Olanzapine (injection)

Olanzapine (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Shanshan Cen, M.D. [2]

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Black Box Warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING: 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.

Overview

Olanzapine (injection) is an atypical antipsychotic that is FDA approved for the treatment of acute agitation associated with schizophrenia and bipolar I mania. There is a Black Box Warning for this drug as shown here. Common adverse reactions include orthostatic hypotension, peripheral edema, hypercholesterolemia, hyperglycemia, hyperprolactinemia, Increased appetite, serum triglycerides raised, weight increased, constipation, xerostomia, akathisia, asthenia, dizziness, somnolence, tremor, personality disorder.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Olanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania.

Dosage

• Dose Selection for Agitated Adult Patients with Schizophrenia and Bipolar I Mania

The efficacy of intramuscular olanzapine for injection in controlling agitation in these disorders was demonstrated in a dose range of 2.5 mg to 10 mg. The recommended dose in these patients is 10 mg. A lower dose of 5 or 7.5 mg may be considered when clinical factors warrant . If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. However, the efficacy of repeated doses of intramuscular olanzapine for injection in agitated patients has not been systematically evaluated in controlled clinical trials. Also, the safety of total daily doses greater than 30 mg, or 10 mg injections given more frequently than 2 hours after the initial dose, and 4 hours after the second dose have not been evaluated in clinical trials. Maximal dosing of intramuscular olanzapine (e.g., 3 doses of 10 mg administered 2 to 4 hours apart) may be associated with a substantial occurrence of significant orthostatic hypotension. Thus, it is recommended that patients requiring subsequent intramuscular injections be assessed for orthostatic hypotension prior to the administration of any subsequent doses of intramuscular olanzapine for injection. The administration of an additional dose to a patient with a clinically significant postural change in systolic blood pressure is not recommended.

If ongoing olanzapine therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg/day as soon as clinically appropriate.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Olanzapine (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Olanzapine (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Olanzapine (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Olanzapine (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Olanzapine (injection) in pediatric patients.

Contraindications

• None with olanzapine for injection monotherapy.

• For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products.

Warnings

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING: 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.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Olanzapine (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Olanzapine (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Olanzapine (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Olanzapine (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Olanzapine (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Olanzapine (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Olanzapine (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Olanzapine (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Olanzapine (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Olanzapine (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Olanzapine (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Olanzapine (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Olanzapine (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Olanzapine (injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Olanzapine (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Olanzapine (injection) in the drug label.

Pharmacology

There is limited information regarding Olanzapine (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Olanzapine (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Olanzapine (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Olanzapine (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Olanzapine (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Olanzapine (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Olanzapine (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Olanzapine (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Olanzapine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• OLANZAPINE ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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