Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)
STAT RX USA LLC
OLANZAPINE
OLANZAPINE 5 mg
ORAL
PRESCRIPTION DRUG
Oral ZYPREXA is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see Clinical Studies (14.1)] . When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions (5.5, 5.6)] . Monotherapy — Oral ZYPREXA is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy was established in three clinical trials in adult patients with manic or mixed ep
The ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15 mg tablets are elliptical, blue, and debossed with LILLY and tablet number. The 20 mg tablets are elliptical, pink, and debossed with LILLY and tablet number. The tablets are available as follows: a Identi-Dose® (unit dose medication, Lilly). ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) are yellow, round, and debossed with the tablet strength. The tablets are available as follows: ZYPREXA is a registered trademark of Eli Lilly and Company. ZYDIS is a registered trademark of Catalent Pharma Solutions. a ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is manufactured for Eli Lilly and Company by Catalent Pharma Solutions, United Kingdom, SN5 8RU. ZYPREXA IntraMuscular is available in: Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP] for up to 1 hour if necessary. Discard any unused portion of reconstituted ZYPREXA IntraMuscular. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze.
New Drug Application
ZYPREXA - OLANZAPINE TABLET STAT RX USA LLC ---------- Medication Guide ZYPREXA® (zy-PREX-a) (olanzapine) Tablet ZYPREXA® ZYDIS® (zy-PREX-a ZY-dis) (olanzapine) Tablet, Orally Disintegrating Read the Medication Guide that comes with ZYPREXA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about ZYPREXA. What is the most important information I should know about ZYPREXA? Serious side effects may happen when you take ZYPREXA, including: Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ZYPREXA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ZYPREXA is not approved for treating psychosis in the elderly with dementia. High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or even if you have never had diabetes. In rare cases, this could lead to ketoacidosis (build up of acid in the blood due to ketones), coma, or death. Your doctor should do lab tests to check your blood sugar before you start taking ZYPREXA and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when ZYPREXA is stopped. People with diabetes and some people who did not have diabetes before taking ZYPREXA need to take medicine for high blood sugar even after they stop taking ZYPREXA. If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking ZYPREXA. Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking ZYPREXA: • feel very thirsty • need to urinate more than usual • feel very hungry • feel weak or tired • feel sick to your stomach • feel confused, or your breath smells fruity. High Leggi il documento completo
ZYPREXA - OLANZAPINE TABLET STAT RX USA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZYPREXA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZYPREXA. ZYPREXA (OLANZAPINE) TABLET FOR ORAL USE ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING FOR ORAL USE ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION FOR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 1996 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _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. ZYPREXA IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.14, 17.2) WHEN USING ZYPREXA AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE BOXED WARNING SECTION OF THE PACKAGE INSERT FOR SYMBYAX. RECENT MAJOR CHANGES Indications and Usage: Schizophrenia (1.1) 12/2009 Bipolar I Disorder (Manic or Mixed Episodes) (1.2) 12/2009 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder (1.3) 12/2009 ZYPREXA IntraMuscular: Agitation Associated with Schizophrenia and Bipolar I Mania (1.4) 12/2009 Dosage and Administration: Schizophrenia (2.1) 12/2009 Bipolar I Disorder (Manic or Mixed Episodes) (2.2) 12/2009 Warnings and Precautions: Orthostatic Hypotension (5.8) 05/2010 Leukopenia, Neutropenia, and Agranulocytosis (5.9) 08/2009 Hyperprolactinemia (5.15) 01/2010 INDICATIONS AND USAGE ZYPREXA (olanzapine) is an atypical antipsychotic indicated: _As oral formulation for the:_ Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia Leggi il documento completo