Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)
Ajanta Pharma Limited
OLANZAPINE
OLANZAPINE 2.5 mg
ORAL
PRESCRIPTION DRUG
- None with olanzapine monotherapy. None with olanzapine monotherapy. - When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax® . When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax® . - For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. When using olanzapine and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax® . Teratogenic Effects, Pregnancy Category C — In oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the maxi
Olanzapine Tablets, USP 2.5 mg tablets are white colored, round, biconvex, film-coated tablets debossed ‘OL1’ on one side and plain on other side. The 5 mg tablets are white colored, round, biconvex, film-coated tablets debossed ‘OL2’ on one side and plain on other side. The 7.5 mg tablets are white colored, capsule shaped, biconvex, film-coated tablets debossed ‘OL3’ on one side and plain on other side. The 10 mg tablets are white colored, round, biconvex, film-coated tablets debossed ‘OL4’ on one side and plain on other side. The 15 mg tablets are blue colored, oval shaped, biconvex, film-coated tablets debossed ‘OL5’ on one side and plain on other side. The 20 mg tablets are pink colored, capsule shaped, biconvex, film-coated tablets debossed ‘OL6’ on one side and plain on other side. The tablets are available as follows: Store olanzapine tablets at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. 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 from light and moisture.
Abbreviated New Drug Application
OLANZAPINE - OLANZAPINE TABLET Ajanta Pharma Limited ---------- MEDICATION GUIDE Medication Guide OlanzapineTablets, USP (oh lan' za peen) Read the Medication Guide that comes with olanzapine tablets before youstart 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 aboutyour medical condition or treatment. Talk with your doctor or pharmacist ifthere is something you do not understand or you want to learn more about olanzapine tablets. What is the most important information I should know about olanzapinetablets? Olanzapinetablets 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. Theseserious side effects are described below. 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 are not approved for treating psychosis in elderly people with dementia. 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 starttaking olanzapine tablets and during treatment. In people who do not havediabetes, sometimes high blood sugar goes away when olanzapine tablets arestopped. People with diabetes and some people who did not have diabetes beforetaking olanzapine tablets need to take medicine for high blood suga Prečítajte si celý dokument
OLANZAPINE - OLANZAPINE TABLET AJANTA PHARMA LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLANZAPINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE TABLETS. OLANZAPINE TABLETS, 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 SYMBYAX . RECENT MAJOR CHANGES Warnings and Precautions: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (5.4) 10/2016 Falls (5.8) 02/2017 INDICATIONS AND USAGE 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 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) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) 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) Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adoles Prečítajte si celý dokument