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ProCentra

(dextroamphetamine sulfate)

ProCentra (dextroamphetamine sulfate); CII

Full Prescribing Information DailyMed Drug Information

Summary

ProCentra is an immediate-release, short-acting oral solution of single-entity dextroamphetamine sulfate, approved for ADHD from age 3 through 16 and for narcolepsy. It contains only the d-isomer and gives a short block of coverage per dose rather than a school day. Its differentiator is the liquid: the only immediate-release amphetamine titratable in fractions of a milligram for a preschooler or a child who cannot swallow. Schedule II; brand and generic.

Forms & Strengths

  • Oral solution (bubblegum, colorless; 16 fl oz bottle): 5 mg/5 mL, that is 1 mg/mL

Dosing

  • Age:
    • ADHD: 3-16 y/o, the range this label's indication is written for
    • Narcolepsy: ≥ 6 y/o, no upper bound
  • Onset: 30 to 60 min
  • Duration: 4 to 6 hours
  • Initial Dose:
    • ADHD, 3-5 y/o: 2.5 mg daily, that is 2.5 mL
    • ADHD, 6-16 y/o: 5 mg once or twice daily
    • Narcolepsy, 6-11 y/o: 5 mg daily
    • Narcolepsy, ≥ 12 y/o: 10 mg daily
  • Titration:
    • ADHD, 3-5 y/o: 2.5 mg every 7 days
    • ADHD, 6-16 y/o: 5 mg every 7 days
    • Narcolepsy, 6-11 y/o: 5 mg every 7 days
    • Narcolepsy, ≥ 12 y/o: 10 mg every 7 days
  • Max Dose:
    • ADHD: 40 mg/day at any age; the label says only in rare cases will it be necessary to exceed this
    • Narcolepsy: usual range 5-60 mg/day in divided doses
  • Considerations: The maximum is set by indication, not by age or weight. First dose on awakening, then one or two more at 4-6 hour intervals. This is a solution, not a suspension; it does not need shaking.

Pharmacology

  • Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
  • Delivery / Release: A true solution, already dissolved; no disintegration step, no modified-release component
  • Formulation: d-isomer only; at the same milligram dose as a mixed-salt or racemic amphetamine, more CNS effect and less of the peripheral contribution the l-isomer carries
  • Metabolism: 10 mg gave a mean peak of 33.2 ng/mL, half-life 11.75 hours, 38% urinary recovery over 48 hours; excretion is pH dependent
  • Half-life is not duration: the dosing interval is 4 to 6 hours despite an 11.75 hour half-life
  • Class Positioning: the moiety and release profile of Zenzedi in a form a 3 year old can take and that titrates continuously; Dexedrine Spansule is the extended-release sibling
  • Against Dyanavel XR, the other liquid amphetamine: pure d-isomer, immediate-release, several doses daily

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 3-16 y/o, within a total treatment program
  • Narcolepsy (ICD-10: G47.419): patients ≥ 6 y/o; the label notes it seldom occurs under 12

Off-Label Uses

  • ADHD over age 16 (ICD-10: F90.x): outside this label's range, though the tablets carry an adult indication elsewhere. Use in a 17 year old who cannot swallow tablets is expert consensus.

  • Where the evidence does not support use:

    • Non-ADHD, non-narcolepsy indications in youth: AHRQ CER 267 graded none (AHRQ 2024).
    • Weight management: unlike Evekeo, this label carries no obesity indication. Not supported.
    • Cognitive enhancement without ADHD: not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse, and addiction. High abuse potential leading to substance use disorder; overdose and death, more so at higher doses or by snorting or injection. Assess risk before prescribing; reassess throughout.
  • Contraindicated:
    • Known hypersensitivity to amphetamine products
    • MAOI use, current or within 14 days; hypertensive crisis
  • Use with caution (Warnings, not contraindications):
    • Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
    • Pre-existing hypertension; pre-existing psychosis; bipolar disorder, for treatment-emergent mania
    • Motor or phonic tics or Tourette syndrome; peripheral vasculopathy including Raynaud phenomenon
    • Substance use disorder in the household; a palatable liquid in a 16 ounce bottle is a different risk from a blister pack
  • Screen before starting:
    • Cardiac history, family history of sudden death or arrhythmia, and exam
    • Personal and family history of tics; mania risk from personal or family depression, bipolar disorder or suicide
    • Abuse and diversion risk; baseline height, weight, BP, HR

Drug Interactions

  • MAOIs (including furazolidone): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Confirm a 14 day washout.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone): serotonin syndrome. Start lower; stop both drugs if symptoms appear.
  • CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
  • Acidifying agents (ascorbic acid, fruit juices, ammonium chloride): lower absorption and efficacy. A caregiver mixing a dose into orange juice is creating this interaction; instruct that the dose is given straight.
  • Alkalinizing agents (bicarbonate, antacids, acetazolamide): raise levels. Reduce the dose rather than assuming lost tolerance.
  • Tricyclic antidepressants (desipramine, protriptyline): sustained rise in brain d-amphetamine. Monitor BP and HR; titrate slowly.
  • Sympathomimetics and antihypertensives: additive cardiovascular effect; hypotensive effect antagonized. Avoid OTC decongestants; recheck BP.

Administration

  • First dose on awakening, one or two more at 4-6 hour intervals, with or without food.
  • This is a solution, not a suspension. It does not need shaking. Any instruction to shake the bottle was carried over from a different product.
  • Measure with a calibrated oral syringe, never a spoon: at 1 mg/mL a 2.5 mg dose is 2.5 mL. Confirm the pharmacy supplied one; this label names no dosing device.
  • Give the dose straight, not in juice. Fruit juice acidifies and lowers absorption, and is a common invisible cause of apparent treatment failure.
  • Avoid late evening doses; the label names resulting insomnia.
  • Interrupt occasionally to see whether symptoms recur at a level requiring continued therapy; a label instruction.
  • Store at room temperature in a tight, light-resistant container, securely and preferably locked.

Side Effects

  • Common: decreased appetite and weight loss, insomnia, overstimulation, irritability and dysphoria, headache, dizziness, tremor, dry mouth, unpleasant taste, bowel change, palpitations, tachycardia, elevated blood pressure.
  • Serious:
    • Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor.
    • Psychosis or mania, roughly 0.1% in pooled stimulant trials; consider discontinuing.
    • Serotonin syndrome; stop both drugs and treat supportively.
    • Peripheral vasculopathy including Raynaud phenomenon; reduce or stop.
    • Growth suppression; interrupt in a child not growing as expected.
    • New or worsening tics; rhabdomyolysis; intestinal ischemia.
    • Impotence and changes in libido, which an adolescent may not volunteer.

Monitoring & Labs

  • Cardiovascular: HR and BP at baseline, each dose change, and every 6 months; mean rise 2-4 mm Hg and 3-6 bpm.
  • Growth: height, weight and BMI charted at baseline and every 6 months; this matters most in the 3 to 5 year olds the formulation exists to serve.
  • Appetite and sleep: every visit; usually fixed by timing rather than dose.
  • Psychiatric, tics and digits: psychosis, mania, aggression and dysphoria at each visit and 2 weeks after any increase; ask about motor and phonic tics and inspect the digits.
  • Dosing technique: watch the caregiver draw a dose at first follow-up and whenever response turns erratic; ask whether it is being mixed into juice, which looks like tolerance.
  • Volume accounting: at each refill reconcile volume dispensed against daily dose and days elapsed; a liquid cannot be pill-counted.
  • Abuse and diversion: adherence and PDMP check at each refill; reassess need for therapy at least annually.
  • Laboratory: none routinely; amphetamines interfere with urinary steroid assays.

Discontinuation & Taper

  • Can be stopped abruptly at therapeutic doses; no taper required.
  • Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
  • End-of-dose rebound irritability and hunger is pharmacodynamic offset, not withdrawal.
  • Planned interruptions are asked for by this label; drug holidays suit appetite or growth as the limiting problem.

Pregnancy & Lactation

  • Pregnancy: No adequate controlled studies. Embryotoxic and teratogenic in two mouse strains at about 41 times the maximum human dose; not in rabbits at 7 or rats at 12.5 times.
  • Pregnancy, human data: one VATER-association case report, bony deformity with tracheoesophageal fistula and anal atresia, after first-trimester use with lovastatin. One confounded case is not a causal finding.
  • Pregnancy, clinical: increased premature delivery and low birth weight in dependent mothers; infants may withdraw. Weigh rather than abstain.
  • Lactation: the label says amphetamines enter milk and mothers should not nurse.
  • Lactation, dextroamphetamine: four mothers on a mean 18 mg daily gave a median milk level of 219 mcg/L, 5.7% of the maternal dose, with all four infants normal. (LactMed 2025)
  • Lactation, milk supply: a 20 mg dose suppressed prolactin about 40% postpartum; large doses may impair production where lactation is not established. (LactMed 2025)

Counseling Points

  • Counsel the family on:

    • That this bottle does not need shaking, unlike ADHD liquids they may have used before. Say it explicitly.
    • Giving the dose straight rather than in orange juice, because acid turns a working dose into a failing one.
    • Measuring with the oral syringe, and that 1 mL equals 1 mg so a small volume error is a large dose error.
    • The 4-6 hour window, and that a second or third dose usually covers the afternoon.
    • End-of-dose rebound irritability and hunger; not a signal to increase the dose.
    • Appetite suppression peaking midday; largest meal at breakfast and in the evening.
    • Storing the bottle locked; bringing a teacher rating scale to the next visit.

  • Advise them to call for:

    • Chest pain on exertion, fainting, or a racing heart that does not settle.
    • New hallucinations, or new suspicious or fearful thinking.
    • Numbness or colour change in the fingers or toes.
    • A new or worse tic, new throat clearing or blinking; weight loss.
    • Any accidental swallow by another child; for a 16 ounce bottle of a Schedule II liquid that is an emergency call.

References

  1. DailyMed. ProCentra (dextroamphetamine sulfate) oral solution prescribing information. Independence Pharmaceuticals. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1548cce2-fb6b-4f17-8a3b-868933f6c9d6
  2. FDA. openFDA National Drug Code Directory, generic_name "dextroamphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22dextroamphetamine%22&limit=1000
  3. LactMed. Dextroamphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/
  4. AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
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