Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)
Lake Erie Medical DBA Quality Care Products LLC
ARIPIPRAZOLE
ARIPIPRAZOLE 5 mg
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)] Pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s 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 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/pregnancyregistr
Aripiprazole tablets 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with "2" on one side and "16" on other side. Aripiprazole tablets 5 mg are white to off-white, round, uncoated tablets, debossed with "5" on one side and "17" on other side. 55700-399-30 Aripiprazole tablets 10 mg are white to off-white, round, uncoated tablets, debossed with "10" on one side and "18" on other side. Aripiprazole tablets 15 mg are white to off-white, round, uncoated tablets, debossed with "15" on one side and "19" on other side. Aripiprazole tablets 20 mg are white to off-white, round, uncoated tablets, debossed with "20" on both sides. Aripiprazole tablets 30 mg are white to off-white, round, uncoated tablets, debossed with "30" on one side and "21" on other side. 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 Lake Erie Medical DBA Quality Care Products LLC ---------- 17 PATIENT COUNSELING INFORMATION See Medication Guide Discuss the following issues with patients prescribed aripiprazole: Clinical Worsening of Depression and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see WARNINGS AND PRECAUTIONS (5.2)]. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with aripiprazole and should counsel them in its appropriate use. A patient Medication Guide including information about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for aripiprazole. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that aripiprazole is not approve Prečítajte si celý dokument
ARIPIPRAZOLE- ARIPIPRAZOLE TABLET LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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 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, Metabolic Changes (5.6) 12/2014 INDICATIONS AND USAGE Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for: (1) Schizophrenia (14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2 ) 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 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 hypersensitivity to Prečítajte si celý dokument