Drug Detail:Mydayis (Amphetamine and dextroamphetamine mixed salts)
Generic Name: DEXTROAMPHETAMINE SULFATE 3.125mg, DEXTROAMPHETAMINE SACCHARATE 3.125mg, AMPHETAMINE ASPARTATE MONOHYDRATE 3.125mg, AMPHETAMINE SULFATE 3.125mg
Dosage Form: capsule, extended release
Drug Class: CNS stimulants
Important Information Prior to Initiating Treatment
Prior to initiating treatment with MYDAYIS, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].
Assess the risk of abuse, prior to prescribing and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for MYDAYIS use [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].
General Instructions for Use
Because the effects of MYDAYIS may last up to 16 hours and there is potential for insomnia, administer once daily in the morning upon awakening. 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 [see Adverse Reactions (6.1), Clinical Studies (14)].
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.
Administration Instructions
Administer MYDAYIS orally with or without food. Advise patients to take MYDAYIS consistently either with food or without food [see Clinical Pharmacology (12.3)].
MYDAYIS may be administered in one of the following ways:
- Swallow MYDAYIS capsules whole, or
- Open capsule and sprinkle the entire contents over a spoonful of applesauce. The sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the sprinkled applesauce in its entirety without chewing.
- The dose of a single capsule should not be divided.
Dosing Information
Adult Use (18 to 55 years)
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 patients. Dosage may be adjusted in increments of 12.5 mg no sooner than weekly, up to a maximum dose of 50 mg once daily, based on the therapeutic needs and response of the patient. Doses above 50 mg daily have shown no additional clinically meaningful benefit.
Pediatric Use (13 to 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 a recommended maximum dose of 25 mg once daily. The 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.
Dosage Modifications due to Drug Interactions
Agents that alter gastrointestinal and urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust MYDAYIS dosage accordingly [see Drug Interactions (7.1)].
Dosage in Patients with Renal Impairment
In adult patients with severe renal impairment (GFR between 15 to < 30 mL/min/1.73 m2), the recommended starting dose of MYDAYIS is 12.5 mg daily with a maximum recommended dose of 25 mg daily. MYDAYIS is not recommended for use in patients with end stage renal disease (ESRD < 15 ml/min/1.73 m2). In pediatric patients (13 to 17 years) with severe renal impairment, the maximum dose is 12.5 mg, if tolerated [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Switching from other Amphetamine Products
For patients switching from another medication or any other amphetamine products, discontinue that treatment, and titrate with MYDAYIS using the titration schedule [see Dosage and Administration (2.4)].
Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see Warnings and Precautions (5.9), Description (11), Clinical Pharmacology (12.3)].
