Amphetamine XR

Class
Psychostimulants
Subclass
Amphetamines
Substance name
Amphetamine, amfetamine XR
Brand names
Dyanavel XR®, Adzenys XR-ODT®, Adderall XR®
Contains
Amphetamine sulfate
Dextroamphetamine sulfate
Dextroamphetamine saccharate
Amphetamine aspartate monohydrate
Common formulations
Extended-release tablet, Extended-release oral suspension, Orally disintegrating tablet
See also
Amphetamine salts (Adderall®, Mydayis®)
Dosage and administration
Adults patients
Treatment of ADHD
•
Start at: 2.5-5 mg PO qAM
•
Maximum: 20 mg per day
Taken with or without food. Consider titrating in 2.5-10 mg increments every 4-7 days based on clinical response.
Alternative
•
12.5 mg PO qAM
Taken with or without food. Individualize dose based on therapeutic needs and response.
Indications for use
Labeled indications
Adults
•
Treatment of ADHD
Children
•
Treatment of ADHD
Safety risks
Boxed warnings
Drug abuse, drug misuse, stimulant use disorder
•
Use extreme caution in all patients. Assess the risk of abuse, misuse, and addiction before prescribing amphetamine. Reassess the risk throughout treatment and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Contraindications
Hypersensitivity to amphetamine or its components
Serious cardiac disease
•
Avoid using amphetamine in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Elicit a careful history, family history of sudden death or ventricular arrhythmia and perform a physical examination to screen for cardiac diseases before initiating amphetamine.
Concomitant use of MAOIs
•
Do not use amphetamine with or within 14 days of stopping MAOIs.
Warnings and precautions
Exacerbation of psychosis
•
Use caution in patients with a psychotic disorder.
Exacerbation of Tourette's syndrome, motor tics, verbal tics
•
Use caution in patients with Tourette's syndrome or a history of motor or verbal tics. Assess family history and clinically evaluate patients for Tourette's syndrome and motor or verbal tics before initiating amphetamine.
Manic or mixed episodes
•
Use caution in patients with bipolar disorder. Screen patients for risk factors for developing a manic episode before prescribing amphetamine.
Psychosis, mania
•
Maintain a high level of suspicion, as CNS stimulants, including amphetamine, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, and mania, even in patients without a prior history of psychotic illness or mania.
Raynaud's phenomenon
•
Maintain a high level of suspicion, as CNS stimulants, including amphetamine, have been associated with an increased risk of peripheral vasculopathy, including Raynaud's phenomenon. Monitor for digital changes.
Serotonin syndrome
•
Use caution in patients taking CYP2D6 inhibitors, SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, or St. John's wort. Reduce amphetamine dose and monitor for serotonin syndrome during treatment initiation and titration.
Tachycardia
•
Maintain a high level of suspicion, as CNS stimulants, including amphetamine, cause an increase in BP. Monitor patients for potential tachycardia and hypertension.
Weight loss, growth delay
•
Use caution in pediatric patients. Closely monitor growth.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available. Amphetamine undergoes renal excretion, thus renal impairment may inhibit its elimination and result in prolonged exposure.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available. Amphetamine is partially metabolized hepatically, thus hepatic impairment may result in prolonged exposure.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Monitor neonates for withdrawal symptoms.
Breastfeeding
Do not use during breastfeeding.
Low excretion in breastmilk (5-25%).
Low levels in breastfed infants (5-25%).
May potentially cause adverse effects in breastfed infants.
No overt adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Abdominal pain, dry mouth, headache, insomnia, loss of appetite
Common 1-10%
•
Agitation, anxiety, infections, photosensitivity of skin, constipation, bruxism, ↓ libido, somnolence, stuttering, palpitations, muscle twitching, dyspnea, sweating, erectile dysfunction, dysmenorrhea, accidental injury, asthenia, dizziness, emotional lability, fatigue, dyspepsia, fever, nausea, nervousness, diarrhea, tachycardia, vomiting, weight loss, urinary tract infections
Unknown frequency
•
Myocardial infarction, cardiomyopathy, intestinal ischemia, Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatillomania, restlessness, irritability, dyskinesia, euphoria, depression, tremor, paresthesia, aggressive behavior, motor tics, verbal tics, blurred vision, change in taste, mydriasis, skin rash, urticaria, angioedema, anaphylaxis, hair loss, rhabdomyolysis, raynaud's phenomenon
Interactions
Drug(s)
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