Methylphenidate ER chewable tablets now available for ADHD treatment

Kye Pharmaceuticals is introducing Quillivant ER Chewable Tablets (methylphenidate HCl extended-release chewable tablets) in three strengths: 20 mg (scored), 30 mg (scored) and 40 mg (not scored). It is the only extended-release methylphenidate product available in a chewable tablet in Canada.1 Quillivant ER is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children six to 12 years of age. Health Canada has not authorized the product’s use in children < 6 years or 13 to 17 years of age.2 Methylphenidate is a central nervous system stimulant. It is believed to act primarily through indirect mechanisms, such as release of dopamine and norepinephrine from neuronal pools, and inhibition of neurotransmitter reuptake.2 Quillivant ER chewable tablets contain approximately 30% immediate-release and 70% extended-release methylphenidate.2 Peak effect occurs about five hours after administration of a single 40 mg dose, and the mean plasma terminal elimination half-life is about 5.2 hours.2 Compared to an immediate-release formulation of methylphenidate chewable tablet (given in two equal doses of 20 mg, six hours apart), methylphenidate mean peak concentration and exposure (AUC∞) were about 20% and 11% lower, respectively, after single-dose administration of a Quillivant ER 40 mg chewable tablet.2The dosage of Quillivant ER chewable tablets should be individualized and slowly adjusted to the lowest effective dose. Children should start with 20 mg once daily in the morning, with or without food. The dose should then be titrated up or down weekly, in increments of 10 mg, 15 mg or 20 mg. The 10 mg and 15 mg doses can each be achieved by breaking the scored 20 mg and 30 mg tablets in half. Daily doses above 60 mg are not recommended.2 If switching from another methylphenidate product, the manufacturer recommends discontinuing the previous product and titrating the dosage of Quillivant ER chewable tablets using the titration schedule specified above. Quillivant ER should not be substituted for other methylphenidate products on a milligram-per-milligram basis, because of different methylphenidate base compositions and differing pharmacokinetic profiles.2Decreased appetite is the most common adverse effect of Quillivant ER chewable tablets. Other possible adverse effects include mood swings, insomnia, irritability, upper abdominal pain and taste disturbance. More serious potential adverse effects include increases in blood pressure and heart rate, and the potential for drug dependence. The product should not be used in children with symptomatic cardiovascular disease or known structural cardiac abnormalities. Consult the product monograph for details on other potential adverse effects, warnings and precautions.2 In terms of drug interactions, Quillivant ER should be used cautiously with other drugs that increase blood pressure or heart rate. Methylphenidate may inhibit the metabolism of warfarin, anticonvulsants (e.g., phenobarbital, phenytoin, primidone) and some antidepressants (e.g., tricyclics, SSRIs); downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. Methylphenidate should not be administered with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment (hypertensive crises may result). Serious adverse events including sudden death have been reported when used with clonidine.2In a press release accompanying the launch of Quillivant ER chewable tablets, Dr. Sohail Khattak, a pediatrician, pharmacologist and toxicologist at the Kids Clinic in Ajax, ON commented that “The introduction of a chewable tablet formulation of methylphenidate with an innovative extended-release delivery system represents a major advancement for young Canadian patients and their caregivers managing ADHD. This novel approach ensures lasting effects and a convenient dosing regimen that enhances treatment adherence.”1Kye Pharmaceuticals also gained Health Canada approval for Quillivant ER Oral Suspension (methylphenidate HCl extended-release powder for oral suspension, 5 mg/mL when reconstituted), but the suspension dosage form will not be marketed until later this year. Quillivant ER oral suspension and chewable tablets are not interchangeable.2References1. Kye Pharmaceuticals announces the availability of Quillivant ER chewable tablets for the treatment of children with ADHD. July 2, 2024. (accessed July 11, 2024).2. Kye Pharmaceuticals. Quillivant ER Chewable Tablets (methylphenidate HCl extended-release chewable tablets) product monograph. Mississauga, ON; September 20, 2023. (accessed July 11, 2024).

Methylphenidate ER chewable tablets now available for ADHD treatment

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