Granisetron Hydrochloride, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth or given by IV prevent or treat nausea and vomiting after surgery, chemotherapy, or radiation therapy. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: 5-HT3 receptor antagonist; antiemetic (antinausea)

Generic and brand names: granisetron hydrochloride, injection; Sustol; granisetron hydrochloride, oral

What is this medicine used for?

This medicine is given to prevent nausea and vomiting caused by chemotherapy or radiation therapy. It is also given to prevent or treat nausea and vomiting after surgery.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart problems such as a heart attack, heart failure, or an irregular or slow heartbeat
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Too little potassium or magnesium in your blood

Also tell your healthcare provider if you take diuretics (water pills), or medicine to control heart rhythms.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Ask your healthcare provider or pharmacist about anything you do not understand.

Take the tablets 1 hour before you receive your chemotherapy or radiation treatment. Sometimes, a second dose is taken about 12 hours after your first dose of this medicine. Take the exact dose as directed by your healthcare provider.

Check with your healthcare provider before using this medicine in children under age of 18.

The injection form of this medicine is given by your healthcare provider as an IV infusion through a needle into a large vein. If you are receiving this medicine to prevent nausea or vomiting due to chemotherapy, a healthcare provider will give the medicine about 30 minutes before chemotherapy. If you are receiving this medicine to prevent or treat nausea or vomiting after surgery, a healthcare provider will give the medicine at the beginning of your surgery, or shortly before the end of your surgery, or when needed after surgery.

What if I miss a dose?

If you are taking this medicine before chemotherapy, radiation therapy, or surgery as instructed by your healthcare provider, do not miss a dose. If you miss a dose, take it as soon as you remember. If you are not sure of what to do if you miss a dose, contact your healthcare provider.

If you are taking this medicine on a regularly scheduled basis and you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache.

What should I watch out for?

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination
• Stiff muscles
• Fast heartbeat
• Rapid changes in blood pressure or dizziness
• Increased body temperature, sweating, or flushing
• Nausea
• Vomiting
• Diarrhea

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fast, slow, or irregular heartbeat; severe dizziness or fainting; trouble breathing; chest pain; yellowing of your skin or eyes; trouble urinating; severe stomach pain or swelling; hallucinations; slurred speech; loss of coordination or unsteadiness; severe headache.

Other: Mild headache, mild dizziness, drowsiness, shivering, nausea, vomiting, tiredness, diarrhea, constipation, stomach pain, pain or redness at the spot where the shots or infusions were given.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Anagrelide (Agrylin)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, and sotalol (Betapace, Sorine)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifampin (Rifadin), tedizolid (Sivextro), telavancin (Vibativ), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, amoxapine, buspirone, citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lithium (Lithobid), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Apomorphine (Apokyn)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), daunorubicin (Cerubidine), degarelix (Firmagon), doxorubicin (Doxil), idarubicin (Idamycin), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Diuretics (water pills) such as bumetanide, chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), metolazone (Zaroxolyn), and torsemide (Demadex)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Famotidine (Pepcid)
• Fingolimod (Gilenya)
• HIV medicines such as lopinavir/ritonavir (Kaletra), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Ivabradine (Corlanor)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Mirabegron (Myrbetriq)
• Natural remedies such as SAMe and St. John’s wort
• Pain medicines such as buprenorphine, codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Tetrabenazine (Xenazine)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the pills at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

Store the liquid form of this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.