height) in pediatric patients treated with stimulants; patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted Stimulants may lower the convulsive threshold in patients with a history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures; if seizures occur, discontinue drug Difficulties with accommodation and blurry vision reported Periodic complete blood cell count, differential, and platelet counts are advised during prolonged therapy Use may result in a persistent loss of skin pigmentation at and around the application site; monitor for signs of skin depigmentation and advise patients to immediately inform healthcare provider if changes in skin pigmentation occur; discontinue use in patients with chemical leukoderma Use may lead to contact sensitization; discontinue if contact sensitization is suspected Avoid exposing site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing the patch Psychiatric adverse reactions CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder CNS stimulants may also induce a manic or mixed episode in patients Before initiating treatment, screen for risk factors for developing a manic episode (eg, history or family history of suicide, bipolar disorder, and depression) CNS stimulants at recommended doses, may cause psychotic or manic symptoms (eg, hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania; consider discontinuing therapy if such symptom occur Serious cardiovascular reactions Sudden death, stroke, and myocardial infarction report in adults Sudden death reported in pediatric patients with structural cardiac abnormalities and other serious heart problems Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems Further evaluate for developing exertional chest pain, unexplained syncope, or arrhythmias during treatment Drug interaction overview MAOIs Contraindicated Do administer during or within 14 days of discontinuing MAOI treatment Coadministration of MAOIs with CNS stimulants can cause hypertensive crisis, which increases the risk of death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure Antihypertensive drugs Monitor BP and adjust dose of antihypertensive drugs accordingly Methylphenidate may decrease effectiveness of antihypertensive drugs Risperidone Monitor for signs of extrapyramidal symptoms (EPS) Dose changes in either risperidone and/or methylphenidate may increase the risk of EPS Vasopressor agents Use with caution Vasopressors may exacerbate the effects of methylphenidate on BP Anticoagulants, antidepressants, and selective serotonin reuptake inhibitors Decrease adjustments of these drugs may be required when coadministered methylphenidate; monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing methylphenidate Studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), and some tricyclic drugs (eg, imipramine, clomipramine, desipramine) and selective serotonin reuptake inhibitors Pregnancy Published studies and postmarketing reports on use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes Animal data No teratogenic effects were observed with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 2x and 9x the maximum recommended human dose (MRHD) of 100 mg/day given to adolescents on a mg/m2 basis, respectively However, spina bifida was observed in rabbits at a dose 31x the MRHD given to adolescents Decrease in pup body weight was observed in a pre- and postnatal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 3.5x the MRHD given to adolescents Clinical considerations CNS stimulant medications can cause vasoconstriction and thereby decrease placental perfusion No fetal and/or neonatal adverse reactions reported with use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers Pregnancy exposure registry Monitors pregnancy outcomes in females exposed to ADHD medications Encourage providers to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 Lactation Limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk There are no reports of adverse effects on breastfed infant and no effects on milk production; however, long-term neurodevelopmental effects on infants from CNS stimulant exposure are unknown Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gainPregnancy 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 Mechanism of action is unknown May block reuptake of norepinephrine and dopamine into presynaptic neurons; may stimulate CNS like amphetamines; may stimulate cerebral cortex and subcortical structures Absorption Peak plasma concentration (steady-state) Children: 15.7 ng/mL (12.5 cm2); 42.9 ng/mL (37.5 cm2) Adolescents: 8.32 ng/mL (12.5 cm2); 16.5 ng/mL (37.5 cm2) Minimum plasma concentration (steady-state) Children: 1.04 ng/mL (12.5 cm2); 1.96 ng/mL (37.5 cm2) Peak: 0.544 ng/mL (12.5 cm2); 1.02 ng/mL (37.5 cm2) AUC (steady-state) Children: 163 ng·hr/mL (12.5 cm2); 447 ng·hr/mL (37.5 cm2) Adolescents: 85.7 ng·hr/mL (12.5 cm2); 167 ng·hr/mL (37.5 cm2) Heat exposure When applied to inflamed skin both the rate and extent of absorption are increased as compared with intact skin When applied to inflamed skin, lag time is no greater than 1 hr, peak plasma time is 4 hr, and both Cmax and AUC are approximately 3-fold higher Metabolism Metabolized mostly to a-phenyl-2-piperidine acetic acid (PPAA) Topical Administration Apply patch on hip 2 hr before desired onset; remove after 9 hr; alternate application site Place adhesive side on a clean, dry area of the hip; area should not be oily, damaged, or irritated; apply patch to hip area avoiding the waistline, since clothing may cause the patch to rub off If patients or caregivers experience difficulty separating patch from release liner or observe transfer of adhesive to liner, tearing and/or other damage to patch during removal from liner, discard patch and apply a new patch; patients or caregivers should inspect release liner to ensure that no adhesive containing medication has transferred to the liner If adhesive transfer has occurred, discard patch Apply intact patches only; press tpatch firmly in place with the palm of the hand for approximately 30 seconds, making sure that there is good contact of the patch with the skin, especially around edges; exposure to water during bathing, swimming, or showering can affect patch adherence; patches should not be applied or re-applied with dressings, tape, or other common adhesives Advise patients to avoid exposing application site to direct external heat sources (eg, hair dryers, heating pads, electric blankets, heated water beds) while wearing the patch When heat is applied to patch application, both rate and extent of absorption are significantly increased Removal of patch Peel off slowly If necessary, gently apply an oil-based product (eg, petroleum jelly, olive oil, mineral oil) to the patch edges, gently working the oil underneath the patch edges If any adhesive remains on skin following patch removal, apply an oil-based product to patch sites and remove any residual adhesive that remains Storage Unopened patches: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F); store in protective pouch Opened patches: Use patches within 2 months; once an individual patch has been removed from the pouch, use immediately; do not refrigerate or freeze Disposal of patches: Fold patch so that adhesive side adheres to itself and should be flushed down the toilet or disposed of in an appropriate lidded container If patient stops using medication, remove each unused patch from its individual pouch, separated from the protective liner, folded onto itself, and disposed of in same manner as used patches 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. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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