Dyanavel Xr

— THERAPEUTIC CATEGORIES —
  • ADHD

Dyanavel Xr Generic Name & Formulations

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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