Classes
DEA Class; Rx
Common Brand Names; Focalin, Focalin XR
- Stimulants;
- ADHD Agents
Description
CNS stimulant; d-enantiomer of methylphenidate
Used for attention-deficit hyperactivity disorder (ADHD)
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; reactions may include angioedema and anaphylaxis
Notable tension and agitation, glaucoma, Tourette syndrome, motor tics, anxiety
MAOIs: Risk of severe hypertensive reaction; do not use within 14 days of taking MAOI
Adverse Effects
- Abdominal pain (15%)
- Headache (25-39%)
- Insomnia (5-17%)
- Restlessness (12%)
- Anxiety (5-11%)
- Anorexia (5-7%)
- Fever (5%)
- Dizziness (6%)
- Mood swings (<3%)
- Nausea (9%)
- Pruritus (<3%)
- Pharyngolaryngeal pain (4-7%)
- Irritability (5%)
- Depression (<3%)
- Dyspepsia (5-9%)
- Anaphylaxis
- Hypersensitivity reactions
- Rhabdomyolysis
- Drowsiness
- Dyskinesia
- Tourette’s syndrome (rare)
- Toxic psychosis
- Serotonin syndrome in combination with serotonergic drugs
- Abnormal liver function, ranging from transaminase elevation to severe hepatic injury
Warnings
Should be used as part of a comprehensive treatment program of attention deficit disorder
Caution in patients with history of drug dependence or alcoholism, HTN, preexisting structural cardiac abnormalities
Discontinue if no improvement after 1 month
Reevaluate need for treatment q6Week
Associated with peripheral vasculopathy, including Raynaud phenomenon; monitor for digital changes during therapy and seek further evaluation (eg, rheumatology) if necessary
Difficulties with visual accommodation and blurring of vision have been reported with stimulant treatment
Do not use for depression, fatigue
Sudden deaths, stroke, and myocardial infarction reported in adults taking stimulants at usual doses
Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation
Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients
Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported
Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected
Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures
Pregnancy and Lactation
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, during pregnancy
Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate; Limited published literature, based on milk sampling from seven 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
20 mg/day PO immediate-release formulation; 40 mg/day PO extended-release formulation.
20 mg/day PO immediate-release formulation; 40 mg/day PO extended-release formulation.
20 mg/day PO immediate-release formulation and 30 mg/day PO extended-release formulation (FDA-approved labeling); however, up to 50 mg/day PO has been used off-label (both formulations).
6 to 12 years: 20 mg/day PO immediate-release formulation and 30 mg/day PO extended-release formulation (FDA-approved labeling); however, up to 50 mg/day PO has been used off-label (both formulations).
1 to 5 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Dexmethylphenidate Hydrochloride
tablet
- 2.5mg
- 5mg
- 10mg
capsule, extended-release
- 5mg
- 10mg
- 15mg
- 20mg
- 25mg
- 30mg
- 35mg
- 40mg