Kytril Injection

DRUG DESCRIPTION

KYTRIL (granisetron hydrochloride) Injection is a serotonin-3 (5-HT3) receptor antagonist. 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 C18H24N4OHCl, 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 20C. KYTRIL Injection is a clear, colorless, sterile nonpyrogenic, aqueous solution for intravenous administration.

KYTRIL 1 mg/mL is available in 1 mL single-use and 4 mL multi-use vials. KYTRIL 0.1 mg/mL is available in a 1 mL single-use vial.

1 mg/mL: Each 1 mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solution's pH ranges from 4.0 to 6.0.

0.1 mg/mL: Each 1 mL contains 0.112 mg granisetron hydrochloride equivalent to granisetron, 0.1 mg; sodium chloride, 9 mg; citric acid, 2 mg. Contains no preservative. The solution's pH ranges from 4.0 to 6.0.

What are the precautions when taking granisetron hydrochloride (Kytril Injection)?

Before using granisetron, tell your doctor or pharmacist if you are allergic to it; or to other 5-HT3 blockers (e.g., dolasetron, ondansetron); 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, especially of: stomach/intestinal problems (e.g., recent surgery, ileus, swelling).

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

Granisetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation...

Read All Potential Precautions of Kytril Injection


Kytril Injection Consumer (continued)

SIDE EFFECTS: Headache, diarrhea, dizziness, fever, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor 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 right away if you have any serious side effects, including: stomach/abdominal pain.

Get medical help right away if any of these rare but serious side effects occur: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 using granisetron, tell your doctor or pharmacist if you are allergic to it; or to other 5-HT3 blockers (e.g., dolasetron, ondansetron); 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, especially of: stomach/intestinal problems (e.g., recent surgery, ileus, swelling).

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

During pregnancy, this medication should be used only when clearly needed. 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.



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