Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)
ScieGen Pharmaceuticals Inc
ARIPIPRAZOLE
ARIPIPRAZOLE 10 mg
ORAL
PRESCRIPTION DRUG
Aripiprazole orally disintegrating tablets are indicated for the treatment of: - Schizophrenia [ see CLINICAL STUDIES ( 14.1) ] - Irritability Associated with Autistic Disorder [see Clinical Studies ( 14.4)] - Treatment of Tourette’s Disorder [see Clinical Studies ( 14.5)] 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 Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. Healthcare providers
Aripiprazole orally disintegrating tablets, USP are round tablets with markings on either side. Aripiprazole orally disintegrating tablets, USP are available in the strengths and packages listed in Table 33. Tablets Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ARIPIPRAZOLE- ARIPIPRAZOLE ORALLY DISINTEGRATING TABLET ScieGen Pharmaceuticals Inc ---------- MEDICATION GUIDE Aripiprazole Orally Disintegrating Tablets, USP (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 orally disintegrating tablets? (For other side effects, also see “What are the possible side effects of aripiprazole orally disintegrating tablets?”). Serious side effects may happen when you take aripiprazole orally disintegrating tablets, including: • Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole orally disintegrating 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 orally disintegrating 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) 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 i Прочитать полный документ
ARIPIPRAZOLE- ARIPIPRAZOLE ORALLY DISINTEGRATING TABLET SCIEGEN PHARMACEUTICALS INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS. ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS 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 ( 5.5) 08/2019 INDICATIONS AND USAGE Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia ( 14.1) Irritability Associated with Autistic Disorder ( 14.4) Treatment of Tourette’s disorder ( 14.5) DOSAGE AND ADMINISTRATION INITIAL DOSE RECOMMENDED DOSE MAXIMUM DOSE Schizophrenia – adults ( 2.1) 10 mg/day to 15 mg/day 10 mg/day to 15 mg/day 30 mg/day Schizophrenia – adolescents ( 2.1) 2 mg/day 10 mg/day 30 mg/day Irritability associated with autistic disorder – pediatric patients ( 2.4) 2 mg/day 5 mg/day to 10 mg/day 15 mg/day Tourette’s disorder – ( 2.5) Patients < 50 kg 2 mg/day 5 mg/day 10 mg/day Patients ≥ 50 kg 2 mg/day 10 mg/day 20 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 Orally Disintegrating Tablets: 10 mg and 15 mg ( 3) CONTRAINDICATIONS Known hypersensitivity to aripip Прочитать полный документ