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CONCERTA® - ADHD Treatment For Children

CONCERTA® Basics read more
Is CONCERTA® Right for My Child? read more
What to Expect From CONCERTA® read more
The Value of Continued ADHD Treatment read more
ADHD Resources read more
CONCERTA® Basics

The Dose Makes the Difference

Overview

One morning dose of CONCERTA® provides all-day ADHD symptom control. CONCERTA® is the only ADHD treatment with the unique OROS® delivery system, which slowly releases medication at an increasing rate throughout the day. One morning dose covers your child's busy day — including the all-important homework hours between the hours of 4 and 6 pm.

CONCERTA® is proven to help manage the symptoms of inattention, hyperactivity, and impulsivity. With these symptoms under control, your child can focus better and pay closer attention to the things he or she is doing throughout the day. All of this may help your child manage ADHD symptoms at school, at home, and at play.

CONCERTA® is approved for doses up to 54 mg per day in children and 72 mg per day in adolescents. Children are typically started on a daily dose of 18 mg of CONCERTA®. But, like many ADHD medications, your child's dosage may need to be adjusted to achieve better results. This approach is called titration. Your child's healthcare professional can determine which dose is right for your child.

Help your child get on the path to success in managing ADHD symptoms. If your child has been diagnosed with ADHD, ask about managing everyday challenges of ADHD with CONCERTA®.

Is CONCERTA® Right for My Child?

Proven Effective

Overview

Everyday activities can be a challenge when your child has ADHD. But making the decision to treat your child's ADHD symptoms is an important first step. If your child has been diagnosed with ADHD, ask a healthcare professional how CONCERTA® can help your child manage ADHD symptoms.

Methylphenidate, the medication in CONCERTA®, is recommended among first-line therapies by the American Academy of Pediatrics as part of a total treatment program for ADHD. Part of this includes a team of people focused on helping your child like family members, caregivers, teachers, and your child's healthcare professional. This treatment approach may also include behavioral therapy.

If your child has been diagnosed with ADHD, ask his or her healthcare professional how treatment with CONCERTA® can help your child manage the everyday challenges of ADHD.

What to Expect From CONCERTA®

Overview

As a parent, you'll want to know what to expect from your child's treatment with CONCERTA®. Every child is unique and will have his or her own response to ADHD medication. For your child to get the most out of treatment, it's important to work closely with your child's healthcare professional. It is also important to discuss any side effects with your child’s healthcare professional.

Your child only needs to take CONCERTA® once a day, in the morning, with or without food. CONCERTA® works throughout the day to provide long-lasting ADHD symptom control.* CONCERTA® offers a unique time-released formulation (OROS® technology) that provides all-day ADHD symptom control. CONCERTA® improves focus. And can help your child control his or her hyperactive and/or impulsive behavior.

CONCERTA® should not be used in children less than 6 years old because it has not been studied in this age group. CONCERTA® may not be right for you or your child. Before starting CONCERTA®, tell your doctor or your child’s doctor about all health conditions . Your doctor or your child's doctor can discuss potential side effects. Please read the accompanying Medication Guide before speaking with your doctor or your child's doctor.

CONCERTA® comes in a range of doses so your child can get the right amount to help manage his or her symptoms. Most children are started on 18 mg of CONCERTA®. But it may be necessary to adjust this dosage to get the best treatment results. This adjustment process is called titration. CONCERTA® is approved in dosages up to 54 mg per day for children and 72 mg per day for adolescents. Children under 6 years of age should not take CONCERTA®.

A typical dose adjustment schedule may look like this:

Week 1: One 18-mg tablet once daily
Week 2: Two 18-mg tablets once daily for a total of 36 mg
Week 3: Three 18-mg tablets once daily for a total of 54 mg

During the first few weeks of treatment, it's important that you and your child's healthcare professional discuss how your child's treatment is going. This may help your child quickly get to the dose that works best. Track your child's symptoms to monitor his or her treatment progress. Only your child's healthcare professional should adjust their dose of CONCERTA®.

The most common side effect (greater than 5%) for CONCERTA® in children was abdominal pain upper.

*In Studies 1 and 2, symptoms of ADHD were evaluated by laboratory schoolteachers using the Swanson, Kotkin, Agler, M-Fynn, and Pelham (SKAMP) laboratory school rating scale. The combined results from these two studies demonstrated statistically significant improvements in attention and behavior in patients treated with CONCERTA® versus placebo that were maintained through 12 hours after dosing
The Value of Continued ADHD Treatment

ADHD Doesn't Take a Break

Overview

ADHD symptoms can impact your child 7 days a week, at home, school and in social settings. The symptoms of ADHD don't take a weekend or summer break. So, medication may be a necessary part of your child's everyday routine.

If you're considering a break from CONCERTA® during weekends, holidays, or summer vacation, you should first consult with your child's healthcare professional before making any decision about treatment changes.

Managing your child's ADHD symptoms can improve his or her ability to focus, even during breaks from school. Continued treatment with CONCERTA® may help your child have a better time managing his or her ADHD symptoms during weekend or summer activities like long car trips, organized sports, or summer camp.

CONCERTA® can help your child manage the daily challenges of ADHD symptoms. So, by continuing with once-daily CONCERTA® you could be providing important support to help your child maintain focus even in less-structured environments.

ADHD Resources

More Answers and Help Are Available

The more you know about ADHD, the better you can manage your child's condition. When you understand how ADHD affects your child's life, you can start developing strategies to manage the everyday challenges of ADHD.

Here are some helpful resources you can use for education and support:

United States Department of Education

Find out about your child's rights under federal laws designed to ensure that children with disabilities, including ADHD, receive an appropriate education.
http://www.ed.gov/offices/OSERS/Policy/IDEA/index.html

National Dissemination Center for Children With Disabilities (NICHCY)

NICHCY serves as a central source of information about educational rights, special education resources, individualized education programs (IEPs) and more.
http://www.nichcy.org

National Center for Learning Disabilities (NCLD)

By providing information, promoting research and advocating for educational rights, the NCLD works to help people with learning disabilities in school, work and life.
http://www.ncld.org

Attention Deficit Disorder Association (ADDA)

This international organization has been providing information, resources and networking opportunities to adults with ADHD since 1989.
http://www.add.org

American Medical Association (AMA)

This professional organization for doctors is dedicated to the art and science of medicine and promoting public health.
http://www.ama-assn.org/

CHADD.org

Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD) is a national nonprofit organization that provides advocacy and support for people with ADHD.
www.chadd.org

NIMH.NIH.gov

The National Institute of Mental Health provides useful information about ADHD in children, adolescents and adults.
http://www.nimh.nih.gov

Learning Disabilities Association of America (LDA)

LDA is one of the largest nonprofit volunteer organizations advocating for individuals with learning disabilities.
http://www.ldanatl.org/

ADDitude Magazine

Stay on top of the latest information about ADHD in children, adolescents and adults.
http://www.additudemag.com

The Mayo Clinic

The Mayo Clinic is dedicated to the diagnosis and treatment of virtually every type of complex illness, including ADHD.
http://www.mayoclinic.com

IMPORTANT SAFETY INFORMATION

Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs. Keep CONCERTA® in a safe place to prevent misuse and abuse.

Who should not take CONCERTA®?

CONCERTA® should not be taken by patients who have:

  • allergies to methylphenidate or other ingredients in CONCERTA®
  • significant anxiety, tension or agitation
  • glaucoma
  • tics, Tourette’s syndrome or family history of Tourette’s syndrome
  • current or past use of monoamine oxidase inhibitor (MAOI)
  • esophagus, stomach or intestinal narrowing

Children under 6 years of age should not take CONCERTA®.

Tell your healthcare professional if you or your child has had:

  • any heart problems, heart defects, high blood pressure or a family history of these problems
  • has had depression, abnormal thoughts or visions, bipolar disorder, or seizures
  • numbness, pain, skin color change or sensitivity to temperature in fingers or toes

Contact your healthcare professional immediately if you or your child:

  • develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity
  • if aggressive behavior or hostility develops or worsens while taking CONCERTA®

Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

Your child’s healthcare professional should check height and weight often and may interrupt CONCERTA® treatment if your child is not growing or gaining weight as expected.

Stimulants may impair the ability of a patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA® does not adversely affect your ability to engage in such activities.

The most common adverse reactions in double-blind clinical trials (>5%) reported:

  • in children and adolescents was upper abdominal pain
  • in adult patients were decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety, dizziness, weight decreased, irritability and increased sweating

CONCERTA® is a registered trademark of ALZA Corporation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information including Boxed WARNING and the Medication Guide for CONCERTA®.

cp-180018v1

INDICATION

CONCERTA® (methylphenidate HCl) Extended-release Tablets CII is a prescription medication approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs. Keep CONCERTA® in a safe place to prevent misuse and abuse.

Who should not take CONCERTA®?

CONCERTA® should not be taken by patients who have:

  • allergies to methylphenidate or other ingredients in CONCERTA®
  • significant anxiety, tension or agitation
  • glaucoma
  • tics, Tourette’s syndrome or family history of Tourette’s syndrome
  • current or past use of monoamine oxidase inhibitor (MAOI)
  • esophagus, stomach or intestinal narrowing

Children under 6 years of age should not take CONCERTA®.

Tell your healthcare professional if you or your child has had:

  • any heart problems, heart defects, high blood pressure or a family history of these problems
  • has had depression, abnormal thoughts or visions, bipolar disorder, or seizures
  • numbness, pain, skin color change or sensitivity to temperature in fingers or toes

Contact your healthcare professional immediately if you or your child:

  • develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity
  • if aggressive behavior or hostility develops or worsens while taking CONCERTA®

Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

Your child’s healthcare professional should check height and weight often and may interrupt CONCERTA® treatment if your child is not growing or gaining weight as expected.

Stimulants may impair the ability of a patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA® does not adversely affect your ability to engage in such activities.

The most common adverse reactions in double-blind clinical trials (>5%) reported:

  • in children and adolescents was upper abdominal pain
  • in adult patients were decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety, dizziness, weight decreased, irritability and increased sweating

CONCERTA® is a registered trademark of ALZA Corporation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information including Boxed WARNING and the Medication Guide for CONCERTA®.

cp-180018v1

+
INDICATION

CONCERTA® (methylphenidate HCl) Extended-release Tablets CII is a prescription medication approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.