Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)
REMEDYREPACK 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)] . 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
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 31722-819-30 Bottles of 100 Tablets NDC 31722-819-01 Blister card of 10 Unit dose tablets NDC 31722-819-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-819-32 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 31722-820-30 Bottles of 100 Tablets NDC 31722-820-01 Blister card of 10 Unit dose tablets NDC 31722-820-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-820-32 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 31722-827-30 Bottles of 100 Tablets NDC 31722-827-01 Blister card of 10 Unit dose tablets NDC 31722-827-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-827-32 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 31722-828-30 Bottles of 100 Tablets NDC 31722-828-01 Blister card of 10 Unit dose tablets NDC 31722-828-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-828-32 Aripiprazole tablets USP, 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 31722-829-30 Bottles of 100 Tablets NDC 31722-829-01 Blister card of 10 Unit dose tablets NDC 31722-829-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-829-32 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 31722-830-30 Bottles of 100 Tablets NDC 31722-830-01 Blister card of 10 Unit dose tablets NDC 31722-830-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-830-32 Store at 20º to 25º C (68º to 77ºF) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET REMEDYREPACK INC. ---------- SPL MEDGUIDE SECTION Aripiprazole Tablets (air-eh-PIP-rah-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 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 vis Læs hele dokumentet
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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. (5.2) 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 tablets are an atypical antipsychotic. The oral formulations are indicated for: •Schizophrenia ( 14.1) 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 • 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 hypersensititivity 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. Læs hele dokumentet