Dyanavel Xr Oral Suspension Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
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How Supplied
Oral susp—464mL; Ext-rel tabs—30
Manufacturer
Generic Availability
Mechanism of Action
Dyanavel Xr Oral Suspension Indications
Indications
Dyanavel Xr Oral Suspension 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 AM. Tabs: Swallow whole; may divide 5mg tabs into equal halves. ≥6yrs: initially 2.5mg or 5mg once daily; may increase by 2.5mg–10mg/day every 4–7 days; max 20mg/day.
Dyanavel Xr Oral Suspension Contraindications
Contraindications
Dyanavel Xr Oral Suspension Boxed Warnings
Boxed Warning
Abuse, misuse, and addiction.
Dyanavel Xr Oral Suspension Warnings/Precautions
Warnings/Precautions
High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for serotonin syndrome; discontinue if occurs. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. 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 Oral Suspension Pharmacokinetics
Absorption
Median time to peak plasma concentrations: 4–5 (2 to 7) hours for oral susp; 5 hours (2 to 9) for ext-rel tabs. Relative bioavailability: 106% (dextroamphetamine) and 111% (levoamphetamine) for oral susp; 105% (dextroamphetamine) and 106% (levoamphetamine) for ext-rel tabs.
Elimination
Renal. Half-life: 12.4 hours (d-amphetamine) and 15.1 hours (l-amphetamine) for oral susp; 13.5 hours (d-amphetamine) and 17.3 hours (l-amphetamine) for ext-rel tabs.
Dyanavel Xr Oral Suspension Interactions
Interactions
Dyanavel Xr Oral Suspension Adverse Reactions
Adverse Reactions
Dyanavel Xr Oral Suspension Clinical Trials
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Dyanavel Xr Oral Suspension Note
Not Applicable
Dyanavel Xr Oral Suspension Patient Counseling
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