CONCERTA® proven safety profile for short- and long-term use

In addition to wanting help to overcome the daily challenges of ADHD, your patients and parents of younger patients, want an ADHD treatment that is safe and effective, with minimal side effects.

According to online surveys:

    Among adults with ADHD1

  • 83% expressed that it is important for an ADHD medication to have a low incidence of insomnia
  • 87% feel it’s important that an ADHD medication infrequently affect their mood
  • CONCERTA® has a low incidence of initial insomnia (4.3%), insomnia (12.3%), and mood lability (1.4%)
  • Among parents of children and adolescents with ADHD2

  • 94% feel it is important for their child’s ADHD medication to have a low incidence of insomnia
  • 74% expressed that it is important for an ADHD medication to have a low incidence of appetite suppression
  • CONCERTA® has a low incidence of mood lability (<1%), insomnia (2.8%), and appetite suppression.

 

In controlled clinical trials, CONCERTA® was shown to be generally well tolerated by patients of all ages — children, adolescents, and adults. See the results now:

Reference 1: Survey conducted online within the United States by Harris Interactive on behalf of Ortho-McNeill-Jannsen Pharmaceuticals, Inc. between June 10 and June 20, 2008, among 153 adults aged 18 and older who live in the US and are both diagnosed with and currently taking medication for ADHD

Reference 2: Survey conducted online within the United States by Harris Interactive on behalf of Ortho-McNeill-Jannsen Pharmaceuticals, Inc. between May 21 and June 2, 2008, among 152 adults who have a child aged 6 to 17 who has been diagnosed with ADHD and is currently taking medication for more than 3 months.

CONCERTA® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

IMPORTANT SAFETY INFORMATION

CONCERTA® should not be taken by patients with: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; Tourette's syndrome, tics, or family history of Tourette's syndrome; current or recent use of monoamine oxidase inhibitors (MAOIs). Children under 6 years of age should not take CONCERTA.®

Abuse of methylphenidate may lead to dependence. CONCERTA® should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, other serious cardiac problems, or patients with pre-existing severe gastrointestinal narrowing. Use with caution in patients with hypertension and other cardiovascular conditions, psychosis, bipolar disorder, and history of seizures/EEG abnormalities. Stimulants may cause new psychotic or manic symptoms; discontinuation of treatment may be appropriate. Aggressive behavior or hostility should be monitored in patients beginning ADHD treatment. Methylphenidate may produce difficulties with visual accommodation and blurring of vision. Hematologic monitoring is advised during prolonged therapy. Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

The most common adverse reaction (>5%) reported in children and adolescents was abdominal pain upper. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

Please see full U.S. Prescribing Information

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This information is intended for the use of our customers and healthcare professionals in the United States and Puerto Rico only. McNeil Pediatrics recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may be not be appropriate for use outside the United States and Puerto Rico.

CONCERTA® and OROS® are registered trademarks of ALZA Corporation © Ortho-McNeil-Janssen Pharmaceuticals, Inc. Titusville, NJ, USA. All rights reserved.

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Last Modified Date: Jun 15 2010 at 16:01:16 EDT