Kytril

DRUG DESCRIPTION

KYTRIL Tablets and KYTRIL Oral Solution contain granisetron hydrochloride, an antinauseant and antiemetic agent. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4O•HCl, while its chemical structure is:

KYTRIL® (granisetron hydrochloride) Structural Formula Illustration

granisetron hydrochloride

Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C.

Tablets for Oral Administration

Each white, triangular, biconvex, film-coated KYTRIL Tablet contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg. Inactive ingredients are: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

Oral Solution

Each 10 mL of clear, orange-colored, orange-flavored KYTRIL Oral Solution contains 2.24 mg of granisetron hydrochloride equivalent to 2 mg granisetron. Inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, orange flavor, purified water, sodium benzoate, and sorbitol.

What are the possible side effects of granisetron (Granisol, Kytril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using granisetron and call your doctor at once if you have a serious side effect such as:

  • chest pain, uneven heart rate;
  • pale skin, easy bruising or bleeding; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache;
  • diarrhea or constipation;
  • ...

Read All Potential Side Effects and See Pictures of Kytril »

What are the precautions when taking granisetron (Kytril)?

Before taking granisetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Granisetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting)...

Read All Potential Precautions of Kytril »


Kytril Consumer (continued)

SIDE EFFECTS: Diarrhea, constipation, stomach pain, weakness, headache, fever, dizziness, drowsiness, trouble sleeping, and anxiety may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this highly unlikely but very serious side effect occurs: unusual muscle movements or stiffness.

Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking granisetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Granisetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using granisetron, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using granisetron safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Kytril Patient Information Including Side Effects

Brand Names: Granisol, Kytril

Generic Name: granisetron (oral) (Pronunciation: gra NIS e tron)

  • What is granisetron (Kytril)?
  • What are the possible side effects of granisetron (Kytril)?
  • What is the most important information I should know about granisetron (Kytril)?
  • What should I discuss with my healthcare provider before taking granisetron (Kytril)?
  • How should I take granisetron (Kytril)?
  • What happens if I miss a dose (Kytril)?
  • What happens if I overdose (Kytril)?
  • What should I avoid while taking granisetron (Kytril)?
  • What other drugs will affect granisetron (Kytril)?
  • Where can I get more information?

What is granisetron (Kytril)?

Granisetron blocks the actions of chemicals in the body that may cause nausea and vomiting.

Granisetron is used to prevent nausea and vomiting caused by cancer chemotherapy or radiation therapy, and anesthesia used during surgery.

Granisetron may also be used for other purposes not listed in this medication guide.

What are the possible side effects of granisetron (Kytril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using granisetron and call your doctor at once if you have a serious side effect such as:

  • chest pain, uneven heart rate;
  • pale skin, easy bruising or bleeding; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache;
  • diarrhea or constipation;
  • nausea, vomiting, stomach pain or upset;
  • loss of appetite;
  • drowsiness, weakness;
  • dizziness, anxiety;
  • sleep problems (insomnia); or
  • temporary hair loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about granisetron (Kytril)?

You should not use this medication if you are allergic to granisetron.

Before taking granisetron, tell your doctor if you have recently had stomach or intestinal surgery. You may need a dose adjustment or special tests to safely take granisetron.

Do not take granisetron on the days you do not have chemotherapy, unless your doctor has told you to.

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