Atomoxetine Hydrochloride (Page 7 of 8)

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See Medication Guide provided separately.

17.1 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.

17.2 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.

17.3 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)].

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 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.

17.6 Ocular Irritant

Atomoxetine hydrochloride is an ocular irritant. Atomoxetine hydrochloride 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 atomoxetine hydrochloride.

17.9 Food

Patients may take atomoxetine hydrochloride 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 atomoxetine hydrochloride 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.

Distributed by:

Caraco Pharmaceutical Laboratories, Ltd.

1150 Elijah McCoy Drive, Detroit, MI 48202

Manufactured by:

Sun Pharmaceutical Ind. Ltd.

Halol-Baroda Highway,

Halol-389 350, Gujarat

India.

ISS. 09/2010

MEDICATION GUIDE

Atomoxetine Hydrochloride Capsules

Read the Medication Guide that comes with atomoxetine hydrochloride 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 hydrochloride?

The following have been reported with use of atomoxetine hydrochloride:

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 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 hydrochloride
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 hydrochloride 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 hydrochloride 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 hydrochloride.

Your doctor should check your blood pressure or your child’s blood pressure and heart rate regularly during treatment with atomoxetine hydrochloride.

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 hydrochloride.

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

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

Who should not take atomoxetine hydrochloride?

Atomoxetine hydrochloride 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 hydrochloride capsules. See the end of this Medication Guide for a complete list of ingredients.
Atomoxetine hydrochloride may not be right for you or your child. Before starting atomoxetine hydrochloride 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
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can atomoxetine hydrochloride 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 hydrochloride and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine hydrochloride 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 hydrochloride without talking to your doctor first.

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

See “What is the most important information I should know about atomoxetine hydrochloride?” 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
  • trouble sleeping
  • sexual side effects
  • menstrual cramps
  • problems passing urine
Other information for children, teenagers, and adults:
  • Erections that won’t go away (priapism) have occurred rarely during treatment with atomoxetine hydrochloride. 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 hydrochloride may affect your ability or your child’s ability to drive or operate heavy machinery. Be careful until you know how atomoxetine hydrochloride affects 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 hydrochloride capsules?
  • Store atomoxetine hydrochloride capsules in a safe place at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).
  • Keep atomoxetine hydrochloride capsules and all medicines out of the reach of children.
General information about atomoxetine hydrochloride

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

This Medication Guide summarizes the most important information about atomoxetine hydrochloride. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine hydrochloride that was written for healthcare professionals. For more information about atomoxetine hydrochloride call Caraco Pharmaceutical Laboratories Ltd. at 1-800-818-4555.

What are the ingredients in atomoxetine hydrochloride capsules?

Active ingredient: atomoxetine hydrochloride.

Inactive ingredients: pregelatinized starch, colloidal silicon dioxide, gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 2 (25 mg, 40 mg, 60 mg), iron oxide yellow (18 mg, 60 mg, 80 mg, 100 mg), iron oxide red (80 mg, 100 mg).

The imprinting edible black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.

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.

Distributed by:

Caraco Pharmaceutical Laboratories, Ltd.

1150 Elijah McCoy Drive, Detroit, MI 48202

Manufactured by:

Sun Pharmaceutical Ind. Ltd.

Halol-Baroda Highway,

Halol-389 350, Gujarat

India.

ISS. 08/2010

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