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FDA Approves Concerta (Methylphenidate) 27 mg Extended Release for Attention Deficit/Hyperactivity Disorder

FORT WASHINGTON, PA -- April 2, 2002 -- The U.S. Food and Drug Administration (FDA) has approved Concerta® (methylphenidate HCl) 27 mg Extended-release Tablets, offering greater dosing flexibility for the treatment of attention deficit/hyperactivity disorder (ADHD).

Concerta is also available in 18 mg, 36 mg, and 54 mg strengths.

Concerta can be initiated and dosed safely and effectively, even in patients who have never taken ADHD medication. "It is recommended that Concerta therapy be initiated with 18 mg taken once daily in the morning and titrated up to 36 mg if no improvement in symptoms is seen," said Patrick Ciccone, MD, vice president, Medical, McNeil Consumer & Specialty Pharmaceuticals. "The Concerta 27 mg tablet provides ADHD patients an interim dose between the 18 and 36 mg tablets for a more gradual titration."

Nearly 85 percent of patients in a long-term, open-label study were successfully titrated up to 36 and 54 mg doses of Concerta.

Taken once a day, Concerta is an integral part of a total ADHD treatment program. Concerta uses an advanced Oros® extended-release delivery system to deliver a controlled rate of medication throughout the day. The Oros tri-layer tablet is designed to release the medication in Concerta in a smoothly delivered pattern maintaining improved attention and behavior through 12 hours, including during activities outside of school or work.

Because of its unique Oros system, Concerta minimizes the ups and downs patients often experience with stimulant medications taken several times a day. Research confirms that a single dose of Concerta is as effective as the standard three-times-a-day dosing regimen of methylphenidate, the most commonly prescribed medication for ADHD.

Concerta also eliminates the need for dosing in and out of school or work, since it is taken once in the morning (with or without food). This is especially important for patients who participate in academic, job-related, or social activities outside of school or work.

"For children in particular, Concerta can help to eliminate the feelings of embarrassment they may feel having to take medication in the middle of the school day or during activities outside of school," said Dr. Ciccone. "And, once-a-day dosing means the medication is kept in the home and in the hands of parents."

The American Academy of Pediatrics recommends the use of stimulant medications such as Concerta as part of a total treatment program for children with ADHD. Practice parameters published by the American Academy of Child & Adolescent Psychiatry (AACAP) affirm the use of stimulant medication for first-line treatment of ADHD.

The AACAP guidelines also note that, "The newer stimulant preparations such as Concerta are less prone to abuse and diversion than the immediate-release methylphenidate tablets and are more suitable for adolescents with ADHD who are at risk for abusing their stimulant medications."

Concerta should not be taken by patients who have significant anxiety, tension, or agitation, since Concerta may make these conditions worse; are allergic to methylphenidate or any of the other ingredients in Concerta; have glaucoma; have tics or Tourette's syndrome, or a family history of Tourette's syndrome; are taking a prescription monoamine oxidase inhibitor (MAOI). Concerta should not be administered to patients with pre-existing, severe gastrointestinal narrowing. Concerta should not be used in children under six years, since safety and efficacy in this age group have not been established.

Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence.

SOURCE: McNeil Consumer & Specialty Pharmaceuticals

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