Vistogard is used to treat hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disease that is caused by uridine deficiency. Vistogard is a pyrimidine analog that works by replacing the uridine that cannot be normally produced in patients with hereditary orotic aciduria.
Vistogard is also used as an emergency treatment for patients who had an overdose of the cancer medicines fluorouracil or capecitabine, or who develop certain severe or life-threatening side effects within 4 days of receiving these cancer medicines.
This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: Granule.
Before using Vistogard, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.
For this medicine, the following should be considered:
Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric Population: Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of uridine triacetate in children.
Geriatric Population: Although appropriate studies on the relationship of age to the effects of Vistogard® have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Vistogard® in the elderly.
No information is available on the relationship of age to the effects of Xuriden™ in geriatric patients.
Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.
Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
3 Proper Usage
Proper usage of Vistogard requires strict adherence to your doctor’s orders. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a patient instruction leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take Xuriden™ with food. You may take Vistogard® without regard to meals. It is important to take all doses of Vistogard®, even if you feel well.
Measure the dose by using either a scale accurate to at least 0.1 gram, or a graduated teaspoon, accurate to the fraction of the dose to be given.
Throw away any unused granules left in the packet.
To mix Xuriden™ or Vistogard® with food:
Mix the measured amount of granules in 3 to 4 ounces of applesauce, pudding, or yogurt in a small, clean container.
Swallow the mixture immediately and do not chew the granules. Do not save any of the mixtures to use later.
Drink at least 4 ounces of water.
You may also mix Xuriden™ with milk or infant formula:
Pour 5 mL of milk or infant formula into a medicine cup.
Use an oral syringe to draw up the 5 mL of milk or infant formula.
Cap the tip of the syringe, remove the plunger and pour the measured amount of granules into the syringe.
Gently swirl the syringe to mix the granules with the liquid.
Place the tip of the syringe in the patient's mouth between the cheek and gum at the back of the mouth. Gently push the plunger all the way down.
Refill the syringe with another 5 mL of milk or infant formula.
Gently swirl to rinse any remaining granules and flush it to the patient's mouth.
This may be followed by a bottle of milk or infant formula if desired.
If you are taking Vistogard® through a nasogastric tube or gastrostomy tube:
Mix 100 mL of food starch-based thickening product in water and stir until the thickener has dissolved.
Crush the contents of 1 full 10-gram packet of granules into a fine powder.
Add the crushed Vistogard® granules to 100 mL of the thickener mixture. For children receiving less than 10 grams, prepare the mixture at a ratio of no greater than 1 gram per 10 mL of the mixture.
Take this medicine through a nasogastric tube or gastrostomy tube.
Flush the tube with water.
Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (oral granules):
For treatment of hereditary orotic aciduria:
Adults and Children — Dose is based on body weight and must be determined by your doctor. The starting dose is 60 milligrams (mg) per kilogram (kg) of body weight (1 to 3 packets) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per kg of body weight (2 to 4 packets) once a day.
For emergency treatment of patients who have an overdose of fluorouracil or capecitabine:
Adults — 10 grams (1 packet) every 6 hours for 20 doses.
Children — Dose is based on body size and must be determined by your doctor. The starting dose is 6.2 grams per square meter (m) of body size (not to exceed 10 grams per dose) every 6 hours for 20 doses.
Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you vomit within 2 hours of taking a dose of Vistogard®, take another dose immediately. Then, take your next dose at your regularly scheduled time.
Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.
4 Precautions To Take
Before using Vistogard, there are some precautions you must take. It is important that your doctor checks your progress at regular visits.
This is to make sure that this medicine is working properly and to check for unwanted effects.
Along with its needed effects, Vistogard may cause some unwanted side effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence Not Known:
Rash or itching skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.
Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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