OLANZAPINE- olanzapine tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

REMEDYREPACK INC.

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 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 ( 5.5)] . Monotherapy — 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 manic

Обзор продуктов:

Olanzapine tablets are supplied as follows:  2.5 mg tablets: Yellow, oval shaped uncoated tablets debossed with ‘551’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-551-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-551-88 Bottles of 100’s with Non Child Resistant Cap ….……………….. NDC 62756-551-08 Bottles of 1000’s with Non Child Resistant Cap …………….…… NDC 62756-551-18 5 mg tablets: Yellow, oval shaped uncoated tablets debossed with ‘552’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-552-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-552-88 Bottles of 100’s with Non Child Resistant Cap….…………….….. NDC 62756-552-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-552-18 7.5 mg tablets: Yellow, round shaped uncoated tablets debossed with ‘553’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-553-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-553-88 Bottles of 100’s with Non Child Resistant Cap….……….……….. NDC 62756-553-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-553-18 10 mg tablets: Yellow, oval shaped uncoated tablets debossed with ‘554’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-554-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-554-88 Bottles of 100’s with Non Child Resistant Cap….…………….….. NDC 62756-554-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-554-18 15 mg tablets: Yellow, oval shaped uncoated tablets debossed with ‘555’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-555-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-555-88 Bottles of 100’s with Non Child Resistant Cap….………………... NDC 62756-555-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-555-18 20 mg tablets: Yellow, oval shaped uncoated tablets debossed with ‘556’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-556-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-556-88 Bottles of 100’s with Non Child Resistant Cap….…………….….. NDC 62756-556-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-556-18 Olanzapine orally disintegrating tablets are supplied as follows:  5 mg tablets: Yellow, round shaped uncoated tablets debossed with ‘O5’ on one side and plain on other side. Unit-dose pack of 10........................................................ NDC 62756-751-66 Unit-dose pack of 30........................................................ NDC 62756-751-64 10 mg tablets: Yellow, round shaped uncoated tablets debossed with ‘O10’ on one side and plain on other side. Unit-dose pack of 10........................................................ NDC 62756-754-66 Unit-dose pack of 30........................................................ NDC 62756-754-64 15 mg tablets: Yellow, round shaped uncoated tablets debossed with ‘O15’ on one side and plain on other side. Unit-dose pack of 10........................................................ NDC 62756-755-66 Unit-dose pack of 30........................................................ NDC 62756-755-64 20 mg tablets: Yellow, round shaped uncoated tablets debossed with ‘O20’ on one side and plain on other side. Unit-dose pack of 10........................................................ NDC 62756-757-66 Unit-dose pack of 30........................................................ NDC 62756-757-64 Store olanzapine tablets and olanzapine orally disintegrating tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [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 and olanzapine orally disintegrating tablets from light and moisture.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

OLANZAPINE- OLANZAPINE TABLET
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Olanzapine Tablets
Olanzapine Orally Disintegrating Tablets
(oh lan′ za peen)
Read the Medication Guide that comes with olanzapine tablets or
olanzapine orally disintegrating 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.
What is the most important information I should know about olanzapine?
Olanzapine 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 is 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 or
olanzapine orally disintegrating tablets and during treatment. In
people who do not have diabetes,
sometimes high blood sugar goes away when olanzapine tablets or
olanzapine orally disintegrating tablets
is stopped. People with

Характеристики продукта

OLANZAPINE- OLANZAPINE TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OLANZAPINE.
OLANZAPINE TABLETS, FOR ORAL USE
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, 5.13, 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 10/2016
Symptoms (DRESS) ( 5.4)
Orthostatic Hypotension ( 5.7) 07/2015
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 b