# ProCentra ### (dextroamphetamine sulfate) **[ProCentra](https://wiki.joshnp.com/books/drug-library/page/procentra)** (dextroamphetamine sulfate); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1548cce2-fb6b-4f17-8a3b-868933f6c9d6&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1548cce2-fb6b-4f17-8a3b-868933f6c9d6)
--- ### **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](https://wiki.joshnp.com/link/34) in a form a 3 year old can take and that titrates continuously; [Dexedrine Spansule](https://wiki.joshnp.com/link/118) is the extended-release sibling - **Against [Dyanavel XR](https://wiki.joshnp.com/link/16),** 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/