# Adzenys XR-ODT ### (amphetamine extended-release orally disintegrating tablet)
**[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)
--- **Forms/Strengths** - Orally Disintegrating Tablets**: 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 min - **Duration:** ~12 hours - **Release Profile:** 50% IR, 50% ER - **Considerations:** Orange-flavored. May be taken with or without food. **Allow tablet to disintegrate in saliva before swallowing.** - [Adderall XR Equivalent Doses](https://wiki.joshnp.com/link/40#bkmrk-equivalent-doses-of-) - **Initial Dose:** - 6-17 y/o: 6.3 mg - 18+ y/o: 12.5 mg - **Titration:** 3.1 mg - 6.3 mg weekly - **Max Dose:** - 6-12 y/o: 18.8 mg/day - 13+ y/o: 12.5 mg/day
#### **Equivalent Doses of ADZENYS XR-ODT and ADDERALL XR**
ADZENYS XR-ODT 3.1 mg6.3 mg9.4 mg12.5 mg15.7 mg18.8 mg
ADDERALL XR 5 mg10 mg15 mg20 mg25 mg30 mg

**Important Note:** To avoid substitution errors and overdosage, **do not substitute** for other amphetamine products on a milligram-per-milligram basis due to different amphetamine base compositions and pharmacokinetic profiles.

--- ### **Quick Facts** - **Mixed amphetamine salts** (75% dextroamphetamine base, 25% levoamphetamine base); increases synaptic **norepinephrine and dopamine** via enhanced release and reuptake inhibition - Dual-release profile (**50% immediate, 50% extended**) for rapid onset and all-day coverage in ADHD - **Improves core ADHD symptoms**: inattention, hyperactivity, impulsivity - **Black box warning**: High potential for **abuse, misuse, addiction**, overdose, and death; Schedule II controlled substance - Unique **ODT formulation** dissolves on tongue without water; orange flavor improves palatability - Common effects: **appetite suppression, insomnia, ↑BP/HR**; monitor growth in children - **Not interchangeable** with other amphetamines on mg basis due to base equivalence differences --- ### **Indications** - **Attention Deficit Hyperactivity Disorder (ADHD) (ICD-10: F90.0)** --- ### **Off-Label Uses** - Narcolepsy (ICD-10: G47.411)**: Occasionally used off-label, though not FDA-approved for this indication. --- ### **How to Take** - Take **once daily in the morning** to reduce the risk of insomnia. - **Do not crush, chew, or split** the tablet. - Place the **orally disintegrating tablet (ODT) on the tongue** and allow it to dissolve completely; do not swallow whole. - Can be taken **with or without food**. --- ### **Side Effects** - **Common:** - **CNS**: insomnia, headache, anxiety, irritability, dizziness - **GI**: decreased appetite, weight loss, dry mouth, nausea, abdominal pain - **CV**: ↑heart rate, ↑blood pressure - **Other**: asthenia (fatigue) - **Serious:** - **Black box**: **Abuse/misuse/addiction** leading to overdose/death - **CV**: sudden death, myocardial infarction, stroke, arrhythmias (esp. with structural heart defects) - **Psych**: new/exacerbated psychosis, mania, aggression, hallucinations - **Peripheral vasculopathy**: Raynaud's-like symptoms (pain, numbness, color change in fingers/toes) - **Serotonin syndrome** (with serotonergics): hyperthermia, rigidity, seizures - **Growth suppression** in children --- ### **Monitoring / Labs** - **Baseline/periodic**: BP, HR, weight, height (pediatrics), BMI - Assess growth every 3-6 months in children; plot on charts - Monitor for **psychiatric changes**, tics, substance misuse - **LFTs, CBC** if long-term or symptoms (e.g., dark urine) - ECG if cardiac history --- ### **Education** - **When to Call the Doctor:** - Chest pain, palpitations, shortness of breath, fainting - Severe anxiety, hallucinations, mood changes, suicidal thoughts - Finger/toe pain, numbness, color changes (cold/pale/blue) - Prolonged erection (>4 hours), uncontrolled tics/movements - Signs of overdose: agitation, hallucinations, hyperthermia, seizures - **Safety Tips:** - Take only as prescribed; **store securely** (controlled substance) - Avoid alcohol, caffeine, OTC decongestants (↑CV effects) - Report all meds/supplements to avoid interactions - No driving/operating machinery until effects known - **Tapering may be required** if discontinuing after long-term use. - **Parent Tips for Pediatric Patients:** - Give **before school** to minimize sleep interference - Use pill organizer or reminders; track appetite/weight weekly - Partner with school (teacher reports on focus/behavior) - Promote healthy meals/snacks despite appetite loss - Watch for **growth delays**; annual pediatrician review --- ### **Additional Information** - **Contraindications:** - Known hypersensitivity to amphetamines - **MAOI use within 14 days** (hypertensive crisis) - Advanced arteriosclerosis, symptomatic heart disease, moderate-severe HTN, hyperthyroidism, glaucoma - History of drug abuse - **Pregnancy:** **Category C**; potential fetal harm (↓birth weight, withdrawal); use only if benefit > risk (APLENZIN registry) - **Lactation:** Excreted in milk; **avoid** or discontinue nursing - **Drug Interactions:** - **CYP2D6 inhibitors** (e.g., bupropion, fluoxetine): ↑amphetamine levels - **MAOIs/serotonergics**: serotonin syndrome, hypertensive crisis - **Acidifiers** (vit C): ↓absorption; **alkalinizers** (NaHCO3): ↑levels - **Pressors** (decongestants): additive HTN/tachycardia --- ### **References** 1. Amphetamine XR-ODT Prescribing Information, Aytu BioPharma, 2023, [https://www.fffenterprises.com/assets/downloads/product-information/aytu-biopharma/pi-AMPHETAMINE-XR-ODT.pdf](https://www.fffenterprises.com/assets/downloads/product-information/aytu-biopharma/pi-AMPHETAMINE-XR-ODT.pdf) 2. DailyMed: Amphetamine extended-release orally disintegrating tablets, 2023, [https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=48d0f55c-f847-4d26-b2ed-94b5a2770228](https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=48d0f55c-f847-4d26-b2ed-94b5a2770228)