Dolasetron (injection)

Dolasetron (injection)
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: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

ANZEMET Injection is indicated for the following:

The prevention of postoperative nausea and vomiting (PONV) in adults and children 2 years and older

• As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ANZEMET Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

• When prophylaxis has failed, a repeat dose should not be initiated as rescue therapy.

The treatment of postoperative nausea and/or vomiting in adults and children 2 years and older

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• ANZEMET Injection is contraindicated in patients known to have hypersensitivity to the drug.

• ANZEMET Injection solution administered intravenously is contraindicated in adult and pediatric patients for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy due to dose dependent QT prolongation. Mean QTc effects over 20 ms are expected in this patient population

Warnings

Adverse Reactions

Clinical Trials Experience

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

Drug Interactions

There is limited information regarding Dolasetron (injection) Drug Interactions in the drug label.

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 Dolasetron (injection) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Dolasetron (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

• ANZEMET ®

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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