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atomoxetine 25 MG Oral Capsule

1 INDICATIONS AND USAGE Atomoxetine capsules are 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.

Glenmark Pharmaceuticals Inc., USA


4 years ago CAPSULE BLUE 267 25 atomoxetine 25 MG Oral Capsule

CAPSULE BLUE 267 25

4 years ago CAPSULE BLUE 267 25 atomoxetine 25 MG Oral Capsule

267 25 CAPSULE BLUE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied a

ATOMOXETINE base equivalent.

ATOMOXETINE capsules USP 10 mg a 18 mg a 25 mg a 40 mg a 60 mg a 80 mg a 100 mg a Color Opaque white, Opaque white Opaque yellow, Opaque white Opaque blue, Opaque white Opaque blue, Opaque blue Opaque blue, Opaque yellow Opaque Reddish brown, Opaque white Opaque Reddish brown, Opaque Reddish brown Identification 265/10 266/18 267/25 268/40 269/60 270/80 271/100 10 mg 18 mg 25 mg 40 mg 60 mg 80 mg 100 mg NDC Codes: Bottles of 30 with child-resistant closure 68462-265-30 68462-266-30 68462-267-30 68462-268-30 68462-269-30 68462-270-30 68462-271-30 Bottles of 1500 68462-271-51 Bottles of 2000 68462-265-23 68462-266-23 68462-267-23 68462-268-23 68462-269-23 68462-270-23 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep bottles tightly closed.


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