Cotempla XR-ODT is a once-daily medication taken in the morning
for the treatment of ADHD in patients 6 to 17 years of age.
How Cotempla XR-ODT may help your child
Take some time to review the results from our clinical study.

Clinical Study Results

Cotempla XR-ODT was evaluated in a laboratory classroom setting that is similar to a child’s classroom at school. 87 patients aged 6 to 12 years with ADHD participated in the study.
Cotempla XR-ODT works fast. With ADHD symptom improvement throughout the day

The SKAMP Rating Scale* was used by independent trained professionals to measure a child’s attention, behavior and quality of work during the classroom testing day.

  • At 7am, children were given their assigned medication (Cotempla XR-ODT or Sugar Pill). Trained professionals did not know if a child was administered Cotempla XR-ODT or a sugar pill.
  • Next, the children began activities similar to a school day while trained professionals observed and rated their behaviors and interactions.
  • The trained raters completed SKAMP ratings for all study participants over 12 hours at: 8am, 10am, 12pm, 2pm, 5pm, 7pm, and 8pm.

Time (Hours) After Taking Cotempla XR-ODT or Sugar Pill

Children were rated on these 13 items with total scores ranging from 0 to 78. A lower score means fewer symptoms.
Individual results may vary.

Key Findings from the Study
Cotempla XR-ODT works fast – on average patients demonstrated a 61% improvement in ADHD Symptoms after 1 hour.
When taken in the morning, Cotempla XR-ODT improved the symptoms of ADHD throughout the day, even 12 hours after taking it.
Cotempla XR-ODT works – from the early part of the school day to homework time.
The most common side effects in >5% of study participants included: decreased appetite, stomach pain, headache, trouble sleeping, respiratory tract infection, mood swings, irritability, cough, and vomiting.

 

SKAMP RATING SCALE

Children we were rated on a scale of 0-6 for each item listed. (0= no impairment, 6 = maximal impairment) Each child in the study received a Total Score ranging from 0 to 78.

  1. Getting started on assignments for classroom periods
  2. Sticking with tasks or activities for the allotted time
  3. Participating in an activity or classroom discussion
  4. Stopping and making transition to the next period
  5. Interacting with other children (eg, other students)
  6. Interacting with adults (eg, teacher or aide)
  7. Remaining quiet according to classroom rules
  1. Staying seated according to classroom rules
  2. Completing assigned work
  3. Performing work accurately
  4. Being careful and neat while writing or drawing
  5. Complying with teacher’s usual requests or directions
  6. Following the rules established for the classroom

Take the next step. Talk to your child’s doctor about Cotempla XR-ODT
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Important Safety Information

Cotempla XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.
Who should not take Cotempla XR-ODT?

Do not give Cotempla XR-ODT to your child if they are:

  • allergic to methylphenidate or any ingredients in Cotempla XR-ODT.
  • taking or has taken an anti-depression medicine called monoamine oxidase inhibitor (MAOI) within the past 14 days.
What is the most important information I should know about Cotempla XR-ODT?

Cotempla XR-ODT can cause serious side effects. Tell your healthcare provider about health conditions, including if your child:

  • has ever abused or been dependent on alcohol, prescription medicines, or street drugs. Cotempla XR-ODT has a high chance for abuse and can cause physical and psychological dependence.
  • has any heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects. Increased blood pressure and heart rate have been reported. Your healthcare provider should check for heart problems prior to prescribing Cotempla XR-ODT and will check your child’s blood pressure and heart rate regularly during treatment. Call the healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while during treatment.
  • has mental problems, or a family history of suicide, bipolar illness, or depression. This is important because the following could occur: new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (hearing voices, or seeing or believing things that are not real) or new manic symptoms. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment.
  • develops painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. Get medical help right away if your child develops priapism.
  • has circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, and/or change color from pale, to blue, to red. Tell your healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in their fingers or toes. Call the healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking Cotempla XR-ODT.
  • is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking Cotempla XR-ODT. Treatment may be stopped if your child is not gaining weight or height.
  • is pregnant or plans to become pregnant. It is not known if Cotempla XR-ODT will harm the unborn baby. If your child becomes pregnant during treatment with Cotempla XR-ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants.
  • is breastfeeding, or plans to breastfeed. You and your healthcare provider should decide if your child will take Cotempla XR-ODT or breastfeed.
  • takes any medicines, including prescription and over-the-counter medicines (especially for depression, including MAOIs), vitamins, and herbal supplements. Cotempla XR-ODT and some medicines may interact with each other and cause serious side effects, or sometimes the dose of the other medicine will need to be adjusted.
Do not start any new medicine while taking Cotempla XR-ODT without talking to your healthcare provider first.
What should I avoid during treatment with Cotempla XR-ODT?

  • You should avoid drinking alcohol during treatment with Cotempla XR-ODT.

Common side effects of Cotempla XR-ODT include:

Decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure.

These are not all the possible side effects of Cotempla XR-ODT. Call your healthcare provider for medical advice about side effects.

What is Cotempla XR-ODT?
Cotempla XR-ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. Cotempla XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.
For additional safety information, click here for Medication Guide and Full Prescribing Information and discuss with your healthcare provider.
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.