Focalin Generic Name & Formulations
Legal Class
CII
General Description
Dexmethylphenidate HCl (single-isomer methylphenidate) 2.5mg, 5mg, 10mg+; tabs; +dye-free.
Pharmacological Class
CNS stimulant.
See Also
How Supplied
XR caps, tabs—100
Manufacturer
Generic Availability
YES
Focalin Indications
Indications
Attention deficit hyperactivity disorder.
Focalin Dosage and Administration
Adults and Children
<6yrs: not established. Individualize. ≥6yrs: initially 2.5mg twice daily at least 4hrs apart; may increase by 2.5–5mg weekly; max 20mg/day. Switching from racemic methylphenidate (eg, Ritalin): ½ of racemic methylphenidate dose.
Focalin Contraindications
Contraindications
During or within 14 days of MAOIs.
Focalin Boxed Warnings
Boxed Warning
Abuse and dependence.
Focalin Warnings/Precautions
Warnings/Precautions
High potential for abuse and dependence; monitor. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.
Focalin Pharmacokinetics
See Literature
Focalin Interactions
Interactions
See Contraindications. Hypertensive crisis with MAOIs. Avoid concomitant use with halogenated anesthetics (eg, halothane). Risk of serotonin syndrome with serotonergic drugs. May antagonize antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.
Focalin Adverse Reactions
Adverse Reactions
Dyspepsia, dry mouth, decreased appetite, headache, anxiety, pharyngolaryngeal pain, anorexia, nausea, abdominal pain, fever; weight loss, hypertension, tachycardia, priapism.
Focalin Clinical Trials
See Literature
Focalin Note
Not Applicable
Focalin Patient Counseling
See Literature