Label: ATOMOXETINE- atomoxetine capsule

  • NDC Code(s): 31722-714-30, 31722-715-30, 31722-716-30, 31722-717-30, view more
  • Packager: Camber Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 20, 2021

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES. ATOMOXETINE Capsules for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS


    Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine is approved for ADHD in pediatric and adult patients. Atomoxetine is not approved for major depressive disorder.
    Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions ( 5.1)].


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  • 1 INDICATIONS AND USAGE
    1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).     The efficacy ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Acute Treatment - Dosing of children and adolescents up to 70 kg body weight - Atomoxetine capsules should be initiated at a total daily dose of approximately 0.5 mg/kg and increased ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Each capsule contains atomoxetine hydrochloride equivalent to 10 mg (white opaque/white opaque), 18 mg (yellow/white opaque), 25 mg (opaque blue/white opaque) , 40 mg (blue opaque/blue opaque) ...
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity - Atomoxetine capsules are contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product - [see Warnings and ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Suicidal Ideation - Atomoxetine increased the risk of suicidal ideation in short-term studies in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Pooled ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Atomoxetine was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical ...
  • 7 DRUG INTERACTIONS
    7.1 Monoamine Oxidase Inhibitors - With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy: Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including atomoxetine, during ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Atomoxetine is not a controlled substance. 9.2 Abuse - In a randomized, double-blind, placebo-controlled, abuse-potential study in adults comparing effects of ...
  • 10 OVERDOSAGE
    10.1 Human Experience - There is limited clinical trial experience with atomoxetine overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of ...
  • 11 DESCRIPTION
    Atomoxetine, USP is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochoride is the - R(-) isomer as determined by x-ray diffraction. The chemical designation is (-) ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis — Atomoxetine hydrochloride was not carcinogenic in rats and mice when given in the diet for 2 years at time-weighted ...
  • 14 CLINICAL STUDIES
    14.1 ADHD Studies in Children and Adolescents - Acute Studies — The effectiveness of atomoxetine in the treatment of ADHD was established in 4 randomized, double-blind, placebo-controlled ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Atomoxetine capsules USP, 10 mg are white opaque / white opaque size 5 hard gelatin capsules imprinted with ‘I’ on cap and ‘105’ on body, filled with white to off-white ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). General Information - Physicians should instruct their patients to read the Medication Guide ...
  • MEDICATION GUIDE
    Atomoxetine Capsules, USP - (a'' toe mox' e teen)   Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking it ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Atomoxetine Capsules, USP 10mg container label - Atomoxetine Capsules, USP 18mg container label - Atomoxetine Capsules, USP 25mg container label - Atomoxetine Capsules, USP 40mg container ...
  • INGREDIENTS AND APPEARANCE
    Product Information