once-daily dosing

Triple-bead delivery for extended release1

Titration

For pediatric patients (ages 13-17 years), the recommended starting dose is 12.5 mg once daily in the morning upon awakening. Dosage may be adjusted in increments of 12.5 mg, no sooner than weekly, up to recommended max dose 25 mg/day. Dose should be individualized according to the needs and response of the patient. Doses higher than 25 mg have not been evaluated in clinical trials in pediatric patients.

For adult patients, the recommended starting dose of Mydayis is 12.5 mg once daily in the morning upon awakening. Initial doses of 25 mg once daily may be considered for some adult patients. Dosage may be adjusted in increments of 12.5 mg, no sooner than weekly, up to a max 50 mg/day, based on therapeutic needs and response of the patient. Doses above 50 mg/day have shown no additional clinically meaningful benefit.

Pharmacological treatment of ADHD may be needed for an extended period. Periodically re-evaluate the long-term use of Mydayis and adjust dosage as needed.

Dosing

Take Mydayis by mouth once daily in the morning upon awakening due to potential for insomnia and because effects may last up to 16 hours post-dose. In the event of a missed dose, do not administer later in the day. Do not administer additional medication to make up for the missed dose.

Administration (with or without food)

Capsule may be taken with or without food but should be taken the same way each time. Capsule may be swallowed whole or opened and sprinkled entirely on a spoonful of applesauce. Patients must swallow entire mixture right away without chewing or storing. The dose of a single capsule should not be divided.

Mydayis capsule may be swallowed whole or opened and sprinkled entirely on a spoonful of applesauce.

CAPSULE

APPLESAUCE  

Capsules shown are not actual size.
Beads shown are not actual color.

Dosing Safety Information

  • Prior to treatment, assess for cardiac disease and risk of abuse; after prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse, dependence and overdose, and periodically re-evaluate the need for Mydayis use.
  • Patients with severe renal impairment: Adult starting dose 12.5 mg/day; adult maximum dose 25 mg/day; pediatric (ages 13-17) maximum dose 12.5 mg/day, if tolerated. Patients with end-stage renal disease (ESRD): Not recommended for use.
  • To avoid substitution errors and overdosage, do not substitute for other amphetamines on mg-per-mg basis because of different amphetamine base compositions and differing PK profiles.
Reference
  1. Mydayis [package insert]. Lexington, MA; Shire US Inc.