Focalin XR 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, 20, 25, 30, 35, and
40 mg extended-release capsules. Focalin XR 5, 10, 15, 20, 25, 30, 35, and 40
mg extendedrelease capsules provide in a single dose the same amount of
dexmethylphenidate as dosages of 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 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)
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 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
Inactive ingredients: ammonio methacrylate copolymer,
FD&C Blue #2 (5 mg, 15 mg, 25 mg, 35 mg, and 40 mg strengths), FDA/E172
yellow iron oxide (10 mg, 15 mg, 30 mg, 35 mg, and 40 mg strengths), gelatin,
ink Tan SW-8010, methacrylic acid copolymer, polyethylene glycol, sugar
spheres, talc, titanium dioxide, and triethyl citrate.
What are the possible side effects of dexmethylphenidate (Focalin, Focalin XR)?
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:
- dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, numbness, seizure);
- fast or uneven heart rate;
- blurred vision or other visual changes;
- unusual behavior, confusion; or
- twitching or tics.
Read All Potential Side Effects and See Pictures of Focalin XR »
What are the precautions when taking dexmethylphenidate hydrochloride (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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis),...
Read All Potential Precautions of Focalin XR »
Last reviewed on RxList: 5/31/2012
This monograph has been modified to include the generic and brand name in many instances.