March 28, 2017
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Aristada

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Aristada

ARISTADA®
(aripiprazole lauroxil) Injection

WARNING

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

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

DRUG DESCRIPTION

ARISTADA (aripiprazole lauroxil) is an atypical antipsychotic.

The chemical name of ARISTADA is 7-{4-[4-(2,3-dichlorophenyl)-piperazin-1-yl]butoxy}-2oxo-3,4-dihydro-2H-quinolin-1-yl)methyl dodecanoate. The empirical formula is C36H51Cl2N3O4 and its molecular weight is 660.7 g/mol. The chemical structure is:

ARISTADA® (aripiprazole lauroxil) Structural Formula Illustration

ARISTADA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following strengths of aripiprazole lauroxil (and deliverable volumes from a single-use pre-filled syringe): 441 mg (1.6 mL), 662 mg (2.4 mL) and 882 mg (3.2 mL). The inactive ingredients include sorbitan monolaurate (3.8 mg/mL), polysorbate 20 (1.5 mg/mL), sodium chloride (6.1 mg/mL), sodium phosphate dibasic anhydrous, sodium phosphate monobasic and water for injection.

Last reviewed on RxList: 3/13/2017
This monograph has been modified to include the generic and brand name in many instances.

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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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