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FDA Approves Use Of Concerta (Methylphenidate HCl) 72 mg for Treatment of Attention Deficit Hyperactivity Disorder

FORT WASHINGTON, PA -- October 26, 2004 -- The U.S. Food and Drug Administration (FDA) has approved Concerta® (methylphenidate HCl) Extended-release Tablets CII for use in adolescents with Attention Deficit Hyperactivity Disorder (ADHD), expanding the product's labeling to include a 72 mg dosing regimen.

"Concerta can now be safely and effectively dosed up to 72 mg a day," said Minnie V. Baylor-Henry, R.Ph., J.D., Vice President, Medical & Regulatory Affairs, McNeil Consumer & Specialty Pharmaceuticals. "This additional dosage form offers doctors, parents, and patients greater dosing flexibility for the management and treatment of ADHD," she added.

Concerta 72 mg may be warranted when symptoms of ADHD are not responding to lower doses of the medication. Previous clinical research demonstrates that a few weeks after taking their initial dose of Concerta eight out of ten patients were given higher doses of the medication to achieve effective symptom management. In a clinical study of adolescents ages 13-18 years, Concerta 72 mg significantly reduced ADHD symptoms, such as difficulty paying attention to schoolwork.
Concerta tablets are currently available in 18 mg, 27 mg, 36 mg, and 54 mg strengths. There is no 72 mg tablet. While physicians will determine how the medication should best be taken by adolescents for whom it is prescribed, it is believed Concerta 72 mg will most often be taken as a once-a-day morning dose of two Concerta 36 mg tablets.


About Concerta
Concerta® (methylphenidate HCl) CII is a once-daily extended-release formulation of methylphenidate approved to treat ADHD. The efficacy of Concerta has been demonstrated in studies conducted in children and adolescents. Only a doctor can determine if medication is the right treatment for individuals with ADHD.
Concerta uses an advanced OROS® extended-release delivery system to deliver a controlled rate of medication throughout the day. Because of its unique OROS system, Concerta minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day.

Concerta should not be taken by patients with: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in Concerta; glaucoma, Tourette's syndrome, tics, or family history of Tourette's syndrome; current/recent use of monoamine oxidase inhibitors (MAOIs). Abuse of methylphenidate may lead to dependence. Concerta should not be taken by children under six years of age.
In clinical studies with children using Concerta, the most common side effects were headache, stomach pain, sleeplessness, and decreased appetite. In clinical studies with adolescents using Concerta, the most common side effects were headache, accidental injury, and, sleeplessness.

Concerta is marketed in the U.S. by McNeil Consumer & Specialty Pharmaceuticals. For more information about Concerta, including full U.S. prescribing information, please visit www.concerta.net or call 1-888-440-7903.


SOURCE: McNeil Consumer & Specialty Pharmaceuticals

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