OLANZAPINE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Indoco Remedies Limited

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Oral olanzapine tablets 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 13-17), 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 tablets 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

產品總結:

The olanzapine 2.5 mg tablets are oval, biconvex, white to off white coloured film coated tablets debossed with '45' on one side and ‘I’ on other side, 5 mg, tablets are  round, biconvex, white to off white coloured film coated tablets debossed with '46' on one side and ‘I’ on other side, 7.5 mg tablets are round, biconvex, white to off white coloured film coated tablets debossed with '47' on one side and ‘I’ on other side, and 10 mg tablets are round, biconvex, white to off white coloured film coated tablets debossed with '48' on one side and ‘I’ on other side . The 15 mg tablets are capsule shaped, biconvex, blue coloured, film coated tablets debossed with '49' on one side and ‘I’ on other side. The 20 mg tablets are oval, biconvex, pink coloured, film coated tablets debossed with '50' on one side and ‘I’ on other side. The tablets are available as follows: Store olanzapine tablets at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 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 tablets from light and moisture.

授权状态:

Abbreviated New Drug Application

资料单张

Indoco Remedies Limited
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SPL MEDGUIDE SECTION
Medication Guide
Olanzapine Tablets USP
(oh lan' za peen)
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 aboutolanzapine
tablets?
Olanzapinetablets 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 tablets 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 and
during treatment. In people who do not have diabetes, sometimes high
blood sugar goes away when
olanzapine tablets is 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 s

产品特点

OLANZAPINE - OLANZAPINE TABLET
INDOCO REMEDIES LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE TABLETS, 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 TABLETS IS NOT APPROVED FOR THE TREATMENT OF
PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS. (5.1, 8.5, 17) 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, Tardive Dyskinesia (5.6) 10/2019
Warnings and Precautions, Use in Patients
with Concomitant Illness (5.14) Removed 4/2020
Warnings and Precautions, Anticholinergic
(antimuscarinic) Effects (5.14) 4/2020
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 13-17): 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 13-17): Efficacy was esta