Amphetamine and Dextroamphetamine

Amphetamine/Dextroamphetamine is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. 

• Amphetamine/Dextroamphetamine is available under the following different brand names: Adderall XR, Mydayis.

Adult dosage

• Each tablet/capsule 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)

Attention Deficit Hyperactivity Disorder (ADHD)

Adult dosage

• Tablet: 5 mg orally once daily initially; may increase by 5-10 mg/day once per week; administer daily dose in 2-3 doses; not to exceed 40 mg/day

Pediatric dosage

Tablet

• Children younger than 3 years of age: Safety and efficacy not established
• Children aged 3-6 years of age: 2.5 mg/day; may increase by 2.5 mg once weekly; not to exceed 40 mg per day or divided every 8 hours; use intervals of 4-6 hours between additional doses
• Children older than 6 years of age: 5 mg orally once daily or every 12 hours; may increase by 5 mg once weekly; not to exceed 40 mg per day or divided every 8 hours; use intervals of 4-6 hours between additional doses

Extended-release capsule

Adult dosage

Adderall XR

• 20 mg orally taken in the morning or switching from another medication
• May increase by increments of 5-10 mg/week; not to exceed 60 mg/day

Pediatric dosage

Adderall XR

• Children younger than 6 years of age: Safety and efficacy not established
• Children aged 6-12 years of age: 5-10 mg orally in the morning initially; may increase by 5-10 mg/day once weekly; not to exceed 30 mg/day
• Children aged 13-17 years of age: 10 mg orally in the morning initially; may increase to 20 mg/day after 1 week if symptoms not controlled; doses up to 60 mg/day have been used, but there is no evidence that higher doses increase effectiveness 

Mydayis

Adult dosage

• 18-55 years: 12.5 mg taken in the morning initially
• May increase by increments of 12.5 mg/week; not to exceed 50 mg/day
• Note: 25 mg taken in the morning may be considered as an initial dose for some patients

Pediatric dosage

• Children younger than 13 years of age: Safety and efficacy not established; younger children experienced higher plasma exposure than those aged 13 years or older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite. 
• Children aged 13-17 years of age: 12.5 mg in the morning initially 
• May increase by increments of 12.5 mg/week; not to exceed 50 mg/day

Narcolepsy

Adult dosage

• 5-60 mg orally once daily; may increase by 10 mg/day once per week
• No more than 60 mg given once daily or divided doses with intervals of 4-6 hours between doses

Pediatric dosage

• Children younger than 6 years of age: Safety and efficacy not established
• Children aged 6-12: 5mg/day orally initially in divided doses; may increase by 5 mg/day per week; not to exceed 60 mg per day or divided doses with intervals of 4-6 hours between doses
• Children aged 12 years or older: 10 mg/day orally initially; may increase by 10 mg/day per week; not to exceed 60 mg given per day or divided doses with intervals of 4-6 hours between doses

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Amphetamine/Dextroamphetamine include:

• stomach pain, 
• nausea, 
• loss of appetite, 
• weight loss, 
• mood changes, 
• nervousness, 
• irritableness, 
• fast heart rate, 
• headache, 
• dizziness, 
• sleep problems (insomnia), and 
• dry mouth 

Serious side effects of Amphetamine/Dextroamphetamine include:

• hives, 
• difficulty breathing, 
• swelling in the face or throat, 
• chest pain, 
• trouble breathing, 
• lightheadedness, 
• hallucinations, 
• new behavior problems, 
• aggression, 
• hostility, 
• paranoia, 
• numbness, 
• pain, 
• cold feeling, 
• unexplained wounds, 
• skin color changes (pale, red, or blue appearance) in the fingers or toes, 
• seizure, 
• muscle twitches (tics), 
• changes in the vision, 
• agitation, 
• fever, 
• sweating, 
• shivering, 
• fast heart rate, 
• muscle stiffness, 
• twitching, 
• loss of coordination, 
• nausea, 
• vomiting, and 
• diarrhea

Rare side effects of Amphetamine/Dextroamphetamine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Amphetamine/Dextroamphetamine has severe interactions with the following drugs:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selefiline
  • selegiline transdermal
  • tranylcypromine
• Amphetamine/Dextroamphetamine has serious interactions with at least 37 other drugs. 
• Amphetamine/Dextroamphetamine has moderate interactions with at least 220 other drugs.
• Amphetamine/Dextroamphetamine has minor interactions with at least 56 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

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)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amphetamine/Dextroamphetamine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amphetamine/Dextroamphetamine?”

Cautions

• Preexisting cardiac structural abnormalities associated with risk of sudden death (if abused)
• Time to maximum concentration decreased when coadministered with acid-suppressing drugs (e.g., 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 hazardous 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
• Drug interaction overview
  • Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort
  • Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism; potential for a pharmacokinetic interaction exists with coadministration of CYP2D6 inhibitors which may increase risk with increased exposure to amphetamines and derivatives; in these situations, consider alternative non-serotonergic drug or alternative drug that does not inhibit CYP2D6
  • If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor patients for emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome

Pregnancy and Lactation

• Pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/
• Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified drug-associated risk of major birth defects and miscarriage; adverse pregnancy outcomes, including premature delivery and low birth weight, reported in infants born to mothers taking amphetamines during pregnancy
• Amphetamines cause vasoconstriction and thereby may decrease placental perfusion; in addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery; infants born to mothers taking amphetamines during pregnancy have increased risk of premature delivery and low birth weight
• Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness
• Based on limited case reports in published literature, amphetamine is present in human milk; there are no reports of adverse effects on breastfed infant
• Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown; large doses of amphetamine might interfere with milk production, especially in women whose lactation is not well established
• Because of potential for serious adverse reactions in nursing infants, advise patients that breastfeeding is not recommended during therapy.