Atomoxetine 10 mg Capsule, 1,000-count

1 INDICATIONS AND USAGE Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1)

1.1Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14) ].

1.2Diagnostic Considerations A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder.

The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired.

The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can’t wait turn, intrusive.

For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.

1.3Need for Comprehensive Treatment Program Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis.

Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.

2 DOSAGE AND ADMINISTRATION Initial, Target and Maximum Daily Dose (2.1) (Acute and Maintenance/Extended Treatment) Body Weight Initial Daily Dose Target Total Daily Dose Maximum Daily Dose Total 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 Dosing adjustment – Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). ( 2.5 , 12.3 )

2.1Acute Treatment Dosing of children and adolescents up to 70 kg body weight - Atomoxetine capsules should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day [see Clinical Studies (14) ]. The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less.

Dosing of children and adolescents over 70 kg body weight and adults - Atomoxetine capsules should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. There are no data that support increased effectiveness at higher doses [see Clinical Studies (14) ].

The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.

2.2Maintenance/Extended Treatment It is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The benefit of maintaining pediatric patients (ages 6 to 15 years) with ADHD on atomoxetine hydrochloride after achieving a response in a dose range of 1.2 to 1.8 mg/kg/day was demonstrated in a controlled trial. Patients assigned to atomoxetine hydrochloride in the maintenance phase were generally continued on the same dose used to achieve a response in the open label phase.

The physician who elects to use atomoxetine capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Clinical Studies (14.1) ].

2.3General Dosing Information Atomoxetine capsules may be taken with or without food. Atomoxetine capsules can be discontinued without being tapered. Atomoxetine capsules are not intended to be opened, they should be taken whole [see Patient Counseling Information ( 17 )] . The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.

2.4Screen for Bipolar Disorder Prior to Starting Atomoxetine Prior to initiating treatment with atomoxetine, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6 )].

2.5Dosing in Specific Populations Dosing adjustment for hepatically impaired patients - For those ADHD patients who have hepatic insufficiency (HI), dosage adjustment is recommended as follows: For patients with moderate HI (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose (for patients without HI). For patients with severe HI (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of normal [see Use In Specific Populations ( 8.6 ) ] . Dosing adjustment for use with a strong CYP2D6 inhibitor or in patients who are known to be CYP2D6 PMs - In children and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, or in patients who are known to be CYP2D6 PMs, atomoxetine hydrochloride should be initiated at 0.5 mg/kg/day and only…

3 DOSAGE FORMS AND STRENGTHS Each capsule contains atomoxetine HCl equivalent to 10 mg (Opaque white, opaque white), 18 mg (Opaque dark gold, opaque white), 25 mg (Opaque dark blue, opaque white), 40 mg (Opaque dark blue, opaque dark blue), 60 mg (Opaque dark blue, opaque dark gold) 80 mg (Opaque dark brown, opaque white) and 100 mg (Opaque dark brown, opaque dark brown) of atomoxetine. Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80 or 100 mg mg of atomoxetine. ( 3 , 11 , 16 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). 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 [see Warnings and Precautions ( 5.1 )].

Severe Liver Injury Patients initiating atomoxetine hydrochloride should be cautioned that severe liver injury may develop. Patients should be instructed to contact their healthcare provider immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms. [See Warnings and Precautions (5.2)]. Screening Patients for Bipolar Disorder Instruct patients and their caregivers to look for signs of activation of mania/hypomania [see Warnings and Precautions ( 5.6 )].

Aggression or Hostility Instruct patients and their caregivers to contact their healthcare provider as soon as possible should they notice an increase in aggression or hostility [see Warnings and Precautions ( 5.7 )]. 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 [see Warnings and Precautions ( 5.10 )].

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 healthcare provider 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: 0122

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 tha…