OLANZAPINE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Aphena Pharma Solutions - Tennessee, LLC

INN (Jina la Kimataifa):

OLANZAPINE

Tungo:

OLANZAPINE 20 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. [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 (5.5, 5.6)] . Information describing the use of olanzapine tablets and olanzapine orally disintegrating tablets in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Monoth

Bidhaa muhtasari:

Olanzapine Tablets, USP 2.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “2.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-620-30) Olanzapine Tablets, USP 5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-621-30) Olanzapine Tablet, USPs 7.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “7.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-622-30) Olanzapine Tablets, USP 10 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “10” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-623-30) Olanzapine Tablets, USP 15 mg are light blue, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 15” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-624-30) Olanzapine Tablets, USP 20 mg are light pink, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 20” on the other side. They are supplied as follows: Bottles of 30s (NDC 60429-625-30) Store olanzapine tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect olanzapine tablets from light and moisture.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
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Medication Guide
Olanzapine Tablets, USP
20 mg
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.
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 17.
4.
Weight gain, especially in teenagers age 13 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:
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.
Call your doctor if you hav

Tabia za bidhaa

OLANZAPINE- OLANZAPINE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 TABLETS ARE NOT APPROVED FOR THE TREATMENT
OF PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS. (5.1, 5.14, 17.2)
WHEN USING OLANZAPINE TABLETS AND FLUOXETINE IN COMBINATION, ALSO
REFER TO THE BOXED WARNING SECTION
OF THE PACKAGE INSERT FOR SYMBYAX
.
RECENT MAJOR CHANGES
None
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)
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
(14.2). Maintenance efficacy has not been
systematically evaluated.
_As olanzapine tablets 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
.
DOSA