FDA Approves Cotempla XR for ADHD

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Attention-deficit hyperactivity disorder (ADHD) is the most common behavioral disorder starting in childhood. It is a chronic condition that can include attention difficulty, hyperactivity, and impulsiveness.

Common ADHD treatments include Adderall (amphetamine salt combo), Vyvanse, and Concerta (methylphenidate er) – and we now have a new one to add to the list!

Recently, the FDA approved Cotempla XRthe first methylphenidate extended release orally disintegrating tablet for ADHD.

What is Cotempla XR indicated for?

Cotempla is indicated for the treatment of ADHD in pediatric patients 6 to 17 years of age. It will be available as an orally disintegrating tablet in the strengths of 8.6 mg, 17.3 mg, and 25.9 mg.

Since Cotempla XR is an orally disintegrating tablet, it is to be dissolved on top of the tongue once daily in the morning. Remember that no liquid is needed as the tablet will dissolve completely on the tongue and can be swallowed with saliva. Do not crush or chew the tablet.

Be sure that you remove the tablet from the foil with dry hands, and immediately place it on the top of the tongue.

What are the most common side effects associated with Cotempla XR?

The most common side effects include a decrease in appetite, insomnia, nausea, vomiting, heartburn, stomach pain, weight loss, anxiety, irritability and increased blood pressure. Speak with your doctor if you experience any of these side effects for a prolonged period of time.

Are there any other methylphenidate extended-release products available?

Ritalin LA (methylphenidate LA), Ritalin SR (methylphenidate SR), Concerta (methylphenidate ER), Metadate CD (methylphenidate CD), DaytranaQuillivant XR and Quillichew ER are all similar to Cotempla XR.

Where can I find more information?

For more information on Cotempla XR, read the press release by the manufacturer, Neos Therapeutics, here.

The manufacturer, Neos Therapeutics, expects that Cotempla XR will be commercially available in a portable, child-resistant blister pack in the fall of 2017.  

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