Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)
Aphena Pharma Solutions - Tennessee, LLC
OLANZAPINE
OLANZAPINE 20 mg
ORAL
PRESCRIPTION DRUG
Olanzapine Tablets, USP 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. [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)] . Information describing the use of olanzapine tablets and olanzapine orally disintegrating tablets in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Monoth
Olanzapine Tablets, USP 2.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “2.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-620-30) Olanzapine Tablets, USP 5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-621-30) Olanzapine Tablet, USPs 7.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “7.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-622-30) Olanzapine Tablets, USP 10 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “10” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-623-30) Olanzapine Tablets, USP 15 mg are light blue, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 15” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-624-30) Olanzapine Tablets, USP 20 mg are light pink, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 20” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-625-30) Store olanzapine tablets 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]. Protect olanzapine tablets from light and moisture.
Abbreviated New Drug Application
OLANZAPINE- OLANZAPINE TABLET, FILM COATED Aphena Pharma Solutions - Tennessee, LLC ---------- Medication Guide Olanzapine Tablets, USP 20 mg Read the Medication Guide that comes with olanzapine 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. What is the most important information I should know about olanzapine tablets? Olanzapine 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. 4. Weight gain, especially in teenagers age 13 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 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: Your doctor should do tests to check your blood sugar before you start taking olanzapine tablets and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine tablets are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine tablets need to take medicine for high blood sugar even after they stop taking olanzapine tablets. If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking olanzapine tablets. Call your doctor if you hav Διαβάστε το πλήρες έγγραφο
OLANZAPINE- OLANZAPINE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLANZAPINE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLANZAPINE TABLETS, USP. OLANZAPINE 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 TABLETS ARE NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.14, 17.2) WHEN USING OLANZAPINE TABLETS AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE BOXED WARNING SECTION OF THE PACKAGE INSERT FOR SYMBYAX . RECENT MAJOR CHANGES None INDICATIONS AND USAGE Olanzapine Tablets, USP are 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) 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) Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. _As olanzapine tablets and fluoxetine in combination for the:_ Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax . DOSA Διαβάστε το πλήρες έγγραφο