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Evekeo

(amphetamine sulfate)

Evekeo (amphetamine sulfate); CII

Full Prescribing Information DailyMed Drug Information

Summary

Evekeo is an immediate-release, short-acting tablet of racemic amphetamine sulfate, approved for ADHD from age 3, narcolepsy from age 6, and short-term use in exogenous obesity from age 12. Unlike Adderall it is a single-entity salt rather than a mixed-salt blend, and unlike Zenzedi it carries the l-isomer too; that racemic composition is why you would reach for it. Schedule II; brand and generic.

Forms & Strengths

  • Tablets (5 mg single-scored, 10 mg double-scored): 5 mg, 10 mg

Dosing

  • Age:
    • ADHD: ≥ 3 y/o
    • Narcolepsy: ≥ 6 y/o
    • Exogenous obesity: ≥ 12 y/o
  • Onset: 30 to 60 min
  • Duration: 4 to 6 hours
  • Initial Dose:
    • ADHD, 3-5 y/o: 2.5 mg daily
    • ADHD, ≥ 6 y/o: 5 mg once or twice daily
    • Narcolepsy, 6-11 y/o: 5 mg daily
    • Narcolepsy, ≥ 12 y/o: 10 mg daily
    • Exogenous obesity, ≥ 12 y/o: 5-10 mg per dose, 30-60 min before meals
  • Titration:
    • ADHD, 3-5 y/o: 2.5 mg every 7 days
    • ADHD, ≥ 6 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
    • Narcolepsy: usual range 5-60 mg/day in divided doses
    • Exogenous obesity: up to 30 mg/day in divided doses of 5-10 mg
  • Considerations: First dose on awakening, then one or two further doses at 4-6 hour intervals; the maximum is set by indication, not by weight, and late evening doses cause insomnia.

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: Plain immediate-release tablet; single early peak, one block of coverage per dose
  • Formulation: Racemic amphetamine sulfate, equal d- and l-isomer. Per the label the l-isomer is more potent in cardiovascular activity and much less potent in CNS excitatory effects
  • Metabolism: CYP2D6 forms active 4-hydroxyamphetamine; urinary excretion is pH dependent; this label publishes no half-life
  • Class Positioning: A single salt, not the 3:1 d:l blend of Adderall, so relatively more peripheral effect per unit of CNS effect; unlike pure-dextroamphetamine Zenzedi and ProCentra it adds the l-isomer back
  • Interchange: not milligram-for-milligram equivalent to any other amphetamine moiety

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 3 y/o, within a total treatment program
  • Narcolepsy (ICD-10: G47.419): patients ≥ 6 y/o
  • Exogenous obesity (ICD-10: E66.9): patients ≥ 12 y/o, short-term adjunct of a few weeks, second-line only; the label puts the gain over placebo at a fraction of a pound per week

Off-Label Uses

  • None established for this moiety outside its labelled indications.

  • Where the evidence does not support use:

    • Non-ADHD indications in youth: AHRQ CER 267 graded none; insufficient (AHRQ 2024).
    • Weight management under 12, first-line, or beyond a few weeks: not supported.
    • Cognitive enhancement without ADHD: not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse, and addiction. High potential for abuse, 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 in this label, not contraindications):
    • Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
    • Hypertension, including mild, which the label names explicitly
    • Pre-existing psychosis; bipolar disorder, for treatment-emergent mania
    • Prior seizure or prior EEG abnormality; this label carries an explicit Seizures warning and directs discontinuation if a seizure occurs
    • Motor or verbal tics, or Tourette syndrome
    • Peripheral vasculopathy including Raynaud phenomenon
    • Substance use disorder in the patient or the household
  • Screen before starting:
    • Cardiac history, family history of sudden death or arrhythmia, and exam
    • Personal and family history of tics or Tourette syndrome
    • Mania risk: personal or family depression, bipolar disorder, suicide
    • Abuse and diversion risk; baseline height, weight, BP and HR

Drug Interactions

  • MAOIs (also linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Do not co-prescribe; confirm a 14 day washout.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone, St John's Wort): 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.
  • Urinary pH agents: acidifiers (ascorbic acid, fruit juice, ammonium chloride, methenamine) lower levels and efficacy; alkalinizers (bicarbonate, antacids, acetazolamide, thiazides) raise them. Check both before changing the dose.
  • Tricyclic antidepressants (desipramine, protriptyline): sustained rise in brain d-amphetamine, potentiated cardiovascular effect. Monitor BP and HR; titrate slowly.
  • Sympathomimetics and antihypertensives: additive cardiovascular effect; hypotensive effect antagonized. Avoid OTC decongestants; recheck blood pressure.

Administration

  • First dose on awakening; one or two further doses at 4-6 hour intervals.
  • Split the scored 5 mg tablet for the 2.5 mg preschool starting dose.
  • Exogenous obesity only: dose 30 to 60 minutes before a meal; that timing does not apply to ADHD or narcolepsy.
  • Avoid late evening doses; the label names resulting insomnia.
  • No suspension, chewable or sprinkle form exists; any instruction to shake or open belongs to another product.
  • Interrupt occasionally to see whether symptoms recur at a level requiring continued therapy; this is a label instruction.
  • Store securely, preferably locked.

Side Effects

  • Common: decreased appetite and weight loss, insomnia, overstimulation, irritability and dysphoria, headache, dizziness, 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 through it.
    • Psychosis or mania at recommended doses, roughly 0.1% in pooled stimulant trials; consider discontinuing.
    • Serotonin syndrome; stop both drugs and treat supportively.
    • Seizure; discontinue.
    • Peripheral vasculopathy including Raynaud phenomenon, rarely digital ulceration; reduce or stop, refer if persistent.
    • Growth suppression; interrupt in a child not growing or gaining as expected.
    • New or worsening tics and Tourette syndrome; discontinue if clinically appropriate.
    • Rhabdomyolysis, intestinal ischemia; priapism, a surgical emergency.

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, investigate beyond that.
  • Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two major percentile lines.
  • Appetite and sleep: every visit; usually fixed by timing rather than dose.
  • Psychiatric: psychosis, mania, aggression, dysphoria at each visit and 2 weeks after any increase.
  • Tics and digits: ask about tics and inspect fingers and toes for colour change, coolness or unexplained wounds at each visit.
  • Abuse and diversion: adherence, pill counts and PDMP check at each refill; reassess need for therapy at least annually.
  • Laboratory: none routinely; amphetamines interfere with urinary steroid determinations.

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. Warn the family in advance.
  • 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, 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. LactMed: one narcolepsy case gave 1.9% to 2.1% of the maternal weight-adjusted dose. (LactMed 2025)
  • Lactation, practical: some experts accept therapeutic doses, monitoring the infant for irritability, insomnia and feeding difficulty.
  • Lactation, milk supply: prolactin suppressed 25% to 40% dose-dependently; large doses may impair milk production where lactation is not yet established. (LactMed 2025)

Counseling Points

  • Counsel the family on:

    • 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.
    • Moving the last dose earlier rather than adding a sleep aid.
    • Appetite suppression peaking midday; largest meal at breakfast and in the evening.
    • Avoiding vitamin C loading and fruit juice around dosing, and asking before any antacid.
    • Secure, preferably locked storage; sharing a Schedule II medication is a felony.
    • Bringing a teacher rating scale to the next visit, and expecting a planned trial off medication.

  • Advise them to call for:

    • Chest pain on exertion, fainting, or a racing heart that does not settle.
    • Any seizure, or a new staring spell.
    • New hallucinations, or new suspicious or fearful thinking.
    • Numbness, coldness or colour change in the fingers or toes, or an unexplained sore on a digit.
    • A new or markedly worse tic; new throat clearing or blinking.
    • Weight loss, or clothes fitting more loosely over a few weeks.
    • A painful erection lasting more than a few hours.

References

  1. DailyMed. Evekeo (amphetamine sulfate) tablets, USP prescribing information. Azurity Pharmaceuticals. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f469fb38-0380-4621-9db3-a4f429126156
  2. FDA. openFDA National Drug Code Directory, generic_name "amphetamine sulfate". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22amphetamine%22&limit=1000
  3. LactMed. Amphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
  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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