# 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) |
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**Forms/Strengths**
- Orally Disintegrating Tablets**: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg
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### **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 mg | 6.3 mg | 9.4 mg | 12.5 mg | 15.7 mg | 18.8 mg |
| ADDERALL XR
| 5 mg | 10 mg | 15 mg | 20 mg | 25 mg | 30 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.
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### **Quick Facts**
- Increases synaptic norepinephrine/dopamine via enhanced presynaptic release and reuptake inhibition
- Improves focus, attention, impulse control
- Common side effects: decreased appetite, insomnia, elevated blood pressure
- Extended-release ODT with dual-phase (immediate and delayed) release for rapid onset and sustained effect
- Unique ODT formulation that disintegrates on the tongue without water
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### **Indications**
- **Attention Deficit Hyperactivity Disorder (ADHD) (ICD-10: F90.0)**
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### **Off-Label Uses**
- Narcolepsy (ICD-10: G47.411)**: Occasionally used off-label, though not FDA-approved for this indication.
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### **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**.
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### **Side Effects**
- **Common**:
- Insomnia, irritability, anxiety
- Decreased appetite, weight loss
- Dry mouth, nausea, abdominal pain
- Increased blood pressure, heart rate
- **Serious**:
- Rare cardiovascular events (arrhythmias, sudden death in at-risk populations)
- Psychiatric effects: mania, aggression, or psychosis
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### **Monitoring / Labs**
- **Cardiovascular:** Baseline and routine monitoring of **heart rate and blood pressure**.
- **Growth in Pediatrics:** Regular monitoring of **height and weight** to detect growth suppression.
- **Psychiatric Symptoms:** Observe for **mood changes, anxiety, or psychosis**.
- **Abuse Potential:** Monitor for **misuse or diversion**.
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### **Education**
- **When to Call the Doctor**
- **Severe mood changes, aggression, or suicidal thoughts.**
- **Chest pain, rapid heartbeat, or shortness of breath.**
- **Uncontrolled movements, tics, or worsening anxiety.**
- **Numbness, coldness, or color changes in fingers or toes.**
- **Signs of serotonin syndrome, such as agitation, rapid heartbeat, or tremors.**
- **Safety Tips:**
- **Monitor blood pressure and heart rate** regularly, especially in patients with cardiovascular risk.
- **Use caution in patients with anxiety, bipolar disorder, or psychosis**, as symptoms may worsen.
- **Avoid caffeine and other stimulants,** which may amplify side effects.
- **Ensure adequate hydration and nutrition,** as appetite suppression is common.
- **Tapering may be required** if discontinuing after long-term use.
- **Tips for Pediatric Patients**:
- **Encourage a balanced diet** to counteract appetite suppression.
- **Monitor school performance and behavioral changes.**
- **Administer in the morning before school** for optimal effect.
- **Observe for sleep disturbances and adjust timing if necessary.**
- **Communicate with teachers and caregivers** about medication effects.
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### **Additional Information**
- **Contraindications:**
- **Hypersensitivity** to amphetamines or formulation components.
- **Use within 14 days of MAOI therapy** (risk of hypertensive crisis).
- Symptomatic **cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma**.
- **History of substance use disorder**, unless benefits outweigh risks.
- **Pregnancy:**
- **Category C**; use only if benefits outweigh risks.
- May cause **neonatal withdrawal symptoms** or **low birth weight**.
- **Lactation:**
- **Excreted in breast milk**; **not recommended** due to potential infant exposure.
- **Drug Interactions:**
- **Serotonergic drugs** (e.g., SSRIs, SNRIs, MAOIs) increase **serotonin syndrome risk**.
- **Acidifying agents** (e.g., ascorbic acid) may reduce drug absorption.
- **Alkalinizing agents** (e.g., sodium bicarbonate) may increase amphetamine levels.
- May potentiate **hypertensive effects** of certain medications (e.g., decongestants, beta-agonists).