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ADHD refers to a chronic biobehavioral disorder that initially manifests in childhood and is characterized by hyperactivity, impulsivity, and/or inattention. Not all of those affected by ADHD manifest all three behavioral categories. These symptoms can lead to difficulty in academic, emotional, and social functioning. The diagnosis is established by satisfying specific criteria and may be associated with other neurological, significant behavioral, and/or developmental/learning disabilities. Therapy may consider the use of medication, behavioral therapy, and adjustments in day-to-day lifestyle activities.
Studies in the United States indicates approximately 8%-10% of children satisfy diagnostic criteria for ADHD. ADHD is, therefore, one of the most common disorders of childhood. ADHD occurs two to four times more commonly in boys than girls (male to female ratio 4:1 for the predominant...
FOCALIN XR
(dexmethylphenidate hydrochloride)
WARNING
DRUG DEPENDENCE
Focalin XR (dexmethylphenidate hydrochloride) 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. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
Focalin XR (dexmethylphenidate hydrochloride) is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR (dexmethylphenidate hydrochloride) uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR (dexmethylphenidate hydrochloride) capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a second delayed release of dexmethylphenidate. Focalin XR (dexmethylphenidate hydrochloride) is available as 5, 10, 15, 20, 30, and 40 mg extended-release capsules. Focalin XR (dexmethylphenidate hydrochloride) 5, 10, 15, 20, 30, and 40 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5, 5, 7.5, 10, 15 or 20 mg of Focalin given b.i.d. as tablets.
Dexmethylphenidate hydrochloride, the d-threo enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant.
Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R')-(+)-. Its empirical formula is C14H19NO2•HCl. Its molecular weight is 269.77 and its structural formula is
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Note* = asymmetric carbon center
Dexmethylphenidate hydrochloride is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Inactive ingredients: ammonio methacrylate copolymer, FD&C Blue #2 (5 mg, 15 mg and 40 mg strengths), FDA/E172 yellow iron oxide (10 mg, 15 mg, 30, and 40 mg strengths), gelatin, ink Tan SW-8010, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using dexmethylphenidate and call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Focalin XR »
Before taking dexmethylphenidate, tell your doctor or pharmacist if you are allergic to it; or to methylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, severe anxiety/tension, certain eye problem (glaucoma), personal or...
Last reviewed on RxList: 12/27/2010
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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