Dolasetron

Dolasetron is used to prevent nausea and vomiting caused by cancer chemotherapy. Dolasetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

Dolasetron may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• tiredness
• heartburn
• chills
• less frequent urination

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or seek emergency medical treatment:

• dizziness
• rapid, pounding, or irregular heart beat
• hives
• rash
• itching
• difficulty swallowing or breathing
• dizziness, light-headedness, or fainting
• fast, slow or irregular heartbeat
• agitation
• hallucinations (seeing things or hearing voices that do not exist)
• fever
• excessive sweating
• confusion
• nausea, vomiting, or diarrhea
• loss of coordination
• stiff or twitching muscles
• seizures
• coma (loss of consciousness)

Dolasetron may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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

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

There are many other medicines that can increase your risk of heart rhythm problems if you use them together with dolasetron.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with dolasetron, especially:

• anagrelide;
• droperidol;
• methadone;
• ondansetron;
• an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;
• cancer medicine--arsenic trioxide, vandetanib;
• an antidepressant--citalopram, escitalopram;
• anti-malaria medication--chloroquine, halofantrine;
• heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or
• medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete. Other drugs may interact with dolasetron, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

There are many other medicines that can increase your risk of heart rhythm problems if you use them together with dolasetron.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with dolasetron, especially:

• anagrelide;
• droperidol;
• methadone;
• ondansetron;
• an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;
• cancer medicine--arsenic trioxide, vandetanib;
• an antidepressant--citalopram, escitalopram;
• anti-malaria medication--chloroquine, halofantrine;
• heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or
• medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete. Other drugs may interact with dolasetron, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Dolasetron is a prescription medicine used to prevent nausea and vomiting caused by chemotherapy. Dolasetron is also used to prevent or treat nausea and vomiting after surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-done studies that have been done in humans with dolasetron. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

• Store dolasetron tablets at room temperature in the container it came in, tightly closed.
• Keep this and all medications out of the reach of children.

Dolasetron can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with dolasetron.

Taking dolasetron while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;

• medicine to treat a psychiatric disorder;

• a narcotic (opioid) medication; or

• medicine to prevent nausea and vomiting.

This list is not complete and many other drugs can interact with dolasetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Dolasetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. Dolasetron works to block the signals to the brain that cause nausea and vomiting.

dolasetron is available only with your doctor's prescription.

Injection: Prevention and treatment of postoperative nausea and vomiting in adults and children ≥2 years

Oral: Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy (initial and repeat courses) in adults and children ≥2 years

Refer to adult dosing.

Apomorphine: Antiemetics (5HT3 Antagonists) may enhance the hypotensive effect of Apomorphine. Avoid combination

Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Hydroxychloroquine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Mequitazine: Dolasetron may enhance the arrhythmogenic effect of Mequitazine. Management: Concurrent administration of intravenous dolasetron with mequitazine is contraindicated. Avoid combination

MiFEPRIStone: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Moderate Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Panobinostat: Dolasetron may enhance the arrhythmogenic effect of Panobinostat. Monitor therapy

Probucol: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Promazine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Serotonin Modulators: Antiemetics (5HT3 Antagonists) may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. Monitor therapy

Tapentadol: Antiemetics (5HT3 Antagonists) may diminish the analgesic effect of Tapentadol. Monitor therapy

TraMADol: Antiemetics (5HT3 Antagonists) may diminish the analgesic effect of TraMADol. Monitor therapy

Vinflunine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Xipamide: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Administration advice:
-Rapid IV administration (e.g., 12.5 mg injected in less than 30 seconds) should be avoided. The IV formulation may be injected IV over 30 seconds or diluted and infused over a period of up to 15 minutes.
-Patients using this drug for postoperative nausea and vomiting prophylaxis/treatment and whose dosage requirements are lower than the tablet formulation or those unable to swallow tablets may use the IV formulation for oral administration. The oral tablet is bioequivalent to the IV solution given orally. The dose should be mixed in apple or apple-grape juice; the diluted product may be kept at room temperature and should be used within 2 hours of preparation. Use of the tablet formulation is recommended in children old enough to swallow tablets.


Storage requirements:
-The manufacturer product information should be consulted.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-The manufacturer product information should be consulted.

General:
-Routine prophylaxis is not recommended for postoperative patients with little expectation of nausea and vomiting; however, use is recommended for patients who should avoid postoperative nausea and vomiting, even with low risk of postoperative nausea and vomiting.

Monitoring:
-Electrolyte levels, especially in patients at risk for hypomagnesemia or hypokalemia
-ECG, especially in patients with congestive heart failure, bradycardia, renal impairment, and geriatric patients

Patient advice:
-Inform patients that this drug may cause drowsiness, and that they should avoid driving or operating machinery until the full effects are known.
-Patients should be advised to immediately report any signs/symptoms associated with serotonin syndrome to their prescribers. Patients should also report lightheadedness, syncope episodes, or any perceived changes in heart rate.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
-Tell patients to report all concurrent prescription and nonprescription medications or herbal products they are taking.