Classes
DEA Class; Rx
Common Brand Names; Adderall XR, Mydayis
- Stimulants;
- ADHD Agents
Description
Central nervous system (CNS) stimulant
Used for attention-deficit hyperactivity disorder (ADHD) and narcolepsy
Patients with structural heart defects, cardiomyopathy, or heart-rhythm disturbances may be at risk for adverse cardiac events
Indications
Contraindications
Hypersensitivity
Hyperthryroidism
Glaucoma
Hypertension, advanced arteriosclerosis, symptomatic CVD
Symptomatic cardiovascular disease
Moderate-to-severe hypertension
Agitated states, history of drug abuse
MAO inhibitors given within 14 days (risk of severe hypertensive reaction)
Adverse Effects
- Loss of appetite (22-36%)
- Headache (<26%)
- Insomnia (12-27%)
- Abdominal pain (11-14%)
- Weight loss (4-11%)
- Anxiety (8%)
- Vomiting (7%)
- Nervousness (6%)
- Tachycardia (6%)
- Fever (5%)
- Nausea (5-8%)
- Infection (4%)
- Emotional lability (2-9%)
- Dizziness (2-7%)
- Diarrhea (2-6%)
- Fatigue (2-4%)
- Dry mouth (2-4%)
- Dyspepsia (2-4%)
Warnings
Preexisting cardiac structural abnormalities associated with risk of sudden death (if abused)
Time to maximum concentration decreased when coadministered with acid-suppressing drugs (eg, proton pump inhibitors)
Associated with peripheral vasculopathy, including Raynaud phenomenon
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment
May impair ability to engage in potentially hazardouse activities due to CNS effects
Potential exists for drug dependency
Use caution in hypertension, history of psychosis, seizure disorders, elderly, or Tourette’s syndrome (may unmask tics)
Abrupt discontinuation may result in symptoms for withdrawal
Sudden deaths, stroke, and myocardial infarction reported in adults taking stimulants at usual doses
Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation
Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients
Pregnancy and Lactation
Pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed during pregnancy
Based on limited case reports in published literature, amphetamine is present in human milk; there are no reports of adverse effects on breastfed infant
Maximum Dosage
For immediate-release tablets, 40 mg/day PO for ADHD (doses up to 60 mg/day PO have been used for weight more than 50 kg) or 60 mg/day PO for narcolepsy. For extended-release Adderall XR capsules, 20 mg/day PO is the recommended dose; in clinical trials for adult ADHD, 60 mg/day PO was the highest titration dose used. For extended-release Mydayis capsules, 50 mg/day PO for ADHD.
For immediate-release tablets, 60 mg/day PO for narcolepsy; geriatric patients have not been evaluated for ADHD. For extended-release capsules, geriatric patients have not been evaluated.
For immediate-release tablets, 40 mg/day PO for ADHD (doses up to 60 mg/day PO have been used for weight more than 50 kg) or 60 mg/day PO for narcolepsy. In clinical trials of extended-release Adderall XR capsules, titration doses were allowed up to 40 mg/day PO for weight 75 kg or less and from 50 to 60 mg/day PO for weight more than 75 kg; however, there was no consistent evidence that doses above 20 mg/day PO conferred additional benefit. For extended-release Mydayis capsules, 25 mg/day PO for ADHD.
6 years and older: For immediate-release tablets, 40 mg/day PO for ADHD (doses up to 60 mg/day PO have been used for weight more than 50 kg) or 60 mg/day PO for narcolepsy. For extended-release Adderall XR capsules, 30 mg/day PO for ADHD. For extended-release Mydayis capsules, safety and efficacy have not been established.
3 to 5 years: Maximum dosage information is not provided by FDA-approved labeling; doses should not exceed 40 mg/day PO for immediate-release tablets. Do not use extended-release capsules.
Less than 3 years: Safety and efficacy have not been established.
Not indicated.
How supplied
Each tab/cap contains equal portions of the following: amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate
tablet: Schedule II
- 5mg (1.25mg/1.25mg/1.25mg/1.25mg)
- 10mg (2.5mg/2.5mg/2.5mg/2.5mg)
- 20mg (5mg/5mg/5mg/5mg)
- 30mg (7.5mg/7.5mg/7.5mg/7.5mg)
capsule, extended-release: Schedule II
- 5mg (1.25mg/1.25mg/1.25mg/1.25mg) (Adderall XR)
- 10mg (2.5mg/2.5mg/2.5mg/2.5mg) (Adderall XR)
- 12.5mg (3.125mg/3.125mg/3.125mg/3.125mg) (Mydayis)
- 15mg (3.75mg/3.75mg/3.75mg/3.75mg) (Adderall XR)
- 20mg (5mg/5mg/5mg/5mg) (Adderall XR)
- 25mg (6.25mg/6.25mg/6.25mg/6.25mg) (Adderall XR, Mydayis)
- 30mg (7.5mg/7.5mg/7.5mg/7.5mg) (Adderall XR)
- 37.5mg (9.375mg/9.375mg/9.375mg/9.375mg) (Mydayis)
- 50mg (12.5mg/12.5mg/12.5mg/12.5mg) (Mydayis)
