pharmacopeia
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/api/v1/drug/dextroamphetamine

Boxed warning

ABUSE, MISUSE, AND ADDICTION XELSTRYM 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 XELSTRYM, can result in overdose and death [see OVERDOSAGE (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing XELSTRYM, 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 XELSTRYM treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see WARNINGS AND PRECAUTIONS (5.1) and DRUG ABUSE AND DEPENDENCE (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. XELSTRYM 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 XELSTRYM, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction.

Mechanism of action

Sourced from openFDA

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.

Dopamine UptakeMonoamine OxidaseNorepinephrine Uptake

Indications

Sourced from openFDA
  • XELSTRYM ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see CLINICAL STUDIES (14) ] . Limitations of Use The use of XELSTRYM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use in Specific Populations (8.4) ].ICD-10: F90.9

Contraindications

Sourced from openFDA
  • XELSTRYM is contraindicated in patients: with known hypersensitivity to amphetamine products or other components of XELSTRYM.contraindicated

Dosage & administration

Sourced from openFDA

Pediatric patients (6 to 17 years): Recommended starting dose is 4.5 mg/9 hours. Titrate dosage in weekly increments of 4.5 mg up to a maximum recommended dose of 18 mg/9 hours ( 2.2 ) Adults: Recommended starting dose is 9 mg/9 hours. Maximum recommended dose is 18 mg/9 hours ( 2.2 ) Apply one XELSTRYM transdermal system 2 hours before an effect is needed and remove within 9 hours ( 2.3 ) Apply XELSTRYM to one of the following sites: hip, upper arm, chest, upper back or flank. Change the site of application when applying a new transdermal system ( 2.3 ) Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles ( 2.5 ) Severe renal impairment: Maximum recommended dose is 13.5 mg/9 hours ( 2.6 ) End stage renal disease (ESRD): Maximum recommended dose is 9 mg/9 hours ( 2.6 ) 2.1 Pretreatment Screening Prior to treating patients with XELSTRYM, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS AND PRECAUTIONS (5.2) ] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating XELSTRYM [see WARNINGS AND PRECAUTIONS (5.11) ] . 2.2 Recommended Dosage Pediatric Patients 6 to 17 years Recommended starting dose of XELSTRYM in pediatric patients 6 to 17 years is 4.5 mg/9 hours. Dosage may be adjusted in weekly increments of 4.5 mg up to a maximum recommended dose of 18 mg/9 hours.

Warnings & precautions

Sourced from openFDA

Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating XELSTRYM, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing XELSTRYM ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted ( 5.5 ) Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful observation for digital changes is necessary during XELSTRYM treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ) Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue XELSTRYM and initiate supportive treatment ( 5.7 , 10 ) Contact Sensitization: Use of XELSTRYM may lead to contact sensitization. Discontinue XELSTRYM if contact sensitization is suspected ( 5.8 ) Application Site Reactions: During wear time or immediately after removal of XELSTRYM, local skin reactions may occur.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling Known hypersensitivity to amphetamine products or other ingredients of XELSTRYM [see CONTRAINDICATIONS (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS (4) and DRUG INTERACTIONS (7.1) ] Abuse, Misuse, and Addiction [see BOXED WARNING, WARNINGS AND PRECAUTIONS (5.1) and DRUG ABUSE AND DEPENDENCE (9.2, 9.3) ] Risks to Patients with Serious Cardiac Disease [see WARNINGS AND PRECAUTIONS (5.2) ] Increased Blood Pressure and Heart Rate [see WARNINGS AND PRECAUTIONS (5.3) ] Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see WARNINGS AND PRECAUTIONS (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see WARNINGS AND PRECAUTIONS (5.6) ] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.7) ] Contact Sensitization [see WARNINGS AND PRECAUTIONS (5.8) ] Application Site Reactions [see WARNINGS AND PRECAUTIONS (5.9) ] Use of External Heat [see WARNINGS AND PRECAUTIONS (5.10) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see WARNINGS AND PRECAUTIONS (5.11) ] Most common adverse reactions (incidence ≥2% and greater than the rate for placebo) in pediatric patients 6 to 17 years treated with XELSTRYM were decreased appetite, headache, insomnia, tic, abdominal pain, vomiting, nausea, irritability, blood pressure increased, and heart rate increased ( 6.1 ) Most common adverse reactions (incidence ≥5% and at a rate at least twice plac…

Use in specific populations

Sourced from openFDA

Pregnancy: May cause fetal harm ( 8.1 ) Lactation: Breastfeeding not recommended ( 8.3 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including XELSTRYM, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. Risk Summary Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage (see DATA ). Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy [see CLINICAL CONSIDERATIONS ]. No apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis.

Pharmacokinetics

Sourced from openFDA
Metabolism
Following a single 9-hour application of XELSTRYM in pediatric patients 6 to 12 years with ADHD, the C max and AUC of dextroamphetamine were dose-proportional over the dose range of 4.5 mg/9 hours to 18 mg/9 hours. After a single dose of 18 mg/9 hours of XELSTRYM or 70 mg of lisdexamfetamine in adults, the peak plasma concentration (C max ) of dextroamphetamine were 44.6 ng/mL and 67.6 ng/mL, respectively; and area under concentration curve (AUC inf ) of dextroamphetamine were 996 ng*h/mL and 1260 ng*h/mL, respectively.

Overdosage

Sourced from openFDA

Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. Dextroamphetamine is not dialyzable. Remove all transdermal systems immediately and cleanse the area(s) to remove any remaining adhesive. The continuing absorption of dextroamphetamine from the skin, even after removal of the transdermal system, should be considered when treating patients with overdose. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Approval history

Sourced from openFDA
  • Aug 2, 1976NDANDA017078Impax Labs Inc
  • Jan 31, 2001ANDAANDA040361Barr
  • Oct 11, 2001NDANDA021303Takeda Pharms Usa
  • Jan 29, 2002ANDAANDA040436Specgx Llc
  • Feb 11, 2002ANDAANDA040422Barr
  • Jun 14, 2002ANDAANDA040439Sandoz
  • Jun 20, 2017NDANDA022063Takeda Pharms Usa
  • Mar 22, 2022NDANDA215401Noven Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
47,736 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective5,70212%
  2. 2Fatigue3,7057.8%
  3. 3Nausea3,3076.9%
  4. 4Headache3,0466.4%
  5. 5Anxiety2,8896.1%
  6. 6Depression2,4655.2%
  7. 7Feeling Abnormal2,2834.8%
  8. 8Pain2,0084.2%
  9. 9Somnolence1,9974.2%
  10. 10Dizziness1,9884.2%
  11. 11Insomnia1,9304.0%
  12. 12Off Label Use1,7713.7%
  13. 13Vomiting1,4643.1%
  14. 14Weight Decreased1,3802.9%
  15. 15Condition Aggravated1,3792.9%

Literature

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Recent PubMed references pinned to Dextroamphetamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 202 ClinicalTrials.gov registrations naming Dextroamphetamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dextroamphetamine work?
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.
What is Dextroamphetamine used for?
According to FDA labeling, Dextroamphetamine carries indications including: XELSTRYM ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see CLINICAL STUDIES (14) ] . Limitations of Use The use of XELSTRYM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use in Specific Populations (8.4) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dextroamphetamine?
Dextroamphetamine is classified as Centrally acting sympathomimetics, Central Nervous System Stimulant, Dopamine Uptake Inhibitors, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Bronchodilation, Central Nervous System Stimulation, Increased Cerebral Cortex Dopamine Activity, Increased Cerebral Cortex Norepinephrine Activity.
What are the brand names for Dextroamphetamine?
Dextroamphetamine is marketed under brand names including Adderall, Dexedrine, Mydayis, ProCentra, Xelstrym, Zenzedi.
What are the contraindications for Dextroamphetamine?
Dextroamphetamine labeling lists contraindications including: XELSTRYM is contraindicated in patients: with known hypersensitivity to amphetamine products or other components of XELSTRYM.. Always consult the full prescribing information and a clinician.
Note. Data for dextroamphetamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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