দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Aripiprazole Oral Tablets are 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 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/.
Aripiprazole tablets, USP 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with "2" on one side and "16" on other side. Bottles of 30 NDC 13668-216-30 Bottles of 90 NDC 13668-216-90 Bottles of 100 NDC 13668-216-01 Bottles of 500 NDC 13668-216-05 Bottles of 6250 NDC 13668-216-69 100 Unit dose Tablets NDC 13668-216-74 Aripiprazole tablets, USP 5 mg are white to off-white, round, uncoated tablets, debossed with "5" on one side and "17" on other side. Bottles of 30 NDC 13668-217-30 Bottles of 90 NDC 13668-217-90 Bottles of 100 NDC 13668-217-01 Bottles of 500 NDC 13668-217-05 Bottles of 6250 NDC 13668-217-69 100 Unit dose Tablets NDC 13668-217-74 Aripiprazole tablets, USP 10 mg are white to off-white, round, uncoated tablets, debossed with "10" on one side and "18" on other side. Bottles of 30 NDC 13668-218-30 Bottles of 90 NDC 13668-218-90 Bottles of 100 NDC 13668-218-01 Bottles of 500 NDC 13668-218-05 Bottles of 7000 NDC 13668-218-52 100 Unit dose Tablets NDC 13668-218-74 Aripiprazole tablets, USP 15 mg are white to off-white, round, uncoated tablets, debossed with "15" on one side and "19" on other side. Bottles of 30 NDC 13668-219-30 Bottles of 90 NDC 13668-219-90 Bottles of 100 NDC 13668-219-01 Bottles of 500 NDC 13668-219-05 Bottles of 5000 NDC 13668-219-51 100 Unit dose Tablets NDC 13668-219-74 Aripiprazole tablets, USP 20 mg are white to off-white, round, uncoated tablets, debossed with "20" on both sides. Bottles of 30 NDC 13668-220-30 Bottles of 90 NDC 13668-220-90 Bottles of 100 NDC 13668-220-01 Bottles of 500 NDC 13668-220-05 Bottles of 3400 NDC 13668-220-68 100 Unit dose Tablets NDC 13668-220-74 Aripiprazole tablets, USP 30 mg are white to off-white, round, uncoated tablets, debossed with "30" on one side and "21" on other side. Bottles of 30 NDC 13668-221-30 Bottles of 90 NDC 13668-221-90 Bottles of 100 NDC 13668-221-01 Bottles of 500 NDC 13668-221-05 Bottles of 2500 NDC 13668-221-31 100 Unit dose Tablets NDC 13668-221-74 Tablets Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET Denton Pharma, Inc. DBA Northwind Pharmaceuticals ---------- SPL MEDGUIDE MEDICATION GUIDE Aripiprazole (AR-i-PIP-ra-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) 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 heal সম্পূর্ণ নথি পড়ুন
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS ---------- 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 WARNINGS: 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 Anagrelide is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. (1) (1) 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 সম্পূর্ণ নথি পড়ুন