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:

AvPAK

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

Product summary:

Atomoxetine capsules, USP 10 mg* are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap, imprinted “APO AM10” in black ink. Atomoxetine capsules, USP 18 mg* are available for oral administration as hard gelatin capsules with a white opaque body and a gold opaque cap, imprinted “APO AM18” in black ink. Atomoxetine capsules, USP 25 mg* are available for oral administration as hard gelatin capsules with a white opaque body and a blue opaque cap, imprinted “APO AM25” in black ink. Atomoxetine capsules, USP 40 mg* are available for oral administration as hard gelatin capsules with a blue opaque body and a blue opaque cap, imprinted “APO AM40” in black ink. Atomoxetine capsules, USP 60 mg* are available for oral administration as hard gelatin capsules with a gold opaque body and a blue opaque cap, imprinted “APO AM60” in black ink. They are supplied as follows: NDC 50268-059-13 (10 capsules per card, 3 cards per carton) Atomoxetine capsules, USP 80 mg* are available for oral administration as hard gelatin capsules with a white opaque body and an orange opaque cap, imprinted “APO AM80” in black ink. Atomoxetine capsules, USP 100 mg* are available for oral administration as hard gelatin capsules with an orange opaque body and an orange opaque cap, imprinted “APO AM100” in black ink. * Atomoxetine base equivalent. Store atomoxetine capsules, USP at 20° to 25°C (68° to 77°F) excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ATOMOXETINE HYDROCHLORIDE- ATOMOXETINE HYDROCHLORIDE CAPSULE
AvPAK
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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 above signs, especi

Summary of Product characteristics

ATOMOXETINE HYDROCHLORIDE- ATOMOXETINE HYDROCHLORIDE CAPSULE
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ATOMOXETINE CAPSULES, FOR ORAL USE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATOMOXETINE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATOMOXETINE CAPSULES
.
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
None .
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
DO SE
TARGET TOTAL DAILY
DO SE
MAXIMUM TOTAL DAILY
DO SE
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). (2.4, 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 Glaucoma. ( 4.3)
Pheochromocytoma or history of pheochromocytoma. ( 4.4)
Severe Cardiovascular Disorders that might deteriorate with clinically
important increases in HR and BP. ( 4.5)
WARNINGS AND PRECAUTIONS
Suicidal Ideation - Monitor for suicidality, clinical worsening, and
unusual changes in behavior. (5.1)
Severe Liver Injury- Should be di