Atomoxetine (Page 10 of 12)

16.2 Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

General Information

Physicians should instruct their patients to read the Medication Guide before starting therapy with atomoxetine hydrochloride 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 atomoxetine hydrochloride 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 atomoxetine hydrochloride.

Suicide Risk

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

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 atomoxetine hydrochloride. The parents or guardians of pediatric patients taking atomoxetine hydrochloride and adult patients taking atomoxetine hydrochloride should be instructed that priapism requires prompt medical attention.

Ocular Irritant

Atomoxetine hydrochloride is an ocular irritant. Atomoxetine 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.

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 Registry

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy [see Use in Specific Populations (8.1)].

Food

Patients may take atomoxetine 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 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.

Rx Only

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Revised: 0320

Medication Guide

ATOMOXETINE CAPSULES, USP

(A-toe-MOX-e-teen)

Read the Medication Guide that comes with atomoxetine capsules 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 take the place of talking to your doctor about your treatment or your child’s treatment with atomoxetine hydrochloride.

What is the most important information I should know about atomoxetine capsules?

The following have been reported with use of atomoxetine capsules:

1. Suicidal thoughts and actions in children and teenagers:

Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine hydrochloride clinical studies with over 2,200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1,000 patients developed suicidal thoughts. Tell your child or teenager’s doctor if your child or teenager (or there is a family history of):

  • has bipolar illness (manic-depressive illness)

  • had suicide thoughts or actions before starting atomoxetine capsules.

The chance for suicidal thoughts and actions may be higher:

  • early during atomoxetine hydrochloride treatment
  • during dose adjustments

Prevent suicidal thoughts and action in your child or teenager by:

  • paying close attention to your child or teenager’s moods, behaviors, thoughts, and feelings during atomoxetine hydrochloride treatment
  • keeping all follow-up visits with your child or teenager’s doctor as scheduled

Watch for the following signs in your child or teenager during atomoxetine capsules treatment:

  • anxiety
  • agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility
  • aggressiveness
  • impulsivity
  • restlessness
  • mania
  • depression
  • suicide thoughts

Call your child or teenager’s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

2. Severe liver damage:

Atomoxetine capsules can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:

  • itching
  • right upper belly pain
  • dark urine
  • yellow skin or eyes
  • unexplained flu-like symptoms

3. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting atomoxetine capsules.Your doctor should check your blood pressure or your child’s blood pressure and heart rate regularly during treatment with atomoxetine capsules.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine capsules.

4. New mental (psychiatric) problems in children and teenagers :

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

Call your child or teenager’s doctor right away about any new mental symptoms because adjusting or stopping atomoxetine hydrochloride treatment may need to be considered.

What is atomoxetine hydrochloride?

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine hydrochloride may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Atomoxetine capsules has not been studied in children less than 6 years old.

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