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Focalin Xr Generic Name & Formulations
Legal Class
CII
General Description
Dexmethylphenidate HCl (single-isomer methylphenidate) 5mg, 10mg, 15mg, 20mg, 25mg, 30mg, 35mg, 40mg; ext-rel caps (contains immediate-release + e-c del-rel beads).
Pharmacological Class
CNS stimulant.
See Also
How Supplied
XR caps, tabs—100
Manufacturer
Generic Availability
YES
Focalin Xr Indications
Indications
Attention deficit hyperactivity disorder.
Focalin Xr Dosage and Administration
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
<6yrs: not established. Take in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. 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.
Focalin Xr Contraindications
Contraindications
During or within 14 days of MAOIs.
Focalin Xr Boxed Warnings
Boxed Warning
Abuse and dependence.
Focalin Xr 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 Xr Pharmacokinetics
See Literature
Focalin Xr 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 Xr Adverse Reactions
Adverse Reactions
Dyspepsia, dry mouth, decreased appetite, headache, anxiety, pharyngolaryngeal pain, anorexia, nausea, abdominal pain, fever; weight loss, hypertension, tachycardia, priapism.
Focalin Xr Clinical Trials
See Literature
Focalin Xr Note
Not Applicable
Focalin Xr Patient Counseling
See Literature
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