Cotempla XR-ODT is a stimulant medication used to treat attention deficit hyperactivity disorder (ADHD) in children. It contains a central nervous system (CNS) stimulant called methylphenidate.

Cotempla XR-ODT is a grape-flavored tablet that is taken in the morning and is marketed as an "on the go" medication that dissolves in the mouth and works quickly.

Exactly how Cotempla XR-ODT works in children with ADHD is not known. However, people with ADHD have been found to have low levels of dopamine and noradrenaline, which are two neurotransmitters (chemical messengers) found in the brain. Cotempla XR-ODT boosts the levels of these neurotransmitters by preventing their re-uptake from the space between nerve cells (neurons) in the brain. It increases activity in the brain, especially in the areas that help regulate behavior and attention.

Medications containing methylphenidate, such as Cotempla XR-ODT, are schedule II federally controlled substances because they can be a target for people who abuse prescription medicines or street drugs. Selling or giving away Cotempla XR-ODT may harm others, and is against the law.

Cotempla XR-ODT was approved for use by the US Food and Drug Administration (FDA) in 2017, although methylphenidate in another formulation was first approved many years earlier in 1955.

What is Cotempla XR-ODT used for?

Cotempla XR-ODT is a prescription medicine used for the treatment of ADHD in children from 6 to 17 years of age. It may help increase attention and decrease impulsiveness and hyperactivity.

It is not known if it is safe and effective in children under 6 years of age.

Cotempla XR-ODT can cause serious side effects, including:

• Abuse and dependence. This medication contains methylphenidate. Cotempla XR-ODT, other methylphenidate containing products, and amphetamines, have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check your child for signs of abuse and dependence before and during treatment with this medication.
  • Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Heart-related problems, including:
  • sudden death in children who have heart problems or heart defects
  • increased blood pressure and heart rate
    
    Your healthcare provider should check your child carefully for heart problems before starting this medication. Tell your healthcare provider if your child has any heart problems, heart defects, or high blood pressure, or a family history of these problems.
    Your healthcare provider should check your child's blood pressure and heart rate regularly during treatment with Cotempla XR-ODT.
    
    Call your healthcare provider right away 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 during treatment.
• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
    
    Tell your healthcare provider about any mental problems your child has, or about a family history of suicide, bipolar illness, or depression.
    
    Call your healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

• Take Cotempla XR-ODT exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose if needed.
• Take 1 time each day in the morning.
• Cotempla XR-ODT can be taken with or without food but take it the same way each time.
• Take Cotempla XR-ODT as follows:
  • Keep in the blister pack until your child is ready to take it. Take Cotempla XR-ODT right after opening the blister pack. Do not store the tablet for future use.
  • Use dry hands when opening the blister pack.
  • Remove the tablet by peeling back the foil on the blister pack. Do not push the tablet through the foil.
  • As soon as the blister is opened, remove the tablet and place it on the tongue. Do not chew or crush the tablet.
  • The tablet will dissolve and can be swallowed with saliva. No liquid is needed to take the tablet.

Your healthcare provider may sometimes stop your child's treatment with this medication for a while to check ADHD symptoms.

The recommended starting dose for Cotempla XR-ODT for patients 6 to 17 years of age is 17.3 mg given orally once daily in the morning. The dosage may be increased weekly in increments of 8.6 mg to 17.3 mg per day. Daily dosage above 51.8 mg is not recommended.

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

• allergic to methylphenidate, or any of the ingredients in Cotempla XR-ODT. See below for a complete list of ingredients.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

What should I tell my doctor before taking Cotempla XR-ODT?

Before taking Cotempla XR-ODT, tell your child's healthcare provider about all medical conditions, including if your child:

• has heart problems, heart defects, or high blood pressure
• has mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• has circulation problems in fingers or toes

If a dose of Cotempla XR-ODT is missed, it should be taken as soon as you remember. If it is near bedtime or near the time of the next dose then skip the missed dose and take the next dose at the regular time. Do not take a double dose.

If too much Cotempla XR-ODT is taken, call your healthcare provider or go to the nearest hospital emergency room right away.

Avoid drinking alcohol during treatment with Cotempla XR-ODT.

Cotempla XR-ODT can cause serious side effects, including:

• See "Important information" above.
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If your child develops priapism, get medical help right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Signs and symptoms may include:
  • fingers or toes may feel numb, cool, or painful
  • fingers or toes may 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 the fingers or toes.
    
    Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with this medication.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment. Treatment may be stopped if your child is not gaining weight or height.

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 (affect liability)
• increased heart rate
• increased blood pressure

These are not all the possible side effects of this medication.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all of the medicines that 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.

Your healthcare provider will decide whether Cotempla XR-ODT can be taken with other medicines.

Especially tell your healthcare provider if your child takes medicine to treat depression, including MAOIs.

Know the medicines that your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist when your child get a new medicine.

Do not start any new medicine during treatment without talking to your healthcare provider first.