Atomoxetine (Page 8 of 9)

14.2 ADHD Studies in Adults

The effectiveness of atomoxetine in the treatment of ADHD was established in 2 randomized, double-blind, placebo-controlled clinical studies of adult patients, age 18 and older, who met DSM-IV criteria for ADHD.

Signs and symptoms of ADHD were evaluated using the investigator-administered Conners Adult ADHD Rating Scale Screening Version (CAARS), a 30-item scale. The primary effectiveness measure was the 18-item Total ADHD Symptom score (the sum of the inattentive and hyperactivity/impulsivity subscales from the CAARS) evaluated by a comparison of mean change from baseline to endpoint using an intent-to-treat analysis.

In 2 identical, 10-week, randomized, double-blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either atomoxetine or placebo. Atomoxetine was administered as a divided dose in the early morning and late afternoon/early evening and titrated according to clinical response in a range of 60 to 120 mg/day. The mean final dose of atomoxetine for both studies was approximately 95 mg/day. In both studies, ADHD symptoms were statistically significantly improved on atomoxetine, as measured on the ADHD Symptom score from the CAARS scale.

Examination of population subsets based on gender and age (<42 and ≥42) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Atomoxetine Capsules USP, 25 mg* are blue opaque/off-white opaque, size ‘4’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘F’ on blue opaque cap & ‘43’ on off-white opaque body with black ink.
Unit dose packages of 30 (3 x 10) NDC 60687-567-21

Atomoxetine Capsules USP, 40 mg* are blue opaque/blue opaque, size ‘2’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘F’ on blue opaque cap & ‘45’ on blue opaque body with black ink.
Unit dose packages of 30 (5 x 6) NDC 60687-326-25

* Atomoxetine base equivalent.

16.2 Storage and Handling

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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 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 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.

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

Ocular Irritant
Atomoxetine 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 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 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.

Dispense with Medication Guide
To order more Medication Guides call American Health Packaging at 1-800-707-4621.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Rising Pharmaceuticals, Inc. as follows:
(25 mg / 30 UD) NDC 60687-567-21 packaged from NDC 64980-375
(40 mg / 30 UD) NDC 60687-326-25 packaged from NDC 64980-376

Distributed by:
American Health Packaging
Columbus, OH 43217

8432625/0521F

MEDICATION GUIDE

8432625/0521F

Atomoxetine Capsules, USP
(a” toe mox’ e teen)

Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking them 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 capsules.

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 capsules clinical studies with over 2200 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 1000 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 capsules 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 capsules 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 capsules treatment may need to be considered.

What are atomoxetine capsules?
Atomoxetine capsules are selective norepinephrine reuptake inhibitor medicine. They are used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine capsules 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 have not been studied in children less than 6 years old.

Who should not take atomoxetine capsules?
Atomoxetine capsules should not be taken if you or your child:

  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil ® (phenelzine sulfate), Parnate ® (tranylcypromine sulfate) and Emsam ® (selegiline transdermal system).
  • have an eye problem called narrow angle glaucoma
  • are allergic to anything in atomoxetine capsules. See the end of this Medication Guide for a complete list of ingredients.
  • have or have had a rare tumor called pheochromocytoma.

Atomoxetine capsules may not be right for you or your child. Before starting atomoxetine capsules tell your doctor or your child’s doctor about all health conditions (or a family history of) including:

  • have or had suicide thoughts or actions
  • heart problems, heart defects, irregular heart beat, high blood pressure, or low blood pressure
  • mental problems, psychosis, mania, bipolar illness, or depression
  • liver problems
  • are pregnant or plan to become pregnant. It is not known if atomoxetine capsules will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • There is a pregnancy registry for females who are exposed to ADHD medications, including atomoxetine capsules, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to atomoxetine capsules and their baby. If you or your child becomes pregnant during treatment with atomoxetine capsules, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/.
  • are breastfeeding or plan to breastfeed. It is not known if atomoxetine passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take atomoxetine capsules.

Can atomoxetine capsules be taken with other medicines?
Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Atomoxetine capsules and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine capsules can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • asthma medicines
  • anti-depression medicines including MAOIs
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking atomoxetine capsules without talking to your doctor first.

How should atomoxetine capsules be taken?

  • Take atomoxetine capsules exactly as prescribed. Atomoxetine capsules come in different dose strength capsules. Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or open the capsules. Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow atomoxetine capsules whole. A different medicine may need to be prescribed.
  • Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine capsule. If any of the powder gets in your eyes or your child’s eyes, rinse them with water right away and call your doctor.
  • Atomoxetine capsules can be taken with or without food.
  • Atomoxetine capsules are usually taken once or twice a day. Take atomoxetine capsules at the same time each day to help you remember. If you miss a dose of atomoxetine capsules, take them as soon as you remember that day. If you miss a day of atomoxetine capsules, do not double your dose the next day. Just skip the day you missed.
  • From time to time, your doctor may stop atomoxetine capsules treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine capsules. Children should have their height and weight checked often while taking atomoxetine capsules. Atomoxetine capsules treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much atomoxetine or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of atomoxetine capsules?
See “What is the most important information I should know about atomoxetine capsules?” for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.

Other serious side effects include:

  • serious allergic reactions (call your doctor if you have trouble breathing, see swelling or hives, or experience other allergic reactions)
  • slowing of growth (height and weight) in children
  • problems passing urine including
    • trouble starting or keeping a urine stream
    • cannot fully empty the bladder

Common side effects in children and teenagers include:

  • upset stomach
  • decreased appetite
  • nausea or vomiting
  • dizziness
  • tiredness
  • mood swings

Common side effects in adults include:

  • constipation
  • dry mouth
  • nausea
  • decreased appetite
  • dizziness
  • sexual side effects
  • problems passing urine

Other information for children, teenagers, and adults:

  • Erections that won’t go away (priapism) have occurred rarely during treatment with atomoxetine capsules. If you have an erection that lasts more than 4 hours, seek medical help right away. Because of the potential for lasting damage, including the potential inability to have erections, priapism should be evaluated by a doctor immediately.
  • Atomoxetine capsules may affect your ability or your child’s ability to drive or operate heavy machinery. Be careful until you know how atomoxetine capsules affect you or your child.
  • Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store atomoxetine capsules?

  • Store atomoxetine capsules in a safe place at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
  • Keep atomoxetine capsules and all medicines out of the reach of children.

General information about atomoxetine capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine capsules for a condition for which it was not prescribed. Do not give atomoxetine capsules to other people, even if they have the same condition. They may harm them.

This Medication Guide summarizes the most important information about atomoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine capsules that was written for healthcare professionals. For more information about atomoxetine capsules call 1-866-562-4597 (toll-free). For more information about packaging or labeling call American Health Packaging at 1-800-707-4621.

What are the ingredients in atomoxetine capsules?
Active ingredient: atomoxetine hydrochloride.
Inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.

Nardil ® is a registered trademark of Pfizer Inc.
Parnate ® is a registered trademark of GlaxoSmithKline.
Emsam ® is a registered trademark of Somerset Pharmaceuticals Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Dispense with Medication Guide
To order more Medication Guides call American Health Packaging at 1-800-707-4621.

Distributed by:
American Health Packaging Columbus, OH 43217

8432625/0521F

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