ADHD FAQs – Cotempla XR-ODT

ADHD FAQs

We created some questions and answers to help you and your child along the journey.

A diagnosis of ADHD can bring both relief and apprehension. It is important to know that it isn’t your child’s fault. Nor is it your fault. ADHD is a medical condition that can be treated. While there is no cure for ADHD, there are many resources and tools that can help you, your child, and your family better understand how to treat and manage your child’s ADHD symptoms.

FAQs

This list of FAQs can help you understand ADHD, available treatments, and Cotempla XR-ODT specifically. If there are any questions you still have that aren’t answered here, please consult with your child’s doctor.

What are the various treatments used for ADHD?

There are two main types of ADHD medications: stimulant and non-stimulant medications. Medications also come in several different forms to meet the different needs of patients. This includes orally disintegrating tablets (ODTs), liquids, patches, capsules and tablets. Before medication treatment begins, your child’s doctor should discuss the benefits and the possible side effects of these medications.

Do ADHD treatments cure ADHD?

Medications for ADHD can be very effective but they are not a cure for ADHD. Medications can help children control his or her ADHD symptoms on the day the medication is taken. If a child does not take their medication, you should not expect to see improvement in their symptoms. Treatment for ADHD varies with each patient, and a treatment plan that includes ADHD medication may help your child manage this condition.

How can I know that my child has ADHD?

At times, many children can have trouble focusing and paying attention. All kids make careless mistakes in their school work…or forget to do their homework from time to time. Children with ADHD have significantly more challenges in their concentration, impulsivity, and hyperactivity that can negatively impact them at school and at home. If you are concerned that your child might have ADHD, make an appointment with his or her doctor.

What is Cotempla XR-ODT?

Cotempla XR-ODT (methylphenidate) is an extended-release orally disintegrating tablet approved for the treatment of ADHD in children ages 6 to 17. “Extended release” means the active drug is released in the body throughout the day. ODT means “orally disintegrating tablet.” Cotempla XR-ODT dissolves quickly in the mouth so that your child does not need to swallow it whole and can be taken without water.

Can Cotempla XR-ODT Improve attention and reduce the symptoms of hyperactivity and lmpulsivity?

Yes. In a clinical study, Cotempla XR-ODT was shown to work fast and improve attention and behavior throughout the day. Learn more about the Cotempla XR-ODT clinical study by clicking here. It is important to remember that everybody is different and results will vary from patient to patient.

How does an orally disintegrating tablet differ from a traditional pill?

An orally disintegrating tablet (ODT) dissolves quickly in the mouth without water.

How long will my child need to take medication?

The course of treatment with ADHD medications depends on the individual patient’s situation and response to overall treatment. Your child’s doctor may talk to you about trial periods without medication to assess your child’s response to treatment. Your child’s doctor will talk to you about the risks and benefits of stopping treatment.

How quickly can I expect Cotempla XR-ODT to work in my child?

Cotempla XR-ODT is a stimulant medication. Many researchers and clinicians believe that stimulant medications like Cotempla XR-ODT can have an immediate effect on ADHD symptoms. Of course, all patients are different and results will vary from patient to patient.

What types of side effects are most common with ADHD medications?

There are many different ADHD medications available for patients with ADHD. Each medication has a unique side effect profile. Click here to learn more about the side effects patients experienced while taking Cotempla XR-ODT in our clinical study. Your child’s doctor will be able to provide you with information on the most common side effects of other ADHD medications.

What If I suspect an accidental overdose In my child?

If you suspect an accidental overdose of Cotempla XR-ODT, call your child’s doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What Important safety Information should I know about Cotempla XR-ODT?

Review Important Safety Information and the patient Medication Guide.

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.