Brand names: Aptensio, Concerta, Cotempla, Daytrana, Jornay, ... show all 10 brands Methylin, QuilliChew, Quillivant, Relexxii, Ritalin
Drug class: Respiratory and CNS Stimulants

Medically reviewed by Drugs.com on Sep 10, 2025. Written by ASHP.

Introduction

Piperidine-derivative; CNS stimulant.

Uses for Methylphenidate

Attention Deficit Hyperactivity Disorder (ADHD)

Used orally (as methylphenidate hydrochloride immediate-release conventional tablets [Ritalin], oral solution [Methylin], and chewable tablets; also, as extended-release oral suspension [Quillivant XR], tablets, capsules [Aptensio XR], chewable tablets [Quillichew ER], and delayed- and extended-release capsules [Jornay PM]) for the treatment of ADHD in adults and pediatric patients ≥6 years of age.

Used orally (as methylphenidate hydrochloride extended-release trilayer core tablets [Concerta] and bilayer core tablets [Relexxii] for the treatment of ADHD in adults ≤65 years of age and pediatric patients ≥6 years of age.

Used orally (as methylphenidate hydrochloride CD extended-release capsules [generic equivalent of Metadate CD]) for the treatment of ADHD in pediatric patients 6–15 years of age.

Used orally (as methylphenidate hydrochloride extended-release capsules [Ritalin LA]) for the treatment of ADHD in pediatric patients 6–12 years of age.

Used orally (as methylphenidate extended-release orally disintegrating tablets [Cotempla XR-ODT]) and transdermally (as methylphenidate transdermal system [Daytrana]) for the treatment of ADHD in pediatric patients between 6–17 years of age.

Safety and efficacy in children <6 years of age^{† [off-label]} not established, but has been evaluated in several controlled clinical studies in children up to 6 years of age.

The American Academy of Pediatrics (AAP) has developed guidelines for children and adolescents with ADHD. For pediatric patients 6–12 years of age, an FDA-approved drug for ADHD should be prescribed, in addition to parent training in behavior management (PTBM) and/or behavioral classroom interventions. For choice of medication, evidence is particularly strong for stimulant medications (e.g., methylphenidate). For adolescents 12–18 years, an FDA-approved drug should be prescribed with the adolescent's assent. Behavioral and other evidence-based training interventions should also be prescribed if available.

AAP states that methylphenidate may be considered for treatment of ADHD in preschool-aged children^{† [off-label]} (4 years of age to the sixth birthday) if first-line treatments (i.e., PTBM and/or behavioral classroom interventions) do not provide substantial improvement and there is continued moderate to severe disturbance in the child's functioning.

International experts have published recommendations for the treatment of ADHD in adults. Treatment of ADHD in adults should follow a multimodal approach that includes psychoeducation, pharmacotherapy, cognitive behavior therapy, and coaching for ADHD. First-line pharmacotherapy agents include long-acting stimulants such as mixed amphetamine salts, methylphenidate, and lisdexamfetamine.

Narcolepsy

Used orally (as methylphenidate hydrochloride immediate-release conventional tablets [Ritalin], oral solution [Methylin], chewable tablets, and extended-release tablets) for the treatment of narcolepsy.

The American Academy of Sleep Medicine (AASM) provides a strong recommendation for the use of several agents for the treatment of narcolepsy in adults, including modafinil, pitolisant, sodium oxybate, and solriamfetol. A conditional recommendation is given for armodafinil, dextroamphetamine, and methylphenidate.

Autism Spectrum Disorder (ASD)† [off-label]

Has been used for the symptomatic treatment of inattention, impulsivity, and hyperactivity in pediatric patients 6-18 years of age with ASD.

Guidelines from AAP suggest the use of psychostimulants (e.g., methylphenidate, dexmethylphenidate, mixed amphetamine salts, lisdexamfetamine, dextroamphetamine) for symptoms of hyperactivity, impulsivity, inattention, and distractibility in pediatric patients with ASD if problems persist after behavioral interventions. Patients should start with a low dose, with increases as needed and tolerated. Stimulants may be most effective in children who do not have a comorbid intellectual disability.

Amphetamine-type Stimulant Use Disorder† [off-label]

Has been used for the treatment of amphetamine-type stimulant use disorder.

American Society of Addiction Medicine (ASAM) and American Academy of Addiction Psychiatry (AAAP) guidelines state that long-acting methylphenidate may be considered as a treatment option to reduce use of amphetamine-type stimulants. For patients with a moderate or higher frequency of use of amphetamine-type stimulants (i.e., ≥10 days per month) or for patients with co-occurring ADHD, long-acting methylphenidate can be given additional consideration.

Idiopathic Hypersomnia† [off-label]

Has been used for the treatment of idiopathic hypersomnia.

AASM guidelines state that methylphenidate (versus no treatment) is suggested for the treatment of idiopathic hypersomnia in adults.

Methylphenidate Dosage and Administration

General

Pretreatment Screening

• Evaluate pediatric patients and adults for cardiac disease (i.e., obtain careful medical history, perform physical examination, and screen for family history of sudden death or ventricular arrhythmias).

• Screen for a family history and clinically evaluate for motor or verbal tics or Tourette’s syndrome prior to initiating therapy.

• Because CNS stimulants, including methylphenidate, have a high potential for abuse and dependence, assess the risk of abuse, misuse, and addiction prior to initiating therapy.

• Screen for pre-existing psychotic or manic symptoms/illness, risk factors for developing a manic episode (comorbid or history of depressive symptoms or family history of suicide, bipolar disorder, or depression.

• Due to the risk of GI obstruction with methylphenidate extended-release bilayer and trilayer core tablets (e.g., Relexxii, Concerta, generics), screen for pre-existing esophageal motility disorders, small bowel inflammatory disease, short gut syndrome, past history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel's diverticulum.

• Because QuilliChew ER contains phenylalanine, consider total combined daily amount of phenylalanine from all sources prior to initiating in patients with phenylketonuria.

Patient Monitoring

• Routinely monitor patients receiving methylphenidate therapy for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically needed.

• Monitor patients receiving stimulants for signs of abuse, misuse, and addiction during therapy.

• Monitor all patients for the development of hypertension and tachycardia.

• Periodic monitoring of CBC, differential, and platelet counts are recommended during prolonged therapy.

• Closely monitor growth (height and weight) in children receiving methylphenidate therapy.

• Closely monitor patients with a history of increased intraocular pressure (IOP) or open angle glaucoma for ophthalmologic changes.

• Monitor patients receiving the methylphenidate transdermal system for loss of skin pigmentation, especially at application sites.

• Monitor for the emergence of seizures.

• Monitor for digital changes due to risk of Raynaud's phenomenon.

• Monitor for the emergence or worsening of psychotic or manic symptoms/episodes.

Dispensing and Administration Precautions

Handling and Disposal

• Methylphenidate should be disposed of by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site when it is no longer needed. If there is no take-back program or authorized DEA collection site available, the drug can be mixed with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds and disposed of in a sealed plastic bag in the household trash. After removal of a methylphenidate transdermal system, fold used systems so that the adhesive side adheres to itself and then flush down the toilet or dispose of in an appropriate lidded container. Any unused systems that are no longer needed should be removed from their packaging, separated from the protective liner, folded so that the adhesive side adheres to itself, and then flushed down the toilet or disposed of in an appropriate lidded container.

• The Institute for Safe Medication Practices (ISMP) includes methylphenidate and methadone on their List of Confused Drug Names, and recommends using special safeguards to ensure the accuracy of prescriptions for these drugs.

Administration

Administer orally or percutaneously by topical application of a transdermal system.

Oral Administration

Immediate-release Preparations (Conventional Tablets, Chewable Tablets, or Oral Solution)

Administer 2 or 3 times daily.

The manufacturers recommend that conventional tablets, chewable tablets, or oral solution be taken 30–45 minutes before meals.

To avoid insomnia, administer the last daily dose before 6 p.m.

Administer chewable tablets with a full glass (i.e., ≥240 mL [8 ounces]) of water or other fluid to avoid choking.

Extended-release Tablets (Generics)

Swallow tablets whole; do not crush or chew.

May be used when the 8-hour dosage of the extended-release preparation corresponds to the titrated 8-hour dosage of the conventional tablets.

Administer 30–45 minutes before a meal.

Extended-release Trilayer (Concerta; Generics) and Bilayer (Relexxii) Core Tablets

Administer once daily in the morning without regard to meals.

Swallow tablets whole; do not crush, divide, or chew.

Extended-release Orally Disintegrating Tablets (Cotempla XR-ODT)

Administer once daily in the morning in a consistent manner relative to food intake.

Administer immediately following removal from the blister package; do not save for later use. Remove tablet from blister package with dry hands by peeling back the foil and not by pushing the tablet through the foil. Place tablet on patient's tongue and allow to disintegrate in saliva without chewing or crushing. Administration of liquid with the tablet is not required.

Powder for Extended-release Suspension (Quillivant XR)

Administer once daily in the morning without regard to meals.

Must be reconstituted prior to dispensing.

To reconstitute powder, tap bottle until the powder flows freely, then remove bottle cap and add appropriate amount of water (53, 105, 131, or 158 mL of water to a bottle containing 300, 600, 750, or 900 mg, respectively, of the drug) to yield an extended-release suspension containing 25 mg/5 mL. Insert adapter into neck of bottle and replace bottle cap. Shake vigorously with back and forth motion for ≥10 seconds.

Use the bottle adapter and oral dosing dispenser supplied by manufacturer to administer the oral suspension. Adapter should remain in place as long as the bottle is in use (up to 4 months).

Keep bottle tightly closed and vigorously shake for ≥10 seconds before each use.

To dispense a dose, insert the oral dosing dispenser into the adapter in the upright bottle, then invert the bottle and withdraw the appropriate dose into the oral dosing dispenser. Consult manufacturer's patient information for more detailed information on administration.

Extended-release Capsules (Aptensio XR, Ritalin LA; Generics, including Equivalents of Metadate CD [Methylphenidate Hydrochloride CD])

Administer orally once daily in the morning.

Manufacturer states that methylphenidate hydrochloride CD extended-release capsules should be administered before breakfast. Manufacturer states that administration of Ritalin LA relative to timing and composition of meals may need to be individually adjusted. The manufacturer states Aptensio XR may be administered without regard to meals, but should be administered in a consistent manner relative to food intake.

Swallow capsules whole; do not crush, chew, or divide.

Alternatively, open capsule and sprinkle contents on a small amount (e.g., one tablespoonful) of applesauce; swallow immediately (or within 10 minutes for Aptensio XR) without chewing. Manufacturer states that contents of Ritalin LA capsules should not be mixed with warm applesauce because release properties of the formulation could be affected.

One manufacturer suggests that patient should drink fluids immediately after swallowing the intact capsule or sprinkle/applesauce mixture.

Patients receiving extended-release capsules should avoid consuming alcohol; alcohol may result in more rapid release of drug from these formulations.

If a dose is missed, resume the regular schedule the following morning; do not administer the missed dose later in the day and do not administer an extra dose to make up for the missed dose.

Delayed- and Extended-release Capsules (Jornay PM)

Jornay PM (methylphenidate hydrochloride) capsules exhibit both delayed-release and extended-release properties. Administer once daily in the evening in a consistent manner relative to food intake.

If a dose is missed, administer the missed dose the same evening as soon as it is remembered; if the missed dose is not remembered until the following morning, omit the missed dose and administer the next dose at the regularly scheduled time. Doses should not be administered in the morning.

Initially, administer at 8:00 p.m.; adjust administration time within the range of 6:30–9:30 p.m. to optimize tolerability and efficacy the next morning and throughout that day. Once administration time has been optimized, administer at the same time each day. In clinical trials in children 6–12 years of age, >70% of patients received the drug at 8 p.m.

Swallow capsules whole.

Alternatively, open capsule and sprinkle entire contents onto applesauce; swallow immediately without chewing.

Transdermal Administration (Daytrana)

Apply once daily in the morning, 2 hours before an effect is needed; remove 9 hours after application.

Apply system immediately after opening individually sealed package and removing protective liner.

Do not use if package seal is broken. Do not cut transdermal systems. After separating the system from the protective liner, inspect the liner to ensure that no adhesive (which contains the drug) has been transferred to the liner. Discard the transdermal system if adhesive transfer has occurred or if the system is torn, appears to be damaged, or is difficult to separate from the liner. Use only intact transdermal systems.

Apply the transdermal system to a clean, dry area of the hip that is not oily, damaged, or irritated; avoid applying to the waistline or to areas under tight clothing, since system may rub off. Press system firmly in place with palm of hand for approximately 30 seconds, ensuring good contact with the skin, particularly around the edges. Alternate application sites daily (e.g., opposite hip) if possible.

Do not apply topical preparations (e.g., corticosteroids or other creams; topical solutions, ointments, or emollients) immediately prior to system application; effects on adhesion, methylphenidate absorption, or adverse corticosteroid effects are not known.

Exposure to water during bathing, swimming, or showering can affect adherence to the skin. Do not apply or reapply transdermal systems with dressings, tape, or other common adhesives. If a system does not fully adhere to the skin upon application or becomes partially or fully dislodged during the intended period of use, replace it with a new system applied at a different site; do not exceed total wear time of 9 hours per day regardless of number of systems used.

Remove system by slowly peeling it off the skin. If necessary to facilitate removal, gently apply an oil-based product (i.e., petroleum jelly, olive oil, mineral oil) to the edges of the system and gently work the oil underneath the edges. To remove any adhesive remaining on the skin after system removal, apply an oil-based product to the application site to gently loosen and remove residual adhesive. In the unlikely event that a system remains tightly adhered to the skin despite these measures, patient's clinician or pharmacist should be consulted. Do not use nonmedical adhesive removers and acetone-based products (i.e., nail polish remover) to remove the system or adhesive.

After removal, fold system so that the adhesive side adheres to itself, then flush down the toilet or dispose of in an appropriate lidded container. For unused systems, remove from packaging, separate from the protective liner, fold so that the adhesive side adheres to itself, and then flush down the toilet or dispose of in an appropriate lidded container.

Encourage parents or caregiver to record and monitor the application and removal times and method of disposal for each system. If a system was removed without the parent’s or caregiver’s knowledge or if a system is missing from the tray, the parent or caregiver should be encouraged to ask the child when and how the system was removed.

Dosage

Available as methylphenidate (transdermal) and methylphenidate hydrochloride (oral); dosage of transdermal systems is expressed in terms of methylphenidate, and dosage of oral formulations generally is expressed in terms of the salt. However, dosage of methylphenidate hydrochloride extended-release orally disintegrating tablets (Cotempla XR-ODT) is expressed in terms of methylphenidate; each 8.6, 17.3, or 25.9 mg of methylphenidate is equivalent to 10, 20, or 30 mg, respectively, of methylphenidate hydrochloride.

Carefully adjust dosage according to individual requirements and response.

Some patients receiving longer-acting preparations may require supplemental therapy with an immediate-release formulation of the drug to increase the efficacy, particularly in the morning, or to extend the duration of therapeutic effects later in the day.

Discontinue therapy if a beneficial effect is not attained after appropriate dosage adjustment over 1 month.

If paradoxical aggravation of symptoms occurs, reduce dosage or discontinue the drug.

Periodically reevaluate long-term usefulness and adjust dosage as needed.

Pediatric Patients

ADHD

Extended-release oral formulations may contain both immediate-release and extended-release methylphenidate in various proportions, generally ranging from 20% immediate-release and 80% extended-release drug to equal proportions of each preparation in various delivery systems. Differences in methylphenidate preparations (e.g., method of drug delivery, drug release characteristics, onset and duration of activity, ease of administration) allow for individualization of therapy based on patient needs.

Initial Therapy with Immediate-release Preparations (Conventional Tablets, Chewable Tablets, or Oral Solution)

Oral

Pediatric patients ≥6 years of age: Initially, 5 mg twice daily, before breakfast and lunch. Increase dosage by 5–10 mg daily at weekly intervals based on response and tolerance, up to 60 mg daily; administer daily dosage in 2 or 3 divided doses. Duration of action is approximately 3–4 hours.

Switching to Extended-release Tablets (Generics)

Oral

Pediatric patients ≥6 years of age: Extended-release tablets can be substituted for conventional tablets when the 8-hour dosage of methylphenidate hydrochloride as extended-release tablets corresponds to the titrated 8-hour dosage of the drug administered as conventional tablets.

Initial Therapy with Extended-release Chewable Tablets (QuilliChew ER)

Oral

Pediatric patients ≥6 years of age: Initially, 20 mg once daily in the morning. Clinical studies suggest duration of action is 8–12 hours. Adjust dosage by 10, 15, or 20 mg daily at weekly intervals, up to 60 mg daily. Dosages of 10 and 15 mg may be attained by halving the functionally scored 20 and 30 mg tablets, respectively.

Switching to Extended-release Chewable Tablets (QuilliChew ER)

Oral

Pediatric patients ≥6 years of age: Do not substitute for other methylphenidate preparations on mg-for-mg basis because of different methylphenidate base compositions and pharmacokinetic profiles. In patients being transferred from other methylphenidate formulations, use same initial dosage and follow same dosage titration schedule recommended for patients receiving extended-release chewable tablets as their initial methylphenidate regimen.

Initial Therapy with Extended-release Trilayer (Concerta; Generics) or Bilayer (Relexxii) Core Tablets

Oral

Pediatric patients 6–17 years of age: Initially, 18 mg once daily in the morning. Duration of action of trilayer core tablets (Concerta) is approximately 10–12 hours. Duration of action of bilayer core tablets (Relexxii) is approximately 8-12 hours. If adequate response does not occur, increase dosage at weekly intervals in increments of 18 mg daily up to 54 mg daily in children 6–12 years of age or 72 mg daily (maximum 2 mg/kg daily) in adolescents 13–17 years of age.

Switching to Extended-release Trilayer (Concerta; Generics) or Bilayer (Relexxii) Core Tablets

Oral

For manufacturer's recommendations for switching from conventional methylphenidate preparations to extended-release trilayer or bilayer core tablets, see Table 1.

Initial dosage as extended-release trilayer or bilayer core tablets in patients being switched from conventional tablets should not exceed 72 mg daily. Adjust dosage at weekly intervals in increments of 18 mg daily, up to 54 mg daily in children 6–12 years of age and 72 mg (maximum 2 mg/kg) daily in adolescents.

A 27-mg extended-release trilayer core tablet is available for patients who require a dosage in between 18 mg daily and 36 mg daily. Several bilayer tablet strengths (27 mg, 45 mg, and 63 mg) are also available for in-between dosages during titration.

Initial Therapy with Extended-release Orally Disintegrating Tablets (Cotempla XR-ODT)

Oral

Pediatric patients 6–17 years of age: Initially, 17.3 mg of methylphenidate (equivalent to 20 mg of methylphenidate hydrochloride) once daily in the morning. Adjust dosage by 8.6–17.3 mg daily at weekly intervals, up to 51.8 mg daily (equivalent to 60 mg of methylphenidate hydrochloride daily). Duration of action is approximately 12 hours.

Initial Therapy with Extended-release Oral Suspension (Quillivant XR)

Oral

Pediatric patients ≥6 years of age: Initially, 20 mg once daily in the morning. Increase dosage by 10–20 mg daily at weekly intervals, up to 60 mg daily. Duration of action is approximately 10–12 hours.

Switching to Extended-release Oral Suspension (Quillivant XR)

Oral

Pediatric patients ≥6 years of age: Do not substitute for other methylphenidate preparations on mg-for-mg basis because of different methylphenidate base compositions and pharmacokinetic profiles. In patients being transferred from other methylphenidate formulations, use same initial dosage and follow same dosage titration schedule recommended for patients receiving extended-release suspension as their initial methylphenidate regimen.

Initial Therapy with Extended-release Capsules (Aptensio XR, Methylphenidate Hydrochloride CD, Ritalin LA; Other Generics)

Oral

Aptensio XR or generic equivalents in pediatric patients ≥6 years of age: Initially, 10 mg once daily in the morning. Increase dosage by 10 mg daily at weekly intervals, up to 60 mg daily. Duration of action is approximately 12 hours.

Methylphenidate hydrochloride CD in pediatric patients ≥6 years of age: Initially, 20 mg once daily in the morning. Increase dosage by 10–20 mg daily at weekly intervals, up to 60 mg daily. Duration of action is approximately 6–8 hours.

Ritalin LA in children 6–12 years of age: Initially, 20 mg once daily in the morning. Alternatively, initiate with 10 mg once daily when a lower initial dosage is appropriate. Increase dosage by 10 mg daily at weekly intervals, up to 60 mg daily. Duration of action is approximately 6–8 hours.

Switching to Extended-release Capsules (Ritalin LA; Generics)

Oral

For manufacturer's recommendations for switching from conventional or extended-release methylphenidate hydrochloride tablets to Ritalin LA in children 6–12 years of age, see Table 2.

Do not substitute for other methylphenidate preparations on mg-for-mg basis because of different methylphenidate base compositions and pharmacokinetic profiles. In patients being transferred from therapy with other methylphenidate formulations, use same initial dosage and follow same dosage titration schedule recommended for patients receiving Ritalin LA as their initial methylphenidate regimen.

Initial Therapy with Delayed- and Extended-release Capsules (Jornay PM)

Oral

Pediatric patients 6–17 years of age: Initially, 20 mg once daily in the evening. Adjust dosage by 20 mg daily at weekly intervals, up to 100 mg daily. Following an initial delay in absorption of approximately 8–10 hours, duration of clinical response is approximately 10–12 hours.

Switching to Delayed- and Extended-release Capsules (Jornay PM)

Oral

Do not substitute for other methylphenidate preparations on mg-for-mg basis because of different methylphenidate base compositions and pharmacokinetic profiles. In patients being transferred from therapy with other methylphenidate formulations, use same initial dosage and follow same dosage titration schedule recommended for patients receiving delayed- and extended-release capsules as their initial methylphenidate regimen.

Initial Therapy with or Switching to Transdermal System

Transdermal

Individualize dosage titration, final dosage, and wear time according to patient’s needs and response.

Initially, apply one system delivering 10 mg/9 hours once daily (for initial therapy or for patients switching from other methylphenidate preparations). Increase dosage at weekly intervals, based on response and tolerance, by using the next larger dosage system (i.e., 1 system delivering 15 mg/9 hours, then 1 system delivering 20 mg/9 hours, and then 1 system delivering 30 mg/9 hours).

If shorter duration of effect is desired or if late-day adverse effects appear, may remove system earlier than 9 hours. If aggravation of symptoms or other adverse events occur, reduce dosage or wear time or, if necessary, discontinue therapy.

Adults

ADHD

Extended-release formulations are used more commonly, but may initiate therapy in some patients with an immediate-release formulation to assess tolerability and determine approximate dosage requirements.

Extended-release oral formulations may contain both immediate-release and extended-release methylphenidate in various proportions, generally ranging from 20% immediate-release and 80% extended-release drug to equal proportions of each preparation in various delivery systems. Differences in methylphenidate preparations (e.g., method of drug delivery, drug release characteristics, onset and duration of activity, ease of administration) allow for individualization of therapy based on patient needs.

Therapy with Immediate-release Preparations (Conventional Tablets, Chewable Tablets, or Oral Solution)

Oral

Usual dosage is 20–30 mg administered in 2 or 3 divided doses daily, up to 60 mg daily. Some patients may require 40–60 mg daily, while others may require only 10–15 mg daily.

Switching to Extended-release Tablets (Generics)

Oral

Extended-release tablets can be substituted for conventional tablets when the 8-hour dosage of methylphenidate hydrochloride as extended-release tablets corresponds to the titrated 8-hour dosage of the drug administered as conventional tablets.

Usual dosage: 20–60 mg daily, given as 20–40 mg once daily or as 40 mg in the morning and 20 mg in the early afternoon.

Initial Therapy with Extended-release Chewable Tablets (QuilliChew ER)

Oral

Initially, 20 mg once daily in the morning. Duration of action is 8–12 hours. Adjust dosage by 10, 15, or 20 mg daily at weekly intervals, up to 60 mg daily. Functionally scored 20 mg and 30 mg tablets can be broken to achieve 10-mg and 15-mg doses.

Switching to Extended-release Chewable Tablets (QuilliChew ER)

Oral

Do not substitute for other methylphenidate preparations on mg-for-mg basis because of different methylphenidate base compositions and pharmacokinetic profiles. In patients being transferred from other methylphenidate formulations, use same initial dosage and follow same dosage titration schedule recommended for patients receiving extended-release chewable tablets as their initial methylphenidate regimen.

Initial Therapy with Extended-release Trilayer (Concerta; Generics) or Bilayer (Relexxii) Core Tablets

Oral

Initially, 18 or 36 mg once daily in the morning. Duration of action of Concerta is approximately 10–12 hours. Duration of action of Relexxii is approximately 8–12 hours. If adequate response does not occur, increase dosage by 18 mg daily at weekly intervals, up to 72 mg daily.

Switching to Extended-release Trilayer (Concerta; Generics) or Bilayer (Relexxii) Core Tablets

Oral

For manufacturer's recommendations for switching from conventional methylphenidate preparations to extended-release trilayer or bilayer core tablets, see Table 3.

Initial dosage as extended-release trilayer or bilayer core tablets in patients being switched from conventional tablets should not exceed 72 mg daily. Adjust dosage at weekly intervals in increments of 18 mg daily, up to 72 mg daily.

A 27-mg extended-release trilayer core tablet also is available for patients who require a dosage in between 18 mg daily and 36 mg daily. Several bilayer tablet strengths (27 mg, 45 mg, and 63 mg) are also available for in-between dosages during titration.

Narcolepsy

Oral

Usual dosage of 10 mg (as conventional tablets or oral solution) 2 or 3 times daily; some patients require 40–60 mg daily, in others, 10-15 mg daily may be adequate.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time. Generally, dosage selection for geriatric patients should start at the lower end of the dosage range, reflecting the greater frequency of reduced hepatic, renal, or cardiac function and of concomitant diseases and drug therapy.

Cautions for Methylphenidate

Contraindications

• Known hypersensitivity to methylphenidate or any ingredient in the formulation.

• Concomitant or recent (within 14 days) administration of monoamine oxidase (MAO) inhibitors since hypertensive crisis could result.

• Some methylphenidate hydrochloride extended-release capsules may contain sucrose and should not be used in patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.

Warnings/Precautions

Warnings

Abuse, Misuse, and Addiction

High potential for abuse, misuse, and addiction with methylphenidate. (See Boxed Warning). In addition, the drug can be diverted for nonmedical use into illicit channels or distribution. Assess risk of abuse, misuse, and addiction prior to initiating therapy and monitor for signs of abuse, misuse, and addiction during therapy. Misuse and abuse of CNS stimulants can result in overdosage and death. During long-term CNS stimulant therapy, tolerance can also develop. Abuse by unintended routes of administration (e.g., chewing, snorting, or injecting formulation) can increase the risk of overdosage and death. Abrupt cessation of therapy, rapid dosage reduction, or administration of an antagonist in patients physically dependent on CNS stimulants may result in withdrawal syndrome (e.g., dysphoric mood, fatigue, vivid and unpleasant dreams, insomnia or hypersomnia, increased appetite, psychomotor retardation or agitation). Advise patients and/or caregivers that methylphenidate can be abused and result in dependence. The drug must be store in a safe (preferably locked) location to prevent abuse and misuse. Dispose of the drug at a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site when it is no longer needed. If there is no take-back program or authorized DEA collection site available, the drug can be mixed with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds and disposed of in a sealed plastic bag in the household trash.

Other Warnings and Precautions

Risks to Patients with Serious Cardiac Disease

Sudden unexplained death, stroke, and MI reported in patients with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants for ADHD treatment.

Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy.

In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.

Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.

Increased BP and Heart Rate

Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur. Modest increases not expected to have short-term sequelae; however, monitor all patients for hypertension and tachycardia.

Psychiatric Adverse Effects

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder. Prior to initiating therapy, carefully screen patients with ADHD to determine if they are at risk for developing a manic episode; screening should include a detailed psychiatric history (e.g., current or prior depressive symptoms; family history of suicide, bipolar disorder, or depression).

Psychotic or manic symptoms (e.g., hallucinations, delusional thinking, mania) also may occur with usual dosages in patients without history of psychotic illness. If psychotic or manic symptoms occur, consider discontinuance of therapy.

Seizures

Stimulant therapy may lower the seizure threshold in patients with and without prior seizures or a history of electroencephalography (EEG) abnormalities. If seizures occur during methylphenidate therapy, discontinue the drug.

Priapism

Prolonged and painful erections reported rarely in adult and pediatric patients. Priapism often reported during continued therapy or following an increase in dosage; also has occurred during temporary interruptions in therapy (e.g., drug holidays) or following drug discontinuance.

Patients who develop abnormally sustained, or painful, erections must seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud's Phenomenon

Peripheral vascular disorders, including Raynaud’s phenomenon, reported in patients in all age groups receiving stimulants at therapeutic dosages and at various times throughout treatment course. Manifestations usually intermittent and mild, but ulceration of digits and/or breakdown of soft tissue occur rarely. Carefully observe for digital changes.

Improvement generally occurs following dosage reduction or drug discontinuance; however, some patients may require further evaluation (e.g., referral to rheumatologist).

Long-Term Suppression of Growth in Pediatric Patients

Long-term administration of stimulants associated with at least a temporary suppression of normal weight and/or height patterns in some pediatric patients.

Manufacturers recommend monitoring growth closely during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.

Potential for Gastrointestinal Obstruction

Extended-release trilayer or bilayer core tablets generally should not be used in patients with severe preexisting GI narrowing; because these preparations are nondeformable and do not appreciably change shape in the GI tract, obstruction may occur.

Acute Angle Closure Glaucoma

Angle closure glaucoma reported. Patients at an increased risk for acute angle closure glaucoma (e.g., with significant hyperopia) should undergo ophthalmologist evaluation.

Increased Intraocular Pressure and Glaucoma

Elevated IOP reported. Manufacturers recommend prescribing methylphenidate only when benefits outweigh risks in patients with open-angle glaucoma or abnormally increased IOP. Monitor for ophthalmologic changes if methylphenidate is used in patients with a history of abnormally increased IOP or open angle glaucoma.

Motor and Verbal Tics and Worsening of Tourette's Syndrome

Onset or exacerbation of motor or verbal tics and worsening of Tourette’s syndrome reported with CNS stimulants.

Prior to initiating therapy, screen patients for a family history and clinically evaluate for motor or verbal tics or Tourette’s syndrome. Routinely monitor patients receiving methylphenidate therapy for emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically indicated.

Risks in Patients with Phenylketonuria

Some oral formulations may contain aspartame, which is metabolized in the GI tract to provide phenylalanine. Each 20-, 30-, or 40-mg extended-release chewable tablet (QuilliChew ER) provides 3, 4.5, or 6 mg of phenylalanine, respectively.

External Heat with the Transdermal System

Percutaneous absorption of methylphenidate from the transdermal system may be increased, potentially resulting in overdosage, if the application site is exposed to direct external heat sources (e.g., hair dryers, heating pads, electric blankets, heated water beds) while the transdermal system is being worn.

Contact Sensitization with the Transdermal System

Possible contact sensitization following use of transdermal system. Discontinue transdermal therapy if contact sensitization is suspected (erythema accompanied by evidence of a more intense local reaction [e.g., edema, papules, vesicles] that does not substantially improve within 48 hours or that spreads beyond the application site).

Development of localized contact sensitization to methylphenidate during transdermal therapy may be associated with development of systemic sensitization with subsequent oral administration. 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. Other systemic reactions may include headache, fever, malaise, arthralgia, diarrhea, or vomiting.

If contact sensitization occurs with transdermal therapy, monitor patients closely if oral therapy with the drug is initiated. Some patients sensitized to methylphenidate by exposure to transdermal system may not be able to receive methylphenidate in any form.

Chemical Leukoderma with the Transdermal System

Permanent depigmentation or hypopigmentation reported in patients receiving methylphenidate transdermal system. Usually limited to application sites, but skin color changes affecting other areas of the body also reported. Time to onset has ranged from 2 months to 4 years; affected areas up to 8 inches in diameter reported. Can mimic appearance of vitiligo, particularly if areas distant from application site are affected; possible increased risk in individuals with history of vitiligo and/or family history of vitiligo.

Monitor skin for loss of pigmentation, especially at application sites. If such changes occur, discontinue transdermal methylphenidate and consider alternative therapy.

Risk of Choking with Chewable Tablets

Administration of chewable tablets without adequate fluid may cause tablet contents to swell, resulting in blockage of throat or esophagus and, possibly, choking. Therefore, administer with a full glass (i.e., ≥240 mL [8 ounces]) of water or other fluid. Do not administer in patients with difficulty swallowing.

Specific Populations

Pregnancy

Available data on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, spontaneous abortion, or adverse maternal or fetal outcomes; however, there may be fetal risks associated with CNS stimulant use. CNS stimulants can cause vasoconstriction and thereby decrease placental perfusion.

No fetal and/or neonatal adverse reactions reported with therapeutic dosages of methylphenidate during pregnancy, but premature delivery and low birth-weight infants reported in amphetamine-dependent women.

In animal studies, increased incidence of spina bifida observed in rabbits with methylphenidate administration.

National Pregnancy Registry for ADHD Medications at 866-961-2388 or [Web].

Lactation

Limited data (case reports) suggest breast-fed infants receive 0.2–0.7% of the maternal weight-adjusted dosage of methylphenidate; milk-to-plasma ratios of 1.1–2.7 reported. Adverse effects on breast-fed infants or on milk production not reported to date; however, any long-term neurodevelopmental effects are unknown.

Consider developmental and health benefits of breast-feeding, the importance of methylphenidate to the woman, and any potential adverse effects of either the drug or the underlying maternal condition on the breast-fed infant.

If used in a nursing woman, monitor breast-fed infant for adverse effects (e.g., agitation, insomnia, anorexia, reduced weight gain).

Pediatric Use

Although safety and efficacy not established in children <6 years of age, AAP states methylphenidate may be considered for treatment of ADHD in preschool-aged children^† (4 years of age to the sixth birthday) if first-line treatments (i.e., parent training in behavior management and/or behavioral classroom interventions) do not provide substantial improvement and there is continued, moderate to severe disturbance in the child's functioning. Some studies suggest increased incidence of adverse effects (e.g., weight loss, increased mood lability and dysphoria ) and possibly different adverse effects in preschool-aged children. Systemic exposure may be increased in preschool-aged children. Initiate at low dosage and increase in smaller increments in preschool-aged children; maximum dosages not adequately studied. Additional study and experience required to further elucidate safety and efficacy in this age group.

Long-term administration associated with at least a temporary suppression of normal weight and/or height patterns in children.

In toxicity studies in juvenile rats, methylphenidate associated with long-term behavioral effects (decreased spontaneous locomotor activity in adulthood, deficit in acquisition of a specific learning task in female rats). Clinical relevance unknown.

Geriatric Use

Not studied in patients ≥65 years of age.

Hepatic Impairment

Although methylphenidate has not been studied in patients with hepatic impairment, hepatic impairment is expected to have minimal effects on pharmacokinetics.

Renal Impairment

Although methylphenidate has not been studied in patients with renal impairment, renal impairment is expected to have minimal effects on pharmacokinetics.

Common Adverse Effects

Immediate-release conventional tablets and oral solution: Tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain.

Immediate-release chewable tablets: Nervousness and insomnia; can be minimized with dosage reduction and omitting administration in afternoon or evening.

Extended-release trilayer (e.g., Concerta; generics) and bilayer (e.g., Relexxii) core tablets (>5% of children and adolescents): Abdominal pain. In >5% of adults: Decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, and hyperhidrosis.

Extended-release capsules (Ritalin LA) (>5% of patients): Headache, insomnia, upper abdominal pain, decreased appetite, and anorexia.

CD extended-release capsules (≥5% of patients and twice the rate of placebo): Anorexia and insomnia.

Transdermal patch in pediatric patients 6−12 years of age (≥5% of patients and twice the rate of placebo): Decreased appetite, insomnia, nausea, vomiting, weight loss, tics, affect lability, and anorexia. In adolescents 13−17 years of age (≥5% of patients and twice the rate of placebo): Decreased appetite, nausea, insomnia, weight loss, dizziness, abdominal pain, and anorexia. Most also had erythema at the application site.

Extended-release capsules (Aptensio XR) in ≥5% of pediatric patients 6−17 years of age: Abdominal pain, decreased appetite, and insomnia.

Delayed- and extended-release capsules (Jornay PM) in ≥5% of pediatric patients 6−12 years of age and twice the rate of placebo: Headache, psychomotor hyperactivity, and mood swings.

Drug Interactions

Not metabolized by CYP isoenzymes; does not inhibit CYP isoenzymes at clinically relevant plasma concentrations.

Specific Drugs

Methylphenidate Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration. Low oral bioavailability (10–52%) suggests substantial first-pass metabolism.

Oral solution and immediate-release chewable tablets are bioequivalent to conventional tablets.

Extended-release tablets are absorbed more slowly but to the same extent as conventional tablets.

Peak concentration and AUC were about 20 and 11% lower, respectively, for QuilliChew ER extend-release chewable tablets (single 40-mg dose) than for immediate-release chewable tablets (two 20-mg doses given 6 hours apart).

Peak concentration and AUC were about 26 and 6% higher, respectively, for Cotempla XR-ODT (single dose of two 25.9-mg extended-release orally disintegrating tablets [equivalent to 60 mg of methylphenidate hydrochloride]) than for a 60-mg extended-release capsule formulation of methylphenidate hydrochloride.

Relative bioavailability of Concerta extended-release trilayer and Relexxii extended-release bilayer core tablets given once daily is comparable to that of conventional tablets administered 3 times daily. No substantial accumulation observed with repeated once-daily dosing over dose range of 18–144 mg.

Relative bioavailability of Quillivant XR extended-release oral suspension (single 60-mg dose) is 95% that of immediate-release oral solution (two 30-mg doses given 6 hours apart).

Relative bioavailability of Aptensio XR extended-release capsules given once daily is comparable to that of conventional tablets administered 3 times daily.

Peak plasma concentrations and AUC were slightly lower for methylphenidate hydrochloride CD extended-release capsules (20 mg once daily) than for conventional tablets (10 mg twice daily).

Relative bioavailability of Ritalin LA extended-release capsules given once daily is similar to that of conventional tablets administered at the same total daily dosage in 2 divided doses given 4 hours apart.

Relative bioavailability of Jornay PM delayed- and extended-release capsules administered once daily is approximately 74% that of an immediate-release formulation administered in 3 divided doses daily.

Alcohol increases the rate of drug release in vitro from many extended-release preparations; see Table 4. Results provided in Table 5 for specific strengths generally are considered representative for available strengths of the respective preparations.

For timing of peak plasma concentrations for oral formulations, see Table 5.

Peak plasma methylphenidate concentrations for transdermal systems are attained in about 10 hours (single-dose application) or 8 hours (repeated applications of systems worn for up to 9 hours). Average lag of 2 hours until d-methylphenidate is detectable in plasma after single-dose application; with repeated administration, low concentrations of the drug are detected earlier because of carryover effect.

When applied to inflamed skin, time to peak plasma concentration decreases (to 4 hours) and peak plasma concentration and AUC increase by threefold compared with application to intact skin. When heat is applied to transdermal system after application, peak plasma concentration occurs 0.5 hour earlier, and median peak plasma concentration and AUC are 2-fold and 2.5-fold higher, respectively, compared to application without heat.

Possible increased transdermal absorption following repeated administration. Steady state likely to be achieved by approximately day 14 of dosing.

Because of substantially greater first-pass metabolism following oral compared with transdermal administration, a lower transdermal dose of methylphenidate may result in greater systemic exposure to d-methylphenidate than a higher (on a mg/kg basis) oral dose of the drug. Little, if any, l-methylphenidate is systemically available following oral administration; however, systemic exposure to l-methylphenidate following transdermal administration is almost as great as that to d-methylphenidate.

Duration

For duration of effects for various oral methylphenidate formulations, see Table 6.

Food

Chewable tablets: Administration with high-fat meal delays time to peak plasma concentration by approximately 1 hour and increases AUC by about 20%; magnitude of food effect is comparable to that observed with conventional tablets.

Oral solution: Administration with high-fat meal delays time to peak plasma concentration by approximately 1 hour and increases peak plasma concentration and AUC by about 13 and 25%, respectively.

Extended-release chewable tablets (QuilliChew ER): Administration with high-fat meal increases peak concentration and AUC by about 20% and 4%, respectively, but does not affect time to peak concentration.

Extended-release orally disintegrating tablets (Cotempla XR-ODT): Administration with high-fat meal decreases peak concentration by approximately 24%, increases AUC by approximately 16%, and decreases time to peak concentration by about 30 minutes (from 5 hours in fasted state to 4.5 hours in fed state).

Extended-release trilayer (Concerta) or bilayer (Relexxii) core tablets: High-fat meal does not alter pharmacokinetics.

Extended-release oral suspension (Quillivant XR): Administration with high-fat meal reduces time to peak concentration by approximately 1 hour and increases peak plasma concentration and AUC by approximately 28 and 19%, respectively; not considered clinically important.

Extended-release capsules (Aptensio XR): Administration with high-fat meal decreases second peak plasma concentration, increases the average peak concentration by about 28%, and increases AUC by about 19%; this formulation was administered without regard to meals in clinical trials. Opening the capsules and sprinkling the contents on applesauce does not alter bioavailability.

Extended-release capsules (methylphenidate hydrochloride CD): Administration with high-fat meal delays first peak plasma concentration by approximately 1 hour and increases average peak plasma concentration and AUC by 30 and 17%, respectively. Opening the capsules and sprinkling the contents on applesauce does not alter bioavailability.

Extended-release capsules (Ritalin LA): Administration with high-fat meal delays first and second peak plasma concentrations and decreases second mean peak plasma concentration by 25%. Opening the capsules and sprinkling the contents on applesauce does not alter bioavailability.

Delayed- and extended-release capsules (Jornay PM): Administration at night with high-fat meal decreases mean peak concentration by 14% and delays peak concentration by approximately 2.5 hours, but does not alter extent of absorption. Following administration at night, a morning meal does not affect pharmacokinetics. Opening the capsules and sprinkling the contents on applesauce does not alter pharmacokinetics.

Special Populations

Age and body weight: Systemic exposure may be higher in children than in adults following equivalent oral dosages, but pharmacokinetic profiles generally similar following adjustment for differences in body weight. Systemic exposure in preschool-aged children receiving Aptensio XR extended-release capsules approximately twofold to threefold higher than in older children and adolescents receiving same dosage.

Distribution

Extent

Excreted into breast milk.

Plasma Protein Binding

About 10–33%.

Elimination

Metabolism

Metabolized primarily by de-esterification by carboxylesterase 1A1 to form d-ritalinic acid, which has little or no pharmacologic activity.

Elimination Route

Excreted as metabolites (principally as ritalinic acid), mostly in urine, with a small amount in feces.

Half-life

For methylphenidate elimination half-lives reported for various methylphenidate formulations, see Table 7.

Special Populations

Renal impairment: Expected to have minimal effect on pharmacokinetics since <1% of dose excreted in urine as unchanged drug and major metabolite (ritalinic acid) has little or no pharmacologic activity.

Hepatic impairment: Expected to have minimal effect on pharmacokinetics since main metabolic pathway involves de-esterification by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body.

Body weight: Clearance increases with increasing weight; thus, patients with higher body weight may have lower exposures to total methylphenidate at similar doses.

Stability

Storage

Oral

Conventional and Immediate-release Chewable Tablets and Oral Solution

Room temperature, generally 20–25°C; conventional and chewable tablets may be exposed to 15-30°C. Protect from moisture.

Extended-release Tablets

20–25°C (may be exposed to 15–30°C). Protect from moisture.

Delayed- and Extended-release Capsules

20–25°C (may be exposed to 15–30°C). Protect from moisture.

Extended-release Capsules

Room temperature, generally 20–25°C; Ritalin LA may be exposed to 15-30°C.

Extended-release Orally Disintegrating Tablets

20–25°C (may be exposed to 15–30°C). Store blister packages in reusable travel case after removal from carton.

Extended-release Trilayer and Bilayer Core Tablets

Store trilayer tablets at 25°C and bilayer tablets from 20-25°C (may be exposed to 15–30°C). Protect from moisture.

Powder for Extended-release Suspension

25°C (may be exposed to 15–30°C).

Following reconstitution, 25°C (may be exposed to 15–30°C) in original container for up to 4 months.

Topical

Transdermal System

25°C (may be exposed to 15–30°C). Use all the systems in a tray within 2 months of opening the tray. Apply the system to the skin immediately after removal from the individually sealed package. Do not freeze or refrigerate.

Actions

• Piperidine-derivative CNS stimulant.

• Mechanism of action not fully elucidated; appears to block norepinephrine and dopamine reuptake into the presynaptic neuron and increases their release into the extraneuronal space.

• Racemic mixture; the d-enantiomer is the more pharmacologically active enantiomer.

Advice to Patients

• Stress importance of the patient or caregiver reading the FDA-approved patient labeling (medication guide).

• Educate patients about the risk of abuse, misuse, and addiction with methylphenidate, which can lead to overdose and death. Do not share methylphenidate with others and store the drug in a safe (preferably locked) location to prevent abuse.

• Inform patients of the potential risks in patients with serious cardiovascular disease, including sudden death. Inform clinicians immediately of adverse cardiovascular effects (e.g., exertional chest pain, unexplained syncope, other symptoms suggestive of cardiac disease).

• Inform patients or caregivers that methylphenidate can increase BP and pulse rate.

• Inform patients or caregivers of the potential for psychotic or manic symptoms, even in patients without a history of psychotic symptoms or mania at recommended dosages.

• Inform male patients and their caregivers about the possibility of painful or prolonged penile erections (priapism) and instruct them to seek immediate medical treatment if it occurs.

• Inform patients and caregivers about the risk of peripheral vascular disorders, including Raynaud's phenomenon, and the associated signs and symptoms (e.g., feelings of numbness, coolness, or pain in fingers or toes; changes in color from pale to blue to red). Advise patients to report any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes and to immediately contact their clinician if any signs of unexplained wounds appear on fingers or toes; further clinical evaluation may be appropriate.

• Inform patients and caregivers that methylphenidate can potentially slow growth and cause weight loss in children.

• Inform patients and caregivers that increased intraocular pressure and glaucoma can occur with methylphenidate therapy.

• Inform patients and caregivers that motor and verbal tics and worsening of Tourette’s syndrome can occur during treatment. Instruct patients to inform their healthcare provider if there is an emergence of new tics, worsening of tics, or Tourette’s syndrome worsens.

• In patients receiving conventional tablets or oral solution, administer the last daily dose of these preparations before 6 p.m.

• In patients receiving chewable tablets, administer with a full glass (i.e., ≥240 mL [8 ounces]) of water or other fluid to avoid choking. Stress importance of seeking immediate medical attention if chest pain, vomiting, or difficulty in swallowing or breathing occurs following administration.

• Stress importance of not crushing or chewing extended-release tablets, extended-release capsules, extended-release trilayer or bilayer core tablets, or delayed- and extended-release capsules. Capsules may be opened and the contents sprinkled on applesauce.

• In patients receiving extended-release capsules, delayed- and extended-release capsules, extended-release orally disintegrating tablets, or extended-release chewable tablets, stress importance of not consuming alcohol, since alcohol may result in more rapid release of the drug dose.

• In patients receiving extended-release oral suspension, instruct patients and/or their caregivers on proper use of the dosing dispenser for administration. Provide patient and/or caregiver with a copy of the manufacturer's instructions for administration.

• In patients receiving extended-release trilayer or bilayer core tablets, presence of tablet-like substance in stool is not cause for concern.

• In patients receiving extended-release orally disintegrating tablets, instruct patient or caregiver on appropriate administration technique.

• Advise patients with phenylketonuria that QuilliChew ER extended-release chewable tablets contain aspartame.

• Instruct patients and/or their caregivers regarding procedure for application and removal of the transdermal system. Provide patient and/or caregiver with a copy of the manufacturer's instructions for use. Stress importance of not touching the adhesive layer during application to avoid absorption of the drug; if contact occurs, wash hands immediately after application.

• Inform patients or caregivers that unused or expired Daytrana patches must be disposed of in a special manner. If a take back program is not available, patients should remove Daytrana from its pouch, separate it from its liner, fold it in half with the adhesive sides touching, and flush it immediately down the toilet. The pouch and liner should be placed in a container, the container closed, and then thrown out in the trash (do not flush down the toilet).

• Stress importance of not exposing the Daytranaapplication site to direct external heat sources (e.g., hair dryers, heating pads, electric blankets, heated water beds) while wearing the transdermal system.

• Possibility of dermatologic reactions in patients receiving transdermal therapy; stress importance of discontinuing use and contacting clinician if swelling or blistering occurs.

• Stress importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products, as well as any concomitant illnesses/conditions (e.g., cardiac/cardiovascular disease, mental/psychiatric disorder, suicidal ideation or behaviors, history of substance abuse).

• Stress importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Inform women about pregnancy registry for ADHD medications. Advise nursing women to monitor their infants for agitation, poor feeding, and reduced weight gain.

• Inform patients or caregivers of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Methylphenidate hydrochloride is subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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