HOW SHOULD THIS MEDICINE BE USED?
Anzemet® (dolasetron mesylate) Tablets come in tablet form, which can be taken by the mouth.
TAKE EXACTLY AS PRESCRIBED BY YOUR DOCTOR. DO NOT TAKE LARGER OR SMALLER AMOUNTS OF THIS MEDICINE, OR FOR LONGER THAN RECOMMENDED, UNLESS DIRECTED BY YOUR DOCTOR.
The recommended dose of Anzemet Tablets is 100 mg, taken by mouth within 1 hour before chemotherapy.
The recommended dose for pediatric patients 2 to 16 years of age is 1.8 mg/kg, taken within one hour before chemotherapy, up to a maximum of 100 mg, based on weight.
For children who do not meet the weight requirements for taking Anzemet 100 mg Tablets or children unable to swallow tablets, Anzemet Injection solution may be used instead by mixing it into apple or apple-grape juice for oral dosing.
Elderly Patients & Patients with Kidney Impairment or Failure
These patients should be monitored with ECG while taking Anzemet Tablets, but no dosage adjustment is needed.
WHO SHOULD NOT TAKE ANZEMET?
You should not take Anzemet Tablets if you are allergic to dolasetron mesylate (the active ingredient in Anzemet Tablets) or have any of the following conditions:
- A personal or family history of abnormal heart rhythms, such as congenital long QT syndrome
- Take medications, such as diuretics, that may cause an electrolyte imbalance (for example, low potassium or magnesium levels in your blood) or medications for irregular heartbeat (for example, anti-arrhythmic medications)
- A serious heart condition called “sick sinus syndrome”
- Slow heartbeat or fast, irregular heartbeat (atrial fibrillation), or heart disease that prevents enough blood from reaching your heart (myocardial ischemia)
- You are 65 years or older (consult your physician)
- Kidney disease
You should also be aware that Anzemet Tablets can cause serious heart conditions such as QT syndrome, Toursade de Pointes, or heart block, all of which can lead to loss of heart function, breathing and consciousness.
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 Tablets can also cause what is known as “serotonin syndrome”, which can occur in patients who are taking Anzemet Tablets along with other medicines known to increase serotonin levels in the body (such as certain antidepressants and migraine medicines).
ANZEMET TABLETS ARE USUALLY TAKEN 1 HOUR BEFORE CHEMOTHERAPY. TELL YOUR DOCTOR IF YOU FORGET TO TAKE THE MEDICATION WITHIN THE SPECIFIED TIME PERIOD BEFORE YOUR CHEMOTHERAPY.
If any of the following symptoms occur, you should get immediate medical help:
- Changes in mental status
- Changes in blood pressure, heart rate, sweating, and digestion of your food
Anzemet Tablets also contain inactive ingredients, including carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, synthetic red iron oxide, titanium dioxide, and white wax that can cause allergic reactions or other problems.
TELL YOUR HEALTHCARE PROVIDER IF YOU HAVE ANY OF THE CONDITIONS:
- Congestive heart failure
- Heart rhythm condition causing fast, irregular heartbeat (congenital long QT syndrome)
- Slow heartbeat (bradycardia)
- Sick sinus syndrome
- Kidney disease
- Heart disease that prevents enough blood from reaching your heart (myocardial ischemia)
- You are taking heartbeat regulating medications to prolong PR interval (such as verapamil) and QRS interval (e.g., flecainide or quinidine)
- You are taking a serotonin and norepinephrine reuptake inhibitor (SNRI), a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor, mirtazapine, fentanyl, lithium, tramadol, or intravenous methylene blue
- If you notice a change in your heart rate, feel lightheaded, or have an irregular heartbeat or fainting episode.
Patients under 2 years old should not take Anzemet Tablets because its safety and effectiveness for children under 2 has not been established.
CANCER: Anzemet Tablets have been shown to cause liver cancer in mice at 4, 7, and 14 times the recommended doses.
FERTILITY: Anzemet Tablets do not affect fertility and reproduction at up to 8 times the recommended dose
Anzemet Tablets have 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 should be prescribed only if clearly needed. You should tell your doctor if you are pregnant before taking Anzemet.
NURSING MOTHERS: It is unknown if Anzemet 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 done for older patients taking Anzemet Tablets.
TAKING OTHER MEDICINES:
Tell your doctor if you are taking Anzemet Tablets with other medicines used for chemotherapy, particularly those that prolong ECG intervals and/or cause low levels of potassium or magnesium in the blood, or medicines used to treat depression or migraines.
The following medicines are known to have interactions with Anzemet Tablets:
- 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)
THIS LIST IS NOT COMPLETE AND OTHER DRUGS MAY INTERACT WITH ANZEMET TABLETS. TELL YOUR DOCTORS ABOUT ALL MEDICINES YOU USE. THIS INCLUDES PRESCRIPTION, OVER-THE-COUNTER, VITAMIN AND HERBAL PRODUCTS. DO NOT START ANY NEW MEDICATIONS WITHOUT TELLING YOUR DOCTOR.