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 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 Monitor pregnancy outcomes in females exposed to ADHD medications during pregnancy Register by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/ 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 treatmentPregnancy 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. 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 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. 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. View explanations for tiers and restrictions 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 PA Prior Authorization 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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