OLANZAPINE tablet, orally disintegrating

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

TYA Pharmaceuticals

ИНН (Международная Имя):

OLANZAPINE

состав:

OLANZAPINE 20 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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   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 .   — 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 or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one monotherapy maintenance trial   deciding among the alternative treatments available for adolescents, clinicians should consider

Обзор продуктов:

NDC:64725-0757-1 in a BOX, UNIT-DOSE of 30 TABLET, ORALLY DISINTEGRATINGS 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 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]. 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.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

OLANZAPINE - OLANZAPINE TABLET, ORALLY DISINTEGRATING
TYA Pharmaceuticals
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MEDICATION GUIDE
Read the Medication Guide that comes with 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
orally disintegrating tablets. Olanzapine orally disintegrating
tablets are not approved for treating
psychosis in elderly people with dementia. 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 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 disintegrating tablets need to take medicine
for high blood sugar even after they
stop taking olanzapine orally disintegrating tablets. If you have
diabetes, follow your doctor’s instructions
about how often to check your blood sugar while taking olanzapine
orally disintegrating tablets. if you
have any of these symptoms of high blood sugar (hyperglycemia) while
taking olanzapine orally
disintegrating tablets: High fat levels may happen in people treated
with olanzapine orally
disintegrating tablets, especially in teenagers (13 to 17 years old).
You may not have any symptoms, so
your doctor should do blood tests to check your cholesterol and
triglyceride levels before you start taking
olanzapine orally disintegrating tablets and during treatment. Weight
gain is very common in people
who take olanzapine orally disintegrating tablets. Teenagers (13 to 17
years old) are more likely to ga

Характеристики продукта

OLANZAPINE - OLANZAPINE TABLET, ORALLY DISINTEGRATING
TYA PHARMACEUTICALS
----------
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 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. (5.1,5.14,17.2)
WHEN USING OLANZAPINE AND FLUOXETINE IN COMBINATION, ALSO REFER TO THE
SECTION OF THE PACKAGE INSERT
FOR SYMBYAX*. BOXED WARNING
RECENT MAJOR CHANGES
none
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
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 ( ).
Maintenance efficacy has not been systematically
evaluated. 14.2
_As Olanzapine 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*.
DOSAGE AND ADMINIS