# Dyanavel XR ### (amphetamine ER)
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ae304b29-0b40-40ec-ad0d-76b742d4a9b9&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae304b29-0b40-40ec-ad0d-76b742d4a9b9)
--- **Forms/Strengths** - **Tablets:** 5 mg, 10 mg, 15 mg, and 20 mg - **Liquid:** 2.5 mg/mL (Total Bottle: 464 mL) --- ### **Dosing** - **Age:** ≥ 6 y/o - **Onset:** ~60 min - **Duration:** up to 13 hours - **Considerations:** May be taken with or without food. Liquid and tablet formulations are interchangeable. - **Tablet:** The 5mg dose is scored to allow for accurate dosing down to 2.5mg. - **Liquid:** Bubblegum flavor - **Initial Dose:** - 6-12 y/o: 2.5-5 mg - 13+ y/o: 5-10 mg - **Titration:** - 6-12 y/o: 2.5 mg every 4-7 days - 13+ y/o: 5 mg every 4-7 days - **Max Dose:** 20 mg --- ### **Quick Facts** - Increases synaptic dopamine and norepinephrine; improves focus, attention, and impulse control - Extended-release oral suspension; liquid formulation for ease of administration - Unique delivery system provides consistent, sustained symptom control - Common side effects: decreased appetite, insomnia, increased heart rate, elevated blood pressure --- ### **Indications** - ADHD** (ICD-10: F90.0) --- ### **Off-Label Uses** - **N/A** --- ### **How to Take** - Take **once daily in the morning** to reduce the risk of insomnia. - Can be taken **with or without food**. - **Shake the suspension well** before each dose to ensure even distribution. - **Measure dose accurately** using a provided oral syringe or dosing cup—do not use household spoons. --- ### **Side Effects** - --- ### **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. --- ### **Education** - **When to Call the Doctor:** - Severe **mood changes, aggression, or suicidal thoughts**. - Chest pain, rapid heartbeat, shortness of breath (**cardiovascular concerns**). - Uncontrolled movements, tics, or worsening anxiety. - Numbness, coldness, or color changes in fingers or toes (**circulatory issues**). - Unexplained weight loss or **delayed growth in pediatric patients**. - **Safety Tips:** - **Monitor blood pressure and heart rate**, 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. - **Parent Tips for Pediatric Patients:** - **Encourage a nutrient-dense diet** to counteract appetite suppression. - Administer in the **morning before school** for optimal effect. - Monitor **school performance and behavioral changes**. - Observe for **sleep disturbances**; adjust timing if necessary. - Communicate regularly with **teachers and caregivers** about medication effects. --- ### **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).