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Focalin™ XR - Food and Drug Administration

focalin xr (dexmethylphenidate hydrochloride) extended-release capsules Rx only Prescribing Information DESCRIPTION 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 , 5, or 10 mg of Focalin tablets given Dexmethylphenidate hydrochloride, the d-threo enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant.

interpeak minimum, and the time until the second peak. The first peak concentration and the extent of absorption were unchanged after food relative to the fasting state, although the second peak was ... methylphenidate being detectable after administration of up to 40 mg dexmethylphenidate in adults. After

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