Finished product reference
Dextroamphetamine Sulfate
Tablet · Oral · 5 mg
- List code
- 2236
- Pharmacologic class
- Central Nervous System Stimulant
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 , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
What it is and how it works
Mechanism of Action Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.
Indications
® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older . 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 . XELSTRYM is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older 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 ( 5.5 , 8.4 ).
Dosage and administration (summary)
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 Adults: Recommended starting dose is 9 mg/9 hours. Maximum recommended dose is 18 mg/9 hours Apply one XELSTRYM transdermal system 2 hours before an effect is needed and remove within 9 hours Apply XELSTRYM to one of the following sites: hip, upper arm, chest, upper back or flank.
Contraindications
is contraindicated in patients: with known hypersensitivity to amphetamine products or other components of XELSTRYM. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports taking monoamine oxidase inhibitors (MAOI), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis Known hypersensitivity to amphetamine products or other ingredie…
Warnings and precautions
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 Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse Psychiatric Adverse Reactions: Prior to initiating XELSTRYM, screen patients for risk factors for developing a manic episode.
Pregnancy
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including XELSTRYM, during pregnancy.
Storage and supply
How Supplied XELSTRYM (dextroamphetamine) transdermal system is a translucent product with a printed backing on one side and a release liner on the other packaged in an individual pouch supplied as: 4.5 mg/9 hours transdermal system (system size: 4.76 cm 2 ) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouc…
Source: Dextroamphetamine (Xelstrym) — US FDA prescribing information, 2025-12-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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