fects on Urine Outflow from the Bladder
5.10 Priapism
5.11 Effects on Growth
5.12 Laboratory Tests
5.13 Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients who are known to be CYP2D6 PMs
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Spontaneous Reports
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase Inhibitors
7.2 Effect of CYP2D6 Inhibitors on Atomoxetine
7.3 Antihypertensive Drugs and Pressor Agents
7.4 Albuterol
7.5 Effect of Atomoxetine on P450 Enzymes
7.6 Alcohol
7.7 Methylphenidate
7.8 Drugs Highly Bound to Plasma Protein
7.9 Drugs that Affect Gastric pH
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Insufficiency
8.7 Renal Insufficiency
8.8 Gender
8.9 Ethnic Origin
8.10 Patients with Concomitant Illness
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
10.1 Human Experience
10.2 Management of Overdose
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 ADHD studies in Children and Adolescents
14.2 ADHD studies in Adults
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
17.1 General Information
17.2 Suicide Risk
17.3 Severe Liver Injury
17.4 Aggression or Hostility
17.5 Priapism
17.6 Ocular Irritant
17.7 Drug-Drug Interaction
17.8 Pregnancy
17.9 Food
17.10 Missed Dose
17.11 Interference with Psychomotor Performance
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)
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)].
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 eva luation 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
