ATOMOXETINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . 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. Adequa

Product summary:

Product: 50090-4235 NDC: 50090-4235-0 30 CAPSULE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ATOMOXETINE HYDROCHLORIDE- atomoxetine hydrochloride capsule
A-S Medication Solutions
----------
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.
What is the most important information I should know about atomoxetine
capsules?
The following have been reported with use of atomoxetine:
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 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 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 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 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

Summary of Product characteristics

ATOMOXETINE HYDROCHLORIDE- ATOMOXETINE HYDROCHLORIDE CAPSULE
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATOMOXETINE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATOMOXETINE CAPSULES.
ATOMOXETINE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED 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)_
RECENT MAJOR CHANGES
Dosage and Administration, Screen for Bipolar Disorder Prior to
Starting Atomoxetine Capsules (2.4)
1/2022
Warnings and Precautions, Emergence of New Psychotic or Manic Symptoms
(5.5) 1/2022
Warnings and Precautions, Screening Patients for Bipolar Disorder
(5.6) 1/2022
Warnings and Precautions, Aggressive Behavior or Hostility (5.7)
1/2022
INDICATIONS AND USAGE
Atomoxetine is a selective norepinephrine reuptake inhibitor indicated
for the treatment of Attention-
Deficit/Hyperactivity Disorder (ADHD). (1.1)
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 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
Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, and
in patients known to be CYP2D6
poor metabolizers (PMs). (2.5, 12.3)
DOSAGE FORMS AND STRENGTHS
Each capsule contains atomoxetine hydrochloride equivalent to 10, 18,
25, 40, 60, 80, or 100 mg of
atomoxetine. (3, 11, 16)
CONTRAINDICATIONS
Hypersensitivity to atomoxetine or other constituents of product.
(4.1)
Atomoxetine use within 2 weeks after discontinuing MAOI or other drugs
that affect brain monoamine
concentrations. (4.2, 7.1)
Narrow Angle