Dyanavel Xr Tablets

— THERAPEUTIC CATEGORIES —
  • ADHD

Dyanavel Xr Tablets Generic Name & Formulations

General Description

Amphetamine 5mg (functionally scored), 10mg, 15mg, 20mg; ext-rel tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Oral susp—464mL; Ext-rel tabs—30

Manufacturer

Generic Availability

NO

Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.

Dyanavel Xr Tablets Indications

Indications

Attention deficit hyperactivity disorder.

Dyanavel Xr Tablets 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 Tablets Contraindications

Contraindications

During or within 14 days of MAOIs.

Dyanavel Xr Tablets Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Dyanavel Xr Tablets 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 Tablets 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.

Metabolism

Hepatic.

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 Tablets 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 Tablets Adverse Reactions

Adverse Reactions

Dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, tachycardia; hypertension.

Dyanavel Xr Tablets Clinical Trials

See Literature

Dyanavel Xr Tablets Note

Not Applicable

Dyanavel Xr Tablets Patient Counseling

See Literature