ADDERALL XR CII
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); 5mg, 10mg, 15mg, 20mg, 25mg, 30mg; ext-rel caps.
Shire US, Inc.
Indications for ADDERALL XR:
Attention deficit hyperactivity disorder.
Swallow whole or may sprinkle contents of caps on applesauce; do not chew beads. Avoid afternoon doses; give upon awakening. >17yrs: 20mg once daily in the AM. Severe renal impairment (GFR 15–<30mL/min/1.73m2): 15mg once daily in the AM. ESRD (GFR <15mL/min/1.73m2): not recommended. Switching from Adderall immediate-release: give total daily dose of immediate-release once daily in the AM.
Swallow whole or may sprinkle contents of caps on applesauce; do not chew beads. <6yrs: not studied. Avoid afternoon doses; give upon awakening. 6–12yrs: initially 10mg once daily in the AM, may increase by 5mg or 10mg per day at weekly intervals; max 30mg/day; with severe renal impairment: max 20mg/day. 13–17yrs: initially 10mg once daily in the AM; may increase to 20mg/day after 1 week. Severe renal impairment (GFR 15–<30mL/min/1.73m2): 5mg once daily in the AM. ESRD (GFR <15mL/min/1.73m2): not recommended. Switching from Adderall immediate-release: give total daily dose of immediate-release once daily in the AM.
Advanced arteriosclerosis. Symptomatic cardiovascular disease. Moderate-to-severe hypertension. Hyperthyroidism. Glaucoma. History of drug abuse. Agitation. During or within 14 days of MAOIs. Hypersensitivity to sympathomimetics.
Potential for abuse.
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 before initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for new or worsening aggressive behavior or hostility. Seizure disorder. Monitor for serotonin syndrome; discontinue if occurs. Evaluate for tics or Tourette's syndrome prior to therapy. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Renal impairment. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers: not recommended.
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, sympathomimetics, norepinephrine, meperidine; adjust dose or use alternatives. May antagonize adrenergic blockers, antihistamines, antihypertensives, phenobarbital, phenytoin, veratrum alkaloids, ethosuximide. Monitor effects with concomitant PPIs.
Anorexia, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, fever, weight loss; also Adults: dry mouth, headache, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, UTIs, prolonged erections; hypertension, visual disturbances.
Caps—100; Tabs—contact supplier.