DYANAVEL XR 5
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DYANAVEL XR 5 (DYANAVEL XR 5).
CNS stimulant; blocks reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their synaptic concentrations.
| Metabolism | Primarily hepatic via carboxylesterase 1 (CES1) to active metabolite dexmethylphenidate; further metabolism by CYP2D6 and carboxylesterases. |
| Excretion | Renal: ~90% as unchanged amphetamine and metabolites. Fecal: minimal (<5%). |
| Half-life | Terminal elimination half-life for d-amphetamine is 10-13 hours; for l-amphetamine, 13-16 hours. Clinical context: Twice-daily dosing may be required for sustained effect. |
| Protein binding | d-Amphetamine: ~20% bound to albumin and alpha1-acid glycoprotein; l-amphetamine: ~15% bound. |
| Volume of Distribution | Vd: 3-4 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Oral: Approximately 100% (extended-release formulation provides prolonged absorption). |
| Onset of Action | Oral: Approximately 30-60 minutes; peak effect at 3 hours. |
| Duration of Action | Duration of effect is up to 12 hours with once-daily dosing; clinical effect lasts approximately 8-12 hours. |
| Molecular Weight | 135.21 |
20 mg orally once daily in the morning; may increase by 10 mg weekly based on response; maximum 60 mg/day.
| Dosage form | TABLET, EXTENDED RELEASE |
| Renal impairment | GFR 30-89 mL/min: no adjustment; GFR <30 mL/min: not recommended; hemodialysis: not recommended. |
| Liver impairment | Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50%; Child-Pugh Class C: not recommended. |
| Pediatric use | Children 6-12 years: initial 10 mg orally once daily; may increase by 5-10 mg weekly; maximum 30 mg/day. Children ≥13 years: same as adult dosing. |
| Geriatric use | Start at 10 mg orally once daily; titrate cautiously; monitor for cardiovascular effects and tolerance. |
| 1st trimester | Amphetamines are considered teratogenic; increased risk of congenital malformations, especially cardiovascular and oral clefts. Use only if potential benefit justifies risk. |
| 2nd trimester | May cause fetal growth restriction and premature birth. Monitor fetal growth closely. Use only if clearly needed. |
| 3rd trimester | Use near term is associated with increased risk of neonatal withdrawal symptoms (e.g., irritability, feeding difficulties) and preterm delivery. Avoid if possible. |
Clinical note
Comprehensive clinical and safety monograph for DYANAVEL XR 5 (DYANAVEL XR 5).
| Placental transfer | Amphetamines readily cross the placenta; fetal plasma levels can approach maternal levels. In utero exposure associated with adverse outcomes. |
| Breastfeeding | Amphetamines are excreted into breast milk with infant exposure estimated at 2-8% of maternal dose. Adverse effects such as insomnia, agitation, and poor feeding have been reported. Avoid breastfeeding or discontinue drug; consider alternative treatments. |
■ FDA Black Box Warning
WARNING: ABUSE AND DEPENDENCE. CNS stimulants (including DYANAVEL XR) have a high potential for abuse and dependence, which can lead to tolerance and severe psychological dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
| Serious Effects |
Hypersensitivity to amphetamines or other componentsConcurrent use of MAOIs or within 14 days of discontinuationGlaucomaHyperthyroidismAgitated statesHistory of drug abuseSymptomatic cardiovascular disease including moderate to severe hypertension, advanced arteriosclerosis, and tachyarrhythmias
| Precautions | Serious cardiovascular events: sudden death, stroke, myocardial infarction in patients with structural cardiac abnormalities or other serious heart problems., Blood pressure and heart rate increases: monitor frequently., Psychiatric adverse events: exacerbation of pre-existing psychosis, mania, or aggressive behavior; new onset of psychotic or manic symptoms., Seizures: may lower seizure threshold in patients with prior history or EEG abnormalities., Prolonged erections (priapism): medical intervention required., Peripheral vasculopathy: including Raynaud's phenomenon., Long-term suppression of growth in children: monitor height and weight. |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) - Limited data; potential for adverse effects in nursing infants. |
| Teratogenic Risk | First trimester: Limited human data; animal studies show teratogenic effects at high doses. Second/third trimester: Increased risk of preterm birth, low birth weight, and withdrawal symptoms. Chronic use may cause neonatal adaptation syndrome (irritability, poor feeding). |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, weight gain, and signs of toxicity. Fetal monitoring for intrauterine growth restriction and preterm labor. Neonatal monitoring for withdrawal symptoms. |
| Fertility Effects | Amphetamines may impair female fertility by disrupting ovulation and menstrual cycles. Limited data on male fertility; no definite effects reported. |
| Food/Dietary | Avoid high-fat meals before administration as they may delay absorption. No specific food interactions are documented; however, acidic foods (e.g., citrus juices) may alter amphetamine excretion. Grapefruit has no known interaction. Maintain a balanced diet to mitigate appetite suppression. |
| Clinical Pearls | DYANAVEL XR 5 is an extended-release amphetamine suspension indicated for attention deficit hyperactivity disorder. The capsule can be swallowed whole or opened and sprinkled onto applesauce. Administer in the morning to avoid insomnia. Monitor for growth suppression in children and for cardiovascular events in patients with known structural cardiac abnormalities. The prodrug formulation (lisdexamfetamine) is not interchangeable; DYANAVEL XR contains mixed amphetamine salts. |
| Patient Advice | Take this medication exactly as prescribed, typically once daily in the morning to prevent sleep problems. · Swallow the capsule whole or sprinkle the contents onto a tablespoon of applesauce and consume immediately without chewing. · Avoid alcohol while taking this medication as it may increase the risk of cardiovascular adverse effects. · Notify your doctor if you experience chest pain, shortness of breath, dizziness, or palpitations. · Store at room temperature away from moisture and heat. Keep out of reach of children. |