Country: United States
Language: English
Source: NLM (National Library of Medicine)
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)
XLCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Aripiprazole oral tablets are indicated for the treatment of: - Schizophrenia [see Clinical Studies (14.1)] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-p
Aripiprazole tablets, USP 2 mg are light green to green, modified rectangular, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘94’ on other side. Bottles of 30 Tablets NDC 72865-153-30 Bottles of 500 Tablets NDC 72865-153-05 Aripiprazole tablets, USP 5 mg are light blue to blue, modified rectangular, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘95’ on other side. Bottles of 30 Tablets NDC 72865-154-30 Bottles of 500 Tablets NDC 72865-154-05 Aripiprazole tablets, USP 10 mg are light pink to pink, modified rectangular, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘96’ on other side. Bottles of 30 Tablets NDC 72865-155-30 Bottles of 500 Tablets NDC 72865-155-05 Aripiprazole tablets, USP 15 mg are light yellow to yellow, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘97’ on other side. Bottles of 30 Tablets NDC 72865-156-30 Bottles of 500 Tablets NDC 72865-156-05 Aripiprazole tablets, 20 mg are white to off-white, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘98’ on other side. Bottles of 30 Tablets NDC 72865-157-30 Bottles of 500 Tablets NDC 72865-157-05 Aripiprazole tablets, USP 30 mg are light pink to pink, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘99’ on other side. Bottles of 30 Tablets NDC 72865-158-30 Bottles of 500 Tablets NDC 72865-158-05 Store at 20º to 25º C (68º to 77ºF) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET XLCare Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Aripiprazole Tablets, USP (ar'' i pip' ra zole) What is the most important information I should know about aripiprazole tablets? (For other side effects, also see “What are the possible side effects of aripiprazole tablets?”) Serious side effects may happen when you take aripiprazole tablets, including: • Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole tablets are not approved for the treatment of patients with dementia-related psychosis. • Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following sympt Read the complete document
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET XLCARE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ARIPIPRAZOLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE TABLETS, FOR ORAL USE. INITIAL U.S. APPROVAL: 2002 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS WITH 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. ARIPIPRAZOLE TABLETS ARE NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1) INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS. MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. (5.3) RECENT MAJOR CHANGES Warnings and Precautions (5.5) 08/2019 INDICATIONS AND USAGE Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for: (1) (1) Schizophrenia (14.1) DOSAGE AND ADMINISTRATION Initial Dose (2) Recommended Dose (2) Maximum Dose (2) Schizophrenia – adults (2.1) (2) 10 to 15 mg/day (2) 10 to 15 mg/day (2) 30 mg/day (2) Schizophrenia – adolescents (2.1) (2) 2 mg/day (2) 10 mg/day (2) 30 mg/day (2) Oral formulations: Administer once daily without regard to meals (2) Known CYP2D6 poor metabolizers: Half of the usual dose (2.7) DOSAGE FORMS AND STRENGTHS Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3) CONTRAINDICATIONS Known hypersensitivity to aripiprazole tablets (4) WARNINGS AND PRECAUTIONS _Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: _Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) (5.2) _Neuroleptic Malignant Syndrome:_ Manage with immediate discontinuation and close monitoring (5.4) Read the complete document