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atomoxetine 100 MG Oral Capsule

1 INDICATIONS AND USAGE Atomoxetine 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 is 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.

apotex corp.


2 years ago CAPSULE ORANGE APO AM100 atomoxetine 100 MG Oral Capsule

CAPSULE ORANGE APO AM100

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Atomoxetine capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap, imprinted “APO AM10” in black ink. They are supplied as follows: NDC Number Size 60505-2830-3 Bottles of 30 Atomoxetine capsules, USP 18 mg are available for oral administration as hard gelatin capsules with a white opaque body and a gold opaque cap, imprinted “APO AM18” in black ink. They are supplied as follows: NDC Number Size 60505-2831-3 Bottles of 30 Atomoxetine capsules, USP 25 mg are available for oral administration as hard gelatin capsules with a white opaque body and a blue opaque cap, imprinted “APO AM25” in black ink. They are supplied as follows: NDC Number Size 60505-2832-3 Bottles of 30 Atomoxetine capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a blue opaque body and a blue opaque cap, imprinted “APO AM40” in black ink. They are supplied as follows: NDC Number Size 60505-2833-3 Bottles of 30 Atomoxetine capsules, USP 60 mg are available for oral administration as hard gelatin capsules with a gold opaque body and a blue opaque cap, imprinted “APO AM60” in black ink. They are supplied as follows: NDC Number Size 60505-2834-3 Bottles of 30 Atomoxetine capsules, USP 80 mg are available for oral administration as hard gelatin capsules with a white opaque body and an orange opaque cap, imprinted “APO AM80” in black ink. They are supplied as follows: NDC Number Size 60505-2835-3 Bottles of 30 Atomoxetine capsules, USP 100 mg are available for oral administration as hard gelatin capsules with an orange opaque body and an orange opaque cap, imprinted “APO AM100” in black ink. They are supplied as follows: NDC Number Size 60505-2836-3 Bottles of 30 16.2 Storage and Handling Store atomoxetine capsules, USP at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

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