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Focalin®: (dexmethylphenidate hydrochloride) Tablets
Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5, 5, or 10 mg for oral administration. Dexmethylphenidate hydrochloride is methyl αphenyl-2-piperidine acetate hydrochloride, (R,R’)-(+)-. Its empirical formula is C14H19NO2•HCl. Its molecular weight is 269.77
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 also contains the following inert ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.
Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of Focalin in the treatment of ADHD was established in 2 controlled trials of patients aged 6 to 17 years of age who met DSM-IV criteria for ADHD
DOSAGE AND ADMINISTRATION
Focalin is administered twice daily, at least 4 hours apart. Focalin may be administered with or without food.
Dosage should be individualized according to the needs and responses of the patient.
Patients New To Methylphenidate
The recommended starting dose of Focalin for patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day (2.5 mg twice daily).
Dosage may be adjusted in 2.5 to 5 mg increments to a maximum of 20 mg/day (10 mg twice daily). In general, dosage adjustments may proceed at approximately weekly intervals.
Patients Currently Using Methylphenidate
For patients currently using methylphenidate, the recommended starting dose of Focalin is half the dose of racemic methylphenidate. The maximum recommended dose is 20 mg/day (10 mg twice daily).
Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F).
[see USP Controlled Room Temperature] Protect from light and moisture.