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atomoxetine 100 MG Oral Capsule

1 INDICATIONS AND USAGE Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine 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) ]. 1.2 Diagnostic Considerations 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 requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can’t wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met. 1.3 Need for Comprehensive Treatment Program 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 this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.

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11 months ago CAPSULE BROWN Rdy 564 atomoxetine 100 MG Oral Capsule

CAPSULE BROWN Rdy 564

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

ATOMOXETINE capsules USP, 10 mg* are white to off-white powder filled in size ‘4’ hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted “RDY” on cap and “519” on body with black ink. They are supplied in bottles of 30’s, 500’s and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-519-30 Bottles of 500 NDC 55111-519-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-519-78

ATOMOXETINE capsules USP, 18 mg* are white to off-white powder filled in size ‘3’ hard gelatin capsules with opaque dark gold colored cap and opaque white colored body imprinted “RDY” on cap and “520” on body with black ink. They are supplied in bottles of 30’s, 500’s and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-520-30 Bottles of 500 NDC 55111-520-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-520-78

ATOMOXETINE capsules USP, 25 mg* are white to off-white powder filled in size ‘3’ hard gelatin capsules with opaque dark blue colored cap and opaque white colored body imprinted “RDY” on cap and “528” on body with black ink. They are supplied in bottles of 30’s, 500’s and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-528-30 Bottles of 500 NDC 55111-528-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-528-78

ATOMOXETINE capsules USP, 40 mg* are white to off-white powder filled in size ‘1’ hard gelatin capsules with opaque dark blue colored cap and opaque dark blue colored body imprinted “RDY” on cap and “521” on body with black ink. They are supplied in bottles of 30’s, 500’s and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-521-30 Bottles of 500 NDC 55111-521-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-521-78

ATOMOXETINE capsules USP, 60 mg* are white to off-white powder filled in size ‘1’ hard gelatin capsules with opaque dark blue colored cap and opaque dark gold colored body imprinted “RDY” on cap and “522” on body with black ink. They are supplied in bottles of 30’s, 500’s and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-522-30 Bottles of 500 NDC 55111-522-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-522-78

ATOMOXETINE capsules USP, 80 mg* are white to off-white powder filled in size ‘1’ hard gelatin capsules with opaque dark brown colored cap and opaque white colored body imprinted “RDY” on cap and “563” on body with black ink. They are supplied in bottles of 30’s, 500’s and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-563-30 Bottles of 500 NDC 55111-563-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-563-78

ATOMOXETINE capsules USP, 100 mg* are white to off-white powder filled in size ‘0’ hard gelatin capsules with opaque dark brown colored cap and opaque dark brown colored body imprinted “RDY” on cap and “564” on body with black ink. They are supplied in bottles of 30’s, 500’s and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-564-30 Bottles of 500 NDC 55111-564-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-564-78 *

ATOMOXETINE base equivalent. 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature].

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