These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005
Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior. Focalin XR is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older (1) (1) Extended-release capsules: 5, 10, 15, 20, 30, and 40 mg (3) Most common adverse reactions (at least 5% and twice the incidence among placebo-treated patients) are dyspepsia, decreased appetite, headache, and anxiety for pediatric patients and dry mouth, dyspepsia, headache, and anxiety for adult patients (6). (6) (6) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 3/2011 Focalin XR should be given cautiously to patients with a history of
These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005 FOCALINXR - dexmethylphenidate hydrochloride capsule, extended release Physicians Total Care, Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydr
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