Trade Names:Focalin- Tablets 2.5 mg- Tablets 5 mg- Tablets 10 mg
Trade Names:Focalin XR- Capsules, extended-release 5 mg- Capsules, extended-release 10 mg- Capsules, extended-release 15 mg- Capsules, extended-release 20 mg
Exact mechanism of action is unknown; however, the drug may block the reuptake of norepinephrine and dopamine into presynaptic neurons and increase release of these monoamines into extraneuronal spaces.
Readily absorbed. T max is 1 to 1.5 h. Extended-release (ER) T max is 6.5 h. Absolute bioavailability is 22% to 25%. High-fat food increased tablet T max to 2.9 h.
Vd is approximately 2.65 L/kg.
Metabolized by deesterification to d-ritalinic acid (inactive).
Approximately 90% recovered in urine (approximately 80% as ritalinic acid). The t ½ is approximately 2 to 4.5 h.
Treatment of attention deficit hyperactivity disorder (ADHD).
Marked anxiety, tension, or agitation; glaucoma; motor tics; family history or diagnosis of Tourette syndrome; MAOI treatment and within 14 days following discontinuation of an MAOI; hypersensitivity to methylphenidate or other components of product.
PO Tablets: 2.5 mg twice daily; adjust dose in 2.5 to 5 mg increments at weekly intervals (max, 10 mg twice daily).Adults
PO ER capsules: 10 mg once daily; adjust dose in 10 mg increments at weekly intervals (max, 20 mg once daily).Children older than 6 yr of age
PO ER capsules: 5 mg once daily; adjust dose in 5 mg increments at weekly intervals (max, 20 mg once daily).Patients Currently Receiving MethylphenidateAdults and children older than 6 yr of age
PO Tablets: 50% of the dose of racemic methylphenidate (max, 10 mg twice daily). ER capsules: 50% of the dose of racemic methylphenidate (max, 20 mg once daily); use same daily dose of dexmethylphenidate tablets when switching from tablets to ER capsules (max, 20 mg once daily).
Store at controlled room temperature (59° to 86°F). Protect from light and moisture.
Coadministration could alter the release of dexmethylphenidate.Anticonvulsants (eg, phenytoin), coumarin anticoagulants (eg, warfarin), SSRIs (eg, fluoxetine), tricyclic antidepressants (eg, amitriptyline)
Effects may be increased by dexmethylphenidate, necessitating a decrease in dosage.Antihypertensive agents, pressor agents (eg, clonidine, dopamine)
Effects may be decreased by dexmethylphenidate. Although an interaction has not been established, serious adverse reactions have been associated with coadministration of clonidine.MAOIs (eg, phenelzine)
Discontinue MAOI therapy at least 14 days before starting dexmethylphenidate.
None well documented.
Insomnia, twitching (motor or vocal tics).ER
Headache (39%); decreased appetite (30%); feeling jittery (12%); anxiety (11%); dizziness (6%); anorexia (1%).
Abdominal pain (15%); nausea (9%); anorexia (6%).ER
Dry mouth (20%); dyspepsia (9%).
Pharyngolaryngeal pain (7%).
Give dexmethylphenidate cautiously to patients with a history of drug dependence or alcohol abuse. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use because severe depression may occur. Withdrawal following chronic therapy may unmask symptoms of the underlying disorder that may require follow-up.
When starting treatment, monitor for appearance or worsening of aggressive behavior or hostility.
Use with caution to treat ADHD in patients with comorbid bipolar disorder because of possible induction of mixed/manic episode.
Treatment-emergent psychotic or manic symptoms (eg, delusional thinking) can occur in children and adolescents without a history of psychotic illness or mania.
Symptoms of behavior disturbances and thought disorder may be exacerbated in patients with a preexisting psychotic disorder.
Convulsive threshold may be lowered in patients with a history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, rarely, in patients without a history of seizures and no prior EEG evidence of seizures. Discontinue therapy in presence of seizures.
Sudden death has occurred in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities. Sudden death, stroke, and MI have occurred in adults taking stimulant drugs at usual doses for ADHD. Do not use stimulant drugs in children, adolescents, or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems.
Agitation, cardiac arrhythmias, confusion, delirium, dryness of mucous membranes, euphoria, flushing, hallucinations, headache, hyperpyrexia, hyperreflexia, hypertension, muscle twitching, mydriasis, palpitations, seizures (may be followed by coma), sweating, tachycardia, tremors, vomiting.
Copyright © 2009 Wolters Kluwer Health.