아토목세틴염산염

Atomoxetine capsules are a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 ) Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.

Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine or other constituents of atomoxetine capsules. Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow angle glaucoma With pheochromocytoma or history of pheochromocytoma With severe cardiac or vascular disorders whose condition would be expected to deteriorate with clinically important increases in blood pressure or heart rate Atomoxetine capsules are contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of atomoxetine capsules. Hypersensitivity reactions included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions ( 5.8 )]. Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions ( 7 )]. With narrow angle glaucoma. In clinical trials, atomoxetine capsules use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of …

Severe Liver Injury: Atomoxetine capsules should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) Serious Cardiovascular Reactions: Prior to atomoxetine capsules treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. Atomoxetine capsules generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias. Consideration should be given to not using atomoxetine capsules in adults with clinically significant cardiac abnormalities. Patients who develop symptoms suggestive of cardiac disease during atomoxetine capsules treatment should stop atomoxetine capsules and undergo a prompt cardiac evaluation. ( 5.3 ) Increase in Blood Pressure and Heart Rate: Heart rate and blood pressure should be measured at baseline, following atomoxetine dosage increase, and periodically while on therapy. ( 5.4 ) New Psychotic or Manic Symptoms and Activation of Mania: If psychotic or manic symptoms occur, consider discontinuing atomoxetine capsules. ( 5.5 ) Aggressive Behavior or Hostility: Monitor for the appearance or worsening of aggressive behavior or hostility. ( 5.7 ) Effects on Urine Outflow: Urinary retention or hesitancy may occur. ( 5.9 ) Priapism: Prompt medical attention is required in the event of suspected priapism. ( 5.10 ) Effect on Growth in Pediatric Patients: Closely monitor growth (e.g., weight, …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ Risk Summary Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Some animal reproduction studies of atomoxetine had adverse developmental outcomes. One of 3 studies in …