • citric acid/glucono-delta-lactone/magnesium carbonate

              citric acid/glucono-delta-lactone/magnesium carbonate will decrease the level or effect of dextroamphetamine transdermal by Other (see comment). Modify Therapy/Monitor Closely. Urinary acidifying agents can lower blood levels and efficacy of amphetamines. Increase dose of dextroamphetamine transdermal based on clinical response.

            • clomipramine

              clomipramine will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • cocaine

              cocaine will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • cyclobenzaprine

              cyclobenzaprine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • dacomitinib

              dacomitinib will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • darunavir

              darunavir will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • desipramine

              desipramine will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • desvenlafaxine

              desvenlafaxine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • dextromethorphan

              dextromethorphan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • doxepin

              doxepin will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • duloxetine

              duloxetine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • eletriptan

              eletriptan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • escitalopram

              escitalopram, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • fluoxetine

              fluoxetine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

              fluoxetine will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • fluvoxamine

              fluvoxamine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • frovatriptan

              frovatriptan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • imipramine

              imipramine will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • L-tryptophan

              L-tryptophan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • lisdexamfetamine

              lisdexamfetamine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • lithium

              lithium, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • lorcaserin

              lorcaserin, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

              lorcaserin will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • maprotiline

              maprotiline, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • meperidine

              meperidine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • methamphetamine

              methamphetamine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • miconazole oral

              miconazole oral will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • milnacipran

              milnacipran, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • mirabegron

              mirabegron will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • mirtazapine

              mirtazapine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • naratriptan

              naratriptan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • nefazodone

              nefazodone, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • nortriptyline

              nortriptyline will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • paroxetine

              paroxetine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

              paroxetine will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • perphenazine

              perphenazine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • phenelzine

              phenelzine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • potassium acid phosphate

              potassium acid phosphate will decrease the level or effect of dextroamphetamine transdermal by Other (see comment). Modify Therapy/Monitor Closely. Urinary acidifying agents can lower blood levels and efficacy of amphetamines. Increase dose of dextroamphetamine transdermal based on clinical response.

            • protriptyline

              protriptyline will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • quinidine

              quinidine will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • rizatriptan

              rizatriptan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • rolapitant

              rolapitant will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • sertraline

              sertraline, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • St John's Wort

              St John's Wort, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • sumatriptan

              sumatriptan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • terbinafine

              terbinafine will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • thioridazine

              thioridazine will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • tipranavir

              tipranavir will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.

            • tramadol

              tramadol, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • tranylcypromine

              tranylcypromine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • trazodone

              trazodone, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • trimipramine

              trimipramine will increase the level or effect of dextroamphetamine transdermal by pharmacodynamic synergism. Modify Therapy/Monitor Closely. May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in dextroamphetamine levels in brain; May be potentiate cardiovascular effects. Monitor frequently and adjust or use an alternant based on clinical response.

            • venlafaxine

              venlafaxine, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • vilazodone

              vilazodone, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • ziprasidone

              ziprasidone, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            • zolmitriptan

              zolmitriptan, dextroamphetamine transdermal. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor for signs and symptoms of serotonin syndrome, particularly during initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and concomitant serotonergic drug(s).

            Minor (0)

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              Adverse Effects

              >10%

              Decreased neutrophils (14%)

              Decreased appetite (12%)

              1-10%

              Decreased WBCs in pediatric patients (10%)

              Insomnia (8%)

              Application site reactions, discomfort (8%)

              Headache (6%)

              Vomiting (4%)

              Abdominal pain (4%)

              Nausea (3%)

              Affect liability (3%)

              Tic (2%)

              Irritability (2%)

              Blood pressure increased (2%)

              Heart rate increased (2%)

              Postmarketing Reports (for amphetamines)

              Cardiac disorders: Palpitations, chest pain, sudden death, myocardial infarction, and cardiomyopathy (isolated reports)

              Eye disorders: Vision blurred, diplopia, difficulties with visual accommodation, and mydriasis

              Gastrointestinal disorders: Dysgeusia, constipation, intestinal ischemia, and other gastrointestinal disturbances

              Hepatobiliary disorders: Eosinophilic hepatitis

              Immune system disorders: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylactic reactions, and serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis

              Musculoskeletal and connective tissue disorders: Rhabdomyolysis

              Nervous system disorders: Seizures, overstimulation, restlessness, dyskinesia, tremor, tics, and paresthesia (including formication)

              Psychiatric disorders: Psychotic episodes at recommended doses, depression, logorrhea, aggression, anger, dermatillomania, bruxism, dysphoria, euphoria, and irritability

              Reproductive system and breast disorders: Impotence, changes in libido, and frequent or prolonged erections

              Skin and subcutaneous tissue disorders: Alopecia

              Vascular disorders: Raynaud phenomenon

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              Warnings

              Black Box Warnings

              Abuse and dependence

              • CNS stimulants, including dextroamphetamine transdermal, other amphetamine-containing products, and methylphenidate, have high potential for abuse and dependence
              • Assess risk of abuse before prescribing and monitor for signs of abuse and dependence during treatment

              Contraindications

              Hypersensitivity to amphetamine products or other components of transdermal system; anaphylactic reactions, Stevens-Johnson syndrome, angioedema, and urticaria have been observed in postmarketing reports

              During or within 14 days following MAOI administration (hypertensive crises may result)

              Cautions

              Has high potential for abuse and dependence

              CNS stimulants may increase BP and HR; monitor for potential tachycardia and hypertension

              Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs and symptoms usually improve after reducing the dose or discontinuing therapy; careful observation for digital changes is necessary during treatment; further clinical evaluation (eg, rheumatology referral) may be appropriate for certain patients

              Advise patients to avoid exposing transdermal system to direct external heat sources (eg, hair dryers, heating pads, electric blankets, heated water beds); heat may increase rate and extent of absorption

              Serious cardiovascular reactions

              • Sudden death, stroke, hypertension, and myocardial infarction reported in adults with CNS stimulants
              • Serious cardiovascular reactions have occurred at recommended doses
              • Sudden death reported in pediatric patients with structural cardiac abnormalities or other serious heart problems taking CNS stimulants
              • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems
              • Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment

              Psychiatric adverse reactions

              • CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder
              • CNS stimulants may induce mixed/manic episode in patients with bipolar disorder
              • Before initiating, screen for risk factors for developing a manic episode (eg, comorbid or history of depressive symptoms, family history of suicide, bipolar disorder, depression)
              • CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (eg, hallucinations, delusional thinking, or mania) in patients without prior history of psychotic illness or mania
              • If these symptoms occur, consider discontinuing treatment

              Growth suppression

              • CNS stimulants associated with weight loss and slowing of growth rate in pediatric patients
              • Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants
              • Consider interrupting treatment in patients who are not growing or gaining height or weight as expected
              • Not approved for use in children aged <6 years

              Application site reactions

              • Local skin reactions (eg, pain, pruritus, burning sensation, erythema, discomfort, edema, swelling) have been reported
              • Inform patients that increased skin irritation, discomfort or pain may occur if the same application site is used repeatedly
              • Instruct patients to select a different application site each day to minimize skin reactions
              • Monitor for these reactions while wearing or immediately after removal; symptoms reported to resolve 2-4 hr after application
              • Discontinue treatment if contact sensitization is suspected

              Serotonin syndrome

              • Coadministration with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants (TCAs), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John Wort may cause serotonin syndrome
              • Coadministration with CYP2D6 inhibitors may also increase risk by increasing exposure to dextroamphetamine
              • If this situation arises, consider use of an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6
              • Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).
              • Discontinue treatment and any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment
              • If coadministered with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate dextroamphetamine transdermal with lower doses, monitor for signs and symptoms of serotonin syndrome during drug initiation or titration
              • Inform patients of increased risk for serotonin syndrome

              Contact sensitization

              • May lead to contact sensitization (allergic contact dermatitis)
              • If contact dermatitis is suspected (erythema accompanied by more intense local reaction such as edema, papules, vesicles that does not significantly improve within 48 hr or spreads beyond the application site), discontinue treatment
              • Manifestations of systemic sensitization may include a flare-up of previous dermatitis or of prior positive patch-test sites, or generalized skin eruptions in previously unaffected skin
              • Patients who develop contact sensitization and require oral amphetamine treatment should be initiated under close medical supervision
              • Some patients may be sensitized to amphetamine by exposure to dextroamphetamine and may not be able to take amphetamine in any form

              Drug interaction overview

              • MAOIs
                • Contraindicated during and within 14 days following MAOI treatment
                • MAOIs slow amphetamine metabolism, increasing amphetamine’s effect on release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis
              • Serotonergic drugs
                • Initiate with lower doses; monitor for signs and symptoms of serotonin syndrome
                • Concomitant use of dextroamphetamine transdermal with serotonergic drugs may increase risk of serotonin syndrome
              • CYP2D6 inhibitors
                • Initiate with lower doses; monitor for signs and symptoms of serotonin syndrome
                • CYP2D6 inhibitors may increase the exposure of dextroamphetamine and increase the risk of serotonin syndrome
              • Alkalinizing agents
                • Avoid coadministration
                • Urinary alkalinizing agents can increase blood levels and potentiate the effects of amphetamine
              • Acidifying agents
                • Increase dose based on clinical response
                • Urinary acidifying agents can lower blood levels and efficacy of amphetamines
              • TCAs
                • Closely monitor and adjust or use alternant based on clinical response
                • Dextroamphetamine may enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in concentrations of dextroamphetamine in the brain; may also potentiate cardiovascular effects
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              Pregnancy & Lactation

              Pregnancy

              Available data from published epidemiologic studies and postmarketing reports on amphetamine use in pregnant females have not identified a drug-associated risk of major birth defects and miscarriage

              Clinical considerations

              • Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy
              • Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness

              Animal data

              • In a pre- and postnatal development study, amphetamine (d- to l- ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine
              • In addition, adverse effects on reproductive performance were observed in pups whose treated mothers
              • Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine

              Pregnancy exposure registry

              Lactation

              There are no reports of adverse effects on breastfed infants

              Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown

              Large doses of amphetamine may interfere with milk production, especially in women whose lactation is not well established

              Breastfeeding is not recommended during treatment

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Transdermal system contains dextroamphetamine, dextro isomer of the compound d,l-amphetamine

              Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity

              Mechanism of action in ADHD is unknown

              Absorption

              Peak plasma concentration (adults)

              • Single 18 mg/9 hr-dose: 44.6 ng/mL
              • Multiple 18 mg/9 hr-doses: 68.8 ng/mL

              Peak plasma time (adults)

              • Single 18 mg/9 hr-dose: 9 hr (single 18 mg/9 hr-dose)
              • Multiple 18 mg/9 hr-dose: 6 hr (single 18 mg/9 hr-dose)

              AUC (adults)

              • Single 18 mg/9 hr-dose: 996 ng·hr/mL
              • Multiple 18 mg/9 hr-doses: 1150 ng·hr/mL

              Effects of heating pad

              • Application of a heating pad on transdermal patch for 6 consecutive hr led to a faster absorption rate by 2 hr compared to without a heating pad

              Metabolism

              Reported to be oxidized to form 4-hydroxyamphetamine, alpha-hydroxy-amphetamine, or norephedrine

              Norephedrine and 4-hydroxyamphetamine: Both active and are oxidized to form 4-hydroxy-norephedrine

              Alpha-hydroxy-amphetamine: Deaminated to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and glycine conjugate hippuric acid

              CYP2D6 is known to be involved with formation of 4-hydroxyamphetamine

              Elimination

              Half-life: 6.4-11.5 hr (adults and pediatric patients)

              Excretion (normal pH): Urine (~50% of oral amphetamine as alpha-hydroxy-amphetamine and 30-40% as amphetamine)

              Pharmacogenomics

              Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism may occur

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              Administration

              Transdermal Administration

              Apply 1 patch at a time for ≤9 hr; use only 1 patch/24 hr

              Apply to clean (void of lotions, oils, or gels), dry (not wet), and intact skin at selected application site

              Application sites include hip, upper arm, chest, upper back, or flank

              Select a different application site each time a new transdermal system is applied

              Avoid touching adhesive side to avoid absorption of amphetamine

              If adhesive side is touched, immediately wash hands with soap and water

              If patch lifts at edges, reattach patch by pressing firmly and smoothing down edges of patch

              If patch comes off completely, apply a new patch

              Do not apply or reapply with dressings, tape, or other common adhesives

              Follow recommendations for discarding used and unused transdermal system

              Avoid exposing application site to direct external heat sources (eg, hair dryers, heating pads, electric blankets, heated water beds) while wearing transdermal system; heat to application site increases both rate and extent of absorption

              Storage

              Unopened transdermal patch

              • Store at 20-25°C (68-77°F); excursions permitted to 15-30ºC (59-86ºF)
              • Store in the individual sealed pouch until use; apply immediately upon removal from protective pouch

              Disposal instructions

              • Once removed, fold used transdermal systems so that adhesive side of system adheres to itself and place in a lidded container
              • Do not flush used transdermal system down toilet
              • If patient stops using the prescription, comply with local laws and regulations on drug disposal of CNS stimulants

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              Images

              No images available for this drug.
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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
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              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.