Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)
STAT RX USA LLC
ATOMOXETINE HYDROCHLORIDE
ATOMOXETINE HYDROCHLORIDE 10 mg
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 ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis re
STRATTERA® Capsules 10 mg* 18 mg* 25 mg* 40 mg* 60 mg* 80 mg* 100 mg* Color Opaque White, Opaque White Gold, Opaque White Opaque Blue, Opaque White Opaque Blue, Opaque Blue Opaque Blue, Gold Opaque Brown, Opaque White Opaque Brown, Opaque Brown Identification LILLY 3227 LILLY 3238 LILLY 3228 LILLY 3229 LILLY 3239 LILLY 3250 LILLY 3251 10 mg 18 mg 25 mg 40 mg 60 mg 80 mg 100 mg NDC Codes: Bottles of 30 0002-3227-30 0002-3238-30 0002-3228-30 0002-3229-30 0002-3239-30 0002-3250-30 0002-3251-30 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 - ATOMXETINE HYROCHLORIDE CAPSULE STAT RX USA LLC ---------- MEDICATION GUIDE STRATTERA® (Stra-TAIR-a) (atomoxetine hydrochloride) 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: 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. 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): • 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 Call your child or teenager’s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. You Přečtěte si celý dokument
STRATTERA - ATOMXETINE HYROCHLORIDE CAPSULE STAT RX USA LLC ---------- 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 HYDROCHLORIDE) CAPSULE 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 Warning and Precautions, Severe Liver Injury (5.2) 06/2009 Warnings and Precautions, Effects on Blood Pressure and Heart Rate (5.4) 09/2008 Boxed Warning 07/2008 Warnings and Precautions, Suicidal Ideation (5.1), Effects on Blood Pressure and Heart Rate (5.4), Effects on Urine Outflow from the Bladder (5.9) 07/2008 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) BODY WEIGHT INITIAL DAILY DO SE TARGET TOTAL DAILY DO SE MAXIMUM TOTAL DAILY DO SE 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). (2.4, 12.3) DOSAGE FORMS AND STRENGTHS Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. (3, 11, 16) 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. (4.2, 7.1) Narrow Angle Glaucoma. (4.3) WARNINGS AND PRECAUTIONS Suicidal Ideation - Monitor for suicidality, clinical worsening, Přečtěte si celý dokument