HOW SHOULD THIS MEDICINE BE USED?
Anzemet® (dolasetron mesylate) Injection is injected into a vein through an IV and is prescribed intravenously by your doctor prior to anesthesia for prevention of nausea and vomiting before surgery or as soon as you become nauseous or begin vomiting after surgery.
YOUR DOCTOR WILL NOT EXCEED THE RECOMMENDED DOSE OF ANZEMET INJECTION.
YOUR DOCTOR WILL NOT MIX ANZEMET INJECTION WITH OTHER DRUGS.
In most cases, only one dose of Anzemet Injection is given while you are still under anesthesia or as soon as you have symptoms of nausea or vomiting post surgery.
The recommended dose of Anzemet injection is 12.5 mg given as a single dose approximately 15 minutes before anesthesia (for prevention) or as soon as nausea or vomiting begins (after surgery). Anzemet Injection can be safely infused as rapidly as 30 seconds or diluted in a compatible IV solution to 50 ml and infused over a period up to 15 minutes.
ANZEMET INJECTION IS NOT FOR PREVENTING NAUSEA OR VOMITING THAT IS CAUSED BY CHEMOTHERAPY OR OTHER CONDITIONS NOT RELATED TO SURGERY.
WHEN INITIAL TREATMENT WITH ANZEMET INJECTION HAS NOT WORKED TO REDUCE NAUSEA AND VOMITING, REPEATED DOSES OF ANZEMET INJECTION SHOULD NOT BE GIVEN.
Anzemet Injection can be given to children 2 years old or older either through an IV into a vein, or it can be mixed with apple or apple-grape juice and given orally.
The recommended IV dose in children 2 to 16 years old is 0.35 mg/kg, with a maximum dose of 12.5 mg given as a single dose approximately 15 minutes before anesthesia (for prevention) or as soon as nausea or vomiting begins (a treatment for nausea and vomiting). Anzemet Injection can be safely infused as rapidly as 30 seconds or diluted in a compatible IV solution to 50 ml and infused over a period up to 15 minutes.
SAFETY AND EFFECTIVENESS IN CHILDREN UNDER 2 YEARS OLD HAS NOT BEEN STUDIED.
Oral Administration of IV Product
Anzemet Injection solution may be mixed into apple or apple-grape juice for oral dosing. With this mode of administration, the recommended dose for children 2 to 16 years old is 1.2 mg/kg up to a maximum 100-mg dose given within 2 hours before surgery. The diluted product may be kept up to 2 hours at room temperature before use.
WHO SHOULD NOT TAKE ANZEMET INJECTION?
You should not receive Anzemet Injection if you are allergic to dolasetron mesylate (the active ingredient of Anzemet Injection) or have any of the following conditions:
- A history of abnormal heart rhythms, such as congenital QT syndrome
- Low levels of potassium or magnesium in your blood or take medicines, that may cause an electrolyte imbalance
- If you are elderly AND have a serious heart condition called “sick sinus syndrome”
ANZEMET INJECTION CAN CAUSE SERIOUS HEART RHYTHM PROBLEMS. YOU SHOULD NOT USE ANZEMET INJECTION IF YOU HAVE A HISTORY OF SERIOUS HEART CONDITIONS SUCH AS LONG QT SYNDROME, OR LOW BLOOD LEVELS OF POTASSIUM OR MAGNESIUM. IF YOU HAVE ANY OF THESE CONDITIONS, ANZEMET INJECTION MAY LEAD TO LOSS OF HEART FUNCTION, BREATHING AND CONSCIOUSNESS. TELL YOUR DOCTOR IF YOU OR ANYONE IN YOUR FAMILY HAS EVER HAD ANY OF THESE CONDITIONS.
IF YOU ARE OLDER YOU CANNOT RECEIVE ANZEMET INJECTION FOR THE TREATMENT OF NAUSEA OR VOMITING ASSOCIATED WITH CHEMOTHERAPY.
To make sure that you can safely receive Anzemet Injection, tell your doctor if you have any of these conditions:
- Congestive heart failure and slow heart rate
- Heart disease, heart abnormalities, and pre-existing problems with your heart
- History of irregular heart beat or atrial fibrillation
- Heart attack
- Receive drugs known to prolong the PR and/or QRS interval (verapamil, flecainide or quinidine)
- Kidney disease
Your doctor may have you undergo ECG monitoring if you receive Anzemet Injection with any of these conditions.
Tell your doctor about all medicines that you use. There are many other medicines that can increase your risk of heart rhythm problems if you use them together with Anzemet.
Anzemet Injection can also cause what is known as “serotonin syndrome”, which can occur if you receive Anzemet Injection alone or in combination with other medications known to increase serotonin levels in the body (such as certain antidepressants and migraine medicines).
TELL YOUR DOCTOR ABOUT ALL MEDICATIONS YOU ARE TAKING, INCLUDING OVER-THE-COUNTER MEDICINES, VITAMINS, AND SUPPLEMENTS. DO NOT START A NEW MEDICATION WITHOUT TELLING YOUR DOCTOR
CANCER: Anzemet Injection has been shown to cause liver cancer in mice at 4, 7 and 14 times the recommended doses.
FERTILITY: Anzemet Injection does not affect fertility and reproduction at up to 8 times the recommended dose
While Anzemet Injection has not been shown to affect fertility or cause harm to the fetus in animal studies, there have been no studies in pregnant women, so Anzemet Injection should be prescribed only if clearly needed. Tell your doctor if you are pregnant.
NURSING MOTHERS: It is unknown if Anzemet Injection passes through to human milk. If you are nursing or considering nursing tell your doctor.
PEDIATRIC USE: Safety and effectiveness in children under the age of 2 has not been studied.
GERIATRIC USE: Older patients are at risk for serious cardiac arrhythmias. ECG monitoring should be conducted if you are an older patient receiving Anzemet Injection.
TAKING OTHER MEDICINES:
Tell your doctor about all other medicines you use, especially:
- Arsenic trioxide (Trisenox)
- Cimetidine (Tagamet)
- Digoxin (digitalis, Lanoxin)
- Tacrolimus (Prograf)
- Tramadol (Ultram)
- Verapamil (Calan, Covera, Isoptin, Verelan, Tarka)
- An antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levoflaxin (Levaquin), moxifloxacin (Avelox), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, Rifater), pentamidine (NebuPent, Pentam), or antibiotics given by injection
- An antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), or desipramine (Norpramin)
- Anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam)
- Cancer medications (chemotherapy) such as daunorubicin (Cerubidine, Daunoxome), doxorubicin (Adriamycin, Doxil), epirubicin (Ellence), idarubicin (Idamycin), mitoxantrone (Novantrone), and others
- A diuretic (water pill)
- Heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), flecainide (Trambocor), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace)
- HIV medicines such as indinavir (Crixivan), saquinavir (Invirase), ritonavir (Norvir), or nelfinavir (Viracept)
- Medicines to treat psychiatric disorders such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon)
- Migraine headache such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig)
- Narcotic medication such as methadone (Methadose, Diskets, Dolophine)
- Other medicines to prevent or treat nausea and vomiting such as ondansetron (Zofran) or droperidol (Inapsine)
- Seizure medicine such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal)
MAKE SURE THAT YOU INFORM YOUR DOCTOR ABOUT ALL MEDICATIONS YOU ARE TAKING SO THAT YOU CAN BE MONITORED FOR POSSIBLE DRUG INTERACTIONS.