Medication Monitor

Generic Name (Trade Name—Company)
March 6, 2019

Methylphenidate hydrochloride XR

(Adhansia XR—Adlon Therapeutics)
Extended-release methylphenidate capsules approved for ADHD treatment

Methylphenidate hydrochloride extended-release (XR) capsules CII, a central nervous system stimulant, offers a methylphenidate treatment option with a longer duration of efficacy in patients with ADHD aged 6 years and older. The product will be available in six capsule strengths: 25, 35, 45, 55, 70, and 85 mg.

The recommended starting dose is 25 mg taken orally once daily in the morning, with or without food. The dose should be titrated in increments of 10 mg to 15 mg at intervals of no less than 5 days. Capsules may be taken whole or opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt.

The most common adverse reactions in adults are insomnia, dry mouth, and decreased appetite; in pediatric patients, they are decreased appetite, insomnia, and decreased weight.

The prescribing information contains a boxed warning for abuse and dependence. Health professionals should assess the risk of abuse before prescribing the drug and monitor patients for signs of abuse and dependence. The drug is contraindicated in patients with a known hypersensitivity to methylphenidate or product components, as well as patients receiving concurrent treatment with a MAOI or those who have used an MAOI within the preceding 14 days.