OLANZAPINE tablet, orally disintegrating

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

olanzapine (UNII: N7U69T4SZR) (olanzapine - UNII:N7U69T4SZR)

متاح من:

TYA Pharmaceuticals

INN (الاسم الدولي):

olanzapine

تركيب:

olanzapine 20 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 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 5.55.6 Oral olanzapine is indicated for acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment o

ملخص المنتج:

NDC:64725-0265-1 in a BOX of 30 TABLET, ORALLY DISINTEGRATINGS Olanzapine orally disintegrating tablets 5 mg are yellow-colored, capsule-shaped tablets, flat on one side and concave on the other side, embossed with R-262 on the flat side and plain on the concave side and are supplied in bottles of 30, carton of 10 packs containing 10 tablets each, carton of 30 packs containing 1 tablet each and carton of 3 packs containing 10 tablets each. Bottles of 30                                                                  NDC 55111-262-30 Carton of 10 packs (NDC 55111-262-78), each pack containing 10 tablets (55111-262-79) Carton of 30 packs (NDC 55111-262-31), each pack containing 1 tablet (55111-262-11) Carton of 3 packs (NDC 55111-262-81), each pack containing 10 tablets (55111-262-79) Olanzapine orally disintegrating tablets 10 mg are yellow-colored, capsule-shaped tablets, flat on one side and concave on the other side, embossed with R-263 on the flat side and plain on the concave side and are supplied in bottles of 30, carton of 10 packs containing 10 tablets each, carton of 30 packs containing 1 tablet each and carton of 3 packs containing 10 tablets each. Bottles of 30                                                                   NDC 55111-263-30 Carton of 10 packs (NDC 55111-263-78), each pack containing 10 tablets (55111-263-79) Carton of 30 packs (NDC 55111-263-31), each pack containing 1 tablet (55111-263-11) Carton of 3 packs (NDC 55111-263-81), each pack containing 10 tablets (55111-263-79) Olanzapine orally disintegrating tablets 15 mg are yellow-colored, capsule-shaped tablets, flat on one side and concave on the other side, embossed with R-264 on the flat side and plain on the concave side and are supplied in bottles of 30, carton of 10 packs containing 10 tablets each, carton of 30 packs containing 1 tablet each and carton of 3 packs containing 10 tablets each. Bottles of 30                                                                   NDC 55111-264-30 Carton of 10 packs (NDC 55111-264-78), each pack containing 10 tablets (55111-264-79) Carton of 30 packs (NDC 55111-264-31), each pack containing 1 tablet (55111-264-11) Carton of 3 packs (NDC 55111-264-81), each pack containing 10 tablets (55111-264-79) Olanzapine orally disintegrating tablets 20 mg are yellow-colored, capsule-shaped tablets, flat on one side and concave on the other side, embossed with R-265 on the flat side and plain on the concave side and are supplied in bottles of 30, carton of 10 packs containing 10 tablets each, carton of 30 packs containing 1 tablet each and carton of 3 packs containing 10 tablets each. Bottles of 30                                                                   NDC 55111-265-30 Carton of 10 packs (NDC 55111-265-78), each pack containing 10 tablets (55111-265-79) Carton of 30 packs (NDC 55111-265-31), each pack containing 1 tablet (55111-265-11) Carton of 3 packs (NDC 55111-265-81), each pack containing 10 tablets (55111-265-79) Store olanzapine 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 orally disintegrating tablets from light and moisture.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
TYA Pharmaceuticals
----------
Medication Guide
Olanzapine Orally Disintegrating Tablets
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.
4. Weight gain, especially in teenagers age 13 to 17.
These serious side effects are described below.
Olanzapine orally disintegrating tablets are not approved for treating
psychosis in elderly people with
dementia. 1. Increased risk of death in elderly people who are
confused, have memory loss and have lost
touch with reality (dementia-related psychosis).
High blood sugar can happen if you have diabetes already or if you
have never had diabetes. High blood
sugar could lead to: 2. High blood sugar (hyperglycemia).
• 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, sometimes high blood
sugar goes away when olanzapine orally disintegrating tablets are
stopped. People with diabetes and some
people who did not have diabetes before taking olanzapine orally
disintegra

خصائص المنتج

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
TYA PHARMACEUTICALS
----------
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._
• 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, ). 5.1417.2
WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE
BOXED WARNING SECTION OF THE
PACKAGE INSERT FOR SYMBYAX.
RECENT MAJOR CHANGES
Indications and Usage, Olanzapine and Fluoxetine in Combination:
Depressive Episodes Associated with Bipolar I Disorder MM/YYYY (1.5)
Dosage and Administration, Olanzapine and Fluoxetine in Combination:
Depressive Episodes Associated with Bipolar I Disorder MM/YYYY (2.5)
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 6week
trial in patients with schizophrenia . The increased
potential (in adolescents compared with adults) for weight gain and
hyperlipidemia may lead clinicians to consider
prescribing other drugs first in adolescents. (14.1)(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 disord