Vistogard

Generic name: Uridine Triacetate

Usage of Vistogard

Vistogard works by slowing down cell damage caused by certain cancer medicines (Capecitabine or fluorouracil).

Vistogard is used to treat an overdose of capecitabine or fluorouracil.

Vistogard is also used in an emergency to treat life-threatening side effects caused by capecitabine or fluorouracil. This includes effects on the heart, nervous system, stomach, intestines, or blood cells.

This medicine may be given before overdose symptoms appear. However, treatment with Vistogard must begin within 96 hours after you last received capecitabine or fluorouracil.

Vistogard side effects

Get emergency medical help if you have signs of an allergic reaction to Vistogard: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Common Vistogard side effects may include:

nausea;

vomiting; or

diarrhea.

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.

Before taking Vistogard

Before you use Vistogard, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. In some cases, you may not be able to use Vistogard, or you may need a dose adjustment or special precautions.

It is not known whether Vistogard will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether uridine triacetate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How to use Vistogard

Usual Adult Dose of Vistogard for Fluorouracil/Capecitabine Overdose:

10 grams (1 packet) orally every 6 hours for 20 doses Comments: Each dose should be mixed with 3 to 4 ounces of soft foods such as applesauce, pudding, or yogurt, and ingested within 30 minutes along with 4 ounces of water. Use: Emergency treatment of a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or for patients who exhibit early-onset, severe, or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

Usual Adult Dose of Vistogard for Orotic Aciduria:

Initial Dose: 60 mg/kg orally once a day Maintenance Dose: Increase dosage to 120 mg/kg orally once a day for insufficient efficacy, such as occurrence of one of the following: -levels of orotic acid in urine remain above normal or increase above the usual or expected range for the patient; -laboratory values (e.g., red blood cell or white blood cell indices) affected by hereditary orotic aciduria show evidence of worsening; -worsening of other signs or symptoms of the disease. Maximum Dose: 8 grams orally once a day Comments: For patients requiring doses in multiples of 2 grams (3/4 teaspoon), an entire drug packet(s) may be administered without weighing or measuring. Use: Treatment of hereditary orotic aciduria

Usual Pediatric Dose for Fluorouracil/Capecitabine Overdose:

6.2 grams/m2 BSA orally every 6 hours for 20 doses Maximum Dose: 10 grams per dose Comments: -Measure the dose using either a scale accurate to at least 0.1 gram, or a graduated teaspoon accurate to 1/4 teaspoon. -Each dose should be mixed with 3 to 4 ounces of soft foods such as applesauce, pudding, or yogurt, and ingested within 30 minutes along with 4 ounces of water. -Unused granules should be discarded and not used for subsequent dosing. -Limited clinical data indicates response and safety are similar in pediatric and adult patients. Use: Emergency treatment of a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or for patients who exhibit early-onset, severe, or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

Usual Pediatric Dose for Orotic Aciduria:

Initial Dose: 60 mg/kg orally once a day Maintenance Dose: Increase dosage to 120 mg/kg orally once a day for insufficient efficacy, such as occurrence of one of the following: -levels of orotic acid in urine remain above normal or increase above the usual or expected range for the patient; -laboratory values (e.g., red blood cell or white blood cell indices) affected by hereditary orotic aciduria show evidence of worsening; -worsening of other signs or symptoms of the disease. Maximum Dose: 8 grams orally once a day Comments: -This drug can be mixed with milk or infant formula for patients receiving up to 2 grams (3/4 teaspoon); the manufacturer product information should be consulted for administration instructions. -For patients requiring doses in multiples of 2 grams (3/4 teaspoon), an entire drug packet(s) may be administered without weighing or measuring. Use: Treatment of hereditary orotic aciduria

Warnings

This medication guide provides information about the Vistogard brand of uridine triacetate. Xuriden is another brand of uridine triacetate that is not covered in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What other drugs will affect Vistogard

Other drugs may interact with uridine triacetate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Disclaimer

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