Anzemet injection

Name: Anzemet injection

Description

ANZEMET (dolasetron mesylate) is an antinauseant and antiemetic agent. Chemically, dolasetron mesylate is (2α,6α,8α,9aβ)-octahydro-3-oxo-2,6-methano-2H-quinolizin-8-yl-lH- indole-3-carboxylate monomethanesulfonate, monohydrate. It is a highly specific and selective serotonin subtype 3 (5-HT3) receptor antagonist both in vitro and in vivo. Dolasetron mesylate has the following structural formula:

The empirical formula is C19H20N2O3 • CH3SO3H • H2O, with a molecular weight of 438.50.

Approximately 74% of dolasetron mesylate monohydrate is dolasetron base.

Dolasetron mesylate monohydrate is a white to off-white powder that is freely soluble in water and propylene glycol, slightly soluble in ethanol, and slightly soluble in normal saline.

ANZEMET Injection (dolasetron mesylate injection) is a clear, colorless, nonpyrogenic, sterile solution for intravenous administration. Each milliliter of ANZEMET Injection (dolasetron mesylate injection) contains 20 mg of dolasetron mesylate and 38.2 mg mannitol, USP, with an acetate buffer in water for injection. The pH of the resulting solution is 3.2 to 3.8.

ANZEMET Injection (dolasetron mesylate injection) multidose vials contain a clear, colorless, nonpyrogenic, sterile solution for intravenous administration. Each ANZEMET multidose vial contains 25 mL (500 mg) dolasetron mesylate. Each milliliter contains 20 mg dolasetron mesylate, 29 mg mannitol, USP, and 5 mg phenol, USP, with an acetate buffer in water for injection. The pH of the resulting solution is 3.2 to 3.7.

What is dolasetron?

Dolasetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Dolasetron injection is used to prevent nausea and vomiting caused by surgery.

Dolasetron injection may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include depression, tremors, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid after receiving dolasetron injection?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

A 7-year-old boy received 6 mg/kg dolasetron mesylate orally before surgery. No symptoms occurred and no treatment was required.

How is Anzemet Injection Supplied

Anzemet Injection (dolasetron mesylate) is supplied as a clear, colorless solution in single and multidose vials.

ANZEMET® Injection
(dolasetron mesylate)
20 mg/mL
Strength Description NDC Number
     
12.5 mg 0.625mL single use vial (Box of 6)   0088-1208-06
100 mg/5 mL 5mL single-use vial   0088-1206-32
500 mg/25 mL 25 mL multidose vial   0088-1209-26

Store at 20–25°C (68–77°F) with excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Protect from light.

PRINCIPAL DISPLAY PANEL - 12.5mg Vial Label

NDC 0088-1208-06

Anzemet® Injection

dolasetron mesylate
injection

12.5mg/0.625mL

What should i discuss with my healthcare provider before receiving dolasetron injection (anzemet)?

You should not receive dolasetron if you are allergic to it.

Dolasetron can cause serious heart rhythm problems. You should not use this medication if you have a history of Long QT syndrome. Tell your doctor if anyone in your family has ever had this condition.

To make sure you can safely receive dolasetron injection, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • a serious heart condition such as "sick sinus syndrome";
  • a heart rhythm disorder such as slow heartbeats, or atrial fibrillation (fast, irregular heart rhythm);
  • congestive heart failure; or
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether dolasetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What should i avoid after receiving dolasetron injection (anzemet)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Where can i get more information?

Your doctor or pharmacist can provide more information about dolasetron injection.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision date: 4/23/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

(web3)