Dolasetron mesylate

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Dolasetron mesylate
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

Dolasetron mesylate is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

ANZEMET Tablets are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older.

Dosage

The recommended doses of ANZEMET Tablets should not be exceeded.

Adults

  • The recommended oral dosage of ANZEMET (dolasetron mesylate) is 100 mg given within one hour before chemotherapy.

Use in the Elderly, Renal Failure Patients, or Hepatically Impaired Patients

  • No dosage adjustment is recommended, however; ECG monitoring is recommended for elderly and renally impaired patients.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Dolasetron mesylate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

  • In controlled clinical trials, 943 adult cancer patients received ANZEMET Tablets. These patients were receiving concurrent chemotherapy, predominantly cyclophosphamide and doxorubicin regimens. The following adverse events were reported in ≥2% of patients receiving either ANZEMET 25 mg or ANZEMET 100 mg tablets for prevention of cancer chemotherapy induced nausea and vomiting in controlled clinical trials (Table 3).
This image is provided by the National Library of Medicine.
  • In clinical trials, the following reported adverse events, assessed by investigators as treatment-related or causality unknown, occurred following oral or intravenous administration of ANZEMET in < 2% of adult patients receiving concomitant cancer chemotherapy:

Cardiovascular:

  • In addition, the following asymptomatic treatment-emergent ECG changes were seen at rates less than or equal to those for active or placebo controls: bradycardia, T wave change, ST-T wave change, sinus arrhythmia, extrasystole (APCs or VPCs), poor R-wave progression, bundle branch block (left and right), nodal arrhythmia, U wave change, atrial flutter/fibrillation.

Dermatologic: Rash, increased sweating.

Gastrointestinal System: Constipation, dyspepsia, abdominal pain, anorexia; pancreatitis.

Hearing, Taste and Vision: Taste perversion, abnormal vision, tinnitus, photophobia.

Hematologic: Hematuria, epistaxis, prothrombin time prolonged, PTT increased, anemia, purpura/hematoma, thrombocytopenia.

Hypersensitivity: Anaphylactic reaction, facial edema, urticaria.

Liver and Biliary System: Transient increases in AST (SGOT) and/or ALT (SGPT) values have been reported as adverse events in less than 1% of adult patients receiving ANZEMET in clinical trials. The increases did not appear to be related to dose or duration of therapy and were not associated with symptomatic hepatic disease. Similar increases were seen with patients receiving active comparator. Hyperbilirubinemia, increased GGT.

Metabolic and Nutritional: Alkaline phosphatase increased.

Musculoskeletal: Myalgia, arthralgia.

Nervous System: Flushing, vertigo, paresthesia, tremor; ataxia, twitching.

Psychiatric: Agitation, sleep disorder, depersonalization; confusion, anxiety, abnormal dreaming.

Respiratory System: Dyspnea, bronchospasm.

Urinary System: Dysuria, polyuria, acute renal failure.

Vascular (Extracardiac): Local pain or burning on IV administration; peripheral ischemia, thrombophlebitis/phlebitis.

Postmarketing Experience

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 Dolasetron mesylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dolasetron mesylate during labor and delivery.

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Dolasetron mesylate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Dolasetron mesylate in the drug label.

Overdosage

  • There is no known specific antidote for dolasetron mesylate, and patients with suspected overdose should be managed with supportive therapy. Individual doses as large as 5 mg/kg intravenously or 400 mg orally have been safely given to healthy volunteers or cancer patients.
  • Following a suspected overdose of ANZEMET Injection, a patient found to have second-degree or higher AV conduction block with ECG should undergo cardiac telemetry monitoring.
  • It is not known if dolasetron mesylate is removed by hemodialysis or peritoneal dialysis.
  • Single intravenous doses of dolasetron mesylate at 160 mg/kg in male mice and 140 mg/kg in female mice and rats of both sexes (6.3 to 12.6 times the recommended human dose based on body surface area) were lethal. Symptoms of acute toxicity were tremors, depression and convulsions.
  • A 59-year-old man with metastatic melanoma and no known pre-existing cardiac conditions developed severe hypotension and dizziness 40 minutes after receiving a 15 minute intravenous infusion of 1000 mg (13 mg/kg) of dolasetron mesylate. Treatment for the overdose consisted of infusion of 500 mL of a plasma expander, dopamine, and atropine. The patient had normal sinus rhythm and prolongation of PR, QRS and QTc intervals on an ECG recorded 2 hours after the infusion. The patient's blood pressure was normal 3 hours after the event and the ECG intervals returned to baseline on follow-up. The patient was released from the hospital 6 hours after the event.

Pharmacology

There is limited information regarding Dolasetron mesylate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Dolasetron mesylate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dolasetron mesylate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dolasetron mesylate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dolasetron mesylate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dolasetron mesylate in the drug label.

How Supplied

  • This image is provided by the National Library of Medicine.

Storage

  • Store at controlled room temperature 20–25°C (68–77°F). Protect from light.

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 mesylate in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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