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Dextroamphetamine and amphetamine: Pediatric drug information

Dextroamphetamine and amphetamine: Pediatric drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Dextroamphetamine and amphetamine: Drug information" and "Dextroamphetamine and amphetamine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Abuse, misuse, and addiction:

Dextroamphetamine/amphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dextroamphetamine/amphetamine, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing dextroamphetamine/amphetamine, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dextroamphetamine/amphetamine treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Brand Names: US
  • Adderall;
  • Adderall XR;
  • Mydayis
Brand Names: Canada
  • Adderall XR;
  • APO-Amphetamine XR;
  • PMS-Amphetamines XR [DSC];
  • SANDOZ Amphetamine XR;
  • Teva-Amphetamine XR
Therapeutic Category
  • Amphetamine;
  • Anorexiant;
  • Central Nervous System Stimulant
Dosing: Pediatric

Dosage guidance:

Dosing: Use lowest effective individualized dose; administer first dose as soon as awake; avoid late evening doses.

Attention-deficit/hyperactivity disorder

Attention-deficit/hyperactivity disorder: Note: Extended-release products are not interchangeable on a mg-per-mg basis; use precaution to ensure appropriate product specific dosing.

Immediate-release tablets:

Children 3 to 5 years: Oral: Initial 2.5 mg once daily in the morning; increase daily dose by 2.5 mg at weekly intervals until optimal response is obtained; maximum daily dose: 40 mg/day administered in 1 to 2 divided doses per day; use intervals of 4 to 6 hours between doses. Note: Select patients may require daily dose to be given in 3 divided doses per day. Although FDA approved, current guidelines do not recommend dextroamphetamine/amphetamine use in children ≤5 years due to insufficient evidence (Ref).

Children ≥6 years and Adolescents: Oral: Initial: 5 mg once or twice daily; increase daily dose by 5 mg at weekly intervals until optimal response is obtained; usual maximum daily dose: 40 mg/day administered in 1 to 2 divided doses; use intervals of 4 to 6 hours between doses; some patients weighing >50 kg may require and tolerate doses up to 60 mg/day in divided doses with frequent monitoring (Ref). Note: Some patients may require daily dose to be administered as 3 divided doses per day.

Extended-release capsules:

Adderall XR:

Initial therapy:

Children 6 to 12 years: Oral: Initial: 5 to 10 mg once daily in the morning; increase daily dose by 5 mg or 10 mg at weekly intervals until optimal response is obtained; usual maximum daily dose: 30 mg/day; some patients weighing >50 kg may require and tolerate doses up to 60 mg/day (Ref)

Adolescents 13 to 17 years: Oral: Initial: 10 mg once daily in the morning; may increase to 20 mg daily after 1 week if symptoms are not controlled; usual maximum daily dose: 20 mg/day; some patients weighing >50 kg may require and tolerate doses up to 60 mg/day with frequent monitoring (Ref)

Converting Adderall to Adderall XR: Patients taking divided doses of immediate-release Adderall tablets may be switched to extended-release Adderall XR capsule using the same total daily dose (taken once daily); titrate dose at weekly intervals to achieve optimal response.

Mydayis: Note: Do not substitute Mydayis for other amphetamine products on a mg-per-mg basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

Adolescents 13 to 17 years: Oral: Initial: 12.5 mg once daily in the morning; may increase by 12.5 mg increments at weekly intervals; maximum daily dose: 25 mg/day

Narcolepsy

Narcolepsy:

Children 6 to 12 years: Immediate-release tablets: Oral: Initial: 5 mg daily; increase daily dose by 5 mg at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day given in 1 to 3 divided doses per day; use intervals of 4 to 6 hours between doses

Adolescents: Immediate-release tablets: Oral: Initial: 10 mg daily; increase daily dose by 10 mg at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day given in 1 to 3 divided doses per day; use intervals of 4 to 6 hours between doses

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Immediate release: Children ≥3 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; use with caution; elimination may be decreased with renal impairment.

Extended release:

Adderall XR: Children ≥6 years and Adolescents ≤17 years:

GFR 15 to <30 mL/minute/1.73 m2: Initial dose: 5 mg once daily; maximum daily dose in children 6 to 12 years: 20 mg/day

GFR <15 mL/minute/1.73 m2: Use not recommended

Mydayis: Adolescents 13 to 17 years:

GFR 15 to <30 mL/minute/1.73 m2: Reduce maximum daily dose to 12.5 mg/day

GFR <15 mL/minute/1.73 m2: Use not recommended

Dosing: Hepatic Impairment: Pediatric

Children ≥3 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; use with caution; elimination may be decreased with hepatic impairment.

Dosing: Adult

(For additional information see "Dextroamphetamine and amphetamine: Drug information")

Attention-deficit/hyperactivity disorder

Attention-deficit/hyperactivity disorder:

Immediate release: Oral: Initial: 5 mg once or twice daily; may increase daily dose based on response and tolerability in 5 to 10 mg increments at intervals ≥1 week up to a usual maximum of 40 mg/day in 1 to 2 divided doses (Ref). Note: Although doses >40 mg/day will rarely be necessary, doses as high as 60 mg/day with close monitoring may be necessary for optimal response in some patients (Ref).

Extended release: Oral: Initial: 10 to 20 mg once daily in the morning; may increase daily dose based on response and tolerability in 10 to 20 mg increments at intervals ≥1 week (Ref). Although doses >40 mg/day will rarely be necessary, doses up to 60 mg/day may be necessary for optimal response in some patients, but the frequency and severity of adverse effects are increased with higher doses (Ref).

Triple-bead extended release: Oral: Initial: 12.5 mg once daily in the morning; may increase daily dose based on response and tolerability in 12.5 mg increments at intervals ≥1 week (Ref). Maximum dose: 50 mg/day.

Narcolepsy, daytime sleepiness

Narcolepsy, daytime sleepiness (alternative agent): Oral: Initial: 10 mg once daily in the morning; may increase daily dose based on response and tolerability in increments of 10 mg every week until optimal response is obtained; usual dosage range: 20 to 60 mg/day in 1 to 3 divided doses (Ref). Some experts recommend initiating therapy with the IR formulation (FDA approved) and transitioning to extended release (off label) once the patient achieves a stable dose. Although the ER formulation is generally dosed once daily, some patients may require a second dose in the early afternoon (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Immediate release: There are no dosage adjustments provided in the manufacturer's labeling; use with caution; the potential exists for elimination of amphetamine to be inhibited resulting in prolonged exposure.

Hemodialysis: There are no specific dosage adjustments provided in the manufacturer's labeling; dextroamphetamine is not dialyzable (Ref).

Extended release: Adderall XR:

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling; use with caution; the potential exists for elimination of amphetamine to be inhibited resulting in prolonged exposure.

Severe impairment (GFR 15 to <30 mL/minute/1.73 m2): 15 mg once daily in the morning.

ESRD (GFR <15 mL/minute/1.73 m2): Use is not recommended; dextroamphetamine is not dialyzable.

Mydayis:

Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.

Severe impairment (GFR 15 to <30 mL/minute/1.73 m2): Maximum dose: 25 mg/day

ESRD (GFR <15 mL/minute/1.73 m2): Use is not recommended; dextroamphetamine is not dialyzable

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Adverse Reactions (Significant): Considerations
Cardiovascular events

Cardiovascular events including acute myocardial infarction (MI), stroke, sudden cardiac death (SCD), increased heart rate, and increased blood pressure have been reported in adult and pediatric patients (Ref). Amphetamine and dextroamphetamine salts, similar to other CNS stimulants, have been associated with sudden cardiac death in children and adolescents with preexisting structural cardiac abnormalities. Available data in patients without congenital heart disease are conflicting (Ref). A large retrospective cohort study showed an overall low incidence and risk of serious cardiovascular events in children and young adults (Ref); similarly, retrospective claims databases have not shown an increase in serious cardiovascular events (MI, sudden death, stroke) with stimulant use in young and middle-aged adults (Ref).

Mechanism : Dose-related; amphetamines increase the mean heart rate and systolic blood pressure by mediating noradrenergic and dopaminergic transmission (Ref). This increase in heart rate and blood pressure can ultimately lead to cardiovascular events such as arrhythmias and/or MI.

Onset: Varied; MI and SCD usually occur within hours (especially in cases of overdose), but arrhythmias usually occur with long-term use (Ref).

Risk factors:

• Higher doses (Ref)

• Prior structural heart disease (Ref)

• Family history of SCD or other cardiovascular diseases (eg, MI, cardiac arrhythmias) (Ref)

• Concurrent use of QTc prolonging medications may increase the risk of arrhythmias

• Strenuous exercise and dehydration (Ref)

Growth suppression

Some studies have reported growth retardation in pediatric patients. Decreased height and weight changes have been described in children <12 years receiving long-term treatment (ie, ≥3 years) (Ref). Similarly, statistically significant reductions in total femoral, femoral neck, and lumbar bone mineral density (BMD) were observed in pediatric patients (age range: 8 to 17 years) actively treated with stimulants (including, but not limited to methylphenidate) when compared to matched unmedicated controls; also reported were significantly more subjects in the stimulant-treated group with BMD measurements in the osteopenic range compared to matched controls (38.3% vs 21.6%) (Ref). An association has been observed between cumulative stimulant exposure in childhood and decreased height velocity, decreased adult height, and increased weight in adulthood (Ref). In contrast, a longitudinal cohort-controlled trial reported no difference in peak height velocity and final adult height in subjects with attention-deficit/hyperactivity disorder and/or treated with stimulants (Ref).

Mechanism: Dose- and time-related; possibly due to effects on CNS growth factors and hepatic growth factors and direct cartilage effects. Weight loss may result from appetite suppression, reduced food intake, increased activity, and metabolic shifts (Ref).

Onset: Growth suppression in children: Delayed; appears to occur after months of active treatment (Ref).

Risk factors:

• Higher doses (Ref)

• Duration of treatment/cumulative exposure (Ref)

• Comorbid autism disorder (Ref)

Psychiatric/behavioral effects

New-onset psychosis or mania and exacerbation of psychotic or manic symptoms (eg, delusional thinking, auditory hallucination and visual hallucination, mania) may occur with neurostimulant use in all ages (Ref); symptoms resemble acute psychosis most commonly observed in schizophrenia (Ref). Amphetamine has also been associated with aggressive behavior or hostility in children; however, a causal relationship has not been established. A study of commercial insurance claims data from 221,846 patients (age: 13 to 25 years) prescribed amphetamines or methylphenidate reported a higher risk of psychosis with amphetamine products compared to methylphenidate (Ref). Studies in adults have suggested that the resolution of the psychotic episode may be incomplete without treatment and may take up to 6 months even if abstinence occurs (Ref).

Mechanism: Psychosis: Amphetamine stimulates the release of dopamine from presynaptic nerve endings and prevents its reuptake. This leads to an increased concentration of dopamine in the neuronal synapse, leading to glutamate dysregulation. Increased dopamine and glutamate dysregulation have been associated with the development of psychotic symptoms (Ref).

Onset: Varied; a study of commercial insurance claims data from 221,846 patients (age: 13 to 25 years) prescribed amphetamines or methylphenidate reported a mean time of 128 days (IQR: 48 to 333 days) from the time medication was dispensed to the first psychotic episode (Ref). In cases of overdose/intoxication, the onset of symptoms is usually acute and within hours.

Risk factors:

• Preexisting mood or psychotic disorders (Ref)

• Prior history of substance use/abuse (Ref)

• Family history of mood and psychotic disorders (eg, major depression, bipolar disorder, and schizophrenia) (Ref)

• Young age (children, adolescents, and young adults) (Ref)

• Concurrent use of corticosteroids (Ref)

Serotonin syndrome

Serotonin syndrome may occur when amphetamines are used in combination with drugs that affect the serotonergic neurotransmitter system in all ages. Early symptoms of serotonin syndrome include tachycardia, shivering, diarrhea, diaphoresis, muscle cramps, agitation, and increased body temperature; these symptoms are usually followed by hypertension, hyperthermia, hyperreflexia, delirium, tremors, and rigidity (Ref). Prompt treatment is needed to minimize risk of adverse outcome, including death (Ref). The incidence of serotonin syndrome from stimulants use is unknown, likely due to under reporting (Ref).

Mechanism: Amphetamines increase serotonin release and inhibit reuptake, which can lead to dangerously high extracellular concentration of serotonin especially when used in combination with other drugs that also increase serotonin concentrations (eg, CYP2D6 inhibitors, serotonin reuptake inhibitors, serotonin-norepinephrine uptake inhibitors) (Ref).

Onset: Rapid; symptoms usually begin within 24 hours of ingestion of the causative agent(s) (Ref).

Risk factors:

• Genetic polymorphism: Poor CYP2D6 metabolizers (Ref)

• Concurrent use of CYP2D6 inhibitors (Ref)

• Concurrent use of serotonergic agents (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions are for the extended-release products in children, adolescents, and adults unless otherwise specified.

>10%:

Cardiovascular: Systolic hypertension (adolescents: 7% to 35%; transient) (table 1)

Dextroamphetamine and Amphetamine: Adverse Reaction: Systolic Hypertension

Drug (Dextroamphetamine and Amphetamine)

Placebo

Population

Dose

Dosage Form

Number of Patients (Dextroamphetamine and Amphetamine)

Number of Patients (Placebo)

Comments

35%

N/A

Adolescents

20 mg

Extended-release capsules

23

N/A

N/A

12%

N/A

Adolescents

10 mg

Extended-release capsules

17

N/A

N/A

7%

11%

Adolescents

10 or 20 mg/day

Extended-release capsules

100

64

Isolated systolic blood pressure elevations ≥15 mmHg

Gastrointestinal: Abdominal pain (children and adolescents: 11% to 14%), anorexia (22% to 36%), xerostomia (adolescents: 2% to 4%; adults: 23% to 35%)

Nervous system: Headache (adults: 26%), insomnia (8% to 31%)

1% to 10%:

Cardiovascular: Palpitations (adults: 2% to 4%), tachycardia (adults: 6%) (table 2)

Dextroamphetamine and Amphetamine: Adverse Reaction: Tachycardia

Drug (Dextroamphetamine and Amphetamine)

Placebo

Population

Dosage Form

Number of Patients (Dextroamphetamine and Amphetamine)

Number of Patients (Placebo)

6%

3%

Adults

Extended-release capsules

191

64

Dermatologic: Diaphoresis (adults: 2% to 4%), skin photosensitivity (adults: 2% to 4%)

Endocrine & metabolic: Decreased libido (adults: 2% to 4%), weight loss (4% to 10%)

Gastrointestinal: Bruxism (adults: 2%), constipation (adults: 2% to 4%), diarrhea (adults: 3% to 6%), dyspepsia (children and adolescents: 2% to 4%), nausea (2% to 8%), teeth clenching (adults: ≤4%), tooth infection (adults: ≤4%), upper abdominal pain (adolescents: 4%), vomiting (children and adolescents: 2% to 7%)

Genitourinary: Dysmenorrhea (adults: 2% to 4%), erectile dysfunction (adults: 2% to 4%), urinary tract infection (adults: 5%)

Infection: Infection (children and adults: 2% to 4%)

Nervous system: Agitation (adults: 2% to 8%), anxiety (adults: 7% to 8%), asthenia (≤6%), depression (adults: 3%), dizziness (2% to 7%), drowsiness (adolescents and adults: 2% to 4%), emotional lability (2% to 9%), fatigue (≤6%), irritability (adolescents: 6%), jitteriness (adults: 2%), nervousness (children and adolescents: 6%), speech disturbance (adults: 2% to 4%), twitching (adults: 2% to 4%)

Respiratory: Dyspnea (adults: 2% to 4%)

Miscellaneous: Accidental injury (children and adolescents: 2% to 4%), fever (children: 5%)

Frequency not defined: Nervous system: Drug abuse, drug dependence

Postmarketing:

Cardiovascular: Acute myocardial infarction (Ref), increased blood pressure (Ref), peripheral vascular disease (Ref), Raynaud phenomenon (Ref)

Dermatologic: Alopecia, dermatillomania, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis (Ref), urticaria

Endocrine & metabolic: Change in libido, growth retardation (Ref), pituitary insufficiency (Ref)

Gastrointestinal: Ischemic bowel disease (intestinal), unpleasant taste

Genitourinary: Azoospermia (Ref), frequent erections, prolonged erection

Hypersensitivity: Anaphylaxis (Ref), angioedema

Nervous system: Aggressive behavior, auditory hallucination (Ref), dysphoria, euphoria, exacerbation of Gilles de la Tourette syndrome, formication, mania (Ref), outbursts of anger, overstimulation, paresthesia, psychosis (Ref), restlessness, talkativeness, tic disorder (including motor tics, vocal tics, and exacerbation of tics) (Ref), tremor, visual hallucination (Ref)

Neuromuscular & skeletal: Dyskinesia (Ref), rhabdomyolysis (Ref)

Ophthalmic: Blurred vision, mydriasis

Respiratory: Non-cardiogenic pulmonary edema (Ref), respiratory failure (Ref)

Contraindications

Hypersensitivity (eg, angioedema, anaphylaxis) to amphetamine or any component of the formulation; during or within 14 days following monoamine oxidase inhibitors (MAOIs) (including MAOIs such as linezolid or IV methylene blue).

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: Amphetamines may impair the ability to engage in potentially hazardous activities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

• Peripheral vasculopathy: Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs/symptoms are usually mild and intermittent, and generally improve with dose reduction or discontinuation. Peripheral vasculopathy effects have been observed at different times, at therapeutic doses, and in all age groups. Digital ulceration and/or soft tissue breakdown have been observed; further evaluation (eg, rheumatology) may be necessary in patients developing signs and symptoms of peripheral vasculopathy.

• Visual disturbance: Difficulty in accommodation and blurred vision has been reported with the use of stimulants.

Disease-related concerns:

• Cardiovascular disorders: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

• Hepatic impairment: Use with caution in patients with hepatic impairment; elimination is reduced.

• Bipolar disorder: May precipitate a mixed or manic episode in patients with bipolar illness.

• Renal impairment: Use with caution in patients with renal impairment; elimination is reduced.

• Seizure disorder: Limited information exists regarding stimulant use in seizure disorder. Whereas patients with attention-deficit/hyperactivity disorder (ADHD) are at an increased risk for seizure activity compared to the general population, a retrospective study using drug claims data showed that the use of stimulant medications was associated with a lower risk (Cortese 2013; Wiggs 2018). Manufacturers of some stimulants recommend discontinuing therapy if seizures occur.

• Tourette syndrome/tics: Use with caution in patients with Tourette syndrome or other tic disorders. Stimulants may exacerbate tics (motor and phonic) and Tourette syndrome; however, evidence demonstrating increased tics is limited. Evaluate for tics and Tourette syndrome prior to therapy initiation (AAN [Pringsheim 2019]; NICE 2018).

Special populations:

• Older adult: Use caution in this age group due to CNS stimulant adverse effects.

• Pediatric: Pediatric patients 12 years of age and younger experienced high plasma exposure to Mydayis and more adverse reactions, including insomnia and decreased appetite, compared to patients 13 years of age and older.

Other warnings/precautions:

• ADHD treatment: Appropriate use: Recommended to be used as part of a comprehensive treatment program for attention-deficit disorders.

• Appropriate use: Mydayis: Medication errors, including substitution and dispensing errors, may occur, leading to possible overdosage. Do not substitute Mydayis for other amphetamine products on a mg-per-mg basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

• Discontinuation of therapy: Abrupt discontinuation following high doses for prolonged periods results in extreme fatigue, mental depression, and sleep EEG changes; may also result in other symptoms of withdrawal.

Dosage Forms Considerations

Products contain equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate, and amphetamine aspartate monohydrate. For example, a 10 mg capsule or tablet contains dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, and amphetamine sulfate 2.5 mg.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral:

Adderall XR: 20 mg, 30 mg, 25 mg

Adderall XR: 5 mg, 15 mg, 10 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Mydayis: 37.5 mg

Mydayis: 50 mg [contains fd&c blue #1 (brilliant blue)]

Mydayis: 25 mg, 12.5 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Generic: 10 mg, 12.5 mg, 15 mg, 20 mg, 25 mg, 30 mg, 37.5 mg, 5 mg, 50 mg

Tablet, Oral:

Adderall: 10 mg, 7.5 mg [scored; contains fd&c blue #1 (brill blue) aluminum lake, saccharin sodium]

Adderall: 15 mg, 12.5 mg, 30 mg, 20 mg [scored; contains fd&c yellow #6(sunset yellow)alumin lake, saccharin sodium]

Adderall: 5 mg [scored; contains saccharin sodium]

Generic: 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg, 5 mg, 7.5 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsule ER 24 Hour Therapy Pack (Adderall XR Oral)

5 mg (per each): $8.55

10 mg (per each): $8.55

15 mg (per each): $8.55

20 mg (per each): $8.55

25 mg (per each): $8.55

30 mg (per each): $8.55

Capsule ER 24 Hour Therapy Pack (Amphet-Dextroamphet 3-Bead ER Oral)

12.5 mg (per each): $11.71 - $12.88

25 mg (per each): $11.71 - $12.88

37.5 mg (per each): $11.71 - $12.88

50 mg (per each): $11.71 - $12.88

Capsule ER 24 Hour Therapy Pack (Amphetamine-Dextroamphet ER Oral)

5 mg (per each): $0.72 - $7.20

10 mg (per each): $0.72 - $7.20

15 mg (per each): $0.72 - $7.20

20 mg (per each): $0.72 - $7.20

25 mg (per each): $0.72 - $7.20

30 mg (per each): $0.72 - $7.20

Capsule ER 24 Hour Therapy Pack (Mydayis Oral)

12.5 mg (per each): $13.55

25 mg (per each): $13.55

37.5 mg (per each): $13.55

50 mg (per each): $13.55

Tablets (Adderall Oral)

5 mg (per each): $12.87

7.5 mg (per each): $12.87

10 mg (per each): $12.87

12.5 mg (per each): $12.87

15 mg (per each): $12.87

20 mg (per each): $12.87

30 mg (per each): $12.87

Tablets (Amphetamine-Dextroamphetamine Oral)

5 mg (per each): $0.17 - $2.06

7.5 mg (per each): $0.28 - $2.06

10 mg (per each): $0.19 - $2.06

12.5 mg (per each): $0.62 - $2.06

15 mg (per each): $0.23 - $2.06

20 mg (per each): $0.23 - $2.06

30 mg (per each): $0.32 - $2.06

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral:

Adderall XR: 20 mg, 30 mg, 25 mg

Adderall XR: 5 mg, 10 mg, 15 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Generic: 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 5 mg

Extemporaneous Preparations

A 1 mg/mL oral suspension may be made with tablets. Crush ten 10 mg tablets in a mortar and reduce to a fine powder. Add small portions of Ora-Sweet and mix to a uniform paste; mix while adding the vehicle in equal proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add sufficient quantity of vehicle to make 100 mL. Label "shake well". Stable 30 days at room temperature.

Additional Information

Treatment of ADHD should include "drug holidays" or periodic discontinuation of medication in order to assess the patient's requirements, decrease tolerance, and limit suppression of linear growth and weight. Medications used to treat ADHD should be part of a total treatment program that may include other components such as psychological, educational, and social measures. The combination of equal parts of d, l-amphetamine aspartate, d, l-amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate results in a 3:1 ratio of the dextro- and levo-isomers of amphetamine.

The duration of action of Adderall is longer than methylphenidate; behavioral effects of a single morning dose of Adderall may last throughout the school day; a single morning dose of Adderall has been shown in several studies to be as effective as twice daily dosing of methylphenidate for the treatment of ADHD (Manos 1999; Pelham 1999; Pliszka 2000).

Controlled Substance

C-II

Administration: Pediatric

Oral:

Immediate-release tablet: Take on awakening; to avoid insomnia, last daily dose should be administered no less than 6 hours before retiring.

Extended-release capsule: Take on awakening. Avoid afternoon doses to prevent insomnia. Swallow capsule whole; do not chew or divide. May be administered with or without food; however, Mydayis should be taken in a consistent manner with regards to food. May open capsule and sprinkle contents on applesauce; consume applesauce/medication mixture immediately; do not store; do not chew sprinkled beads from capsule.

Administration: Adult

Oral: Administer with or without food. Administer Mydayis consistently either with food or without food.

Immediate release: Administer in 1 to 3 divided doses per day with intervals of 4 to 6 hours between doses. To avoid insomnia, late evening doses should be avoided.

Extended release: Administer upon awakening; to avoid insomnia, afternoon doses should be avoided. Capsule may be swallowed whole or it may be opened and the contents sprinkled on applesauce. Applesauce should be consumed immediately without chewing. Do not divide the contents of the capsule. Do not take less than one capsule per day; a single capsule should not be divided.

Storage/Stability

Immediate-release tablets: Store at 20°C to 25°C (68°F to 77°F); protect from light.

Extended-release capsules: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); protect from light.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Adderall: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011522s045lbl.pdf#page=15

Adderall XR: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021303s038lbl.pdf#page=22

Mydayis: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022063s005lbl.pdf#page=25

Use

Immediate release: Tablets (eg, Adderall): Treatment of attention-deficit/hyperactivity disorder (ADHD) (FDA approved in ages ≥3 years and adults); treatment of narcolepsy (FDA approved in ages ≥6 years and adults).

Extended release: Capsules: Treatment of ADHD (eg, Adderall XR: FDA approved in ages ≥6 years and adults; Mydayis: FDA approved in ages ≥13 years and adults).

Medication Safety Issues
Sound-alike/look-alike issues:

Adderall may be confused with Adderall XR, Inderal

Adderall XR may be confused with Adderall

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Risk X: Avoid combination

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Alkalinizing Agents: May decrease the excretion of Amphetamines. Management: Consider alternatives to using amphetamines and alkalinizing agents in combination. If these agents must be used together, patients should be monitored closely for excessive amphetamine effects. Risk D: Consider therapy modification

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Risk C: Monitor therapy

Amisulpride (Oral): Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Amisulpride (Oral). Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Ammonium Chloride: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Risk C: Monitor therapy

Antihypertensive Agents: Amphetamines may diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antipsychotic Agents: May enhance the adverse/toxic effect of Amphetamines. Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy

ARIPiprazole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ARIPiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

ARIPiprazole Lauroxil: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ARIPiprazole Lauroxil. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Asenapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Asenapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Benperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Benperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Blonanserin: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Blonanserin. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Brexpiprazole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Brexpiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Bromperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Bromperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Carbonic Anhydrase Inhibitors: May decrease the excretion of Amphetamines. Risk C: Monitor therapy

Cariprazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Cariprazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

ChlorproMAZINE: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ChlorproMAZINE. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Clothiapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Clothiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

CloZAPine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a moderate CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a strong CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs. Risk C: Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

DroPERidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of DroPERidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Risk C: Monitor therapy

Flupentixol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Flupentixol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

FluPHENAZine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of FluPHENAZine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Gastrointestinal Acidifying Agents: May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Haloperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Haloperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Iloperidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iloperidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Inhibitors of the Proton Pump (PPIs and PCABs): May increase the absorption of Amphetamine. Risk C: Monitor therapy

Inhibitors of the Proton Pump (PPIs and PCABs): May increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Risk C: Monitor therapy

Iobenguane Radiopharmaceutical Products: Amphetamines may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination

Iobenguane Radiopharmaceutical Products: CNS Stimulants may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination

Ioflupane I 123: Amphetamines may diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Loxapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Loxapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Lumateperone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Lumateperone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Lurasidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Lurasidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Mavorixafor: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Methenamine: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Risk C: Monitor therapy

Methotrimeprazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Methotrimeprazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Molindone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Molindone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Amphetamines. While linezolid and tedizolid may interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Risk X: Avoid combination

Multivitamins/Fluoride (with ADE): May decrease the serum concentration of Amphetamines. More specifically, the ascorbic acid (vitamin C) in many multivitamins may decrease amphetamine concentrations. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Amphetamines. Specifically, vitamin C may impair absorption of amphetamines. Risk C: Monitor therapy

OLANZapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of OLANZapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Opioid Agonists: Amphetamines may enhance the analgesic effect of Opioid Agonists. Risk C: Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Paliperidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Paliperidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Periciazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Periciazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Perphenazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Perphenazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Pimozide: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Pimozide. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Pipamperone [INT]: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Pipamperone [INT]. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Polyethylene Glycol-Electrolyte Solution: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Specifically, the risk of seizure may be increased. Risk C: Monitor therapy

Prochlorperazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Prochlorperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Promazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Promazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

QUEtiapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of QUEtiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Quinolones: Amphetamines may enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy

RisperiDONE: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of RisperiDONE. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors): Amphetamines may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors). This could result in serotonin syndrome. Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors) may increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities, including serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability). Initiate amphetamines at lower doses, monitor frequently, and adjust dose as needed. Risk C: Monitor therapy

Serotonergic Agents (High Risk): Amphetamines may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability). Initiate amphetamines at lower doses, monitor frequently, and adjust doses as needed. Risk C: Monitor therapy

Sertindole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sertindole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Sodium Phosphates: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sodium Phosphates. Specifically, the risk of seizure or loss of consciousness may be increased in patients with significant sodium phosphate-induced fluid or electrolyte abnormalities. Risk C: Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sulpiride: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sulpiride. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Thioridazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Thioridazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Thiothixene: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Thiothixene. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Amphetamines. Tricyclic Antidepressants may potentiate the cardiovascular effects of Amphetamines. Amphetamines may enhance the serotonergic effect of Tricyclic Antidepressants. This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) and increased cardiovascular effects when these agents are combined. Risk C: Monitor therapy

Trifluoperazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Trifluoperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Urinary Acidifying Agents: May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Ziprasidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Ziprasidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Zuclopenthixol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Zuclopenthixol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Food Interactions

Amphetamine serum levels may be reduced if taken with acidic food, juices, or vitamin C. Management: Monitor response when taken concurrently.

Pregnancy Considerations

Outcome information related to the use of amphetamine/dextroamphetamine in pregnant women with attention-deficit/hyperactivity disorder is limited (Ornoy 2018).

Data collection to monitor pregnancy outcomes following exposure to amphetamine/dextroamphetamine is ongoing. Health care providers are encouraged to enroll females exposed to amphetamine/dextroamphetamine during pregnancy in the National Pregnancy Registry for Psychostimulants (1-866-961-2388 and/or https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications).

Refer to individual monographs for additional information.

Monitoring Parameters

Prior to initiation of therapy, assess medical history and family history of sudden death or ventricular arrhythmia, and physical exam to assess for cardiac disease; patients should receive further evaluation if findings suggest cardiac disease, such as ECG and echocardiogram; promptly conduct cardiac evaluation in patients who develop exertional chest pain, unexplained syncope, or any other symptom of cardiac disease during treatment. For children already taking a stimulant, it is reasonable to evaluate medical and family history, review physical examination, and order ECG if not done prior to initiation (Vetter 2008).

Monitor growth (weight and height in children; baseline and periodically during therapy); other parameters to monitor periodically during therapy: CBC with differential and platelet count, liver enzymes, blood pressure and heart rate (baseline, following dose increases, and periodically during treatment), appetite, and sleep patterns; observe for abnormal movements. Patients should be reevaluated at appropriate intervals to assess continued need of the medication. Observe for signs/symptoms of new or worsening aggression or hostility, depression, delusional thinking, hallucinations, or mania. Monitor for visual disturbances. Observe for digital changes suggestive of peripheral vasculopathy (eg, Raynaud phenomenon). Monitor for signs of misuse, abuse, substance use disorder, and diversion.

Mechanism of Action

Amphetamines are noncatecholamine, sympathomimetic amines that promote release of catecholamines (primarily dopamine and norepinephrine) from their storage sites in the presynaptic nerve terminals. A less significant mechanism may include their ability to block the reuptake of catecholamines by competitive inhibition.

Pharmacokinetics (Adult Data Unless Noted)

Note: The immediate-release tablets and ER capsules contain d-amphetamine and l-amphetamine salts in the ratio of 3:1.

Duration of action: Immediate-release tablet: 4 to 6 hours (Dopheide 2009); Adderall XR: 8 to 12 hours (Jain 2017); Mydayis: ≤16 hours

Absorption: Extended release: Food does not affect absorption, but prolongs Tmax of Adderall XR by 2 to 3 hours and Mydayis by 4 to 5 hours.

Half-life elimination:

Children 6 to 12 years: d-amphetamine: 9 hours; l-amphetamine: 11 hours

Adolescents 13 to 17 years: d-amphetamine: 11 hours; l-amphetamine: 13 to 14 hours

Adults: d-amphetamine: 10 hours; l-amphetamine: 13 hours

Metabolism: Hepatic oxidation via cytochrome P450 to 4-hydroxyamphetamine (active) norephedrine (active), and alpha-hydroxy-amphetamine with both active metabolites subsequently oxidized to 4-hydroxy-norephedrine. Cytochrome P450 2D6 is primarily responsible for the formation of 4-hydroxy-amphetamine.

Time to peak: Immediate release: 3 hours; Adderall XR: 7 hours; Mydayis: 7 to 10 hours (children and adolescents 6 to 17 years), 8 hours (adults)

Excretion: Urine (highly dependent on urinary pH); excreted as unchanged amphetamine (30% to 40%, may range from ~1% in alkaline urine to ~75% in acidic urine), and derivatives of alpha-hydroxyamphetamine (50%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Pediatric: Children eliminated amphetamine faster than adults. The elimination half-life is approximately 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than in adults. However, children had higher systemic exposure to amphetamine (Cmax and AUC) than adults for a given dose of ER capsules, which was attributed to the higher dose administered to children on a mg/kg basis compared with adults. Upon dose normalization on a mg/kg basis, children showed 30% less systemic exposure compared with adults. Patients 6 to 12 years of age experienced higher systemic exposure (72% to 79% higher Cmax and 83% higher AUC), compared with adults.

Weight: Weight is the primary determinant of apparent differences in the pharmacokinetics of d- and l-amphetamine across the age range. Systemic exposure measured by AUC and Cmax decreased with increases in body weight, while apparent oral volume of distribution, apparent oral clearance, and elimination half-life increased with increases in body weight.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CH) Switzerland: Biphetamine;
  • (GB) United Kingdom: Durophet;
  • (IL) Israel: Attent;
  • (NO) Norway: Adderall | Dextroamphetamine mixed salts lannett;
  • (PR) Puerto Rico: Adderall | Amphetamin salts | Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate | Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate | Mixed amphetamine salts | Mydayis
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