Anzemet Tablets
- Generic Name: dolasetron
- Brand Name: Anzemet Tablets
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Anzemet Tablets Side Effects Center
What Is Anzemet Tablets?
Anzemet (dolasetron mesylate) is an antinauseant and antiemetic agent used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy).
What Are Side Effects of Anzemet Tablets?
Common side effects of Anzemet include:
- headache,
- constipation,
- tiredness,
- drowsiness,
- dizziness,
- diarrhea,
- upset stomach,
- loss of appetite,
- chills,
- shivering,
- numbness or tingly feeling,
- fever,
- sweating,
- rash, or
- joint or muscle pain.
Dosage for Anzemet Tablets
The recommended adult oral dosage of Anzemet is 100 mg given within one hour before chemotherapy.
What Drugs, Substances, or Supplements Interact with Anzemet Tablets?
Anzemet may interact with arsenic trioxide, droperidol, diuretics, antibiotics, antidepressants, anti-malaria medications, heart rhythm medicines, other medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicine, or narcotics. Tell your doctor all medications and supplements you use.
Anzemet Tablets During Pregnancy or Breastfeeding
Anzemet should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Anzemet (dolasetron mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Anzemet Tablets Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
- a light-headed feeling, like you might pass out;
- slow heart rate, weak pulse, slow breathing;
- swelling in your hands or feet;
- little or no urinating; or
- high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Common side effects may include:
- mild headache;
- mild dizziness;
- drowsiness; or
- pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Anzemet Tablets (Dolasetron)
Anzemet Tablets Professional Information
SIDE EFFECTS
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).
Table 3: Adverse Events ≤2% from Chemotherapy-Induced Nausea and Vomiting Studies
| Event | ANZEMET | |
| 25 mg (N=235) |
100 mg (N=227) |
|
| Headache | 42 (17.9%) | 52 (22.9%) |
| Fatigue | 6 (2.6%) | 13 (5.7%) |
| Diarrhea | 5 (2.1%) | 12 (5.3%) |
| Bradycardia | 12 (5.1%) | 9 (4.0%) |
| Dizziness | 3 (1.3%) | 7 (3.1%) |
| Pain | 0 | 7 (3.1%) |
| Tachycardia | 7 (3.0%) | 6 (2.6%) |
| Dyspepsia | 7 (3.0%) | 5 (2.2%) |
| Chills/Shivering | 3 (1.3%) | 5 (2.2%) |
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: Hypotension; edema, peripheral edema. The following events also occurred and with a similar frequency as placebo and/or active comparator: Mobitz I AV block, chest pain, orthostatic hypotension, myocardial ischemia, syncope, severe bradycardia, and palpitations. See PRECAUTIONS section for information on potential effects on ECG.
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.
Furthermore, severe hypotension, bradycardia and syncope have been reported immediately or closely following IV administration.
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.
Post-marketing Experience
There are reports of wide complex tachycardia or ventricular tachycardia and of ventricular fibrillation cardiac arrest following intravenous administration.
To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
The potential for clinically significant drug-drug interactions posed by dolasetron and hydrodolasetron appears to be low for drugs commonly used in chemotherapy because hydrodolasetron is eliminated by multiple routes. See PRECAUTIONS, General for information about potential interaction with other drugs that prolong the QTc interval.
When oral dolasetron (200 mg once daily) was co-administered with cimetidine (300 mg four times daily) for 7 days, the systemic exposure (i.e., AUC) of hydrodolasetron increased by 24% and the maximum plasma concentration of hydrodolasetron increased by 15%. When oral dolasetron (200 mg once daily) was coadministered with rifampin (600 mg once daily) for 7 days, the systemic exposure of hydrodolasetron decreased by 28% and the maximum plasma concentration of hydrodolasetron decreased by 17%.
Caution should be exercised when ANZEMET is co-administered with drugs, including those used in chemotherapy, that prolong ECG intervals and/or cause hypokalemia or hypomagnesemia (see WARNINGS).
In patients taking furosemide, nifedipine, diltiazem, ACE inhibitors, verapamil, glyburide, propranolol, and various chemotherapy agents, no effect was shown on the clearance of hydrodolasetron. Clearance of hydrodolasetron decreased by about 27% when dolasetron mesylate was administered intravenously concomitantly with atenolol. Dolasetron mesylate did not inhibit the antitumor activity of four chemotherapeutic agents (cisplatin, 5-fluorouracil, doxorubicin, cyclophosphamide) in four murine models.
Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin re-uptake inhibitors (SSRIs) and serotonin and noradrenaline re-uptake inhibitors (SNRIs).
Read the entire FDA prescribing information for Anzemet Tablets (Dolasetron)
&Copy; Anzemet Tablets Patient Information is supplied by Cerner Multum, Inc. and Anzemet Tablets Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.