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STRATTERA (ATOMOXETINE HCL): PATIENT COUNSELING INFORMATION

General Information

Physicians should instruct their patients to read the Medication Guide before starting therapy with Strattera (Atomoxetine) and to reread it each time the prescription is renewed.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Strattera (Atomoxetine) capsules and should counsel them in its appropriate use. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Strattera (Atomoxetine HCl).

Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of agitation, anxiety, panic attacks, irritability, insomnia, hostility, impulsivity, aggressiveness, akathisia (psychomotor restlessness), mania, hypomania, other unusual changes in behavior, depression, and suicidal ideation, especially early during Strattera (Atomoxetine HCl) capsules 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.

Severe Liver Injury

Patients initiating Strattera (Atomoxetine Hydrochloride) should be cautioned that severe liver injury may develop. Patients should be instructed to contact their doctor, pharmacist, or other healthcare professional immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms.

Aggression or Hostility

Patients should be instructed to call their doctor as soon as possible should they notice an increase in aggression or hostility.

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 (Atomoxetine Hydrochloride) capsules. The parents or guardians of pediatric patients taking this medication and adult patients taking Atomoxetine (Strattera) should be instructed that priapism requires prompt medical attention.

Ocular Irritant

Atomoxetine (Strattera) capsules is an ocular irritant. This medication is 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.

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.

Pregnancy

Patients should be instructed to consult a doctor or pharmacist if they are nursing, pregnant, or thinking of becoming pregnant while taking Atomoxetine HCl (Strattera).

Food

Patients may take Atomoxetine HCl (Strattera) capsules with or without food.

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 Atomoxetine Hydrochloride (Strattera) in any 24-hour period.

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 Hydrochloride (Strattera) capsules.

Manufactured and distributed by Eli Lilly pharmaceutical company and its divisions.

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