evidence of seizures; discontinue therapy in the presence of seizures Use with caution in patients who use other sympathomimetic drugs Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections Drug interaction overview Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism; potential for a pharmacokinetic interaction exists with coadministration of CYP2D6 inhibitors which may increase risk with increased exposure to amphetamines and derivatives; in these situations, consider alternative non-serotonergic drug or alternative drug that does not inhibit CYP2D6 If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor patients for emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome Pregnancy Pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified drug-associated risk of major birth defects and miscarriage; adverse pregnancy outcomes, including premature delivery and low birth weight, reported in infants born to mothers taking amphetamines during pregnancy Amphetamines cause vasoconstriction and thereby may decrease placental perfusion; in addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery; infants born to mothers taking amphetamines during pregnancy have increased risk of premature delivery and low birth weight Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness Animal data No apparent effects on morphological development reported in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis at doses 2 and 12 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day given to adolescents, on a mg/m² basis However, in a pre- and post-natal 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 Adverse effects on reproductive performance observed in pups whose mothers were treated with amphetamine; long-term neurochemical and behavioral effects reported in animal developmental studies using clinically relevant doses of amphetamine Lactation Based on limited case reports in published literature, amphetamine is present in human milk; there are no reports of adverse effects on breastfed infant Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown; large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established Because of potential for serious adverse reactions in nursing infants, advise patients that breastfeeding is not recommended during therapyPregnancy 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 Sympathomimetic amine that promotes release of dopamine and norepinephrine from their storage sites in the presynaptic nerve terminals; may also block reuptake of catecholamines by competitive inhibition Absorption Well absorbed Onset of action: 30-60 min Duration: 4-6 hr Vd: 3.5-4.6 L/kg (distributes into CNS; mean CSF concentrations are 80% of plasma) Peak plasma time: 3 hr (Adderall); 7 hr (Adderall XR) Metabolism Hepatic via glucuronidation and CYP450 mono-oxygenase Elimination Half-life elimination (children) 6-12 years: 9 hr (d-amphetamine); 11 hr (l-amphetamine) 12-18 years: 11 hr (d-amphetamine); 13-14 hr (l-amphetamine) Half-life elimination (adults) d-amphetamine: 10 hr l-amphetamine: 13 hr Excretion Urine; dependent on urinary pH Oral Administration Tablet May take with or without food Give first dose on awakening; give additional doses (1 or 2) at intervals of 4-6 hr Avoid late evening doses owing to potential insomnia Extended-release capsule May take with or without food Take in morning upon awakening; avoid afternoon doses owing to potential insomnia Swallow capsule whole, OR Open capsule and sprinkle the entire content over a spoonful of applesauce and consume immediately without chewing (do not store) Do not divide content of a single capsule 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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