País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)
Lannett Company, Inc.
ARIPIPRAZOLE
ARIPIPRAZOLE 1 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Aripiprazole Oral Solution is indicated for the treatment of: - Schizophrenia [see Clinical Studies (14.1 )] - Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2 )] - Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3 )] - Irritability Associated with Autistic Disorder [see Clinical Studies (14.4 )] - Treatment of Tourette’s Disorder [see Clinical Studies (14.5 )] Aripiprazole oral solution 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 are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://wome
Aripiprazole Oral Solution (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. Aripiprazole Oral Solution is available as follows: 150 mL bottle NDC 54838-570-59 237 mL bottle NDC 54838-570-70 Oral Solution Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Opened bottles of Aripiprazole Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.
Abbreviated New Drug Application
Lannett Company, Inc. ---------- MEDICATION GUIDE Aripiprazole (ar" i pip' ra zole) Oral Solution What is the most important information I should know about aripiprazole oral solution? (For other side effects, also see “What are the possible side effects of aripiprazole oral solution?”) Serious side effects may happen when you take aripiprazole oral solution, including: • Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole oral solution can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole oral solution 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 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 you Llegiu el document complet
ARIPIPRAZOLE- ARIPIPRAZOLE SOLUTION LANNETT COMPANY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ARIPIPRAZOLE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARIPIPRAZOLE ORAL SOLUTION. ARIPIPRAZOLE ORAL SOLUTION 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) INDICATIONS AND USAGE Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia (14.1) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2) Adjunctive Treatment of Major Depressive Disorder (14.3) 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 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 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 to 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 Major Depressive Disorder - Adults adjunct to antidepressants (2.3) 2 to 5 mg/day 5 to 10 mg/day 15 mg/day Irritability associated with autistic disorder – pediatric patients (2.4) 2 mg/day 5 to 10 mg/day 15 mg/day Llegiu el document complet