Version May 2024
The FDA is requiring updates to the Boxed Warning and other sections in the prescribing information of prescription stimulants to ensure consistency across the class of medicines and address continuing concerns of misuse, abuse, addiction, and overdose. The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get them from other family members or peers. The FDA is adding information that patients should never share prescription stimulants with anyone, and the Boxed Warning will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class, as well as advise health care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction. Information on these risks is being required in several sections of the prescribing information, including Warnings and Precautions, Drug Abuse and Dependence, Overdosage, and Patient Counseling sections; updates to existing Medication Guides are also required to help educate patients and caregivers about these risks.
Further information can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditions.
Dexmethylphenidate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing dexmethylphenidate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dexmethylphenidate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Attention-deficit/hyperactivity disorder (ADHD):
Note: Initial dosing is for patients not currently on methylphenidate or who are on other stimulants. See dosing conversion that follows for patients switching from methylphenidate. Reduce dose or discontinue in patients with paradoxical aggravation of symptoms or other adverse events. Discontinue if no improvement is seen after appropriate dosage adjustment over a 1-month period of time.
Children ≥6 years and Adolescents:
Patients not currently taking methylphenidate:
Immediate release: Oral: Initial: 2.5 mg twice daily; doses should be taken at least 4 hours apart; dosage may be adjusted in increments of 2.5 to 5 mg at weekly intervals; maximum daily dose: 20 mg/day; however, some patients may require and tolerate daily doses up to 50 mg/day with frequent monitoring (Ref)
Extended release: Oral: Initial: 5 mg once daily; dosage may be adjusted in increments of 5 mg/day at weekly intervals; maximum daily dose: 30 mg/day; however, some patients may require and tolerate daily doses up to 50 mg/day with frequent monitoring (Ref)
Conversion to dexmethylphenidate from methylphenidate:
Immediate release: Initial: Half the total daily dose of racemic methylphenidate; maximum daily dexmethylphenidate dose: 20 mg/day; however, some patients may require and tolerate daily doses up to 50 mg/day with frequent monitoring (Ref)
Extended release: Initial: Half the total daily dose of racemic methylphenidate; maximum daily dexmethylphenidate dose: 30 mg/day; however, some patients may require and tolerate daily doses up to 50 mg/day with frequent monitoring (Ref)
Conversion from dexmethylphenidate immediate release to dexmethylphenidate extended release: When changing from Focalin tablets to Focalin XR capsules, switch to the same daily dose using Focalin XR; maximum daily dose: 30 mg/day; however, some patients may require and tolerate daily doses up to 50 mg/day with frequent monitoring (Ref)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥6 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; however, since very little unchanged drug is eliminated in the urine, dosage adjustment in renal impairment is not expected to be required.
Children ≥6 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling (not studied); use with caution.
(For additional information see "Dexmethylphenidate: Drug information")
Attention-deficit/hyperactivity disorder (alternative agent) (Ref): Note: Initial dosing is for patients not currently taking methylphenidate or who are on other stimulants. See dosing conversion that follows for patients switching from methylphenidate.
Immediate release: Oral: Initial: 2.5 mg twice daily; may increase dose based on response and tolerability in increments of 2.5 to 5 mg at weekly intervals up to a maximum dose of 20 mg/day.
Extended release: Oral: Initial: 10 mg once daily; may increase dose based on response and tolerability in increments of 10 mg at weekly intervals up to a maximum dose of 40 mg/day.
Dosing conversions:
IR and ER dexmethylphenidate: Convert using the same total daily dose (up to the maximum recommended dose for given dosage form); adjust frequency as indicated for IR (twice daily) and ER products (once daily).
Methylphenidate to dexmethylphenidate: Initiate dexmethylphenidate IR or ER at one-half the total daily dose of racemic methylphenidate.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, considering extensive metabolism to inactive compounds, renal insufficiency expected to have minimal effect on kinetics of dexmethylphenidate.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults unless otherwise indicated.
>10%:
Gastrointestinal: Abdominal pain (children and adolescents: 15%), decreased appetite (children and adolescents: 30%), xerostomia (adults: 7% to 20%)
Nervous system: Anxiety (5% to 11%), headache (children and adolescents: 25%; adults: 26% to 39%), insomnia (children and adolescents: 5% to 17%), jitteriness (adults: 12%)
1% to 10%:
Dermatologic: Pruritus (children and adolescents: 3%)
Gastrointestinal: Anorexia (children and adolescents: 5% to 7%), dyspepsia (5% to 9%), nausea (children and adolescents: 9%), vomiting (children and adolescents: 2% to 9%)
Nervous system: Depression (children and adolescents: 3%), dizziness (adults: 6%), emotional lability (children and adolescents: 3%), irritability (children and adolescents: 2% to 5%), emotional lability (children and adolescents: 3%)
Respiratory: Nasal congestion (children and adolescents: 5%), pharyngolaryngeal pain (adults: 4% to 7%)
Miscellaneous: Fever (children and adolescents: 5%)
Frequency not defined:
Cardiovascular: Decreased diastolic blood pressure (adults), peripheral vascular disease, Raynaud disease, tachycardia
Endocrine & metabolic: Weight loss (adults)
Nervous system: Drug abuse, drug dependence, tic disorder (motor tics and vocal tics)
Postmarketing:
Hypersensitivity: Hypersensitivity reactions (including anaphylaxis, angioedema)
Neuromuscular & skeletal: Rhabdomyolysis
Hypersensitivity (eg, angioedema, anaphylaxis) to methylphenidate or any component of the formulation; concurrent use with or within 14 days following discontinuation with monoamine oxidase inhibitors.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Cardiovascular events: CNS stimulant treatment has been associated with sudden death in children and adolescents with preexisting structural cardiac abnormalities and sudden death, stroke, and MI have been reported in adults. Consistent with other studies, a large retrospective cohort study involving 1,200,438 children, adolescents, and young adults (aged 2 to 24 years) prescribed methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, pemoline, or atomoxetine found no evidence that current use of an ADHD medication increased risk for sudden cardiac death, acute MI, or stroke (Cooper 2011). Stimulants should be avoided in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, Marfan syndrome, or other serious cardiac problems. Some products are contraindicated in patients with moderate or severe hypertension, angina, heart failure, arrhythmias, or recent MI. Prior to initiating stimulant, assess medical history and family history of sudden death or ventricular arrhythmia; conduct a physical exam to assess for cardiac disease; patients should receive further evaluation if findings suggest cardiac disease, such as ECG and echocardiogram. Promptly conduct cardiac evaluation in patients who develop exertional chest pain, unexplained syncope, or any other symptoms of cardiac disease during stimulant treatment.
• Hypersensitivity reactions: Hypersensitivity reactions including angioedema and anaphylactic reactions have been observed in patients treated with methylphenidate.
• Ocular effects: Acute angle closure glaucoma and increased intraocular pressure have been reported with methylphenidate treatment. Evaluation by an ophthalmologist prior to treatment is recommended in patients at risk for acute angle closure glaucoma (eg, patients with significant hyperopia); use dexmethylphenidate in patients with open angle glaucoma or increased intraocular pressure only if benefits outweigh risks.
• Peripheral vasculopathy: Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs/symptoms are usually mild and intermittent, and generally improve with dose reduction or discontinuation. Peripheral vasculopathy effects have been observed at different times, at therapeutic doses, and in all age groups. Digital ulceration and/or soft tissue breakdown have been observed; further evaluation (eg, rheumatology) may be necessary in patients developing signs and symptoms of peripheral vasculopathy.
• Priapism: Prolonged (>4 hours), painful, and nonpainful erections, sometimes requiring surgical intervention, have been reported with use of other stimulants (methylphenidate, atomoxetine) in pediatric and adult patients according to the manufacturers' labeling and a 2013 FDA warning; there are at least 22 published cases (Baytunca 2016; Bozkurt 2017; Chauhan 2016; Eiland 2014; Esnafoglu 2017; Mann 2017; Unver 2017). Priapism has been reported to develop after some time on the drug, often subsequent to an increase in dose but also during a period of drug withdrawal (drug holidays or discontinuation). Patients with certain hematological dyscrasias (eg, sickle cell disease), malignancies, perineal trauma, or concomitant use of alcohol, illicit drugs, or other medications associated with priapism may be at increased risk (Eiland 2014). Patients who develop abnormally sustained or frequent and painful erections should discontinue therapy and seek immediate medical attention. An emergent urological consultation should be obtained in severe cases. In patients with severe cases of priapism that were slow to resolve and/or required detumescence by aspiration, avoidance of stimulants and atomoxetine may be preferred (Eiland 2014).
• Visual disturbance: Difficulty in accommodation and blurred vision has been reported with the use of stimulants.
Disease-related concerns:
• Cardiovascular disorders: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
• Psychiatric disorders: Use with caution in patients with preexisting psychosis (may exacerbate symptoms of behavior and thought disorder) or bipolar disorder (may induce mixed/manic episode). New-onset psychosis or mania may occur with stimulant use. Patients should be screened for bipolar disorder and risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms; family history of suicide, bipolar disorder, or depression); consider discontinuation if psychotic or manic symptoms (eg, delusional thinking, hallucinations, mania) occur. May be associated with aggressive behavior or hostility in children (causal relationship not established); monitor for development or worsening of these behaviors. Patients with ADHD are at increased risk for suicidal ideation and suicide attempt; however, neither increased risk nor a causal relationship with methylphenidate and attempted suicide has been observed in large cohort trials (Huang 2018; Man 2017). Monitor for suicide-related behavior.
• Seizure disorder: Limited information exists regarding stimulant use in seizure disorder. Whereas patients with ADHD are at an increased risk for seizure activity compared to the general population, a retrospective study using drug claims data showed that the use of stimulant medications was associated with a lower risk (Cortese 2013; Wiggs 2018). Manufacturers of some stimulants recommend discontinuing therapy if seizures occur.
• Tourette syndrome/tics: Use with caution in patients with Tourette syndrome or other tic disorders. Stimulants may exacerbate tics (motor and phonic) and Tourette syndrome; however, evidence demonstrating increased tics is limited. Evaluate for tics and Tourette syndrome prior to therapy initiation (AACAP [Murphy 2013; Pliszka 2007]).
Special populations:
• Pediatric: Use of stimulants has been associated with appetite suppression, weight loss, and slowing of growth rate; monitor growth rate, height, and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.
Other warnings/precautions:
• Discontinuation of therapy: Abrupt discontinuation, rapid dose reduction, or administration of an antagonist may result in withdrawal symptoms including dysphoric mood, fatigue, vivid, unpleasant dreams, insomnia or hypersomnia, increased appetite, and psychomotor retardation or agitation.
CNS stimulant treatment has been associated with sudden death in children and adolescents with preexisting structural cardiac abnormalities; one study reported methylphenidate increased risk for arrhythmia and MI in youth without congenital heart disease (Shin 2016) and a retrospective case-control study reported an association with stimulants and sudden unexplained death in youth (Gould 2009). However, as noted in reviews (Martinez-Raga 2013; Westover 2012) several large studies have not found an association between prescription stimulants and cardiovascular events; though most retrospective studies were large (n=55,383 to 2,131,953), some had statistical power or methodological limitations (Westover 2012). A large retrospective cohort study involving 1,200,438 children and young adults (aged 2 to 24 years) prescribed ADHD medication (methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, pemoline, or atomoxetine) found no evidence that ADHD medication was associated with an increased risk of serious cardiovascular events (ie, acute MI, sudden cardiac death, stroke) in current (adjusted hazard ratio: 0.75; 95% CI: 0.31 to 1.85) or former (adjusted hazard ratio: 1.03; 95% CI: 0.57 to 1.89) users compared with nonusers, nor in current compared with former users. Results were similar with multiple alternative analyses to assess for bias or study assumptions. While point estimates of relative risks for ADHD drugs did not demonstrate increased risk, the upper limit of the 95% CI suggested a doubling of the risk could not be ruled out, although absolute magnitude of increased risk would be low. Data on any individual medication, other than methylphenidate, were too sparse for separate regression analyses (Cooper 2011). Prior to treatment with medications for ADHD, the American Heart Association and the American Academy of Pediatrics recommend that all children and adolescents diagnosed with ADHD have a thorough cardiovascular assessment, including patient and family health histories, determination of all medications used (prescribed and over-the-counter), and a physical examination focused on cardiovascular disease risk factors. An ECG is not mandatory but is reasonable to consider prior to stimulant medication therapy. Prompt evaluation and appropriate referral and testing, if warranted, should occur if any cardiac symptoms present (Vetter 2008).
Evaluation of the effect of stimulants on growth in ADHD diagnosed children <12 years receiving treatment for at least 3 years with stimulants has shown decreased height and weight changes over time compared to age matched control; height: 4.7 to 5.5 cm/year compared to 6.3 cm/year and 2.1 to 3.3 kg/year compared to 4.4 kg/year (Poulton 2016). In 5,315 pediatric patients (age range: 8 to 17 years) actively treated with stimulants (methylphenidate, dexmethylphenidate, dextroamphetamine, atomoxetine, lisdexamfetamine), significant reductions in total femoral, femoral neck, and lumbar bone mineral density (BMD) were observed compared to matched unmedicated controls (n=1,967); also reported were significantly more subjects in the stimulant-treated group with BMD measurements in the osteopenic range compared to matched controls (38.3% to 21.6%); of note, there were no data on duration of medication treatment, dosing, or therapy changes (Howard 2017). A longitudinal cohort-controlled trial reported no different in peak height velocity and final adult height in subjects with ADHD and/or treated with stimulants (Harstad 2014).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule Extended Release 24 Hour, Oral, as hydrochloride:
Focalin XR: 5 mg [contains fd&c blue #2 (indigotine,indigo carmine)]
Focalin XR: 10 mg
Focalin XR: 15 mg [contains fd&c blue #2 (indigotine,indigo carmine)]
Focalin XR: 20 mg
Focalin XR: 25 mg [contains fd&c blue #2 (indigotine,indigo carmine)]
Focalin XR: 30 mg
Focalin XR: 35 mg, 40 mg [contains fd&c blue #2 (indigotine,indigo carmine)]
Generic: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg
Tablet, Oral, as hydrochloride:
Focalin: 2.5 mg, 5 mg, 10 mg
Generic: 2.5 mg, 5 mg, 10 mg
Yes
Capsule ER 24 Hour Therapy Pack (Dexmethylphenidate HCl ER Oral)
5 mg (per each): $7.80 - $9.46
10 mg (per each): $9.10 - $16.45
15 mg (per each): $7.41 - $10.22
20 mg (per each): $9.36 - $16.11
25 mg (per each): $11.73 - $22.26
30 mg (per each): $7.13 - $15.10
35 mg (per each): $12.32 - $23.86
40 mg (per each): $8.17 - $15.30
Capsule ER 24 Hour Therapy Pack (Focalin XR Oral)
5 mg (per each): $16.30
10 mg (per each): $16.54
15 mg (per each): $17.01
20 mg (per each): $17.01
25 mg (per each): $17.86
30 mg (per each): $16.39
35 mg (per each): $18.76
40 mg (per each): $18.76
Tablets (Dexmethylphenidate HCl Oral)
2.5 mg (per each): $0.68
5 mg (per each): $0.97
10 mg (per each): $1.40
Tablets (Focalin Oral)
2.5 mg (per each): $0.81
5 mg (per each): $1.16
10 mg (per each): $1.67
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Treatment with dexmethylphenidate should include "drug holidays" or periodic discontinuation in order to assess the patient's requirements, decrease tolerance, and limit suppression of linear growth and weight. Medications used to treat ADHD should be part of a total treatment program that may include other components such as psychological, educational, and social measures.
Focalin XR capsules use a bimodal release where 1/2 the dose is provided in immediate release beads and 1/2 the dose is in delayed release beads. A single, once-daily dose of a capsule provides the same amount of dexmethylphenidate as two tablets given 4 hours apart. The modified release properties of Focalin XR capsules are pH dependent; thus, concomitant administration of antacids or acid suppressants might alter the release of dexmethylphenidate.
C-II
Oral:
Immediate release: Twice-daily dosing should be administered at least 4 hours apart; may be administered with or without food.
Extended release: Administer once daily in the morning with or without food. Do not crush, chew, or divide capsule; swallow whole. Capsule may be opened and contents sprinkled over a spoonful of applesauce; consume immediately and entirely; do not store for future use.
Extended release: Administer once daily in the morning with or without food; do not crush, chew, or divide. Capsules may be opened and contents sprinkled over a spoonful of applesauce; consume immediately and swallow without chewing; do not store for future use.
Immediate release: Administer twice daily at least 4 hours apart; may be taken with or without food.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Focalin: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021278s028s031lbl.pdf#page=17
Focalin XR: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021802s038s041lbl.pdf#page=20
Treatment of attention-deficit/hyperactivity disorder (ADHD) (FDA approved in ages ≥6 years and adults)
Dexmethylphenidate may be confused with dexmethylphenidate mixed salts, methadone
Focalin may be confused with Focalgin-B, Folotyn
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Risk X: Avoid combination
Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Risk C: Monitor therapy
Amisulpride (Oral): Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Amisulpride (Oral). Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Antihypertensive Agents: Dexmethylphenidate may diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy
Antipsychotic Agents: May enhance the adverse/toxic effect of Dexmethylphenidate-Methylphenidate. Dexmethylphenidate-Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk of extrapyramidal symptoms may be increased when these agents are combined. Risk C: Monitor therapy
ARIPiprazole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ARIPiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
ARIPiprazole Lauroxil: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ARIPiprazole Lauroxil. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Asenapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Asenapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Benperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Benperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Blonanserin: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Blonanserin. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Brexpiprazole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Brexpiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Bromperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Bromperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Risk C: Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Cariprazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Cariprazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
ChlorproMAZINE: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ChlorproMAZINE. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Clothiapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Clothiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
CloZAPine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy
DroPERidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of DroPERidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Esketamine: May enhance the hypertensive effect of CNS Stimulants. Risk C: Monitor therapy
Flupentixol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Flupentixol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
FluPHENAZine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of FluPHENAZine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Haloperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Haloperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Iloperidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iloperidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Inhalational Anesthetics: Dexmethylphenidate-Methylphenidate may enhance the hypertensive effect of Inhalational Anesthetics. Risk X: Avoid combination
Iobenguane Radiopharmaceutical Products: CNS Stimulants may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Ioflupane I 123: Dexmethylphenidate may diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy
Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification
Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification
Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification
Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination
Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy
Loxapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Loxapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Lumateperone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Lumateperone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Lurasidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Lurasidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Methotrimeprazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Methotrimeprazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Molindone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Molindone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Dexmethylphenidate. Risk X: Avoid combination
OLANZapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of OLANZapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Paliperidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Paliperidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Periciazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Periciazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Perphenazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Perphenazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
PHENobarbital: Dexmethylphenidate may increase the serum concentration of PHENobarbital. Risk C: Monitor therapy
Pimozide: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Pimozide. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Pipamperone [INT]: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Pipamperone [INT]. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Polyethylene Glycol-Electrolyte Solution: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Specifically, the risk of seizure may be increased. Risk C: Monitor therapy
Primidone: Dexmethylphenidate may increase serum concentrations of the active metabolite(s) of Primidone. Specifically, phenobarbital concentrations could become elevated. Dexmethylphenidate may increase the serum concentration of Primidone. Risk C: Monitor therapy
Prochlorperazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Prochlorperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Promazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Promazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
QUEtiapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of QUEtiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
RisperiDONE: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of RisperiDONE. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Serotonergic Agents (High Risk): Dexmethylphenidate-Methylphenidate may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: Monitor therapy
Sertindole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sertindole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Sodium Phosphates: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sodium Phosphates. Specifically, the risk of seizure or loss of consciousness may be increased in patients with significant sodium phosphate-induced fluid or electrolyte abnormalities. Risk C: Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Sulpiride: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sulpiride. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Thioridazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Thioridazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Thiothixene: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Thiothixene. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Trifluoperazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Trifluoperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Ziprasidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Ziprasidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
Zuclopenthixol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Zuclopenthixol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy
High-fat meal may increase time to peak concentration. Management: Administer without regard to meals.
Dexmethylphenidate is the more active d-threo enantiomer of racemic methylphenidate; refer to the methylphenidate monograph for additional information.
Prior to initiation of therapy: Assess medical history and family history of sudden death or ventricular arrhythmia, and physical exam to assess for cardiac disease; patients should receive further evaluation if findings suggest cardiac disease, such as ECG and echocardiogram; promptly conduct cardiac evaluation in patients who develop exertional chest pain, unexplained syncope, or any other symptom of cardiac disease during treatment. For children already taking a simulant, it is reasonable to evaluate medical and family history, review physical examination, and order ECG if not done prior to initiation (Vetter 2008).
Periodically during therapy monitor the following: Growth (weight and height parameters in children and adolescents; baseline and periodically during therapy), CBC with differential and platelet count, liver enzymes, blood pressure and heart rate (baseline, following dose increases, and periodically during treatment), appetite, and sleep patterns. Observe for abnormal movements or worsening of tics or Tourette syndrome, and intraocular pressure changes in patients with history of open angle glaucoma or increased intraocular pressure or visual disturbances.
Patients should be reevaluated at appropriate intervals to assess continued need of the medication. Observe for signs/symptoms of new or worsening aggression or hostility, depression, delusional thinking, hallucinations, or mania. Observe for digital changes suggestive of peripheral vasculopathy (eg, Raynaud phenomenon). Monitor for signs of misuse, abuse, substance use disorder, and diversion.
Dexmethylphenidate is the more active, d-threo-enantiomer, of racemic methylphenidate. It is a CNS stimulant; blocks the reuptake of norepinephrine and dopamine, and increases their release into the extraneuronal space.
Onset of action: Rapid, within 1 to 2 hours of an effective dose
Duration of action: Immediate release: 3 to 5 hours; extended release: 9 to 12 hours (Dopheide 2009)
Absorption: Immediate release: Rapid; Extended release: Bimodal (with 2 peak concentrations ~4 hours apart)
Distribution: Vd: 2.65 ± 1.11 L/kg
Protein binding: Unknown; racemic methylphenidate: 12% to 15%
Metabolism: Via de-esterification to inactive metabolite, d-α-phenyl-piperidine acetate (d-ritalinic acid)
Bioavailability: 22% to 25%
Half-life elimination: Immediate release:
Children: 2 to 3 hours
Adults: 3 hours
Time to peak: Fasting:
Immediate release: 1 to 1.5 hours; after a high-fat meal: 2.9 hours
Extended release: First peak: 1.5 hours (range: 1 to 4 hours); Second peak: 6.5 hours (range: 4.5 to 7 hours)
Excretion: Urine (90%, primarily as inactive metabolite)
Pediatric: Children showed somewhat lower AUCs after administration of dexmethylphenidate immediate release.
Sex: In adults, the AUC of dexmethylphenidate immediate release was 25% to 35% higher in women compared with men. After administration of dexmethylphenidate ER, the first peak (Cmax) was 45% higher in women. Parameters for dexmethylphenidate immediate release were similar for boys and girls.
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