DYANAVEL XR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DYANAVEL XR (DYANAVEL XR).
Dyanavel XR is a central nervous system stimulant that increases the levels of dopamine and norepinephrine in the synaptic cleft by inhibiting their reuptake and increasing their release, thereby enhancing neurotransmission in the brain regions involved in attention and impulse control.
| Metabolism | Primarily metabolized by the liver via deamination and oxidation to form inactive metabolites, including benzoic acid and hippuric acid. The metabolism is not significantly mediated by cytochrome P450 enzymes; however, minor involvement of CYP2D6 has been suggested. |
| Excretion | Approximately 30-50% of a dose is excreted unchanged in urine; remainder as metabolites (primarily hippuric acid) via renal elimination. Fecal excretion is minimal. |
| Half-life | Mean terminal elimination half-life is approximately 8-10 hours for d-amphetamine and 12-14 hours for l-amphetamine; the extended-release formulation maintains therapeutic concentrations for 12-14 hours. |
| Protein binding | Approximately 16-20% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution (Vd) is approximately 3-4 L/kg for total amphetamine, indicating extensive tissue distribution. |
| Bioavailability | Oral bioavailability of amphetamine is approximately 90% for the immediate-release formulation; the extended-release formulation (DYANAVEL XR) provides comparable bioavailability with a prolonged absorption phase. |
| Onset of Action | Oral: Onset of clinical effect (improved attention) occurs within 1-2 hours post-dose. |
| Duration of Action | Duration of clinical effect is approximately 12-14 hours based on extended-release profile; once-daily dosing provides symptom control throughout the day. |
| Molecular Weight | 135.21 |
Initial dose: 5 mg orally once daily in the morning. Maximum dose: 20 mg once daily. May increase by 5–10 mg weekly based on tolerability and response.
| Dosage form | SUSPENSION, EXTENDED RELEASE |
| Renal impairment | GFR 30–59 mL/min: maximum recommended dose 10 mg once daily. GFR 15–29 mL/min: maximum recommended dose 5 mg once daily. GFR <15 mL/min: not recommended. |
| Liver impairment | Child-Pugh class A (mild): no adjustment necessary. Child-Pugh class B (moderate): maximum recommended dose 10 mg once daily. Child-Pugh class C (severe): not recommended. |
| Pediatric use | Ages 6–12 years: initial dose 5 mg orally once daily; maximum 20 mg once daily. Ages 13–17 years: initial dose 5 mg once daily; maximum 20 mg once daily. Weight-based: no specific weight-based dosing; use lowest effective dose. |
| Geriatric use | Starting dose: 5 mg once daily; increase cautiously. Monitor for cardiovascular effects (hypertension, tachycardia) and cognitive changes. Consider lower maximum dose due to increased sensitivity. |
| 1st trimester | Avoid due to risk of teratogenicity; animal studies show adverse effects and no adequate human studies. |
| 2nd trimester | Avoid; potential for fetal harm and maternal cardiovascular risks. |
| 3rd trimester | Avoid; may cause neonatal withdrawal syndrome and premature delivery. |
Clinical note
Comprehensive clinical and safety monograph for DYANAVEL XR (DYANAVEL XR).
| Placental transfer | Amphetamines cross the placenta; fetal serum levels are approximately 50-100% of maternal levels. |
| Breastfeeding | Excreted in human milk; potential for serious adverse reactions in nursing infants, including weight loss, tachycardia, and agitation. Use is generally not recommended during breastfeeding. |
| Lactation Rating |
■ FDA Black Box Warning
DYANAVEL XR has a high potential for abuse and dependence. Prolonged use may lead to drug dependence and must be avoided in patients with a history of drug abuse or alcoholism. Careful supervision is required during withdrawal from abusive use because severe depression may occur. Misuse may cause sudden death and serious cardiovascular adverse events.
| Serious Effects |
Known hypersensitivity to amphetamines or other componentsConcurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuationGlaucoma (narrow-angle)Hyperthyroidism or thyrotoxicosisAgitated statesHistory of drug abuseCardiovascular disease including hypertension, arteriosclerosis, and structural cardiac abnormalitiesDuring or within 14 days following administration of MAOIs
| Precautions | Serious cardiovascular events including sudden death, stroke, and myocardial infarction have been reported in patients with structural cardiac abnormalities or other serious heart problems., Blood pressure and heart rate should be monitored regularly., Psychiatric adverse events such as exacerbation of pre-existing psychosis, manic episodes, and aggressive behavior may occur., Long-term suppression of growth (height and weight) has been observed; monitor growth during treatment., May cause peripheral vasculopathy including Raynaud's phenomenon., May lower seizure threshold; use with caution in patients with seizure disorders. |
Loading safety data…
| L4 (possibly hazardous) |
| Teratogenic Risk | Pregnancy Category C. First trimester: Limited human data; animal studies show increased incidence of cardiovascular malformations. Second and third trimesters: Risk of preterm delivery, low birth weight, and neonatal withdrawal syndrome (tremors, irritability, hypertonia). |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and signs of stimulant abuse. Fetal ultrasound to assess growth and potential anomalies. Neonatal monitoring for withdrawal symptoms after delivery. |
| Fertility Effects | No formal studies; animal data suggest potential for reduced fertility at high doses. Clinical implications unclear. |
| Food/Dietary | Avoid high-fat meals immediately before dosing as they may delay absorption, but consistent administration with or without food is acceptable. Avoid grapefruit juice as it may alter amphetamine metabolism. Do not consume alcohol while taking DYANAVEL XR; alcohol may cause rapid release of the drug and increase side effects. |
| Clinical Pearls | DYANAVEL XR (amphetamine extended-release oral suspension) contains 3.2 mg/mL amphetamine base equivalent (as amphetamine sulfate and dextroamphetamine saccharate/amphetamine aspartate monohydrate/amphetamine sulfate). Do not substitute for other amphetamine products on a mg-per-mg basis due to different salt compositions. Administer consistently with or without food; high-fat meals may delay Tmax but do not affect overall absorption. Shake bottle vigorously for at least 10 seconds before each dose. Avoid late evening doses to prevent insomnia. Monitor for growth suppression in children, blood pressure and heart rate, and potential for abuse/dependence. |
| Patient Advice | Shake the bottle well for at least 10 seconds before each dose. · Take exactly as prescribed; do not change dose or stop without consulting your doctor. · Do not take this medication in the late evening as it may cause trouble sleeping. · Avoid alcohol while taking this medication. · This drug has a high potential for abuse; keep in a safe place. · Tell your doctor if you have any heart problems, high blood pressure, or mental health issues. · Report any chest pain, shortness of breath, or fainting to your doctor immediately. · Your doctor may check your growth, heart rate, and blood pressure regularly. · Do not drive or operate machinery until you know how this medication affects you. · Store at room temperature away from moisture and heat. |