Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)
AvPAK
OLANZAPINE
OLANZAPINE 5 mg
ORAL
PRESCRIPTION DRUG
Oral olanzapine 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 to 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 dyslipidemia. 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)] . Monotherapy — Oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy w
For Olanzapine Tablets, USP Olanzapine 2.5 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "2.5" on one side and "66" on other side. Olanzapine 5 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "5" on one side and "67" on other side. Olanzapine 7.5 mg tablets, USP are yellow colored, capsule shaped, biconvex, uncoated tablets, debossed with "7.5" on one side and "168" on other side. Olanzapine 10 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "10" on one side and "169" on other side. Olanzapine 15 mg tablets, USP are yellow colored, oval shaped, biconvex, uncoated tablets, debossed with "15" on one side and "1170" on other side. Olanzapine 20 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with "20" on one side and "1171" on other side. For Olanzapine Orally Disintegrating Tablets, USP The tablets are available as follows : Olanzapine orally disintegrating 5 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "86" on one side and "5" on other side. NDC 50268-615-13 (10 Tablets per card, 3 cards per carton) Olanzapine orally disintegrating 10 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "88" on one side and "10" on other side. NDC 50268-616-13 (10 Tablets per card, 3 cards per carton) Olanzapine orally disintegrating 15 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "89" on one side and "15" on other side. NDC 50268-617-13 (10 Tablets per card, 3 cards per carton) Olanzapine orally disintegrating 20 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with "90" on one side and "20" on other side. Dispensed in Unit Dose package. For Institutional Use Only. Store olanzapine tablets or orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ see USP]. 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 olanzapine tablets or orally disintegrating tablets from light and moisture.
Abbreviated New Drug Application
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING AvPAK ---------- SPL MEDGUIDE Medication Guide Olanzapine (oh-LAN-za-peen) Tablets, USP Olanzapine (oh-LAN-za-peen) Orally Disintegrating Tablets, USP Read the Medication Guide that comes with olanzapine tablets or orally disintegrating tablets 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 olanzapine tablets or orally disintegrating tablets. What is the most important information I should know about olanzapine tablets or orally disintegrating tablets? Olanzapine tablets or orally disintegrating tablets may cause serious side effects, including: 1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). 2. High blood sugar (hyperglycemia). 3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17. 4. Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17. These serious side effects are described below. 1. 1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine tablets or orally disintegrating tablets are not approved for treating psychosis in elderly people with dementia. 2. 2. High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to: • a build up of acid in your blood due to ketones (ketoacidosis) • coma • death Your doctor should do tests to check your blood sugar before you start taking olanzapine tablets or orally disintegrati Baca dokumen lengkapnya
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING AVPAK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION OLANZAPINE ORALLY DISINTEGRATING TABLETS, USP RX ONLY THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLANZAPINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE. OLANZAPINE TABLETS USP, FOR ORAL USE OLANZAPINE ORALLY DISINTEGRATING TABLETS, USP FOR ORAL 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. OLANZAPINE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.14, 17.2) WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE BOXED WARNING SECTION OF THE PACKAGE INSERT FOR OLANZAPINE AND FLUOXETINE HYDROCHLORIDE CAPSULES. INDICATIONS AND USAGE Olanzapine is an atypical antipsychotic indicated: (1) As oral formulation for the: (1) • Treatment of schizophrenia. (1.1) (1) • Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) (1) • Adolescents (ages 13 to 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 dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) (1) • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) (1) • Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) (1) • Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipo Baca dokumen lengkapnya