Focalin, Focalin XR
Classifications: cerebral stimulant; Therapeutic: cerebral stimulant
Pregnancy Category: C
Controlled Substance: Schedule II
2.5 mg, 5 mg, 10 mg tablets; 5 mg, 10 mg, 20 mg extended release capsules
Thought to block the reuptake of norepinephrine and dopamine into the presynaptic neurons and, thereby, increases release
of these substances into the synapse. The mode of action in controlling the symptoms of attention deficit hyperactivity disorder
(ADHD) is not fully understood.
Is effective in controlling ADHD syndrome in conjunction with other measures (psychological, educational, and social).
Attention deficit hyperactivity disorder (ADHD).
Hypersensitivity to dexmethylphenidate or methylphenidate; known structural cardiac abnormalities in children or adults,
cardiomyopathy, congenital heart disease; coronary heart disease; severe agitation, anxiety, or tension; psychotic symptomatology;
substance abuse; glaucoma; motor tics other than Tourette's syndrome; concurrent MAOI therapy; children <6 y; seizures;
pregnancy (category C), lactation.
Moderate to severe hepatic insufficiency; Tourette's syndrome; depression; emotional instability; alcoholism or drug dependence;
history of seizure disorders; hypertension, CHF, cardiac arrhythmias; hyperthyroidism.
Route & Dosage
|Attention Deficit Hyperactivity Disorder
Adult: PO 2.5 mg b.i.d., may increase by 2.5 mg5 mg/d at weekly intervals to max of 20 mg/d. If converting from methylphenidate,
start with ? of methylphenidate dose. Extended release: 10 mg daily, may increase by 5 mg at weekly intervals to max of 20 mg/d
Child (>6 y): PO 2.5 mg b.i.d., may increase by 2.5 mg5 mg/d at weekly intervals to max of 20 mg/d. If converting from methylphenidate,
start with ? of methylphenidate dose. Extended release: 5 mg daily, may increase by 5 mg at weekly intervals to max of 20 mg/d>
- Do not administer with or within 14 d following discontinuation of an MAO inhibitor.
- Give sustained release capsules whole. They should not be crushed or chewed.
- Give b.i.d. doses at least 4 h apart.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)Body as a Whole:
Fever, allergic reactions. CNS:
, nervousness, tics, abnormal thinking, hallucinations, emotional lability, CNS overstimulation or sympathomimetic
effects [angina, anxiety, agitation, biting, blurred vision, delirium, diaphoresis, flushing or pallor, hallucinations,
hyperthermia, labile blood pressure and heart rate (hypotension or hypertension), mydriasis, palpitations, paranoia, purposeless
movements, psychosis, sinus tachycardia, tachypnea, or tremor]. CV:
Hypertension, tachycardia. GI: Abdominal pain,
decreased appetite, nausea, vomiting.
Additive stimulant effects with other stimulants
(including amphetamine, caffeine
); increased vasopressor effects with dopamine, epinephrine, norepinephrine, phenylpropanolamine, pseudoephedrine; mao inhibitors
may cause hypertensive crisis; antagonizes hypotensive effects of guanethidine, bretylium;
may inhibit metabolism and increase serum levels of fosphenytoin, phenytoin, phenobarbital, and primidone, warfarin, tricyclic antidepressants
Well absorbed. Peak:
11.5 h. Metabolism:
De-esterified in liver. No interaction with CYP450 system. Elimination:
Primarily in urine. Half-Life:
Assessment & Drug Effects
- Withhold drug and notify physician if patient has a seizure. Monitor closely for loss of seizure control with a prior history
- Monitor BP in all patients receiving this drug. Monitor cardiac status and report palpitations or other signs of arrhythmias.
- Monitor for potential abuse and dependence on this drug. Careful supervision is needed during drug withdrawal since severe
depression may occur.
- Monitor for signs of aggression or psychotic behavior in adolescents and children.
- Lab tests: Periodic CBC, differential, platelet counts, and LFTs during prolonged therapy.
- Concurrent drugs: Monitor patients on BP-lowering drugs for loss of BP control. Monitor plasma levels of oral anticoagulants
and anticonvulsants; doses of these drugs may need to be decreased.
Patient & Family Education
- Withhold drug and report immediately any of the following signs of overdose: vomiting, agitation, tremors, muscle twitching,
convulsions, confusion, hallucinations, delirium, sweating, flushing, headache, or high temperature.
- Note that drug is usually discontinued if improvement is not observed after appropriate dosage adjustment over 1 mo.