OLANZAPINE tablet, film coated
Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
Φύλλο οδηγιών χρήσης
(PIL)
03-10-2022
Αρχείο Π.Χ.Π.
(SPC)
03-10-2022
Δραστική ουσία:
olanzapine (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)
Διαθέσιμο από:
Dr. Reddy's Laboratories Ltd.
INN (Διεθνής Όνομα):
olanzapine
Σύνθεση:
olanzapine 2.5 mg
Οδός χορήγησης:
ORAL
Τρόπος διάθεσης:
PRESCRIPTION DRUG
Θεραπευτικές ενδείξεις:
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) ]. 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 episode
Περίληψη προϊόντος:
Olanzapine Tablets USP, 2.5 mg are white, film coated, oval, biconvex tablets debossed “R” on 2.5 one side and “0163”on other side and are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-163-30 Bottles of 100 NDC 55111-163-01 Bottles of 500 NDC 55111-163-05 Unit dose packages of 100 (10 x 10) NDC 55111-163-78 Olanzapine Tablets USP, 5 mg are white, film coated, oval, biconvex tablets debossed “R” on 5 one side and “0164” on other side and are supplied in bottles of 30, 100, 500, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 43598-164-30 Bottles of 100 NDC 43598-164-01 Bottles of 500 NDC 43598-164-05 Bottles of 1000 NDC 43598-164-10 Unit dose packages of 100 (10 x 10) NDC 43598-164-78 Olanzapine Tablets USP, 7.5 mg are white, film coated, oval, biconvex tablets debossed “R” on 7.5 one side and “0165” on other side and are supplied in bottles of 30, 60, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 43598-165-30 Bottles of 60 NDC 43598-165-60 Bottles of 100 NDC 43598-165-01 Bottles of 500 NDC 43598-165-05 Unit dose packages of 100 (10 x 10) NDC 43598-165-78 Olanzapine Tablets USP, 10 mg are white, film coated, oval, biconvex tablets debossed “R” on 10 one side and “0166” on other side and are supplied in bottles of 30, 60, 100, 500, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 43598-166-30 Bottles of 60 NDC 43598-166-60 Bottles of 100 NDC 43598-166-01 Bottles of 500 NDC 43598-166-05 Bottles of 1000 NDC 43598-166-10 Unit dose packages of 100 (10 x 10) NDC 43598-166-78 Store olanzapine tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. 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, FILM COATED
Dr. Reddy's Laboratories Ltd.
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Medication Guide
Olanzapine Tablets USP
(oh lan' za peen)
Read the Medication Guide that comes with olanzapine tablets before
you start taking them 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,
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 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:
• 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 are stopped. People with diabetes and some people who did not
have diabetes before taking
olanzapine tablets need to take medicine f
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Αρχείο Π.Χ.Π.
OLANZAPINE- OLANZAPINE TABLET, FILM COATED
DR. REDDY'S LABORATORIES LTD.
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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 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 to 17): Efficacy was established in one 6week
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 o
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