FOCALIN XR CII
Generic Name and Formulations:
Dexmethylphenidate HCl (single-isomer methylphenidate) 5mg, 10mg, 15mg, 20mg, 25mg, 30mg, 35mg, 40mg; ext-rel caps (contains immediate-release + e-c del-rel beads).
Novartis Pharmaceuticals Corp
Indications for FOCALIN XR:
Attention deficit hyperactivity disorder.
Take once daily in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Initially 10mg/day; may increase by 10mg weekly. Usual dose: 20–40mg/day. Doses >40mg/day: not recommended. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.
Take once daily 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/day; may increase by 5mg weekly. Usual dose: 10–30mg/day. Doses >30mg/day: not recommended. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.
Marked anxiety, tension, agitation. Glaucoma. Motor tics. Tourette's syndrome in patient or family. During or within 14 days of MAOIs.
History of drug dependence or alcoholism; monitor for abnormal behavior. 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 before initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for new or worsening aggressive behavior or hostility. Seizure disorder. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR, CBCs, differential, platelet counts. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Hypertensive crisis with MAOIs. Caution with pressor agents. May potentiate coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), tricyclics (eg, imipramine, clomipramine, desipramine), SSRIs; adjust doses. May decrease effectiveness of antihypertensive agents. Caps: may be affected by drugs that affect pH (eg, antacids, acid suppressants). Risk of serotonin syndrome with serotonergic drugs.
Dyspepsia, dry mouth, decreased appetite, headache, anxiety, anorexia, insomnia, nausea, abdominal pain, weight loss; hypertension, tachycardia, visual disturbances, priapism.
XR 5mg, 10mg, 15mg, 20mg, 30mg, 40mg (YES); 25mg, 35mg (NO); tabs (YES)
XR caps, tabs—100