|Updated Warnings/Precautions on serious cardiovascular events.|
Attention deficit hyperactivity disorder (ADHD).
Swallow whole. Give once daily in the AM, or in 2 evenly divided doses (in AM and late afternoon/early PM). <6yrs: not recommended. Acute: ≥6yrs (≤70kg): initially 0.5mg/kg per day; increase after at least 3 days to 1.2mg/kg per day; max 1.4mg/kg or 100mg per day (whichever is less); (>70kg): initially 40mg/day; increase after at least 3 days to 80mg/day, then after 2–4 weeks may increase to max 100mg/day. Maintenance: 6–15yrs: continue with same dose, reevaluate periodically; see full labeling. Concomitant potent CYP2D6 inhibitors: titrate above initial dose at 4-week intervals only if needed. Hepatic insufficiency (moderate): reduce dose by 50%; (severe): reduce dose by 75%. May discontinue without tapering.
SNRI (selective norepinephrine reuptake inhibitor).
During or within 14 days of MAOIs. Narrow angle glaucoma. Pheochromocytoma or history of. Severe cardiovascular disorders that might deteriorate with clinically important increases in HR and BP.
Increased risk of suicidal ideation in children and adolescents. Monitor closely for clinically worsening, suicidality and unusual changes in behavior, esp. during initial therapy and dose adjustments. Severe liver injury (discontinue if jaundice or elevated liver enzymes occur; do not restart). Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Assess cardiovascular status and do physical exam. Hypertension. Tachycardia. Cardio- or cerebrovascular disease. Psychoses. Bipolar disorder. Depression. Monitor growth, BP/pulse (esp. at baseline and after dose increases), worsening of aggressive behavior or hostility. Poor metabolizers (CYP2D6). Reevaluate periodically. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.
MAOIs: see Contraindications. May be potentiated by potent CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Increased cardiovascular effects with albuterol, pressor agents (eg, dobutamine, dopamine).
Nausea, vomiting, fatigue, decreased appetite, abdominal pain, somnolence, weight loss, dizziness, headache, mood swings, tachycardia, hypertension, orthostatic hypotension, mydriasis; rare: severe liver injury, priapism, anaphylaxis. Adults also: constipation, dry mouth, insomnia, sexual dysfunction, urinary retention/hesitation, dysuria, dysmenorrhea, hot flush.
Renal (major), fecal (minor).