Atomoxetine Hydrochloride

Sun Pharma Global FZE

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use atomoxetine hydrochloride safely and effectively. See full prescribing information for atomoxetine hydrochloride capsules. ATOMOXETINE HYDROCHLORIDE CAPSULES for Oral Use Initial U.S. Approval: 2002 RECENT MAJOR CHANGES5.25.8BOXED WARNING Increased risk of suicidal ideation in children or adolescents (5.1) No suicides occurred in clinical trials (5.1) Patients started on therapy should be monitored closely (5.1) INDICATIONS AND USAGE1.1DOSAGE AND ADMINISTRATION2.1 Body Weight Initial Daily Dose Target Total Daily Dose Maximum Total Daily Dose Children and adolescents up to 70 kg 0.5 mg/kg 1.2 mg/kg 1.4 mg/kg Children and adolescents over 70 kg and adults 40 mg 80 mg 100 mg 2.412.3DOSAGE FORMS AND STRENGTHS31116CONTRAINDICATIONS Hypersensitivity to atomoxetine or other constituents of product. (4.1) Atomoxetine hydrochloride capsules use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. (4.2, 7.1) Narrow Angle Glaucoma. (4.3) WARNINGS AND PRECAUTIONS Suicidal Ideation - Monitor for suicidality, clinical worsening, and unusual changes in behavior. (5.1) Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. (5.2) Serious Cardiovascular Events - Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. Atomoxetine hydrochloride generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using atomoxetine hydrochloride in adults with clinically significant cardiac abnormalities. (5.3) Emergent Cardiovascular Symptoms - Patients should undergo prompt cardiac evaluation. (5.3) Effects on Blood Pressure and Heart Rate - Can increase blood pressure and heart rate; orthostasis, syncope and Raynaud’s phenomenon may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. (5.4). Emergent Psychotic or Manic Symptoms - Consider discontinuing treatment if such new symptoms occur. (5.5) Bipolar Disorder - Screen patients to avoid possible induction of a mixed/manic episode. (5.6) Aggressive behavior or hostility should be monitored. (5.7) Possible allergic reactions, including anaphylactic reactions,  angioneurotic edema, urticaria, and rash. (5.8) Effects on Urine Outflow - Urinary hesitancy and retention may occur. (5.9) Priapism - Prompt medical attention is required in the event of suspected priapism. (5.10, 17.5) Growth - Height and weight should be monitored in pediatric patients. (5.11) Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs- Dose adjustment of atomoxetine hydrochloride may be necessary. (5.13) Side EffectsMost common adverse reactions (≥5% and at least twice the incidence of placebo patients) Child and Adolescent Clinical Trials - Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. (6.1) Adult Clinical Trials - Constipation, dry mouth, nausea, fatigue, decreased appetite, insomnia,  erectile dysfunction, urinary hesitation and/or urinary retention and/or dysuria, dysmenorrhea, and hot flush. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Monoamine Oxidase Inhibitors. (4.2, 7.1) CYP2D6 Inhibitors - Concomitant use may increase atomoxetine steady-state plasma concentrations in EMs. (7.2) Pressor Agents - Possible effects on blood pressure. (7.3) Albuterol (or other beta2 agonists) - Action of albuterol on cardiovascular system can be potentiated. (7.4) USE IN SPECIFIC POPULATIONS Pregnancy/Lactation - Pregnant or nursing women should not use unless potential benefit justifies potential risk to fetus or infant. (8.1, 8.3) Hepatic Insufficiency - Increased exposure (AUC) to atomoxetine than with normal subjects in EM subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase). (8.6) Renal Insufficiency - Higher systemic exposure to atomoxetine than healthy subjects for EM subjects with end stage renal disease - no difference when exposure corrected for mg/kg dose. (8.7) Patients with Concomitant Illness - Does not worsen tics in patients with ADHD and comorbid Tourette’s Disorder. (8.10)

FULL PRESCRIBING INFORMATION: CONTENTS*

• WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
• 1 ATOMOXETINE HYDROCHLORIDE INDICATIONS AND USAGE
  • 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)
  • 1.2 Diagnostic Considerations
  • 1.3 Need for Comprehensive Treatment Program
• 2 ATOMOXETINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION
  • 2.1 Acute Treatment
  • 2.2 Maintenance/Extended Treatment
  • 2.3 General Dosing Information
  • 2.4 Dosing in Specific Populations
• 3 DOSAGE FORMS AND STRENGTHS
• 4 ATOMOXETINE HYDROCHLORIDE CONTRAINDICATIONS
  • 4.1 Hypersensitivity
  • 4.2 Monoamine Oxidase Inhibitors (MAOI)
  • 4.3 Narrow Angle Glaucoma
• 5 WARNINGS AND PRECAUTIONS
  • 5.1 Suicidal Ideation
  • 5.2 Severe Liver Injury
  • 5.3 Serious Cardiovascular Events
  • 5.4 Effects on Blood Pressure and Heart Rate
  • 5.5 Emergence of New Psychotic or Manic Symptoms
  • 5.6 Screening Patients for Bipolar Disorder
  • 5.7 Aggressive Behavior or Hostility
  • 5.8 Allergic Events
  • 5.9 Effects on Urine Outflow from the Bladder
  • 5.10 Priapism
  • 5.11 Effects on Growth
  • 5.12 Laboratory Tests
  • 5.13 Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients who are known to be CYP2D6 PMs
• 6 ATOMOXETINE HYDROCHLORIDE ADVERSE REACTIONS
  • 6.1 Clinical Trials Experience
  • 6.2 Postmarketing Spontaneous Reports
• 7 DRUG INTERACTIONS
  • 7.1 Monoamine Oxidase Inhibitors
  • 7.2 Effect of CYP2D6 Inhibitors on Atomoxetine
  • 7.3 Pressor Agents
  • 7.4 Albuterol
  • 7.5 Effect of Atomoxetine on P450 Enzymes
  • 7.6 Alcohol
  • 7.7 Methylphenidate
  • 7.8 Drugs Highly Bound to Plasma Protein
  • 7.9 Drugs that Affect Gastric pH
• 8 USE IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy
  • 8.2 Labor and Delivery
  • 8.3 Nursing Mothers
  • 8.4 Pediatric Use
  • 8.5 Geriatric Use
  • 8.6 Hepatic Insufficiency
  • 8.7 Renal Insufficiency
  • 8.8 Gender
  • 8.9 Ethnic Origin
  • 8.10 Patients with Concomitant Illness
• 9 DRUG ABUSE AND DEPENDENCE
  • 9.1 Controlled Substance
  • 9.2 Abuse
  • 9.3 Dependence
• 10 OVERDOSAGE
  • 10.1 Human Experience
  • 10.2 Management of Overdose
• 11 ATOMOXETINE HYDROCHLORIDE DESCRIPTION
• 12 CLINICAL PHARMACOLOGY
  • 12.1 Mechanism of Action
  • 12.2 Pharmacodynamics
  • 12.3 Pharmacokinetics
• 13 NONCLINICAL TOXICOLOGY
  • 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
• 14 CLINICAL STUDIES
  • 14.1 ADHD studies in Children and Adolescents
  • 14.2 ADHD studies in Adults
• 16 HOW SUPPLIED/STORAGE AND HANDLING
  • 16.1 How Supplied
  • 16.2 Storage and Handling
• 17 PATIENT COUNSELING INFORMATION
  • 17.1 General Information
  • 17.2 Suicide Risk
  • 17.3 Severe Liver Injury
  • 17.4 Aggression or Hostility
  • 17.5 Priapism
  • 17.6 Ocular Irritant
  • 17.7 Drug-Drug Interaction
  • 17.8 Pregnancy
  • 17.9 Food
  • 17.10 Missed Dose
  • 17.11 Interference with Psychomotor Performance
• MEDICATION GUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 10MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 18MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 25MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 40MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 60MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 80MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 100MG

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)

1.2 Diagnostic Considerations

1.3 Need for Comprehensive Treatment Program

2 DOSAGE AND ADMINISTRATION

2.1 Acute Treatment

2.2 Maintenance/Extended Treatment

2.3 General Dosing Information

2.4 Dosing in Specific Populations

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Atomoxetine hydrochloride capsules are contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product [see Warnings and Precautions (5.7)].

4.2 Monoamine Oxidase Inhibitors (MAOI)

4.3 Narrow Angle Glaucoma

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Ideation

5.2 Severe Liver Injury

5.3 Serious Cardiovascular Events

5.4 Effects on Blood Pressure and Heart Rate

5.5 Emergence of New Psychotic or Manic Symptoms

5.6 Screening Patients for Bipolar Disorder

5.7 Aggressive Behavior or Hostility

5.8 Allergic Events

5.9 Effects on Urine Outflow from the Bladder

5.10 Priapism

5.11 Effects on Growth

5.12 Laboratory Tests

5.13 Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients who are known to be CYP2D6 PMs

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Table 1: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine Hydrochloride in Acute (up to 18 weeks) Child and Adolescent Trials

Adverse ReactionReactions reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: blood pressure increased, early morning awakening, flushing, mydriasis, sinus tachycardia, asthenia, palpitations, mood swings, constipation. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: pharyngolaryngeal pain, insomnia (insomnia includes the terms, insomnia, initial insomnia, middle insomnia). The following reaction did not meet this criterion but shows a statistically significant dose relationship: pruritus.	Percentage of Patients Reporting Reaction
	Atomoxetine Hydrochloride (N=1597)	Placebo (N=934)
Gastrointestinal Disorders
Abdominal painAbdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.	18	10
Vomiting	11	6
Nausea	10	5
General Disorders and Administration Site Conditions
Fatigue	8	3
Irritability	6	3
Therapeutic response unexpected	2	1
Investigations
Weight decreased	3	0
Metabolism and Nutritional Disorders
Decreased appetite	16	4
Anorexia	3	1
Nervous System Disorders
Headache	19	15
SomnolenceSomnolence includes the terms: sedation, somnolence.	11	4
Dizziness	5	2
Skin and Subcutaneous Tissue Disorders
Rash	2	1

Table 2: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine Hydrochloride in Acute (up to 18 weeks) Child and Adolescent Trials

Adverse Reaction	Percentage of Patients Reporting Reaction from BID Trials		Percentage of Patients Reporting Reaction from QD Trials
	Atomoxetine Hydrochloride (N=715)	Placebo (N=434)	Atomoxetine Hydrochloride (N=882)	Placebo (N=500)
Gastrointestinal Disorders
Abdominal painAbdominal pain includes the terms : abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.	17	13	18	7
Vomiting	11	8	11	4
Nausea	7	6	13	4
ConstipationConstipation didn't meet the statistical significance on Breslow-Day test but is included in the table because of pharmacologic plausibility.	2	1	1	0
General Disorders
Fatigue	6	4	9	2
Psychiatric Disorders
Mood swingsMood swings didn't meet the statistical significance on Breslow-Day test at 0.05 level but p-value was <0.1 (trend).	2	0	1	1

Table 3: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine Hydrochloride in Acute (up to 25 weeks) Adult Trials

Adverse ReactionReactions reported by at least 2 % of patients treated with atomoxetine, and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: early morning awakening, peripheral coldness, tachycardia, prostatitis, testicular pain, and orgasm abnormal. The following reactions were reported by at least 2 % of patients treated with atomoxetine, and equal to or less than placebo: headache, pharyngolaryngeal pain, irritability.	Percentage of Patients Reporting Reaction
System Organ Class/Adverse Reaction	Atomoxetine Hydrochloride (N=540)	Placebo (N=402)
Cardiac Disorders
Palpitations	3	1
Gastrointestinal Disorders
Dry mouth	21	7
Nausea	21	5
Constipation	9	3
Abdominal painAbdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort	7	5
Dyspepsia	4	2
Vomiting	3	2
General Disorders and Administration Site Conditions
Fatigue	9	4
Chills	3	1
Therapeutic response unexpected	3	1
Feeling jittery	2	0
Investigations
Weight decreased	2	1
Metabolism and Nutritional Disorders
Decreased appetite	11	2
Nervous System Disorders
Dizziness	6	4
SomnolenceSomnolence includes the terms: sedation, somnolence	4	3
Paraesthesia	3	1
Sinus headache	3	1
Tremor	2	0
Psychiatric Disorders
InsomniaInsomnia includes the terms: insomnia, initial insomnia, middle insomnia.	15	7
Libido decreased	4	2
Sleep disorder	3	1
Renal and Urinary Disorders
Urinary hesitation and/or urinary retention	7	1
Dysuria	3	0
Reproductive System and Breast Disorders
Erectile dysfunctionBased on total number of males (atomoxetine hydrochloride, N=326; placebo, N=260).	9	1
DysmenorrheaBased on total number of females (atomoxetine hydrochloride, N=214; placebo, N=142).	6	2
Ejaculation delayedBased on total number of males (atomoxetine hydrochloride, N=326; placebo, N=260). and/or ejaculation disorderBased on total number of males (atomoxetine hydrochloride, N=326; placebo, N=260).	3	1
Menstruation irregularBased on total number of females (atomoxetine hydrochloride, N=214; placebo, N=142).	2	0
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis	4	1
Rash	2	1
Vascular Disorders
Hot flush	8	1

6.2 Postmarketing Spontaneous Reports

7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors

7.2 Effect of CYP2D6 Inhibitors on Atomoxetine

7.3 Pressor Agents

7.4 Albuterol

7.5 Effect of Atomoxetine on P450 Enzymes

7.6 Alcohol

7.7 Methylphenidate

7.8 Drugs Highly Bound to Plasma Protein

In vitro

7.9 Drugs that Affect Gastric pH

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C<sup>2

22

2</sup>

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

[see Boxed Warning and Warnings and Precautions (5.1)]



²

8.5 Geriatric Use

8.6 Hepatic Insufficiency

[see Dosage and Administration (2.3)]

8.7 Renal Insufficiency

8.8 Gender

8.9 Ethnic Origin

8.10 Patients with Concomitant Illness

Tics in patients with ADHD and comorbid Tourette’s Disorder[see Adverse Reactions (6.2)]

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

Animal Experience

10 OVERDOSAGE

10.1 Human Experience

10.2 Management of Overdose

11 DESCRIPTION

RNo₁₇₂₁

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

ex vivo

12.2 Pharmacodynamics

[see Clinical Studies (14.2)]

12.3 Pharmacokinetics

_max

Absorption and distribution<sub>max

maxmaxmax</sub>





Metabolism and elimination_ss,max[see Warnings and Precautions (5.13)]



_ss,max

O

[See Use In Specific Populations (8.4, 8.5, 8.6, 8.7, 8.8, 8.9)]

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis²²

Mutagenesisin vitroin vivo



Impairment of fertility²

14 CLINICAL STUDIES

14.1 ADHD studies in Children and Adolescents

Acute Studies

14.2 ADHD studies in Adults

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Atomoxetine Hydrochloride Capsules	10 mgAtomoxetine base equivalent.	18 mgAtomoxetine base equivalent.	25 mgAtomoxetine base equivalent.	40 mgAtomoxetine base equivalent.	60 mgAtomoxetine base equivalent.	80 mgAtomoxetine base equivalent.	100 mgAtomoxetine base equivalent.
Color	Opaque White, Opaque White	Opaque Yellow, Opaque White	Opaque Blue, Opaque White	Opaque Blue, Opaque Blue	Opaque Blue, Opaque Yellow	Opaque Brown, Opaque White	Opaque Brown, Opaque Brown
Identification	814	815	816	817	818	819	820
NDC Codes:
Bottles of 30 with Child Resistant Cap	47335-814-83	47335-815-83	47335-816-83	47335-817-83	47335-818-83	47335-819-83	47335-820-83
Bottles of 100 with Child Resistant Cap	47335-814-88	47335-815-88	47335-816-88	47335-817-88	47335-818-88	47335-819-88	47335-820-88
Bottles of 100 with Non Child Resistant Cap	47335-814-08	47335-815-08	47335-816-08	47335-817-08	47335-818-08	47335-819-08	47335-820-08
Bottles of 1000 with Non Child Resistant Cap	47335-814-18	47335-815-18	47335-816-18	47335-817-18	47335-818-18	47335-819-18	47335-820-18

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

See Medication Guide provided separately.

17.1 General Information

17.2 Suicide Risk

17.3 Severe Liver Injury

[see Warnings and Precautions (5.2)].

17.4 Aggression or Hostility

17.5 Priapism

17.6 Ocular Irritant

17.7 Drug-Drug Interaction

17.8 Pregnancy

17.9 Food

17.10 Missed Dose

17.11 Interference with Psychomotor Performance

Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Ind. Ltd.

MEDICATION GUIDE

Atomoxetine Hydrochloride Capsules



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.

• 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.

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

 
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

What is atomoxetine hydrochloride?







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

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.
 


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

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?
 
“What is the most important information I should know about atomoxetine hydrochloride?”

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
 



Caraco Pharmaceutical Laboratories Ltd. at 1-800-818-4555

What are the ingredients in atomoxetine hydrochloride capsules?
 
Active ingredient:
 
Inactive ingredients:



^®
®
®

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



Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Ind. Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 10MG

NDC 47335-814-83
Atomoxetine Hydrochloride Capsules
10 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 18MG

NDC 47335-815-83
Atomoxetine Hydrochloride Capsules
18 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 25MG

NDC 47335-816-83
Atomoxetine Hydrochloride Capsules
25 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 40MG

NDC 47335-817-83
Atomoxetine Hydrochloride Capsules
40 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 60MG

NDC 47335-818-83
Atomoxetine Hydrochloride Capsules
60 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 80MG

NDC 47335-819-83
Atomoxetine Hydrochloride Capsules
80 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 100MG

NDC 47335-820-83
Atomoxetine Hydrochloride Capsules
100 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST : PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:47335-814 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE ATOMOXETINE 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN SILICON DIOXIDE GELATIN SODIUM LAURYL SULFATE titanium dioxide Product Characteristics Color Size Imprint Code Shape WHITE (opaque white) 15 mm 814 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-814-83 30 in 1 BOTTLE 2 NDC:47335-814-88 100 in 1 BOTTLE 3 NDC:47335-814-08 100 in 1 BOTTLE 4 NDC:47335-814-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079020 2010-10-05

Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:47335-815 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE ATOMOXETINE 18 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN SILICON DIOXIDE GELATIN SODIUM LAURYL SULFATE titanium dioxide FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape WHITE (opaque white) 16 mm 815 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-815-83 30 in 1 BOTTLE 2 NDC:47335-815-88 100 in 1 BOTTLE 3 NDC:47335-815-08 100 in 1 BOTTLE 4 NDC:47335-815-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079020 2010-10-05

Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:47335-816 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE ATOMOXETINE 25 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN SILICON DIOXIDE GELATIN SODIUM LAURYL SULFATE titanium dioxide FD&C BLUE NO. 2 Product Characteristics Color Size Imprint Code Shape WHITE (opaque white) 16 mm 816 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-816-83 30 in 1 BOTTLE 2 NDC:47335-816-88 100 in 1 BOTTLE 3 NDC:47335-816-08 100 in 1 BOTTLE 4 NDC:47335-816-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079020 2010-10-05

Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:47335-817 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE ATOMOXETINE 40 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN SILICON DIOXIDE GELATIN SODIUM LAURYL SULFATE titanium dioxide FD&C BLUE NO. 2 Product Characteristics Color Size Imprint Code Shape BLUE (opaque blue) 18 mm 817 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-817-83 30 in 1 BOTTLE 2 NDC:47335-817-88 100 in 1 BOTTLE 3 NDC:47335-817-08 100 in 1 BOTTLE 4 NDC:47335-817-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079020 2010-10-05

Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:47335-818 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE ATOMOXETINE 60 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN SILICON DIOXIDE GELATIN SODIUM LAURYL SULFATE titanium dioxide FD&C BLUE NO. 2 FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape YELLOW (opaque yellow) 20 mm 818 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-818-83 30 in 1 BOTTLE 2 NDC:47335-818-88 100 in 1 BOTTLE 3 NDC:47335-818-08 100 in 1 BOTTLE 4 NDC:47335-818-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079020 2010-10-05

Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:47335-819 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE ATOMOXETINE 80 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN SILICON DIOXIDE GELATIN SODIUM LAURYL SULFATE titanium dioxide FERRIC OXIDE YELLOW ferric oxide red Product Characteristics Color Size Imprint Code Shape WHITE (opaque white) 22 mm 819 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-819-83 30 in 1 BOTTLE 2 NDC:47335-819-88 100 in 1 BOTTLE 3 NDC:47335-819-08 100 in 1 BOTTLE 4 NDC:47335-819-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079020 2010-10-05

Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:47335-820 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE ATOMOXETINE 100 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN SILICON DIOXIDE GELATIN SODIUM LAURYL SULFATE titanium dioxide FERRIC OXIDE YELLOW ferric oxide red Product Characteristics Color Size Imprint Code Shape BROWN (opaque brown) 24 mm 820 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-820-83 30 in 1 BOTTLE 2 NDC:47335-820-88 100 in 1 BOTTLE 3 NDC:47335-820-08 100 in 1 BOTTLE 4 NDC:47335-820-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079020 2010-10-05