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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 extended-release 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) stimulant.
Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its empirical formula is C14H19NO2&bul;HCl. Its molecular weight is 269.77 and its structural formula is:
FOCALIN XR (dexmethylphenidate hydrochloride) Structural Formula Illustration
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, 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.
This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Dexmethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.
How to use Focalin XR
Read the Medication Guide provided by your pharmacist before you start taking dexmethylphenidate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily in the morning, with or without food. Taking this medication late in the day may cause trouble sleeping (insomnia).
The dosage is based on your medical condition and response to treatment. Your doctor may direct you to gradually increase or decrease your dose. Also, if you have used it for a long time, do not suddenly stop using this drug without consulting your doctor.
Do not break, crush, or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Swallow the capsules whole. If you have trouble swallowing the capsule, you may open the capsule and carefully sprinkle its contents on a spoonful of cool applesauce. Swallow all of the mixture right away without chewing it. Then drink a glass of cool liquid to make sure you have swallowed all of the dose. Do not prepare the mixture ahead of time.
Methylphenidate and dexmethylphenidate are different medications and do not provide the same amount of medicine. Do not switch between products unless your doctor tells you to.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, suicidal thoughts, or other mental/mood changes) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your condition does not improve or if it worsens.
Focalin XR should not be used in patients being treated (currently or within the preceding 2 weeks) with MAO Inhibitors
Because of possible effects on blood pressure, Focalin XR should be used cautiously with pressor agents.
Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Dexmethylphenidate is metabolized primarily to d-ritalinic acid by de-esterification and not through oxidative pathways.
The effects of gastrointestinal pH alterations on the absorption of dexmethylphenidate from Focalin XR have not been studied. Since the modified release characteristics of Focalin XR are pH dependent, the coadministration of antacids or acid suppressants could alter the release of dexmethylphenidate.
Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in the case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.
Drug Abuse And Dependence
Focalin XR, like other methylphenidate products, is classified as a Schedule II controlled substance by Federal regulation. Abuse, Dependence, Tolerance
DOSAGE AND ADMINISTRATION
Focalin XR is for oral administration once daily in the morning.
Focalin XR may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce
. Focalin XR capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Dosage should be individualized according to the needs and responses of the patient.
Patients New To Methylphenidate
The recommended starting dose of Focalin XR for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients.
Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered. In dose-response (fixed-dose) studies (pediatric from 10 to 30 mg/day and adult from 20 to 40 mg/day), all doses were effective vs. placebo. There was no clear finding, however, of greater average benefits for the higher doses compared to the lower doses. Adverse events and discontinuations, however, were dose-related. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended.
Patients Currently Using Methylphenidate
For patients currently using methylphenidate, the recommended starting dose of Focalin XR is half the total daily dose of racemic methylphenidate. Patients currently using Focalin (dexmethylphenidate) may be switched to the same daily dose of Focalin XR.
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Focalin XR. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Focalin XR for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Dose Reduction And Discontinuation
If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.
If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued.
Store Focalin XR in a secure place out of reach of children, and at room temperature. Do not share your Focalin XR prescription with anyone, even another person with ADHD. Sharing prescription medication is illegal, and can cause harm.
You should not take Focalin XR if you or your child have:glaucoma,tics or Tourette’s syndrome
a history of drug abuse
severe feelings of anxiety, tension, or agitation
an allergy to stimulant medications or any other ingredients in Focalin XR
taken or plan to take a monoamine oxidase inhibitor (MAOI) within 14 days
If you are thinking of becoming pregnant, discuss the use of Focalin XR with your doctor. Animal studies indicate potential harm to a fetus. It is not known if Focalin XR is passed through breastmilk, so it is recommended that mothers do not nurse while taking it.
The most common side effects of Focalin XR are as follows: stomach ache, headache, nausea, decreased appetite, sleep disturbances, anxiety, dry mouth, and dizziness.
Other serious side effects include: serious allergic reaction, slowing of growth in children, seizures, eyesight changes or blurred vision, and priapism.
Taking Focalin XR may impair your or your teenager’s ability to drive, operate machinery, or perform other potentially dangerous tasks. This side effect usually wears off with time. If side effects are bothersome, or do not go away, talk to your doctor. Most people taking this medication do not experience any of these side effects.
Report to your doctor any heart-related problems or a family history of heart and blood pressure problems before beginning any new prescription. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Focalin XR. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Focalin XR.
Also disclose to your physician all mental health issues including any family history of suicide, bipolar illness, tics, or depression. Focalin XR may create new or exacerbate existing behavior problems, bipolar illness, or Tourette’s syndrome. It can cause psychotic or manic symptoms in children and teenagers. Call your doctor immediately if you or your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.
Discuss circulation problems with your doctor before taking Focalin XR, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Focalin XR.
Stimulants like Focalin XR have a high potential for abuse and addiction, especially among people who do not have ADHD. It is a “Schedule II” stimulant, a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce potential for abuse.
The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.
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