STRATTERA- 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:

TYA Pharmaceuticals

INN (International Name):

Atomoxetine hydrochloride

Composition:

Atomoxetine 25 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

Product summary:

NDC:64725-3228-1 in a BOTTLE of 30 CAPSULES Atomoxetine base equivalent. a 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- ATOMOXETINE HYDROCHLORIDE CAPSULE
TYA Pharmaceuticals
----------
MEDICATION GUIDE STRATTERA
®(Stra-TAIR-a)
(atomoxetine) Capsules
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:
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): 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.
•
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
Your child or teenager may need to be closely watched for suicidal
thoughts and actions or need a change
in medicine. Call your child or teenage

Summary of Product characteristics

STRATTERA- ATOMOXETINE HYDROCHLORIDE CAPSULE
TYA PHARMACEUTICALS
----------
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)
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
CO NTRAINDIC ATIO NS:
Severe Cardiovascular Disorders ( ) 4.5
08/2013
WARNINGS AND PRECAUTIONS:
Effects on Blood Pressure and Heart Rate ( ) 5.4
08/2013
Aggressive Behavior or Hostility ( ) 5.7
08/2013
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
(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). ( , ) 2.412.3
DOSAGE FORMS AND STRENGTHS
Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40,
60, 80, or 100 mg of atomoxetine. ( , , ) 31116
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.
( , ) 4.27.1
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