STRATTERA- atomxetine hyrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA LLC

INN (International Name):

ATOMOXETINE HYDROCHLORIDE

Composition:

ATOMOXETINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

STRATTERA is indicated for the treatment of Attention–Deficit/Hyperactivity Disorder (ADHD). The efficacy of STRATTERA 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. Adequate diagnosis re

Product summary:

STRATTERA® Capsules 10 mg* 18 mg* 25 mg* 40 mg* 60 mg* 80 mg* 100 mg* Color Opaque White, Opaque White Gold, Opaque White Opaque Blue, Opaque White Opaque Blue, Opaque Blue Opaque Blue, Gold Opaque Brown, Opaque White Opaque Brown, Opaque Brown Identification LILLY 3227 LILLY 3238 LILLY 3228 LILLY 3229 LILLY 3239 LILLY 3250 LILLY 3251 10 mg 18 mg 25 mg 40 mg 60 mg 80 mg 100 mg NDC Codes: Bottles of 30 0002-3227-30 0002-3238-30 0002-3228-30 0002-3229-30 0002-3239-30 0002-3250-30 0002-3251-30 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

STRATTERA - ATOMXETINE HYROCHLORIDE CAPSULE
STAT RX USA LLC
----------
MEDICATION GUIDE
STRATTERA® (Stra-TAIR-a)
(atomoxetine hydrochloride)
Read the Medication Guide that comes with STRATTERA® 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 STRATTERA.
What is the most important information I should know about STRATTERA?
The following have been reported with use of STRATTERA:
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 STRATTERA 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 STRATTERA
The chance for suicidal thoughts and actions may be higher:
•
early during STRATTERA 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
STRATTERA 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
STRATTERA 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. You

Summary of Product characteristics

STRATTERA - ATOMXETINE HYROCHLORIDE CAPSULE
STAT RX USA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STRATTERA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR STRATTERA.
STRATTERA® (ATOMOXETINE HYDROCHLORIDE) CAPSULE 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
Warning and Precautions, Severe Liver Injury (5.2) 06/2009
Warnings and Precautions, Effects on Blood Pressure and Heart Rate
(5.4) 09/2008
Boxed Warning 07/2008
Warnings and Precautions, Suicidal Ideation (5.1), Effects on Blood
Pressure and Heart Rate (5.4), Effects on Urine Outflow
from the Bladder (5.9) 07/2008
INDICATIONS AND USAGE
STRATTERA 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)
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 HCl 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)
STRATTERA 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,