OLANZAPINE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TYA Pharmaceuticals

INN (International Name):

OLANZAPINE

Composition:

OLANZAPINE 10 mg in 2 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Olanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Efficacy was demonstrated in 3 short-term (24 hours of IM treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolar I disorder (manic or mixed episodes) [see ]. Clinical Studies ( 14.3) “Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. - None with olanzapine monotherapy. - For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these othe

Product summary:

NDC:64725-0955-1 in a CARTON of 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONS Olanzapine for Injection is supplied in a single-use 10mg vial available in a carton of 1 – NDC 0517-0955-04. Store olanzapine for injection vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Reconstituted olanzapine for injection may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature) for up to 1 hour if necessary. Discard any unused portion of reconstituted olanzapine for injection. Protect olanzapine for injection from light, do not freeze.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLANZAPINE - OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
TYA PHARMACEUTICALS
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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. OLANZAPINE (OLANZAPINE)
INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION FOR INTRAMUSCULAR USE. INITIAL U.S. APPROVAL: 2012
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 FOR INJECTION IS NOT APPROVED FOR THE
TREATMENT OF PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS. (5.1,5.14,17.2)
RECENT MAJOR CHANGES
None
INDICATIONS AND USAGE
Olanzapine for injection is an atypical antipsychotic indicated for
the:
Treatment of acute agitation associated with schizophrenia and bipolar
I mania. ( ) 1.4
Efficacy was established in three 1-day trials in adults. ( ) 14.3
DOSAGE AND ADMINISTRATION
Agitation associated with Schizophrenia
and Bipolar I Mania in adults ( ) 2.4
IM: 10 mg (5 mg or 7.5 mg when clinically warranted)Assess for
orthostatic
hypotension prior to subsequent dosing (max. 3 doses 2 to 4 hrs apart)
Lower starting dose recommended in debilitated or pharmacodynamically
sensitive patients or patients with
predisposition to hypotensive reactions, or with potential for slowed
metabolism. ( ) 2.4
DOSAGE FORMS AND STRENGTHS
Intramuscular Injection: 10 mg vial ( ) 3
CONTRAINDICATIONS
None with olanzapine monotherapy.
When using olanzapine in combination with lithium or valproate, refer
to the Contraindications section of the package
inserts for those products. ( ) 4
WARNINGS AND PRECAUTIONS
Increased risk of death and increased incidence of cerebrovascular
adverse events (e.g., stroke, transient ischemic
attack). ( ) _Elderly Patients with Dementia-Related Psychosis:_5.1
The possibility of a suicide attempt is inherent in sc