País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
Atomoxetine hydrochloride (UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)
Carilion Materials Management
ORAL
PRESCRIPTION DRUG
STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) . [see Clinical Studies ( )] 14 A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. The specific etiology of
NDC:68151-4485-3 in a PACKAGE of 1 CAPSULES Atomoxetine base equivalent. a Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
New Drug Application
STRATTERA- ATOMOXETINE HYDROCHLORIDE CAPSULE Carilion Materials Management ---------- MEDICATION GUIDE STRATTERA ®(Stra-TAIR-a) (atomoxetine) Capsules Read the Medication Guide that comes with STRATTERA before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child's treatment with STRATTERA. ® What is the most important information I should know about STRATTERA? The following have been reported with use of STRATTERA: 1. Suicidal thoughts and actions in children and teenagers: Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager's doctor if your child or teenager (or there is a family history of): Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from STRATTERA clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. • has bipolar illness (manic-depressive illness) • had suicide thoughts or actions before starting STRATTERA The chance for suicidal thoughts and actions may be higher: • early during STRATTERA treatment • during dose adjustments Prevent suicidal thoughts and action in your child or teenager by: • paying close attention to your child or teenager's moods, behaviors, thoughts, and feelings during STRATTERA treatment • keeping all follow-up visits with your child or teenager's doctor as scheduled Watch for the following signs in your child or teenager during STRATTERA treatment: • anxiety • agitation • panic attacks • trouble sleeping • irritability • hostility • aggressiveness • impulsivity • restlessness • mania • depression • suicide thoughts Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine. Call your child Leer el documento completo
STRATTERA- ATOMOXETINE HYDROCHLORIDE CAPSULE CARILION MATERIALS MANAGEMENT ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE STRATTERA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STRATTERA. STRATTERA (ATOMOXETINE) CAPSULES FOR ORAL USE INITIAL U.S. APPROVAL: 2002 WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL IDEATION IN CHILDREN OR ADOLESCENTS( ) 5.1 NO SUICIDES OCCURRED IN CLINICAL TRIALS( ) 5.1 PATIENTS STARTED ON THERAPY SHOULD BE MONITORED CLOSELY( ) 5.1 RECENT MAJOR CHANGES CO NTRAINDIC ATIO NS: Severe Cardiovascular Disorders ( ) 4.5 08/2013 WARNINGS AND PRECAUTIONS: Effects on Blood Pressure and Heart Rate ( ) 5.4 08/2013 Aggressive Behavior or Hostility ( ) 5.7 08/2013 INDICATIONS AND USAGE STRATTERA is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( ) 1.1 DOSAGE AND ADMINISTRATION Initial, Target and Maximum Daily Dose ( ) 2.1 (Acute and Maintenance/Extended Treatment) BODY WEIGHT INITIAL DAILY DOSE TARGET TOTAL DAILY DOSE MAXIMUM TOTAL DAILY DOSE Children and adolescents up to 70 kg 0.5 mg/kg 1.2 mg/kg 1.4 mg/kg Children and adolescents over 70 kg and adults 40 mg 80 mg 100 mg Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). ( , ) 2.412.3 DOSAGE FORMS AND STRENGTHS Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. ( , , ) 31116 CONTRAINDICATIONS Hypersensitivity to atomoxetine or other constituents of product. ( ) 4.1 STRATTERA use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. ( , ) 4.27.1 Narrow Angle Glaucoma. ( ) 4.3 Pheochromocytoma or history of pheochromocytoma. ( ) 4.4 Severe Cardiovascular Disorders that might deteriorate with clinically important increases in Leer el documento completo