Atomoxetine

STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. STRATTERA ® is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older.

The precise mechanism by which STRATTERA produces its therapeutic effects in ADHD is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

Prior to initiating treatment with STRATTERA, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. See table below for the recommended STRATTERA dosage. 1 Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening. Age and Body Weight Starting Dosage Target Dosage 1 Maximum Total Daily Dose 1 Pediatrics who weigh less than 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4 mg/kg/day or 100 mg/day (whichever is less) Pediatrics who weigh 70 kg or more and adults 40 mg/day 80 mg/day 100 mg/day For the recommended dosage in patients with hepatic impairment, see Full Prescribing Information. For the recommended dosage with concomitant use of a strong CYP2D6 inhibitor or in CYP2D6 poor metabolizers, see Full Prescribing Information.

STRATTERA is contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of STRATTERA. Hypersensitivity reactions included anaphylaxis, angioneurotic edema, urticaria, and rash. Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI). With narrow angle glaucoma. In clinical trials, STRATTERA use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received STRATTERA.

Boxed warning: All STRATTERA-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Severe Liver Injury: STRATTERA should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. Serious Cardiovascular Reactions: Prior to STRATTERA treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. STRATTERA generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias.

Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): Pediatric Clinical Studies: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. Adult Clinical Studies: Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. Patients should be instructed to use caution when driving a car or operating hazardous machinery (because of somnolence) until they are reasonably certain that their performance is not affected by STRATTERA.

See Table 8 for clinically significant drug interactions with STRATTERA and other drugs. Table 8: Clinically Significant Drug Interactions with STRATTERA and Other Drugs Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management STRATTERA is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue, or in patients who stopped an MAOI within 14 days. Mechanism and Clinical Effect(s) As with other drugs affecting brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability with fluctuations of vital signs, extreme agitation progressing to delirium/coma) with concomitant use of STRATTERA and an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome.

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).