# Adzenys XR-ODT ### (amphetamine) **[Adzenys XR-ODT](https://wiki.joshnp.com/books/drug-library/page/adzenys-xr-odt)** (amphetamine); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c1179269-00b5-48ea-972d-31e614e99b7e&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c1179269-00b5-48ea-972d-31e614e99b7e)
--- ### **Summary** Adzenys XR-ODT is an extended-release amphetamine orally disintegrating tablet approved for ADHD from age 6, taken once daily in the morning. It carries a 3:1 ratio of d- to l-amphetamine, pairing an immediate-release half with a delayed-release half in a tablet that dissolves on the tongue without water. Its differentiator is a full-day amphetamine for a child who will not swallow a capsule; its trap is that strengths are amphetamine base. Schedule II; brand and generic. --- ### **Forms & Strengths** - **Extended-release orally disintegrating tablets** (orange; blister packed; amphetamine base): 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg --- ### **Dosing** - **Age:** ≥ 6 y/o - **Onset:** 30 to 60 min - **Duration:** ~ 12 hours - **Release Profile:** 50% immediate-release / 50% delayed-release amphetamine in one tablet. Delayed, not extended - **Initial Dose:** - 6-17 y/o: 6.3 mg once daily in the morning - ≥ 18 y/o: 12.5 mg once daily, the recommended adult dose rather than a starting dose - **Titration:** 3.1 mg or 6.3 mg every 7 days, patients 6-17 - **Max Dose:** - 6-12 y/o: 18.8 mg/day - 13-17 y/o: 12.5 mg/day - ≥ 18 y/o: 12.5 mg/day recommended; no separate adult maximum is stated - **Considerations:** The adolescent ceiling is LOWER than the child ceiling, and is not a typo: a 13 year old cannot exceed 12.5 mg/day. Strengths are amphetamine base; never convert milligram for milligram. --- ### **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:** 50% immediate-release / 50% delayed-release, from ion-exchange resin particles of which half carry a methacrylic acid coat - **Disintegration** in saliva is a delivery convenience and does not change absorption - **Formulation:** 3:1 d- to l-amphetamine, strengths as amphetamine base where the mixed-salt products state salts - **Metabolism:** CYP2D6 forms active 4-hydroxyamphetamine. d-amphetamine half-life 9-10 h in children 6-12 and 11 h in adults; l-amphetamine 10-11 h and 14 h; excretion is pH dependent - **Class Positioning:** pharmacokinetically [Adderall XR](https://wiki.joshnp.com/link/9) delivered differently, 18.8 mg matching its 30 mg profile; choose it for route, not kinetics - **Against [Dyanavel XR](https://wiki.joshnp.com/link/16),** the other base-dosed amphetamine: no bottle or measuring device, but fixed steps rather than continuous titration --- ### **Indications** - **ADHD** (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o --- ### **Off-Label Uses** - **None established** for this formulation by graded pediatric evidence. - **Where the evidence does not support use:** - **Children under 6:** argued against by this label; the 3.1 mg strength makes a small dose look available, but the age floor applies. - **Above 12.5 mg/day at 13 to 17 y/o:** the lower ceiling is deliberate. Not supported. - **Non-ADHD indications in youth:** AHRQ CER 267 graded none (AHRQ 2024). - **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 non-oral routes. Assess risk before prescribing; reassess throughout. - **Contraindicated:** - Known hypersensitivity to amphetamine or components - MAOI use, current or within 14 days, including linezolid and IV methylene blue - **Use with caution** (Warnings, not contraindications): - Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death - Pre-existing hypertension, because BP and HR rise - Pre-existing psychosis; bipolar disorder, for treatment-emergent mania - Motor or verbal tics, Tourette syndrome, or peripheral vasculopathy including Raynaud phenomenon - Hereditary fructose intolerance; this tablet lists fructose as an inactive ingredient, unlike the swallowed capsule alternatives - 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, HR --- ### **Drug Interactions** - **MAOIs** (also linezolid, IV methylene blue): 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, bupropion, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower. - **Urinary pH agents:** acidifiers (ascorbic acid, fruit juice) lower amphetamine levels; alkalinizers (bicarbonate, acetazolamide, thiazides) raise them. The label directs a dose adjustment either way. - **Sympathomimetics** (decongestants, beta-agonists): additive cardiovascular effect. Avoid OTC decongestants. - **Laboratory assays:** amphetamines interfere with urinary steroid determinations; interpret rather than repeat. --- ### **Administration** - Once daily in the morning, with or without food; food lowers Cmax about 19% and delays Tmax about 2 hours, which the label calls not clinically significant. - Open the blister with dry hands at the moment of dosing; peel the backing, never push the tablet through the foil. - Place the whole tablet on the tongue and let it disintegrate; do not chew or crush, and no water is needed. - **Switching from [Adderall XR](https://wiki.joshnp.com/link/9) only,** at the equivalent once-daily dose; the label permits this for no other amphetamine. - Adzenys 3.1 mg = Adderall XR 5 mg - 6.3 = 10 - 9.4 = 15 - 12.5 = 20 - 15.7 = 25 - 18.8 = 30 mg - **From any other amphetamine:** stop the previous drug and titrate from the beginning. - Avoid late dosing; the delayed-release half puts an afternoon dose near bedtime. - Store securely, preferably locked. --- ### **Side Effects** - **Common,** children 6-12 vs placebo: loss of appetite 22% vs 2%, insomnia 17% vs 2%, abdominal pain 14% vs 10%, emotional lability 9% vs 2%, vomiting 7% vs 4%. - **Also common,** same study: nervousness 6% vs 2%, fever 5% vs 2%, nausea 5% vs 3%, weight loss 4% vs 0%, dizziness, dyspepsia and fatigue each 2%. - **Serious:** - Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor through it. - Increased BP and HR, mean rise 2-4 mm Hg and 3-6 bpm; monitor rather than assume the mean applies. - Psychosis or mania, roughly 0.1% in pooled stimulant trials; consider discontinuing. - Serotonin syndrome; stop both drugs and treat supportively. - Angioedema and anaphylaxis; stop and do not rechallenge. - Peripheral vasculopathy including Raynaud phenomenon; reduce or stop. - Growth suppression; interrupt in a child not growing as expected. - New or worsening tics and Tourette syndrome. --- ### **Monitoring & Labs** - **Cardiovascular:** HR and BP at baseline, each dose change, and every 6 months. - **Growth:** height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two percentile lines. - **Appetite and sleep:** every visit; at 22% and 17% these are the two commonest reasons for stopping. - **Psychiatric:** psychosis, mania, aggression and emotional lability at each visit and 2 weeks after any increase. - **Tics and digits:** ask about tics and inspect fingers and toes at each visit. - **Dose ceiling at the 13th birthday:** review the dose at the visit before a patient turns 13; a child stable at 15.7 or 18.8 mg is above the adolescent ceiling on their birthday. - **Abuse and diversion:** adherence, tablet counts and PDMP check at each refill. - **Laboratory:** none routinely. --- ### **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. - Evening rebound as the second pulse wears off is pharmacodynamic offset, not withdrawal. - Drug holidays suit appetite or growth as the limiting problem. --- ### **Pregnancy & Lactation** - **Pregnancy:** Decades of data have not identified a drug-associated risk of major birth defects or miscarriage. Amphetamines vasoconstrict, may reduce placental perfusion, and stimulate uterine contractions. - **Pregnancy, clinical:** premature delivery and low birth weight reported; background risk 2% to 4% for defects, 15% to 20% for miscarriage. Weigh rather than abstain. - **Neonate:** monitor for withdrawal: feeding difficulty, irritability, agitation, drowsiness. - **Lactation:** in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5; no reported adverse infant effects; the label does not recommend breastfeeding. - **Lactation, milk supply:** prolactin suppressed 25% to 40%; large doses may impair production where lactation is not established. (LactMed 2025) - **Exposure Registry:** National Pregnancy Registry for ADHD Medication, 1-866-961-2388, www.womensmentalhealth.org/pregnancyregistry --- ### **Counseling Points** - **Counsel the family on:** - Peeling the blister backing with dry hands at the moment of dosing; pushing the tablet through the foil crumbles it, and moisture breaks it down. - Letting it dissolve on the tongue without chewing, and that no water is needed. - That the strength number will not match a previous amphetamine prescription, and is not a pharmacy error. - The ceiling dropping at age 13, so nobody is blindsided when the dose is reduced. - Appetite suppression, 22% of children; largest meal at breakfast and in the evening. - Storing it locked and away from younger siblings; the orange flavour looks like a sweet, and 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. - Swelling of the lips, tongue or face after a dose. - Numbness, coldness or colour change in the fingers or toes. - A new or worse tic; weight loss; mood swings new since the last dose change. --- ### **References** 1. DailyMed. Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets prescribing information. Neos Therapeutics Brands. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c1179269-00b5-48ea-972d-31e614e99b7e 2. FDA. openFDA National Drug Code Directory, generic\_name "amphetamine". 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/