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Dyanavel Xr Generic Name & Formulations
Legal Class
CII
General Description
Amphetamine 2.5mg/mL; ext-rel oral susp; bubblegum flavor.
Pharmacological Class
CNS stimulant.
How Supplied
Oral susp—464mL
Manufacturer
Generic Availability
NO
Dyanavel Xr Indications
Indications
Attention deficit hyperactivity disorder.
Dyanavel Xr Dosage and Administration
Adults and Children
Do not substitute for other amphetamine products on a mg-per-mg basis. <6yrs: not established. Individualize. Take in the morning. ≥6yrs: initially 2.5mg or 5mg once daily; may increase by 2.5mg–10mg/day every 4–7 days; max 20mg/day.
Dyanavel Xr Contraindications
Contraindications
During or within 14 days of MAOIs.
Dyanavel Xr Boxed Warnings
Boxed Warning
Abuse and dependence.
Dyanavel Xr Warnings/Precautions
Warnings/Precautions
Abuse potential (monitor). Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode prior to initiating. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for serotonin syndrome; discontinue if occurs. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.
Dyanavel Xr Pharmacokinetics
See Literature
Dyanavel Xr Interactions
Interactions
See Contraindications. Hypertensive crisis with MAOIs (including linezolid, IV methylene blue). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, busprione, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by urinary alkalinizers (eg, sodium bicarbonate, acetazolamide); avoid. Antagonized by acidifiers (eg, ascorbic acid). May potentiate TCAs or sympathomimetics; adjust dose or use alternatives. May interfere with urinary steroid tests.
Dyanavel Xr Adverse Reactions
Adverse Reactions
Dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, tachycardia; hypertension.
Dyanavel Xr Clinical Trials
See Literature
Dyanavel Xr Note
Not Applicable
Dyanavel Xr Patient Counseling
See Literature
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