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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Consumer Important Safety Information

Most Important Information About COTEMPLA XR-ODT:

Abuse, misuse, and addiction. COTEMPLA XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of COTEMPLA XR-ODT, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of COTEMPLA XR-ODT or when it is used in ways that are not approved, such as snorting or injection.
  • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check your child carefully for heart problems before starting COTEMPLA XR-ODT. Tell your healthcare provider if your child has any heart problems, heart disease, or heart defects. Call your 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 taking COTEMPLA XR-ODT.
  • Increased blood pressure and heart rate. Your healthcare provider should check your child’s blood pressure and heart rate regularly during treatment with COTEMPLA XR-ODT.
  • Mental (Psychiatric) problems: Tell your healthcare provider about any mental problems your child has, or about a family history of suicide, bipolar illness, depression, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real), or new manic symptoms. Call your healthcare provider right away if your child has any new or worsening mental symptoms or problems while taking COTEMPLA XR-ODT, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
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 under 6 to 17 years of age. COTEMPLA XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in children 6 to 17 years of age with ADHD. It is not known if    COTEMPLA XR-ODT is safe and effective in children under 6 years of age.
You should avoid drinking alcohol during treatment with COTEMPLA XR-ODT.
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. Never give your COTEMPLA XR-ODT to anyone else because it may cause death or harm them. Selling or giving away COTEMPLA XR-ODT may harm others and is against the law.
Do Not Give COTEMPLA XR-ODT to Your Child if They are: COTEMPLA XR-ODT should not be taken if you or your child:
  • Are allergic to methylphenidate or any of the ingredients in COTEMPLA XR-ODT
  • Are taking or have taken within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor MAOI
Before Taking COTEMPLA XR-ODT Tell Your Child’s Healthcare Provider About All Medical Conditions, Including if Your Child:
  • Has heart problems, heart disease, heart defects, or high blood pressure
  • Has mental problems including psychosis, mania, bipolar illness, or depression
  • Has circulation problems in fingers or toes
  • Have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
  • Have, or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
  • Is pregnant or plans to become pregnant. It is not known if COTEMPLA XR-ODT will harm the unborn baby.
  • Is breastfeeding or plans to breastfeed. COTEMPLA XR-ODT passes into breast milk. You and your healthcare provider should decide if your child will take COTEMPLA XR-ODT or breastfeed.
Tell your healthcare provider about all of the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. COTEMPLA XR-ODT and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with COTEMPLA XR-ODT. Your healthcare provider will decide whether COTEMPLA XR-ODT can be taken with other medicines. Especially tell your healthcare provider if your child takes anti-depression medicines including MAOIs.
Do not start any new medicine during treatment with COTEMPLA XR-ODT without talking to your healthcare provider first.
The most common side effects of COTEMPLA XR-ODT include decreased appetite and problems sleeping. COTEMPLA XR-ODT can cause serious side effects, including:
  • Painful or prolonged erections (priapism). If your child develops priapism, get medical help right away.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon): fingers and toes may feel numb, cool, painful and/or change from pale to blue or red. Tell your healthcare provider if your child has numbness, pain, skin color change, sensitivity to temperature in their fingers or toes, or any signs of unexplained wounds appearing on fingers or toes during treatment with COTEMPLA XR-ODT.
  • Slowing of growth (height and weight in children). Children should have their height and weight checked often during treatment with COTEMPLA XR-ODT. COTEMPLA XR-ODT treatment may be stopped if your child is not gaining weight or height.
  • Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if your child develops changes in their vision or eye pain, swelling, or redness.
  • New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if your child gets any new or worsening tics or worsening Tourette’s syndrome during treatment with COTEMPLA XR-ODT.
  • The most common side effects of methylphenidate products include: decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, increased blood pressure.
These are not all the possible side effects of COTEMPLA XR-ODT.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please click here for Full Medication Guide.