ADZENYS XR-ODT CII

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ADZENYS XR-ODT

ADHD
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Generic Name and Formulations:

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

Select therapeutic use:

Indications for ADZENYS XR-ODT:

Attention deficit hyperactivity disorder.

Adults and Children:

Do not substitute for other amphetamine products on a mg-per-mg basis. <6yrs: not established. Individualize. Take in the morning. 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). ≥17yrs: 12.5mg once daily. Switching from other amphetamine products: see full labeling.

Contraindications:

During or within 14 days of MAOIs.

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. Labor & delivery. Pregnancy (Cat.C); monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

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.

Pharmacological Class:

CNS stimulant.

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.

Generic Availability:

NO

How Supplied:

Cartons—30 (5 blister cards x 6 tabs)

ADZENYS XR-ODT 6.3mg orally disintegrating tabs (Qty:30)

appx. price $309.00