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Strattera (atomoxetine) product monograph for Canada

Strattera (atomoxetine) product monograph for Canada

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Published by: jennabush on Apr 04, 2010
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05/19/2012

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STRATTERA
®
Product Monograph Page 1
PRODUCT MONOGRAPH
STRATTERA
®
 
(atomoxetine capsules)10, 18, 25, 40, 60, 80 and 100 mgSelective Norepinephrine Reuptake Inhibitorfor Attention-Deficit/Hyperactivity Disorder (ADHD)
©
ELI LILLY CANADA INC.3650 Danforth AvenueToronto, Ontario, M1N 2E8.1-888-545-5972
www.lilly.ca
 Date of Revision:September 24, 2009Submission Control
131306
 
Pr
 
STRATTERA
®
Product Monograph Page 2
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION...................................................3
 SUMMARY PRODUCT INFORMATION.....................................................................3INDICATIONS AND CLINICAL USE..........................................................................3Special Diagnostic Considerations...................................................................................3 Need for Comprehensive Treatment Program.................................................................4CONTRAINDICATIONS................................................................................................4WARNINGS AND PRECAUTIONS..............................................................................5ADVERSE REACTIONS..............................................................................................12DRUG ABUSE AND DEPENDENCE..........................................................................21DRUG INTERACTIONS..............................................................................................22DOSAGE AND ADMINISTRATION..........................................................................24OVERDOSAGE.............................................................................................................27ACTION AND CLINICAL PHARMACOLOGY.........................................................28STORAGE AND STABILITY......................................................................................33DOSAGE FORMS, COMPOSITION AND PACKAGING..........................................33
PART II: SCIENTIFIC INFORMATION.........................................................................34
 PHARMACEUTICAL INFORMATION......................................................................34CLINICAL TRIALS......................................................................................................34DETAILED PHARMACOLOGY.................................................................................40TOXICOLOGY..............................................................................................................43REFERENCES...............................................................................................................45
PART III: CONSUMER INFORMATION........................................................................48
 
 
STRATTERA
®
Product Monograph Page 3
STRATTERA
®
 (atomoxetine capsules)PART I: HEALTH PROFESSIONAL INFORMATIONSUMMARY PRODUCT INFORMATION
Route of Administration
 
Dosage Form / Strength
 
Nonmedicinal Ingredients
 Oral 10, 18, 25, 40, 60, 80 or 100 mg capsulesThe capsules also contain pregelatinized starch anddimethicone. The capsule shells contain gelatin,sodium lauryl sulfate, and other inactive ingredients.The capsule shells also contain one or more of thefollowing: FD&C Blue No. 2, synthetic yellow ironoxide, red iron oxide, titanium dioxide.
 
INDICATIONS AND CLINICAL USE
STRATTERA (atomoxetine hydrochloride) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, andadults.A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentivesymptoms 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 levelof 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 athome. The symptoms must not be better accounted for by another mental disorder. For the
 Inattentive
type, at least 6 of the following symptoms must have persisted for at least 6 months:lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure tofollow through on tasks, poor organization, avoids tasks requiring sustained mental effort, losesthings, easily distracted, forgetful. For the
 Hyperactive-Impulsive
type, at least 6 of the followingsymptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat,inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can’t wait turn, intrusive. For a Combined Type diagnosis, both inattentive andhyperactive-impulsive criteria must be met.
Special Diagnostic Considerations
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequatediagnosis requires the use not only of medical but also of special psychological, educational, andsocial resources. Learning may or may not be impaired. The diagnosis must be based upon acomplete history and evaluation of the patient and not solely on the presence of the requirednumber of DSM-IV characteristics.

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