Atomoxetinedosage

Prior to initiating treatment with atomoxetine capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. See table below for the recommended atomoxetine capsule dosage. 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 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. 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.

2.1 Recommendations

Prior to Initiating Atomoxetine Capsules Treatment Prior to initiating treatment with atomoxetine capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

2.2 Administration

Instructions Atomoxetine capsules may be taken with or without food. Take atomoxetine capsules whole; do not open the capsules.

2.3 Recommended

Dosage Table 1 includes the recommended atomoxetine capsules dosage in adult patients and pediatric patients 6 years of age and older for acute treatment of ADHD.

Table 1: Recommended Dosage of Atomoxetine Capsules for Acute Treatment of ADHD Age and Body Weight Starting Dosage Titration Interval Target Dosage Maximum Dosage Pediatric patients who weigh less than 70 kg 0.5 mg/kg/day Minimum of 3 days 1.2 mg/kg/day a,b 1.4 mg/kg/day or 100 mg/day, whichever is less a Pediatric patients who weigh 70 kg or more and adult patients 40 mg/day Minimum of 3 days 80 mg/day a 100 mg/day a,c a Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening. b No additional benefit has been demonstrated with atomoxetine capsules dosages higher than 1.2 mg/kg/day. c If a patient has not achieved an optimal response at 80 mg/day after 2 to 4 additional weeks, may increase the dosage to a maximum of 100 mg/day. There is no data that supports increased effectiveness at a dosage higher than 100 mg/day. The health care provider who elects to use atomoxetine capsules for extended periods should periodically reevaluate the long-term usefulness of atomoxetine capsules for the individual patient.

2.4 Recommended

Dosage in Patients with Hepatic Impairment For patients aged 6 years of age or older with: Severe hepatic impairment (HI) (Child-Pugh Class C), the recommended initial and target atomoxetine capsules dosage is 25% of recommended dosage in patients with normal hepatic function. Moderate HI (Child-Pugh Class B), the recommended initial and target atomoxetine capsules dosage is 50% of the recommended dosage in patients with normal hepatic function. Mild HI (Child-Pugh Class A), the recommended initial and target atomoxetine capsules dosage is the same as those with normal hepatic function.

2.5 Recommended

Dosage with Concomitant Use of Strong CYP2D6 Inhibitors or in CYP2D6 Poor Metabolizers Consider genetic testing to determine the patient’s CYP2D6 metabolizer status. In patients taking a concomitant strong CYP2D6 inhibitor or who are CYP2D6 poor metabolizers, a longer titration interval of 4 weeks is recommended, if ADHD symptoms fail to improve and the initial atomoxetine capsules dosage is well tolerated. The recommended starting, target, and maximum atomoxetine capsules dosages are the same as outlined in Table 1. For other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate), follow the recommended dosage, including the recommended titration interval (minimum of 3 days), as outlined in Table 1.

2.6 Switching to or from a

Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of atomoxetine capsules. In addition, at least 14 days must elapse after stopping atomoxetine capsules before starting an MAOI antidepressant.

2.7 Recommendations for a

Missed Dose If an atomoxetine capsule dose is missed, take the dose as soon as possible, but do not take more than the prescribed total daily amount of atomoxetine capsules in any 24-hour period.

2.8 Recommendations for

Discontinuation When discontinuing atomoxetine capsules, no taper is needed.