Topic

Can it delay puberty or a child is development???
Thanks

 

Does Strattera Have Bad Side Effects?

Yes: It has black box warnings.

http://pi.lilly.com/us/strattera-pi.pdf

1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
STRATTERA safely & effectively. See full prescribing information for
STRATTERA.
STRATTERA® (atomoxetine hydrochloride) 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 --------------------------
Warnings & Precautions, Effects on Blood Pressure & Heart
Rate (5.4)
09/2008
Boxed Warning 07/2008
Warnings & Precautions, Suicidal Ideation (5.1), Effects on
Blood Pressure & Heart Rate (5.4), Effects on Urine Outflow
from the Bladder (5.9)
07/2008
Indications & Usage, Maintenance (1.1) 05/2008
Dosage & Administration, Maintenance (2.2) 05/2008
----------------------------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 & Maximum Daily Dose (2.1)
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 & adults
40 mg 80 mg 100 mg
Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, & 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, & unusual
changes in behavior. (5.1)
• Severe Liver Injury. (5.2)
• Serious Cardiovascular Events - Sudden death, stroke & myocardial
infarction have been reported in association with atomoxetine treatment.
Patients should have a careful history & physical exam to assess for
presence of cardiovascular disease. STRATTERA generally should not be
used in children or adolescents with known serious structural cardiac
abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or
other serious cardiac problems that may place them at increased
vulnerability to its noradrenergic effects. Consideration should be given to
not using STRATTERA in adults with clinically significant cardiac
abnormalities. (5.3)
• Emergent Cardiovascular Symptoms - Patients should undergo prompt
cardiac evaluation. (5.3)
• Effects on Blood Pressure & Heart Rate - Can increase blood pressure
and heart rate; orthostasis, syncope & Raynaud’s phenomenon may
occur. Use with caution in patients with hypertension, tachycardia, or
cardiovascular or cerebrovascular disease. (5.4).
• Emergent Psychotic or Manic Symptoms - Consider discontinuing
treatment if such new symptoms occur. (5.5)
• Bipolar Disorder - Screen patients to avoid possible induction of a
mixed/manic episode. (5.6)
• Aggressive behavior or hostility should be monitored. (5.7)
• Possible allergic reactions, including angioneurotic edema, urticaria, and
rash. (5.8)
• Effects on Urine Outflow - Urinary hesitancy & retention may occur.
(5.9)
• Priapism - Prompt medical attention is required in the event of suspected
priapism. (5.10, 17.5)
• Growth - Height & weight should be monitored in pediatric patients.
(5.11)
• Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known
to be CYP2D6 PMs- Dose adjustment of STRATTERA may be necessary.
(5.13)
-------------------------------ADVERSE REACTIONS------------------------------
Most common adverse reactions (≥5% & at least twice the incidence of
placebo patients)
• Child & Adolescent Clinical Trials - Nausea, vomiting, fatigue,
decreased appetite, abdominal pain, & 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, & 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 fda.gov/med

 

Does Strattera Have Bad Side Effects?

There is no direct published research apparently, but in many cases people seem to find it delays menstruation in females.