ADZENYS XR-ODT Dosage & Rx Info | Uses, Side Effects

Adzenys Xr-odt Generic Name & Formulations

Legal Class

CII

General Description

Amphetamine 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg, 18.8mg; ext-rel orally disintegrating tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Cartons—30 (5 blister cards x 6 tabs)

Manufacturer

Neos Therapeutics

Generic Availability

Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Adzenys Xr-odt Indications

Indications

Attention deficit hyperactivity disorder.

Adzenys Xr-odt 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. 6–17yrs: initially 6.3mg once daily; increase in increments of 3.1mg or 6.3mg at weekly intervals; max 18.8mg/day (6–12yrs) or max 12.5mg/day (13–17yrs). ≥18yrs: 12.5mg once daily. Switching from other amphetamine products: see full labeling.

Adzenys Xr-odt Contraindications

Contraindications

During or within 14 days of MAOIs.

Adzenys Xr-odt Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Adzenys Xr-odt 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 in developing 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. Labor & delivery. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

Adzenys Xr-odt Pharmacokinetics

Absorption

Mean peak plasma concentrations: 44.9 (±8.9) ng/mL occurred at a median time of 5.0 hours (dextroamphetamine); 14.5 (+3.0) ng/mL occurred at a median time of 5.25 hours (levoamphetamine).

Metabolism

Hepatic.

Elimination

Renal. Half-life (dextroamphetamine): 11 hours in adults; 9–10 hours in pediatrics aged 6–12 years; (levoamphetamine): 14 hours in adults; 10–11 hours in pediatrics aged 6–12 years.

Adzenys Xr-odt 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.

Adzenys Xr-odt Adverse Reactions

Adverse Reactions

Loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, fever; hypertension. Also adults: dry mouth, headache, weight loss, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, urinary tract infections.

Adzenys Xr-odt Clinical Trials

See Literature

Adzenys Xr-odt Note

Notes

To register pregnant patients in the National Pregnancy Registry for Psychostimulants, call (866) 961-2388.

Adzenys Xr-odt Patient Counseling