May 25, 2017
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Aripiprazole Oral Solution

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Aripiprazole Oral Solution

ARIPIPRAZOLE
(aripiprazole) Oral Solution

WARNING

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementiarelated psychosis [see WARNINGS AND PRECAUTIONS].

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Aripiprazole is a psychotropic drug that is available as Aripiprazole Oral Solution. Aripiprazole is 7- [4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27C12N3O2 and its molecular weight is 448.38.

ARIPIPRAZOLE oral solution Structural Formula Illustration

Aripiprazole Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include butylated hydroxyanisole, methylparaben, phosphoric acid, propylene glycol, propylparaben, sodium hydroxide, sucralose, and purified water. The oral solution is orange flavored.

Last reviewed on RxList: 1/13/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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