HIGHLIGHTS OF PRESCRIBING INFORMATION FOR ABILIFY (ARIPIPRAZOLE)M THE ANTI-PSCYHOTIC MEDICATION
These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY.
ABILIFY® (aripiprazole) Tablets
ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets
ABILIFY® (aripiprazole) Oral Solution
ABILIFY® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY
Initial U.S. Approval: 2002
BLACK BOX WARNING:
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning.
• Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. ABILIFY is not approved for the
treatment of patients with dementia-related psychosis. (5.1)
• Children, adolescents, and young adults taking antidepressants for Major
Depressive Disorder (MDD) and other psychiatric disorders are at increased
risk of suicidal thinking and behavior. (5.2)
- – - – - – - – - – - – - – - – RECENT MAJOR CHANGES – - – - – - – - – - –
Boxed Warning, Suicidality and Antidepressant Drugs 11/2007
Boxed Warning, Increased Mortality in Elderly Patients with Dementia-Related Psychosis 08/2008
Indications and Usage, Adolescent (13 to 17 years) Schizophrenia (1.1) 05/2008
Adjunctive Therapy (Lithium or Valproate) in Adult and 05/2008
Pediatric (10 to 17 years) Patients with Bipolar Mania (1.2)
Pediatric (10 to 17 years) Bipolar Mania (1.2) 05/2008
Adjunctive Treatment in Adults with MDD (1.3) 11/2007
Dosage and Administration, Adolescent Schizophrenia (2.1) 05/2008
15 mg starting dose in Bipolar Mania (2.2) 05/2008
Adjunctive Therapy (Lithium or Valproate) in Adult and 05/2008
Pediatric Patients with Bipolar Mania (2.2)
Pediatric Bipolar Mania (2.2) 05/2008
Adjunctive Treatment in Adults with MDD (2.3) 11/2007
Warnings and Precautions, Clinical Worsening of Depression and Suicide Risk (5.2) 11/2007
- – - – - – - – - – - – - – - – - ADVERSE REACTIONS – - – - – - – - – - – -
Commonly observed adverse reactions (incidence ≥5% and at least twice that for
placebo) were (6.2):
- Adult patients with Schizophrenia: akathisia
- Pediatric patients (13 to 17 years) with Schizophrenia: extrapyramidal disorder,
somnolence, and tremor
- Adult patients (monotherapy) with Bipolar Mania: akathisia, sedation, restlessness,
tremor, and extrapyramidal disorder
- Adult patients (adjunctive therapy with lithium or valproate) with Bipolar Mania:
akathisia, insomnia, and extrapyramidal disorder
- Pediatric patients (10 to 17 years) with Bipolar Mania: somnolence, extrapyramidal
disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion,
and dizziness
- Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant
therapy): akathisia, restlessness, insomnia, constipation, fatigue, and
blurred vision
- Adult patients with agitation associated with Schizophrenia or Bipolar Mania:
Nausea
For full side effects click on the “Abilify” link to your left on this page.
- – - – - – - – - – - – - – WARNINGS AND PRECAUTIONS – - – - – - – - – - – - – - -
- Elderly Patients with Dementia-Related Psychosis: Increased incidence of
cerebrovascular adverse events (eg, stroke, transient ischemic attack, including
fatalities) (5.1)
- Suicidality and Antidepressants: Increased risk of suicidality in children,
adolescents, and young adults with Major Depressive Disorder (5.2)
- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and
close monitoring (5.3)
- Tardive Dyskinesia: Discontinue if clinically appropriate (5.4)
- Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with
and at risk for diabetes (5.5)
- Orthostatic Hypotension: Use with caution in patients with known cardiovascular
or cerebrovascular disease (5.6)
- Seizures/Convulsions: Use cautiously in patients with a history of seizures or with
conditions that lower the seizure threshold (5.7)
- Potential for Cognitive and Motor Impairment: Use caution when operating
machinery – 5.8
- Suicide: The possibility of a suicide attempt is inherent in Schizophrenia and
Bipolar Disorder. Closely supervise high-risk patients (5.10)
This list is a small portion of the warnngs on the FDA’s website. You decide if you want to take the risk with your own life. But if you are depressed you just might. Huh?
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch and leave a comment on this blog for all to see.
All information posted in this writing is the opinion of the author and is provided for educational purposes only. It is not to be construed as medical advice. Only a licensed medical doctor can legally offer medical advice in the United States. Consult the healer of your choice for medical care and advice.
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