Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)
Avera McKennan Hospital
OLANZAPINE
OLANZAPINE 5 mg
ORAL
PRESCRIPTION DRUG
Oral olanzapine orally disintegrating tablets are 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 (5.4)]. 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 was established in three clinical trials in adult patients with m
Olanzapine Orally Disintegrating Tablets, USP are available containing 5 mg, 10 mg, 15 mg or 20 mg of olanzapine, USP. The 5 mg tablets are yellow, round, unscored tablets debossed with M on one side of the tablet and OE1 on the other side. They are available as follows: NDC 0378-5510-93 bottles of 30 tablets NDC 69189-5510-1 single dose pack with 1 ODT as repackaged by Avera McKennan Hospital Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING Avera McKennan Hospital ---------- MEDICATION GUIDE OLANZAPINE ORALLY DISINTEGRATING TABLETS, USP (oh lan′ za peen) 5 mg, 10 mg, 15 mg and 20 mg Read the Medication Guide that comes with olanzapine orally disintegrating tablets before you start taking them 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 orally disintegrating tablets. What is the most important information I should know about olanzapine orally disintegrating tablets? Olanzapine 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. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine orally disintegrating 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 start taking olanzapine orally disintegrating tablets and during treatment. In people who do not have diabetes, somet Perskaitykite visą dokumentą
OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLANZAPINE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE ORALLY DISINTEGRATING TABLETS. OLANZAPINE ORALLY DISINTEGRATING 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_ • RECENT MAJOR CHANGES Warnings and Precautions: INDICATIONS AND USAGE Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated: _As oral formulation for the:_ • • • • _As Olanzapine and Fluoxetine in Combination for the:_ • ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. OLANZAPINE ORALLY DISINTEGRATING TABLETS ARE NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.12, 17.2) WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE BOXED WARNING SECTION OF THE PACKAGE INSERT FOR SYMBYAX. Metabolic Changes (5.4) 12/2014 Orthostatic Hypotension (5.6) 7/2015 Hyperprolactinemia (5.13) 12/2014 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: Perskaitykite visą dokumentą