Dosing and uses of Adderall XR, Adderall (amphetamine/dextroamphetamine)
Adult dosage forms and strengths
amphetamine/dextroamphetamine
tablet, reg: Schedule II
- 2.5mg/2.5mg
- 3.75mg/3.75mg
- 5mg/5mg
- 6.25mg/6.25mg
- 7.5mg/7.5mg
- 10mg/10mg
- 15mg/15mg
capsule, reg/extended-release: Schedule II
- 2.5mg/2.5mg
- 5mg/5mg
- 7.5mg/7.5mg
- 10mg/10mg
- 12.5mg/12.5mg
- 15mg/15mg
ADHD
Amphetamine/dextroamphetamine
- 5 mg PO qDay; may increase by 5-10 mg/day qWeek
- Not to exceed 40 mg qDay or divided q8hr
Extended release
- 20 mg PO qAM
- Not to exceed 60 mg/day
Narcolepsy
Amphetamine/dextroamphetamine
- 5-60 mg PO qDay; may increase by 10 mg/day qWeek
- No more than 60 mg given qDay or divided doses with intervals of 4-6 hr between doses
Pediatric dosage forms and strengths
amphetamine/dextroamphetamine
tablet, reg: Schedule II
- 2.5mg/2.5mg
- 3.75mg/3.75mg
- 5mg/5mg
- 6.25mg/6.25mg
- 7.5mg/7.5mg
- 10mg/10mg
- 15mg/15mg
capsule, reg/extended-release: Schedule II
- 2.5mg/2.5mg
- 5mg/5mg
- 7.5mg/7.5mg
- 10mg/10mg
- 12.5mg/12.5mg
- 15mg/15mg
ADHD
<3 years: Not recommended
Age 3-6 years: 2.5 mg/day; may increase by 2.5 mg qWeek; not to exceed 40 mg qDay or divided q8hr; use intervals of 4-6 hr between additional doses
>6 years: 5 mg PO qDay or q12hr; may increase by 5 mg qWeek; not to exceed 40 mg qDay or divided q8hr; use intervals of 4-6 hr between additional doses
Extended release
- >6 years: Initial, 5-10 mg PO qAM if needed; may increase by 5-10 mg/day qWeek; not to exceed 30 mg/day
- 13-17 years: Initial, 10 mg PO qAM; may increase to 20 mg/day after 1 week if symptoms not controlled; doses up to 60 mg/day used but no evidence that higher doses increase effectiveness
Narcolepsy
<6 years: Safety and efficacy not established
6-12 years: 5mg/day PO initially in divided doses; may increase by 5 mg/day qWeek; not to exceed 60 mg qDay or divided doses with intervals of 4-6 hr between doses
>12 years: 10 mg/day PO initially; may increase by 10 mg/day qWeek; not to exceed 60 mg given qDay or divided doses with intervals of 4-6 hr between doses
Adderall XR, Adderall (amphetamine/dextroamphetamine) adverse (side) effects
>10% (Extended Release)
Abdominal pain (11-14%)
Headache (<26%)
Insomnia (12-27%)
Loss of appetite (22-36%)
Weight loss (4-11%)
1-10% (Extended Release)
Anxiety (8%)
Diarrhea (2-6%)
Dizziness (2-7%)
Dry mouth (2-4%)
Dyspepsia (2-4%)
Emotional lability (2-9%)
Fatigue (2-4%)
Fever (5%)
Infection (4%)
Nausea (5-2-8%)
Nervousness (6%)
Tachycardia (6%)
Vomiting (7%)
Weight loss (4-9%)
Postmarketing Reports
Cardiovascular: Palpitations; isolated reports of cardiomyopathy associated with chronic amphetamine use
CNS: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania, paresthesia (including formication), bruxism
Eye disorders: Blurred vision, mydriasis
Gastrointestinal: Unpleasant taste, constipation, other gastrointestinal disturbances
Allergic: Urticaria, rash, hypersensitivity reactions (including angioedema and anaphylaxis); serious skin rashes (including Stevens-Johnson syndrome and toxic epidermal necrolysis)
Endocrine: Impotence, changes in libido, frequent/prolonged erections
Skin: Alopecia
Vascular disorders: Raynaud phenomenon
Musculoskeletal: Rhabdomyolysis
Warnings
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)
Cautions
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
Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility
Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected
Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures
Use with caution in patients who use other sympathomimetic drugs
Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications
Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections
Pregnancy and lactation
Pregnancy category: C
Lactation: Not recommended; found in breast milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Adderall XR, Adderall (amphetamine/dextroamphetamine)
Mechanism of action
Sympathomimetic amine that promotes release of dopamine and norepinephrine from their storage sites in the presynaptic nerve terminals; may also block reuptake of catecholamines by competitive inhibition.
Absorption
Well absorbed
Onset of action: 30-60 min
Duration: 4-6 hr
Vd: 3.5-4.6 L/kg (distributes into CNS; mean CSF concentrations are 80% of plasma)
Peak plasma time: 3 hr (Adderall); 7 hr (Adderall XR)
Metabolism
Hepatic via glucuronidation and CYP450 mono-oxygenase
Elimination
Half-life elimination (children)
- 6-12 years: 9 hr (d-amphetamine); 11 hr (l-amphetamine)
- 12-18 years: 11 hr (d-amphetamine); 13-14 hr (l-amphetamine)
Half-life elimination (adults)
- d-amphetamine: 10 hr
- l-amphetamine: 13 hr
Excretion
- Urine; dependent on urinary pH
