Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/720
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Strattera (Capsule)
|
| dailymed-instance:activeIng... | |
| dailymed-instance:boxedWarn... |
WARNING: SUICIDAL
IDEATION IN CHILDREN AND ADOLESCENTS: STRATTERA (atomoxetine)
increased the risk of suicidal ideation in short���term studies in children
or adolescents with Attention���Deficit/Hyperactivity Disorder (ADHD).
Anyone considering the use of STRATTERA in
a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients
who are started on therapy should be monitored closelyfor suicidality (suicidal
thinking and behavior), clinical worsening, or unusual changes in behavior.
Families and caregivers should be advised of the need for close observation
and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is
not approved for major depressive disorder. Pooled analyses
of short���term (6 to 18 weeks) placebo���controlled trials of STRATTERA in
children and adolescents (a total of 12 trials involving over 2200 patients,
including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater
risk of suicidal ideation early during treatment in those receiving STRATTERA compared
to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was
0.4% (5/1357 patients), compared to none in placebo���treated patients
(851 patients). No suicides occurred in these trials [see
Warnings and Precautions (5.1)].
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:Black_ink_(edible),
dailymed-ingredient:Dimethicone,
dailymed-ingredient:FD&C_Blue_No._2,
dailymed-ingredient:Gelatin,
dailymed-ingredient:Red_iron_oxide_(synthetic),
dailymed-ingredient:Starch_(pregelatinized),
dailymed-ingredient:Yellow_iron_oxide_(synthetic),
dailymed-ingredient:sodium_lauryl_sulfate,
dailymed-ingredient:titanium_dioxide
|
| dailymed-instance:genericMe... |
Atomoxetine hydrochloride
|
| dailymed-instance:fullName |
Strattera (Capsule)
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Strattera
|