Focalin® XR (dexmethylphenidate hydrochloride) extended-release capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin® XR uses the proprietary SODAS® (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR 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 is available as 5, 10, 15, and 20 mg extended-release capsules. Focalin XR 5, 10, 15, and 20 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5, 5, 7.5 or 10 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

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 and 15 mg strengths), FDA/E172 yellow iron oxide (10 mg and 15 mg strengths), gelatin, ink Tan SW-8010, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate.

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