Atomoxetine Hydrochloride (3 brand names, 2 dosage forms, 1 route)
Available dosage forms: CAPSULE, SOLUTION.
Routes of administration: ORAL.
Brand Names
- ATOMOXETINE HYDROCHLORIDE
- ATONCY
- STRATTERA
Boxed Warning
All pediatric patients 6 years of age or older treated with atomoxetine oral solution should be monitored and observed closely for suicidal thoughts and behaviors, 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. Consider stopping atomoxetine oral solution in patients who experience emergent suicidal thoughts and behavior [see Warnings and Precautions (5.1)] . Atomoxetine increased the risk of suicidal ideation in pediatric patients 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies [see Warnings and Precautions (5.1)] .
Indications and Usage
Atomoxetine oral solution is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adult and pediatric patients 6 years of age and older. Atomoxetine oral solution 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.
Contraindications
Atomoxetine oral solution is contraindicated in patients: With known hypersensitivity reaction to atomoxetine oral solution or other components of atomoxetine oral solution. Hypersensitivity reactions that occurred with atomoxetine oral solution use included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions (5.8)] . Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions (7)] . With narrow angle glaucoma. In clinical trials, atomoxetine oral solution 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 atomoxetine oral solution. With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had clinically important increase in blood pressure or heart rate (e.g., 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions (5.4)] .
Drug Interactions
See Table 9 for clinically significant drug interactions with atomoxetine oral solution and other drugs. Table 9: Clinically Significant Drug Interactions with Atomoxetine Oral Solution and Other Drugs Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management Atomoxetine oral solution 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 atomoxetine oral solution and an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Strong CYP2D6 Inhibitors Prevention or Management With concomitant use of atomoxetine oral solution and a strong CYP2D6 inhibitor 1, increase the titration interval [see Dosage and Administration (2.5)and Clinical Pharmacology (12.3)] . Mechanism and Clinical Effect(s) Atomoxetine is a CYP2D6 substrate. Concomitant use of atomoxetine oral solution and a strong CYP2D6 inhibitor increases atomoxetine exposure [see Dosage and Administration (2.5)and Clinical Pharmacology (12.3)] . Antihypertensive Drugs Prevention or Management Increase the frequency of monitoring blood pressure and adjust atomoxetine oral solution dosage as clinically appropriate. Mechanism and Clinical Effect(s) Because of increased risk of increased blood pressure, atomoxetine oral solution should be used cautiously with antihypertensive drugs, other drugs that increase blood pressure or pressor drugs (e.g., dopamine, dobutamine). Albuterol or Other Beta 2 (β2) Agonists Prevention or Management Increase the frequency of monitoring blood pressure and heart rate and adjust atomoxetine oral solution dosage as clinically app
Overdosage
During postmarketing use, there have been fatalities reported involving a mixed ingestion overdose of atomoxetine and at least one other drug. There have been no reports of death involving overdose of atomoxetine alone, including intentional overdoses at amounts up to 1,400 mg (14 times the maximum recommended dosage). The most commonly reported symptoms with acute and chronic overdoses of atomoxetine were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate. In some cases of overdose involving atomoxetine, seizures have been reported. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology (12.2)] . If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose of atomoxetine oral solution.