Dr. Reddy's

Atomoxetine

Generic

ID: 55111052230

NaN

Reviews

📜 Prescription Required

FORM

Capsule

STRENGTH

60 mg

QUANTITY

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TL;DR — Quick Summary

Key facts from the full medication guide below

RECENT MAJOR CHANGES SECTION BOXED WARNING SECTION 1 INDICATIONS AND USAGE SPL UNCLASSIFIED SECTION 2 DOSAGE AND ADMINISTRATION

🩺What it's for

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

💊How to take it

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).

ℹ️Common side effects

Most 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, dizziness, erectile dysfunction and urinary hesitation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr.

⚠️Serious risks

Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine hydrochloride in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior.

📋Interactions & cautions

Monoamine Oxidase Inhibitors. (4.2 , 7.1) CYP2D6 Inhibitors - Concomitant use may increase atomoxetinesteady-state plasma concentrations in EMs.(7.2) Antihypertensive Drugs and Pressor Agents - Possible effects on blood pressure. (7.3) Albuterol (or other beta2 agonists) - Action of albuterol on cardiovascular system can be potentiated.

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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- Increase in blood pressure and heart rate; orthostasis and syncope may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. (5.4) . Psychotic or Manic Symptoms- Consider discontinuing atomoxetine capsules if such new symptoms occur. (5.5) Bipolar Disorder- Screen patients for bipolar disorder. (5.6) Aggressive behavior or hostility - Monitor for the appearance or worsening of aggressive behavior or hostility. (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 ) 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)

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