OLANZAPINE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

OLANZAPINE

Composition:

OLANZAPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral olanzapine orally disintegrating 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)]. Oral olanzapine orally disintegrating 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 tri

Product summary:

Olanzapine Orally Disintegrating Tablets, USP are available containing 5 mg, 10 mg, 15 mg or 20 mg of olanzapine, USP. The 5 mg tablets are yellow, round, unscored tablets debossed with M on one side of the tablet and OE1 on the other side. They are available as follows: NDC 0378-5510-93 bottles of 30 tablets The 10 mg tablets are yellow, round, unscored tablets debossed with M on one side of the tablet and OE2 on the other side. They are available as follows: NDC 0378-5511-93 bottles of 30 tablets The 15 mg tablets are yellow, round, unscored tablets debossed with M on one side of the tablet and OE3 on the other side. They are available as follows: NDC 0378-5512-93 bottles of 30 tablets The 20 mg tablets are yellow, round, unscored tablets debossed with M on one side of the tablet and OE4 on the other side. They are available as follows: NDC 0378-5513-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect olanzapine orally disintegrating tablets from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Olanzapine Orally Disintegrating Tablets, USP
(oh lan′ za peen)
Read the Medication Guide that comes with olanzapine orally
disintegrating 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 orally disintegrating tablets.
What is the most important information I should know about olanzapine
orally disintegrating tablets?
Olanzapine orally disintegrating 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 orally
disintegrating 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 orally
disintegrating tablets and during treatment. In people who do not have
diabetes, sometimes high blood
sugar goes

Summary of Product characteristics

OLANZAPINE- OLANZAPINE TABLET, ORALLY DISINTEGRATING
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLANZAPINE ORALLY DISINTEGRATING
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OLANZAPINE ORALLY
DISINTEGRATING TABLETS.
OLANZAPINE TABLETS, ORALLY DISINTEGRATING 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_
•
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 orally disintegrating tablets are an atypical antipsychotic
indicated:
_As oral formulation for the:_
•
•
•
•
_As Olanzapine and Fluoxetine in Combination for the:_
•
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. OLANZAPINE ORALLY DISINTEGRATING TABLETS ARE
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
.
®
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