OLANZAPINE tablet, film coated OLANZAPINE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)

Sẵn có từ:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Tên quốc tế):

OLANZAPINE

Thành phần:

OLANZAPINE 15 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 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) ]. Olanzapine Tablets USP are 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 manic or mixed epi

Tóm tắt sản phẩm:

Olanzapine Tablets USP, 2.5 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and “5767” on the other side, containing 2.5 mg olanzapine. Olanzapine Tablets USP, 5 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and "5768” on the other side, containing 5 mg olanzapine, and packaged in blistercards of 30 tablets. Olanzapine Tablets USP, 7.5 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and "5769” on the other side, containing 7.5 mg olanzapine. Olanzapine Tablets USP, 10 mg are available as off-white, round, unscored, film-coated tablets, debossed with “TEVA” on one side and "5770” on the other side, containing 10 mg olanzapine, and packaged in blistercards of 30 tablets. Olanzapine Tablets USP, 15 mg are available as blue, capsule-shaped, unscored, film-coated tablets, debossed with “TEVA” on one side and “5771” on the other side, containing 15 mg olanzapine, and packaged in blistercards of 30 tablets. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). 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 FROM LIGHT AND MOISTURE KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
Olanzapine (oh LAN za peen)
Tablets USP
Read the Medication Guide that comes with olanzapine 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 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
17or when used in combination with fluoxetine in children age 10 to
17.
4. Weight gain, especially in teenagers age 13 to 17or 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 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 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 t

Đặc tính sản phẩm

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
OLANZAPINE- OLANZAPINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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 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
Indications and Usage, _Olanzapine and Fluoxetine in Combination_:
Depressive Episodes Associated with Bipolar I Disorder (1.5) 07/2013
Dosage and Administration, _Olanzapine and Fluoxetine in Combination_:
Depressive Episodes Associated with Bipolar I Disorder (2.5) 07/2013
Dosing in Special Populations (2.7) 07/2013
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)
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 hyperlipidemia 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 pa