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Medication Guides - U S Food and Drug Renal impairment: Dosage adjustment not necessary Mild hepatic impairment (Child-Pugh class A): Dosage adjustment not necessary Moderate hepatic impairment (Child-Pugh class B): Decrease initial and target dosage by 50% Severe hepatic impairment (Child-Pugh class C): Decrease initial and target dosage by 75% 6 years and ≤70 kg: 0.5 mg/kg PO once daily; increased after ≥3 days to target dosage of ~1.2 mg/kg PO once daily or divided q12hr; total daily dose not to exceed 1.4 mg/kg or 100 mg, whichever is less; no benefit observed with hher doses6 years and ≤70 kg: 0.5 mg/kg PO once daily; increased after ≥3 days to target dosage of ~1.2 mg/kg PO once daily or divided q12hr; total daily dose not to exceed 1.4 mg/kg or 100 mg, whichever is less; no benefit observed with hher doses');" class="calc_link" Nausea (10%) Increases in blood pressure (BP; ≥15-20 mm Hg) and heart rate (HR; ≥20 beats/min) (5-10%) Erectile dysfunction (9%) Hot flashes (8%) Dizziness (5-8%) Urinary hesitation or retention (7%) Decreased weht (4-7%) Depression (4-7%) Irritability ( Paresthesia Cardiovascular: QT prolongation, syncope Peripheral vascular: Raynaud phenomenon General: Lethargy Neurologic: Hypesthesia, paresthesia in children and adolescents, sensory disturbances, tics Psychiatric: Depression and depressed mood, anxiety Seizures: Cases include patients with preexisting seizure disorders and those with identified risk factors for seizures, as well as patients with neither history of nor identified risk factors for seizures; exact relation between atomoxetine and seizures is difficult to evaluate because of uncertainty about background risk of seizures in patients with attention-deficit/hyperactivity disorder (ADHD) Skin: Hyperhidrosis Urogenital: Male pelvic pain, urinary hesitation or retention in children and adolescents Musculoskeletal: Rhabdomyolysis Atomoxetine use has been associated with increased risk of suicidal ideation in short-term studies in children or adolescents with ADHD; this risk must be balanced against clinical need in patients with ADHD Monitor patients closely for suicidal thinking and behavior, clinical worsening, or unusual behavioral changes; families and caregivers should be advised of need for close observation and communication with prescribing healthcare provider Average risk of suicidal ideation in patients receiving atomoxetine has been shown to be ~0.4% (5/1357 patients) Hypersensitivity Narrow-angle glaucoma Administration concomitantly with or within 14 days of monoamine oxidase inhibitor (MAOI) therapy; risk of potentially fatal reaction, including hyperthermia, myoclonus, altered mental status, and neuroleptic malnant syndrome (NMS)-like symptoms Pheochromocytoma: Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with current or previous pheochromocytoma Severe cardiovascular disorders where condition would deteriorate because BP increases by 15-20 mm Hg or HR increases by 20 beats/min; risk is greater in poor CYP2D6 metabolizers If drug is given concomitantly with CYP2D6 inhibitor, wait 4 weeks after initiation before adjusting dosage Liver injury reported within 120 days of initiation of atomoxetine; patients may present with elevated liver enzymes (2 × ULN), followed by recovery upon discontinuance of atomoxetine Orthostatic hypotension and syncope reported Risk of suicidal thoughts in children and adolescents Small risk of allergic reaction Use caution in hypertension, tachycardia (see Contraindications) Sudden deaths, stroke, and myocardial infarction reported in patients with structural cardiac abnormalities or other serious heart problems taking stimulants at usual doses; patients should have a careful history and physical exam to assess for presence of cardiovascular disease; consider not using atomoxetine in adults with cliniy snificant cardiac abnormalities Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weht as expected Urinary hesitancy or sexual dysfunction may occur Rare instances of priapism reported, sometimes necessitating surgical intervention; typiy not reported during initiation but often occurring subsequent to dosage increase; immediate medical attention should be sought for abnormally sustained or frequent and painful erections Drug can be discontinued without being tapered Hypesthesia, paresthesia in children and adolescents, sensory disturbances Rare reports of allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash Use with caution in patietns with bipolar disorder, history of hypertension, hepatic impairment, existing anxiety disorder, history of urinary retention, or tics related to Tourette disorder The above information is provided for general informational and educational purposes only. Medication Guides - U S Food and Drug
[email protected] and DailyMed also contain medication guides as part of drug labeling. Get email alerts when the Medication Guides page is updated. Medication.

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