OLANZAPINE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

TYA Pharmaceuticals

INN (Διεθνής Όνομα):

OLANZAPINE

Σύνθεση:

OLANZAPINE 15 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

NDC:64725-0555-1 in a BOTTLE of 30 TABLETS Olanzapine tablets are supplied as follows:   2.5 mg tablets: Yellow, oval shaped uncoated tablets debossed with ‘2.5’ 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 ‘5’ 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 ‘7.5’ 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 ‘10’ 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 ‘15’ 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 ‘20’ 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 Store olanzapine 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 from light and moisture.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

OLANZAPINE - OLANZAPINE TABLET
TYA Pharmaceuticals
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MEDICATION GUIDE
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. Olanzapine 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 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. if you have any of these symptoms of high blood
sugar (hyperglycemia) while taking
olanzapine tablets: High fat levels may happen in people treated with
olanzapine 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 tablets and during
treatment. Weight gain is very common in people who take olanzapine
tablets. Teenagers (13 to 17 years
old) are more likely to gain weight and to gain more weight than
adults. Some people may gain a lot of
weight while taking olanzapine tablets, so you and your doctor should
check your weight regularly. Talk
to your doctor about ways to control weight gain, such as eating a
healthy, balanced diet, and exercising.

Αρχείο Π.Χ.Π.

OLANZAPINE - OLANZAPINE TABLET
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 TABLETS. OLANZAPINE 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 ADMINISTRATION
Schizophrenia in adults ( ) 2.1
Oral: Start at 5 mg to 10 m