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Dextroamphetamine

Zenzedi · Dexedrine Spansule · ProCentra · Xelstrym

A ScheduleII stimulant with distinct immediate-release, sustained-release and transdermal dosing. Age indications, salt/base strengths, renal caps and application instructions differ.

Therapeutic class
CNS stimulant · Schedule II
Selected brands
Zenzedi · Dexedrine Spansule · ProCentra · Xelstrym
Reference focus
U.S. single-agent tablets / capsules / solution / patch; no mixed-salt conversion
Essential safety

High abuse / overdose risk; no mg-for-mg switch between products.

All selected products carry an abuse, misuse and addiction boxed warning. Avoid serious cardiac disease and MAOIs during / within 14 days. Xelstrym heat exposure increases absorption; remove within 9 hours and use the prescribed renal ceiling.

Warnings and precautions
01

Indications

The selected oral and patch age indications differ.

Oral labeled uses

Zenzedi / ProCentra labels cover narcolepsy and an ADHD treatment-program role in pediatric patients 3–16 years. Dexedrine Spansule covers narcolepsy and ADHD at 6–16 years; it is not recommended below 6 because of increased exposure / adverse reactions. Historical diagnostic wording in these labels is not a current stand-alone diagnostic checklist.

Patch and scope

Xelstrym treats ADHD in adults and pediatric patients≥6 years; it is not narcolepsy-labeled and is not recommended below 6. This profile reviews single-agent dextroamphetamine; mixed amphetamine salts and lisdexamfetamine have separate indications / conversion rules. No off-label adult-oral ADHD regimen or universal stimulant-equivalence chart is supplied.

02

Dosage and administration

Use the product-specific lowest effective regimen.

Zenzedi / ProCentra pediatric ADHD

AgeOral IR selected regimen
3–5 yearsStart 2.5 mg daily; increase daily total by 2.5 mg at weekly intervals if needed
≥6 years in labeled pediatric scopeStart 5 mg once or twice daily; increase daily total by 5 mg weekly. Only rarely necessary to exceed 40 mg / day
TimingFirst dose on awakening; additional 1 or 2 doses 4–6 hours apart. Avoid late-evening dosing

Oral narcolepsy and Spansule

Oral narcolepsy usual total 5–60 mg / day in divided doses. Labels specify age 6–12 start 5 mg / day and weekly 5 mg increases; age 12 orolder start 10 mg / day and weekly 10 mg increases. These age bands overlap at exactly 12; the prescription must resolve the boundary, not a self-directed choice. Spansule ADHD starts 5 mg once / twice daily at≥6 with weekly 5 mg increments; only rarely>40 mg / day. Spansule may be once daily where appropriate; its release profile is not the IR 4–6 hour schedule. Reduce if adverse effects limit treatment.

Xelstrym ADHD / renal dosing

PopulationTransdermal dose delivered over 9 hours
Age 6–17Start 4.5 mg / 9 hours; weekly 4.5 mg increments; maximum 18 mg / 9 hours
AdultStart 9 mg / 9 hours; individualize up to 18 mg / 9 hours
Severe renal GFR 15–<30 mL / min / 1.73 m²Maximum 13.5 mg / 9 hours
ESRD GFR<15 mL / min / 1.73 m²Maximum 9 mg / 9 hours

Patch application and replacement

Apply one patch 2 hours before effect is needed to clean / dry / intact hip, upper arm, chest, upper back or flank; rotate sites. Remove within 9 hours and use only one at a time per 24 hours. Do not expose to external heat or add tape / dressings. If fully detached, discard and use a new patch at a different site; original-plus-replacement total wear must still≤9 hours / 24 hours. Wash hands if adhesive touched. Switching requires stopping the prior amphetamine and titrating Xelstrym, never mg-for-mg conversion.

Liquid and uncertain doses

ProCentra contains 5 mg / 5 mL (1 mg / mL); prescribed 5 mg equals 5 mL. Measure with a calibrated oral device, not a kitchen spoon. Oral labels do not supply a numeric renal / hepatic table; patch caps must not be mechanically applied to oral sulfate doses. Verify missed / uncertain doses with the prescribing plan rather than double or extend patch wear.

03

Safety

Cardiac, psychiatric, growth and vascular effects require active review.

Warnings and precautions

Avoid use with structural cardiac abnormalities, cardiomyopathy, serious arrhythmia, coronary disease or other serious cardiac disease. Monitor BP / pulse; evaluate exertional chest pain, syncope or cardiac symptoms. Screen mania risk; psychosis / mania can emerge. Monitor pediatric height / weight, tics and digital circulation / Raynaud symptoms. Oral labels warn about lowered seizure threshold; stop / evaluate new seizures. Serotonin syndrome is possible, especially with interacting serotonergic / CYP2D6 medicines. Patch sensitization can preclude oral amphetamine tolerance; stop for suspected allergic contact dermatitis. Heat increases patch exposure. Dependence / withdrawal can occur with prolonged use; avoid unsupervised abrupt dose changes.

Contraindications

Selected products contraindicate amphetamine / component hypersensitivity and MAOI use during or within 14 days of stopping, including linezolid or IV methylene blue where applicable. Current selected labels do not retain every older stimulant contraindication as a formal list; serious cardiac disease avoidance and other warnings still apply.

Boxed warning

All selected products warn of high potential for abuse, misuse and addiction, including overdose / death with higher doses or unapproved snorting / injection. Assess risk before treatment, counsel safe locked storage / disposal and reassess / monitor throughout. Schedule II status is not permission to share a prescription.

Adverse reactions

Reported effects include appetite loss / weight loss, insomnia, dry mouth, GI symptoms, headache, dizziness, irritability, tachycardia and BP increases. Serious events include psychosis, arrhythmia, serotonin toxicity, vascular injury and seizures / overdose. Xelstrym adds application-site pain, itching, burning or redness; sensitization differs from uncomplicated erythema. Product / trial rates are not directly comparable.

04

Drug interactions

Serotonergic drugs and urinary pH can change risk / exposure.

MAOIs, serotonin and CYP2D6

MAOI co-use / 14 day washout is contraindicated. SSRIs / SNRIs, triptans, tramadol, fentanyl, lithium, buspirone and other serotonergic drugs can increase serotonin-syndrome risk; CYP2D6 inhibitors can raise amphetamine exposure. If a combination is warranted, selected labels advise lower starts and close monitoring, not a universal numeric adjustment.

pH and cardiovascular interactions

Urinary alkalinization raises exposure; Xelstrym advises avoiding urinary alkalinizing agents. Acidifying agents can lower exposure. Oral GI-pH effects also affect absorption. Do not manipulate urine / diet or self-increase doses. Tricyclic / sympathomimetic combinations may potentiate cardiovascular effects and stimulants may oppose antihypertensives. Review all OTC medicines and the actual label interaction table.

PK versus clinical compatibility

Xelstrym lists no PK-based adjustment for selected guanfacine / venlafaxine / omeprazole combinations, but this does not remove BP, sedation or serotonergic monitoring. Oral labels contain legacy interaction examples that do not establish safe home antidotes or compatibility for every medicine.

05

Use in specific populations

Pregnancy / lactation advice and organ dose rules are formulation specific.

Pregnancy and breastfeeding

Oral labels have limited controlled pregnancy evidence and benefit / risk language; patch epidemiology has not identified a major-malformation / miscarriage signal but preterm birth / low birth weight and neonatal withdrawal remain concerns. No source proves zero fetal risk. Amphetamine enters milk; selected oral labels advise refraining from nursing and Xelstrym does not recommend breastfeeding because of infant cardiovascular / growth / vascular risk. Coordinate maternal treatment and feeding with the clinician.

Children and older adults

IR Zenzedi / ProCentra pediatric ADHD scope 3–16 differs from Spansule 6–16 and Xelstrym≥6 including adults. Follow growth / appetite and response; a clinician may interrupt treatment if growth is inadequate. Xelstrym geriatric trials did not include>65 and dosing should be cautious; no age-only maximum is invented.

Renal and hepatic considerations

Reduced renal clearance requires Xelstrym caps stated above; dextroamphetamine is not dialyzable. Both hepatic and renal dysfunction can prolong exposure, but selected oral labels and patch hepatic text do not provide a numeric Child-Pugh regimen. Do not extrapolate patch base-delivery values to oral sulfate strength.

06

Clinical pharmacology

CNS stimulation involves catecholamine signaling.

Mechanism

Amphetamines are sympathomimetic CNS stimulants. Patch pharmacology describes blocking norepinephrine / dopamine reuptake and increasing release; exact therapeutic ADHD mechanisms are not fully established. Clinical benefit does not mean every adverse peripheral effect is avoided.

Pharmacokinetics

Oral label comparisons show IR peaks around 3 hours and sustained-release around 8 hours with approximately 12 hour half-life in the cited small study. Patch peaks typically 6–9 hours after a single application; post-removal mean half-life ranged 6.4–11.5 hours by population. Wear time, site repetition and heat change patch exposure; drug may continue absorbing after removal. CYP2D6 contributes to metabolism and urinary pH changes renal elimination. These PK observations are not an equivalence conversion.

07

Monitoring and counseling

Monitor cardiac symptoms, growth, behavior and misuse risk.

Monitoring

Before use assess cardiac / personal / family history, exam, tics / Tourette risk, psychiatric risk and abuse / misuse risk. Follow BP / pulse, appetite / height / weight, sleep, behavior, circulation and clinical benefit; patch requires local-skin / heat / adherence checks and renal dose review. No universal screening ECG, laboratory interval or drug-level target is asserted.

Counseling

Take only prescribed doses, keep securely locked, do not share and use take-back disposal. Seek urgent care for chest pain / syncope, severe agitation / fever / rigidity, new psychosis or digit wounds. Apply / remove patch as directed, rotate sites and avoid heat. Used patches retain drug: fold adhesive sides together and keep disposal inaccessible to children / pets; the selected Medication Guide says do not flush patches / pouches / liners. Avoid driving until effects are known.

Overdose or wrong-route use

Seek emergency / Poison Help immediately for overdose, child contact / ingestion or severe symptoms. Remove all patches and clean residual adhesive, but ongoing skin absorption requires medical monitoring. Toxicity includes arrhythmia, hyperthermia, seizures, rhabdomyolysis or coma; dialysis is ineffective. Do not attempt home urine acidification or antidotes.

08

Product identification

Oral strengths are sulfate; patch values are dextroamphetamine delivered.

Representative IR tablet

Product
Zenzedi 5 mg dextroamphetamine sulfate
Route
Oral IR prescription · Schedule II
Appearance
Pink oval;5 / MIA, scored
Example package
Bottle 30 · NDC 24338-851-03

Dosage forms and strengths

Zenzedi sulfate tablets 2.5 / 5 / 7.5 / 10 / 15 / 20 / 30 mg. Dexedrine sulfate Spansule 5 / 10 / 15 mg, brown cap / natural body with IX and strength, body 673 / 674 / 675. ProCentra 5 mg / 5 mL colorless bubblegum solution,16 fl oz NDC 21724-701-05. Xelstrym translucent patch delivers 4.5 / 9 / 13.5 / 18 mg over 9 hours,30 individually pouched systems / carton;4.5 mg NDC 68968-0205-3. Delivered patch dose is not total contained drug or an oral-salt equivalent.

Storage and handling

Selected oral products:20–25°C in tight light-resistant containers; Zenzedi permits excursions 15–30°C and child-resistant closure. Xelstrym:20–25°C, excursions 15–30°C, protect light and keep sealed pouch until immediate application. Secure all products, keep children / pets away from used patches and follow label disposal / take-back instructions. No universal capsule opening / crushing or solution beyond-use period is invented.

09

References

Original sources for the clinical and product information.

  1. DailyMed / AzurityZenzedi tablets · Full prescribing information

    Current SPL version 14, effective 2025-11-26.

  2. DailyMed / AmnealDexedrine Spansule · Full prescribing information

    Current SPL version 15, effective 2025-09-25.

  3. DailyMed / IndependenceProCentra oral solution · Full prescribing information

    Current SPL version 17, effective 2025-05-14.

  4. DailyMed / NovenXelstrym transdermal system · Full prescribing information

    Current SPL version 17, effective 2025-12-23.

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