Focalin Xr

— THERAPEUTIC DISORDERS TREATED —
  • ADHD

Focalin Xr Generic Name & Formulations

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

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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