Dexmethylphenidate

U.S. Brand Names Focalin^TM

Synonyms Dexmethylphenidate Hydrochloride

Use Treatment of attention-deficit/hyperactivity disorder (ADHD)

Pregnancy Risk Factor C

Contraindications Hypersensitivity to dexmethylphenidate, methylphenidate, or any component of the formulation; marked anxiety, tension, and agitation; glaucoma, motor tics, family history or diagnosis of Tourette's syndrome; use during or within 14 days following MAO inhibitor therapy

Warnings/Precautions Recommended to be used as part of a comprehensive treatment program for ADHD. Use with caution in patients with bipolar disorder, diabetes mellitus, cardiovascular disease, hyperthyroidism, seizure disorders, insomnia, porphyria, or hypertension. Use caution in patients with history of ethanol or drug abuse. May exacerbate symptoms of behavior and thought disorder in psychotic patients. Do not use to treat severe depression or fatigue states. Potential for drug dependency exists - avoid abrupt discontinuation in patients who have received for prolonged periods. Visual disturbances have been reported with methylphenidate (rare). Stimulant use has been associated with growth suppression. Stimulants may unmask tics in individuals with coexisting Tourette's syndrome. Safety and efficacy in children <6 years of age not established.

>10%: Gastrointestinal: Abdominal pain (15%)

1% to 10%:

Adverse effects seen with methylphenidate (frequency not defined):

Antihypertensive agents: Effectiveness of antihypertensive agent may be decreased; use with caution

Carbamazepine: Carbamazepine may decrease the serum concentration of methylphenidate.

Clonidine: Severe toxic reactions have been reported in combined use with methylphenidate.

Linezolid: Due to MAO inhibition (see note on MAO inhibitors), concurrent use with methylphenidate should generally be avoided

MAO inhibitors: Severe hypertensive episodes have occurred with amphetamine when used in patients receiving nonselective MAO inhibitors; methylphenidate may be less likely to interact, or reactions may be less severe; use with caution only when warranted; wait 14 days following discontinuation of MAO inhibitor

Phenobarbital: Serum levels may be increased by methylphenidate (in some patients); monitor

Phenytoin: Serum levels may be increased by methylphenidate (in some patients); monitor

Selegiline: When selegiline is used at low dosages (<10 mg/day), an interaction with methylphenidate is less likely than with nonselective MAO inhibitors (see MAO inhibitor information), but theoretically possible; monitor

Sibutramine: Potential for reactions noted with amphetamines (severe hypertension and tachycardia) appears to be low; use with caution

Tricyclic antidepressants: Methylphenidate may increase serum concentrations of some tricyclic agents; clinical reports of toxicity are limited; dosage reduction of tricyclic antidepressants may be required; monitor

Venlafaxine: NMS has been reported in a patient receiving methylphenidate and venlafaxine

Warfarin: Methylphenidate may decrease metabolism of coumarin anticoagulants; effect has not been confirmed in all studies; monitor INR

Dosage Oral: Children 6 years and Adults: Treatment of ADHD: Initial: 2.5 mg twice daily in patients not currently taking methylphenidate; dosage may be adjusted in 2.5-5 mg increments at weekly intervals (maximum dose: 20 mg/day); doses should be taken at least 4 hours apart

When switching from methylphenidate to dexmethylphenidate, the starting dose of dexmethylphenidate should be half that of methylphenidate (maximum dose: 20 mg/day)

Safety and efficacy for long-term use of dexmethylphenidate have not yet been established. Patients should be re-evaluated at appropriate intervals to assess continued need of the medication.

Dose reductions and discontinuation: Reduce dose or discontinue in patients with paradoxical aggravation. Discontinue if no improvement is seen after one month of treatment.

Dosage Forms Tablet, as hydrochloride: 2.5 mg, 5 mg, 10 mg