Classes
DEA Class; Rx
Common Brand Names; Ritalin, Ritalin SR, Ritalin LA, Aptensio XR, Concerta, Metadate, Metadate CD, Metadate ER, Methylin, Quillivant XR, QuilliChew ER, Cotempla XR-ODT, Jornay PM, Adhansia XR, Relexxii
- Stimulants;
- ADHD Agents
methylphenidate transdermal (Rx)
- Classes: ADHD Agents;
- Stimulants
Description
CNS stimulant chemically similar to but with milder peripheral sympathomimetic actions than amphetamines
Used for attention-deficit hyperactivity disorder (ADHD) and narcolepsy
Pediatric patients with structural heart defects, cardiomyopathy, or heart-rhythm disturbances may be at risk for adverse cardiac events
Indications
Indicated for the treatment of attention-deficit hyperactivity disorder (ADHD).
Contraindications
Hypersensitivity to methylphenidate or other components of product
Coadministration with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOIs
Concerta
- Motor tics or family history or diagnosis of Tourette syndrome
- Glaucoma
- Patients with marked anxiety, tension, and agitation
Metadate CD
- Contains sucrose; do not administer to patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency
Adverse Effects
ER capsules (adults)
Insomnia (16%)
Decreased appetite (11%)
Adhansia XR (patients aged 6-12 years)
Decreased appetite (35%)
Upper abdominal pain (15%)
Affect lability (13%)
Nausea or vomiting (13%)
Decreased weight (12%)
Adhansia XR (patients aged 12-17 years)
Decreased appetite (20%)
Aptensio XR
Headache (10.9%)
Concerta or Relexxii (adults)
Decreased appetite (25.3%)
Headache (22.2%)
Dry mouth (14%)
Nausea (12.8%)
Insomnia (12.3%)
Jornay PM
Any insomnia (33%)
Decreased appetite (19%)
Metadate CD
Headache (12%)
Warnings
Assess risk of abuse before prescribing, and monitor for signs of abuse and dependence during therapy
May cause an increase in blood pressure (BP) and heart rate (HR); monitor for hypertension and tachycardia
Prolonged and painful erections, sometimes requiring surgical intervention, reported with methylphenidate products, including another formulation of methylphenidate hydrochloride extended-release tablets, in both pediatric and adult patients
Priapism was not reported with drug initiation but developed during treatment, often after an increase in dose and during a period of drug withdrawal (drug holidays or during discontinuation); if such reaction occurs, seek immediate medical attention
CNS stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs and symptoms are usually intermittent and generally improve after dose reduction or discontinuing treatment; monitor for digital changes is necessary during treatment; further clinical evaluation (eg, rheumatology referral) may be appropriate for certain patients
Closely monitor growth (weight and height) in pediatric patients treated with stimulants; patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted
Stimulants may lower the convulsive threshold in patients with a history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures; if seizures occur, discontinue drug
Difficulties with accommodation and blurry vision reported
Periodic complete blood cell count, differential, and platelet counts are advised during prolonged therapy
Pregnancy and Lactation
Published studies and postmarketing reports on use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7
Maximum Dosage
100 mg/day PO for Adhansia XR; 72 mg/day PO for Concerta and Relexxii; 60 mg/day PO for all other oral formulations.
100 mg/day PO for Adhansia XR; 60 mg/day PO for all other oral formulations. While some dosage forms have not been specifically studied in the elderly, use of stimulants off-label has been described in geriatric adults.
85 mg/day PO for Adhansia XR; 72 mg/day (Max: 2 mg/kg/day) PO for Concerta and Relexxii (FDA-approved labeling); 60 mg/day PO for all other oral formulations excluding Cotempla XR-ODT and Jornay PM (FDA-approved labeling); 51.8 mg/day PO for Cotempla XR-ODT and 100 mg/day PO for Jornay PM; however, doses up to 100 to 108 mg/day PO have been used in patients weighing more than 50 kg for some formulations. For the transdermal patch, 30 mg/9-hour patch per day is the maximum.
6 to 12 years: 85 mg/day PO for Adhansia XR; 54 mg/day PO for Concerta and Relexxii (FDA-approved labeling); 60 mg/day PO for all other oral formulations excluding Cotempla XR-ODT and Jornay PM (FDA-approved labeling); 51.8 mg/day PO for Cotempla XR-ODT and 100 mg/day PO for Jornay PM; however, doses up to 100 to 108 mg/day PO have been used in patients weighing more than 50 kg for some formulations. For the transdermal patch, 30 mg/9-hour patch per day is the maximum.
3 to 5 years: Safety and efficacy have not been established. Maximum doses have not been adequately studied; however, The Preschool ADHD Treatment Study (PATS) has suggested immediate-release doses up to 30 mg/day PO.
1 to 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Methylphenidate hydrochloride
tablet: Schedule II
- Ritalin
- 5mg
- 10mg
- 20mg
capsule, extended-release: Schedule II
- 10mg (Aptensio XR, Ritalin LA, Metadate CD)
- 15mg (Aptensio XR)
- 20mg (Aptensio XR, Ritalin LA, Metadate CD)
- 25mg (Adhansia XR)
- 30mg (Aptensio XR, Ritalin LA, Metadate CD)
- 35mg (Adhansia XR)
- 40mg (Aptensio XR, Ritalin LA, Metadate CD)
- 45mg (Adhansia XR)
- 50mg (Aptensio XR, Metadate CD)
- 55mg (Adhansia XR)
- 60mg (Aptensio XR, Ritalin LA, Metadate CD)
- 70mg (Adhansia XR)
- 85mg (Adhansia XR)
capsule, extended release/delayed release: Schedule II
- 20mg (Jornay PM)
- 40mg (Jornay PM)
- 60mg (Jornay PM)
- 80mg (Jornay PM)
- 100mg (Jornay PM)
tablet, extended-release: Schedule II
- 10mg (Methylin, generics)
- 18mg (Concerta, Relexxii)
- 20mg (Methylin, generics)
- 27mg (Concerta, Relexxii)
- 36mg (Concerta, Relexxii)
- 45mg (Relexxii)
- 54mg (Concerta, Relexxii)
- 63mg (Relexxii)
- 72mg (Relexxii)
extended-release tablet, chewable (scored): Schedule II
- QuilliChew ER
- 20mg
- 30mg
- 40mg
tablet, chewable: Schedule II
- Methylin
- 2.5mg
- 5mg
- 10mg
oral solution: Schedule II
- Methylin
- 5mg/5mL
- 10mg/5mL
transdermal patch: Schedule II
- Daytrana
- 10mg/9hr
- 15mg/9hr
- 20mg/9hr
- 30mg/9hr