STRATTERA- atomoxetine capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lake Erie Medical DBA Quality Care Products LLC

INN (Internationale Bezeichnung):

ATOMOXETINE HYDROCHLORIDE

Zusammensetzung:

ATOMOXETINE HYDROCHLORIDE 25 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Opaque Blue, Opaque White Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

New Drug Application

Gebrauchsinformation

STRATTERA - ATOMOXETINE CAPSULE
Lake Erie Medical DBA Quality Care Products LLC
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STRATTERA - atomoxetine hydrochloride capsule
STRATTERA - atomoxetine hydrochloride
Eli Lilly and Company
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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 you

Fachinformation

STRATTERA - ATOMOXETINE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
STRATTERA 25 MG THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION
NEEDED TO USE. SEE FULL PRESCRIBING
INFORMATION FOR AND INITIAL U.S. APPROVAL.
INDICATIONS AND USAGE
STRATTERA is a selective norepinephrine reuptake inhibitor indicated
for the treatment of Attention-
Deficit/Hyperactivity Disorder (ADHD). (1.1)
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
ADVERSE REACTIONS
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, insomnia, erectile dysfunction,
urinary hesitation and/or urinary retention and/or dysuria,
dysmenorrhea, and hot flush. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ELI LILLY AND COMPANY
AT 1-800-LILLYRX (1-800-545-
5979) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 11/2010
FULL PRESCRIBING INFORMATION: CONTENTS*
*
FULL PRESCRIBING INFORMATION
STRATTERA (atomoxetine HCl) is a selective norepinephrine reuptake
inhibitor. Atomoxetine HCl
is the _R_(-) isomer as determined by x-ray diffraction. The chemical
designation is (-)-_N_-Methyl-3-
phenyl-3-(_o_-tolyloxy)-propylamine hydrochloride. The molecular
formula is C
H NO•HCl, which
corresponds to a molecular weight of 291.82
Atomoxetine HCl is a white to practically white solid, which has a
solubility of 27.8 mg/mL in water.
STRATTERA capsules are intended for oral administration only.
Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40,
60, 80, or 100 mg of atomoxetine.
The