Description

Description

Focalin XR

Focalin XR is an extended-release stimulant ADHD medication used to treat symptoms of attention deficit hyperactivity disorder in children and adults.

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 5, 10, and 20 mg capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5, 5, or 10 mg of Focalin ™ tablets given b.i.d. 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 Note: * = asymmetric carbon centers 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. Focalin XR also contains the following inert ingredients: ammonio methacrylate copolymer, FD&C Blue #2 (5mg strength), FDA/E172 Yellow Iron Oxide (10mg strength), gelatin, ink Tan SW-8010, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate.