Cotempla XR-ODT

Generic name: Methylphenidate
Dosage form: extended-release orally disintegrating tablet
Drug class: CNS stimulants

Usage of Cotempla XR-ODT

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.

Cotempla XR-ODT side effects

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.

    Before taking Cotempla XR-ODT

    Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether Cotempla XR-ODT will harm your unborn baby.

    There is a pregnancy registry for females who are exposed to this medication during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Cotempla XR-ODT and their baby. If your child becomes pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961-2388.

    Tell your healthcare provider if you are breastfeeding or plan 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..

    Relate drugs

    How to use Cotempla XR-ODT

    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.

    Warnings

    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.

    • What other drugs will affect Cotempla XR-ODT

    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.

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords