Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Aripiprazole (UNII: 82VFR53I78) (Aripiprazole - UNII:82VFR53I78)
Safecor Health, LLC
Aripiprazole
Aripiprazole 2 mg
ORAL
PRESCRIPTION DRUG
Aripiprazole Oral Tablets are indicated for the treatment of: 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)] . Teratogenic Effects 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 the third trim
Aripiprazole tablets 2 mg are available for oral administration as green, rectangular, slightly biconvex tablets, engraved "2" on one side and "A" on the other side. Aripiprazole tablets 5 mg are available for oral administration as blue, rectangular, slightly biconvex tablets, engraved “5” on one side and “A” on the other side. Aripiprazole tablets 10 mg are available for oral administration as pink, rectangular, slightly biconvex tablets, engraved “10” on one side and “A” on the other side. Aripiprazole tablets 15 mg are available for oral administration as yellow, round, slightly biconvex tablets, engraved “ARI” over “15” on one side and “APO” on the other side. Aripiprazole tablets 20 mg are available for oral administration as white to off-white, round, slightly biconvex tablets, engraved “ARI” over “20” on one side and “APO” on the other side. Aripiprazole tablets 30 mg are available for oral administration as pink, round, slightly biconvex tablets, engraved “ARI” over “30” on one side and “APO” on the other side. Tablets Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ARIPIPRAZOLE- aripiprazole tablet Safecor Health, LLC ---------- MEDICATION GUIDE Aripiprazole Tablets (ar-i-pip-ra-zole) Read this Medication Guide before you start taking aripiprazole tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about aripiprazole? (For other side effects, also see “What are the possible side effects of aripiprazole?”). Serious side effects may happen when you take aripiprazole, including: Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole is 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) bipolar illness (also called manic-depressive illness) or 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 follo Prečítajte si celý dokument
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET SAFECOR HEALTH, LLC ---------- 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._ 1. 2. RECENT MAJOR CHANGES Warnings and Precautions, Metabolic Changes (5.6) 12/2014 INDICATIONS AND USAGE Aripiprazole tablets are an atypical antipsychotic. The oral formulation is indicated for: 1. 2. DOSAGE AND ADMINISTRATION Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults (2.1) 10-15 mg/day 10-15 mg/day 30 mg/day Schizophrenia – adolescents (2.1) 2 mg/day 10 mg/day 30 mg/day Bipolar mania – adults: monotherapy (2.2) 15 mg/day 15 mg/day 30 mg/day Bipolar mania – adults: adjunct to lithium or valproate (2.2) 10-15 mg/day 15 mg/day 30 mg/day Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate (2.2) 2 mg/day 10 mg/day 30 mg/day 1. 2. DOSAGE FORMS AND STRENGTHS 1. CONTRAINDICATIONS 1. WARNINGS AND PRECAUTIONS 1. 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. (5.2) Schizophrenia (14.1) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2) Oral formulations: Administer once daily without regard to meals (2) Known CYP2D6 poor metabolizers: Half of the usual dose (2.7) Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3) Known hypersensitivity to Prečítajte si celý dokument