ks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during STRATTERA treatment and when the dose is adjusted. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
17.3 Severe Liver Injury
Patients initiating STRATTERA should be cautioned that severe liver injury may develop. Patients should be instructed to contact their physician immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms [see Warnings and Precautions (5.2)].
17.4 Aggression or Hostility
Patients should be instructed to call their doctor as soon as possible should they notice an increase in aggression or hostility.
17.5 Priapism
Rare postmarketing cases of priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with STRATTERA. The parents or guardians of pediatric patients taking STRATTERA and adult patients taking STRATTERA should be instructed that priapism requires prompt medical attention.
17.6 Ocular Irritant
STRATTERA is an ocular irritant. STRATTERA capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.
17.7 Drug-Drug Interaction
Patients should be instructed to consult a physician if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies.
17.8 Pregnancy
Patients should be instructed to consult a physician if they are nursing, pregnant, or thinking of becoming pregnant while taking STRATTERA.
17.9 Food
Patients may take STRATTERA with or without food.
17.10 Missed Dose
If patients miss a dose, they should be instructed to take it as soon as possible, but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.
17.11 Interference with Psychomotor Performance
Patients should be instructed to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.
Literature revised May 12, 2017
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
www.strattera.com
Copyright © 2002, 2017, Eli Lilly and Company. All rights reserved.
STR-0003-USPI-20170512
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MEDICATION GUIDE
MEDICATION GUIDE
STRATTERA® (Stra-TAIR-a)
(atomoxetine) Capsules
Read the Medication Guide that comes with STRATTERA® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not t
