Generic Name and Formulations:
Mixed salts of a single-entity amphetamine product (each cap contains equal parts dextroamphetamine saccharate, dextroamphetamine sulfate, amphetamine aspartate monohydrate, amphetamine sulfate); 12.5mg, 25mg, 37.5mg, 50mg; ext-rel caps.
Shire US, Inc.
Indications for MYDAYIS:
Attention deficit hyperactivity disorder.
Limitations Of use:
Higher plasma exposure and rates of adverse reactions (eg, insomnia, decreased appetite) in patients ≤12yrs than ≥13yrs at the same dose.
Swallow caps whole or may open and sprinkle contents onto applesauce, then consume immediately; do not chew beads. Individualize. Avoid late evening doses; give in the AM upon awakening. 13–17yrs: initially 12.5mg once daily; may increase by 12.5mg at weekly intervals; max 25mg/day.18–55yrs: initially 12.5mg or 25mg once daily; may increase by 12.5mg at weekly intervals; max 50mg/day. Severe renal impairment (GFR 15–<30mL/min/1.73m2): initially 12.5mg daily; max 25mg/day or 12.5mg/day (for 13–17yrs) if tolerated. ESRD (GFR <15mL/min/1.73m2): not recommended. Do not substitute for other amphetamine products on a mg-per-mg basis. Switching from other amphetamine products: see full labeling.
≤12yrs: not established.
During or within 14 days of MAOIs.
Abuse and dependence.
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. Seizure disorder; discontinue if occurs. Monitor for serotonin syndrome; discontinue and treat if occurs. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Reevaluate periodically. Renal impairment: see full labeling. Labor & delivery. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.
See Contraindications. Hypertensive crisis with MAOIs (eg, selegiline, isocarboxazid, phenelzine, tranylcypromine). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by alkalinizers (eg, sodium bicarbonate, PPIs, acetazolamide, some thiazides); caution. Antagonized by acidifiers (eg, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, methenamine salts); increase dose. May potentiate TCAs, sympathomimetics (eg, desipramine, protriptyline); adjust dose or use alternatives. Monitor effects when concomitant PPIs or cimetidine. May interfere with urinary steroid levels.
Insomnia, decreased appetite, decreased weight, irritability, nausea; also adults: dry mouth, increased heart rate, anxiety.
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