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.

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.

Take Vistogard exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Vistogard must be taken every 6 hours, or 4 times per day. You will take a total of 20 doses for the full treatment. It should take 5 full days to complete all doses.

Vistogard comes in a packet of oral granules that must be mixed with soft food before taking. Do not eat the granules by themselves.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

One adult dose is 1 packet (10 grams) of oral granules. A child's dose is smaller than an adult dose, and is based on the child's weight and height.

For a child's dose, you will use less than 1 full packet of oral granules. Measure your child's dose very carefully to make sure you are not giving too much or too little Vistogard.

After measuring the child's dose, throw away the rest of the Vistogard in the opened packet. Do not save it for later use.

For both adults and children: Mix the measured dose with 3 to 4 ounces of soft food such as applesauce, pudding, or yogurt. Swallow the mixture right away without chewing. Do not save it for later use.

After swallowing the Vistogard dose, drink at least 4 ounces of water.

If you vomit within 2 hours after taking Vistogard, measure, mix, and swallow another full dose. Then take the next dose at your regularly scheduled time.

If needed, Vistogard may be given through a nasogastric (NG) or gastronomy tube. Carefully follow your doctor's instructions for measuring and mixing the oral granules when giving the medicine through a feeding tube.

Use Vistogard for the full prescribed length of time, even if you feel well. It is extremely important that you finish all 20 doses to complete your treatment with Vistogard.

Store unopened packets at room temperature away from moisture and heat.

Each single-use packet of this medicine is for one use only. Throw away the packet after measuring your dose, even if there is still some medicine inside it.

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

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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of Vistogard is not expected to produce life threatening symptoms.

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

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.