April 26, 2017
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Vraylar

"The US Food and Drug Administration (FDA) has approved a new medication for the treatment of schizophrenia and bipolar disorder in adults.

The FDA's approval of cariprazine (Vraylar, Forest Laboratories, Inc), an oral, once-dai"...

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Vraylar

VRAYLAR™
(cariprazine) Capsules

WARNING

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED PSYCHOSIS

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

DRUG DESCRIPTION

The active ingredient of VRAYLAR is cariprazine HCl, an atypical antipsychotic. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N',N'-dimethylurea hydrochloride; its empirical formula is C21H33Cl3N4O and its molecular weight is 463.9 g/mol. The chemical structure is:

VRAYLAR™ (cariprazine) Structural Formula Illustration

VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains a white to off-white powder of cariprazine HCl, which is equivalent to 1.5, 3, 4.5, or 6 mg of cariprazine base. In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (1.5, 3, and 6 mg), FD&C Blue 1 (3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (3 and 4.5 mg).

Last reviewed on RxList: 3/10/2017
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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