Cotempla XR-ODT

What is Cotempla XR-ODR?

Cotempla XR-ODT (Generic Name: methylphenidate) is the first methylphenidate-based extended-release orally disintegrating tablet for the treatment of ADHD in children between the ages of 6 and 17. Cotempla XR-ODT contains the same active ingredient as medications like Ritalin and Daytrana, but it dissolves in the patient’s mouth, without chewing or drinking water. According to the FDA, Cotempla XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. The safety and effectiveness of Cotempla XR-ODT has not been established for children under the age of 6.

The National Institute of Mental Health finds the most successful treatment plans use a combination of ADHD medication, like Cotempla XR-ODT, and behavior therapies.

How Do You Use Cotempla XR-ODT?

Before starting or refilling a Cotempla XR-ODT prescription, read the medication guide included with your child’s pills, as it may be updated with new information.

This guide should not replace a conversation with your child’s doctor, who has a holistic view of your or your child’s medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before your child begins taking the medication.

What is the Typical Dosage for Cotempla XR-ODT?

As with all medications, follow your Cotempla XR-ODT prescription instructions exactly. Cotempla XR-ODT is taken orally, once daily in the morning with or without food and water.

The time-release formulation is designed to maintain a steady level of medication in your child’s body throughout the day.

The optimal dosage varies patient by patient. Your doctor may adjust your child’s daily dosage until your child experiences the best response — that is, the lowest dosage at which your child experiences the greatest improvement in symptoms without side effects.

For updated information about dosages, interactions, and precautions, see the Cotempla XR-ODT drug monograph on WebMD.

Cotempla XR-ODT is a grape-flavored quick-dissolving tablet. To keep it from dissolving before your child places the tablet in the mouth, leave it contained in its blister package until your child is ready to take it. When opening the medication, make sure your hands are clean and dry so as not to accidentally trigger dissolution. Peel back the blister package backing to take out the tablet instead of pushing it through the foil. Place the tablet on your child’s tongue to dissolve. Do not crush or chew the tablet.

Your teen should not drink alcohol while taking this medication.

During treatment, your doctor may periodically ask your child to stop taking Cotempla XR-ODT so that they can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.

Some patients report developing a tolerance to Cotempla XR-ODT after long-term use. If you notice that your child’s dosage is no longer controlling symptoms, talk to your child’s doctor to plan a course of action.

What Side Effects are Associated with Cotempla XR-ODT?

The most common side effects of Cotempla XR-ODT are as follows: decreased appetite, difficulty sleeping, nausea, vomiting, stomach ache, abdominal pain, weight loss, anxiety, dizziness, mood swings, increased blood pressure, increased heart rate, and irritability.

Other serious side effects include blurred vision and priapism.There has been some concern that stimulants may cause a slowing of growth in children and adolescents, however research findings are mixed. Some studies show no impact on growth at all,¹ while others find what is considered “negligible” slowing of growth.² If you find evidence of suppressed growth in your child, talk to your doctor about what steps might help.

If side effects are bothersome, or do not go away, talk to your child’s doctor. Most people taking this medication do not experience any of these side effects.

Report to your doctor any heart-related problems or a family history of heart and blood pressure problems. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Cotempla XR-ODT. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Cotempla XR-ODT.

Also disclose to your physician all mental health issues including any family history of suicide, BPD, or depression. Cotempla XR-ODT may create new or exacerbate existing behavior problems or BPD. The manufacturer recommends evaluating patients for risk factors for developing a manic episode prior to treatment. Call your doctor immediately if your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.

Discuss circulation problems with your doctor before taking Cotempla XR-ODT, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your child’s doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Cotempla XR-ODT.

Stimulants like Cotempla XR-ODT have a high potential for abuse and addiction, especially among people who do not have ADHD. It is a “Schedule II Stimulant,” a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce the potential for abuse.

The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

What Precautions Are Associated with Cotempla XR-ODT?

Store Cotempla XR-ODT in a secure place out of the reach of children, and at room temperature. Your child should not share a Cotempla XR-ODT prescription with anyone, even someone with ADHD. Sharing prescription medication is illegal and can cause harm.

Patients should not take Cotempla XR-ODT if they have an allergy or hypersensitivity to Cotempla XR-ODT or any of the ingredients in Cotempla XR-ODT medication, or if they have taken monoamine oxidase inhibitors (MAOIs) within 14 days.

Use caution while taking Cotempla XR-ODT if your child has a history of heart or mental problems or circulation problems.

There are risks associated with taking methylphenidate during pregnancy. If your teen becomes pregnant, discuss the use of Cotempla XR-ODT with your doctor. Cotempla XR-ODT is passed through breastmilk, so it is recommended that mothers do not nurse while taking it.

The safety of Cotempla XR-ODT for children under age six has not been established.

What Interactions Are Associated with Cotempla XR-ODT?

Before taking Cotempla XR-ODT, discuss all other active prescription medications with your child’s doctor. Cotempla XR-ODT can have a dangerous, possibly fatal, interaction with antidepressants including MAOIs.

Your child should not take gastric pH modulators (e.g., an H2-blocker or proton pump inhibitor, like Prilosec).

Share a list of all vitamin or herbal supplements, and prescription and non-prescription medications your child takes with the pharmacist when you fill the prescription, and let all doctors and physicians know your child is taking Cotempla XR-ODT before having any surgery or laboratory tests. The above is not a complete list of all possible drug interactions.

Cotempla XR-ODT and Other ADHD Medications: More Information

• A Parent’s Guide to ADHD Medications
• Free Download: The Complete Guide to ADHD Medications
• The Full Range of Treatment Options for Children with ADHD
• Primer: The Stimulant Medications Used to Treat ADHD

Sources:

¹Pediatrics (2014.) “ADHD, Stimulant Treatment, and Growth: A Longitudinal Study.” https://publications.aap.org/pediatrics/article-abstract/134/4/e935/77034/ADHD-Stimulant-Treatment-and-Growth-A-Longitudinal

²Journal of the American Academy of Child & Adolescent Psychiatry. (2019.) “Trajectories of Growth Associated With Long-Term Stimulant Medication in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder.” https://www.jaacap.org/article/S0890-8567(19)31443-1/fulltext
http://www.neostx.com/products-overview/

https://www.cotemplaxrodthcp.com/#isi
http://www.neostxcontent.com/Labeling/Cotempla/Cotempla_PI.pdf
https://www.additudemag.com/cotempla-xr-odt-fda-approved-to-treat-adhd-in-children/