País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)
Teva Pharmaceuticals USA, Inc.
ARIPIPRAZOLE
ARIPIPRAZOLE 2 mg
ORAL
PRESCRIPTION DRUG
Aripiprazole 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 is 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 Category C Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs (including aripiprazole) during t
Aripiprazole tablets USP are available in the strengths and packages listed in Table 32: Table 32: Aripiprazole Tablet USP Presentations Tablet Strength Tablet Color/Shape Tablet Markings Pack Size NDC Code 2 mg Green capsule-shaped “TV” and “7613” Bottle of 30 0093-7613-56 5 mg Blue capsule-shaped “TV” and “7569” Bottle of 30 0093-7569-56 10 mg Pink capsule-shaped “TV” and “7580” Bottle of 30 0093-7580-56 15 mg Yellow flat faced beveled edge round tablet “TV” and “7581” Bottle of 30 0093-7581-56 20 mg White flat faced beveled edge round tablet “TV” and “7582” Bottle of 30 0093-7582-56 30 mg Pink flat faced beveled edge round tablet “TV” and “7583” Bottle of 30 0093-7583-56 Tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE Aripiprazole (air-eh-PIP-rah- zole) Tablets USP 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 symptoms, especially if they are new, Llegiu el document complet
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET TEVA PHARMACEUTICALS USA, 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 IS 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, Pathological Gambling and Other Compulsive Behaviors (5.7) 08/2016 Warnings and Precautions, Falls (5.9) 02/2017 INDICATIONS AND USAGE Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: (1) Schizophrenia (14.1) DOSAGE AND ADMINISTRATION Initial Recommended Maximum Dose Dose Dose Schizophrenia – adults (2.1) 10 to 15 mg/day 10 to 15 mg/day 30 mg/day Schizophrenia – adolescents (2.1) 2 mg/day 10 mg/day 30 mg/day 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 (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 a Llegiu el document complet