ADHD:
Indications for FOCALIN XR:
Attention deficit hyperactivity disorder.
Adult:
Take in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Initially 10mg once daily; may increase by 10mg weekly; max 40mg/day. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.
Children:
Take in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. <6yrs: not established. Individualize. ≥6yrs: initially 5mg once daily; may increase by 5mg weekly; max 30mg/day. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.
Contraindications:
During or within 14 days of MAOIs.
Boxed Warning:
Abuse and dependence.
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 (Cat.C). Nursing mothers.
See Also:
Pharmacologic Class:
CNS stimulant.
Interactions:
See Contraindications. Hypertensive crisis with MAOIs. Avoid concomitant use with halogenated anesthetics (eg, halothane). May antagonize antihypertensives. Risk of serotonin syndrome with serotonergic drugs.
Adverse Reactions:
Dyspepsia, dry mouth, decreased appetite, headache, anxiety, pharyngolaryngeal pain, anorexia, nausea, abdominal pain, fever; weight loss, hypertension, tachycardia, priapism.
Elimination:
Renal.
Generic Availability:
XR 5mg, 10mg, 15mg, 20mg, 30mg, 40mg (YES); 25mg, 35mg (NO); tabs (YES)
How Supplied:
XR caps, tabs—100
