Manufacturer: Eli Lilly and Company, Indianapolis, IN Indication: Attention-deficit hyperactivity disorder (ADHD)
Drug Class: Atomoxetine is classified as a selective norepinephrine reuptake inhibitor.
Uniqueness of Drug: The precise mechanism by which atomoxetine produces its therapeutic effects in ADHD is unknown, but it is thought to be related to selective inhibition of the presynaptic norepinephrine transporter. Atomoxetine is the first nonstimulant medication approved for the treatment of ADHD in children, adolescents, and adults. It is the only FDA-approved ADHD medication that has proved clinically effective for adults. It is not considered a controlled substance.
Warnings: Although uncommon, allergic reactions—such as angioneurotic edema, urticaria, and rash—have been reported in patients receiving atomoxetine. canadian cialis
The weight and growth of the patient should be monitored during treatment. During acute-treatment studies, patients taking atomoxetine lost an average of 0.4 kg of body weight, whereas placebo-treated patients gained an average of 1.5 kg; in addition, patients receiving atomoxetine grew only an average of 0.9 cm, whereas patients receiving placebo grew an average of 1.1 cm. Patients who require long-term therapy should be monitored; if patients are not growing or gaining weight satisfactorily, interruption of therapy might be necessary.
Atomoxetine should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovas-cular disease because it can bring about an increase in blood pressure and heart rate. The pulse and the blood pressure should be taken as a baseline measurement, after any increase in dosage, and periodically during therapy.
Dosage: Atomoxetine capsules are supplied in the following strengths: 5, 10, 18, 25, 40, and 60 mg. Doses vary according to certain circumstances.
Children and Adolescents Weighing up to 70 kg. Ato moxetine should be initiated at a total daily dose of approximately 0.5 mg/kg of body weight and increased after a minimum of three days to a target total daily dose of approximately 1.2 mg/kg. The drug should be administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon or early evening.
No additional benefit has been demonstrated when doses higher than 1.2 mg/kg per day were given. The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less.
Children and Adolescents Weighing More Than 70 kg and Adults. Atomoxetine should be initiated at a total daily dose of 40 mg; after a minimum of three days, the dose should be increased to a target total daily dose of approximately 80 mg. The drug should be administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon or early evening. After two to four additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response.
No data have supported increased effectiveness at higher doses. The maximum recommended total daily dose for adults and for children and adolescents weighing more than 70 kg is 100 mg.
Maintenance and Extended Treatment. No evidence is available from controlled trials to indicate how long the patient with ADHD should be treated with atomoxetine. Most investigators generally agree, however, that pharmacological treatment of ADHD might be needed for prolonged periods. Nevertheless, the physician who elects to prescribe atomoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for each patient.
Adjustments for Patients with Hepatic Impairment. For patients with ADHD who have hepatic insufficiency, dosage adjustments are recommended. For patients with moderate hepatic insufficiency (Child-Pugh Class B), the initial and target doses should be reduced to 50% of the normal dose (e.g., as for patients without hepatic insufficiency). For patients with severe hepatic insufficiency (Child-Pugh Class C), the initial and target doses should be reduced to 25% of the normal dose.
Adjustments for Use with a Strong CYP2D6 Inhibitor.
- Children and adolescents weighing up to 70 kg. Administration of strong CYP2D6 inhibitors (e.g., paroxetine tablet, fluoxetine, quinidine, atomoxetine) should be initiated at 0.5 mg/kg per day. The dose should be increased to the usual target dose of 1.2 mg/kg per day only if symptoms do not improve after four weeks and if the initial dose is well tolerated.
- Adults and children and adolescents weighing more than 70 kg. Strong CYP2D6 inhibitors should be initiated at 40 mg/day. The dose should be increased to the usual target dose of 80 mg/day only if symptoms do not improve after four weeks and if the initial dose is well tolerated.
P&T Committee Considerations: Atomoxetine is the first new drug in three decades that is intended for the treatment of ADHD symptoms, which include inattention, hyperactivity, and impulsiveness. Atomoxetine’s mechanism of action differs from that of the stimulant-like drugs that have been used to treat ADHD in the past. Because atomoxetine generic does not appear to have a potential for abuse, it is not classified as a controlled substance; however, a prescription is required.
According to the American Psychiatric Association, ADHD affects approximately 3% to 7% of children and approximately 4% of adults. People with ADHD may make careless mistakes, fidget, interrupt others, talk excessively, and have problems paying attention. Although the disorder is not as well defined in adults, symptoms can include a lack of organization, daydreaming, irritability, and lack of motivation.
The drug’s safety and effectiveness have been established in six double-blind, placebo-controlled studies in patients with ADHD. Atomoxetine should be included in the formulary, and perhaps it can be carefully used to replace the controlled-substance drugs.
The AWP of atomoxetine is the same for all capsule strengths: $90.00 for 30 capsules per bottle.