Xuriden (Uridine triacetate): Uses, Side Effects and Dosage

Instructions for Use

XURIDEN ^®(ZUR-uh-den)

(uridine triacetate)

oral granules

Read this Instructions for Use before you prepare XURIDEN for the first time, each time you get a refill, and as needed. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment. Ask your healthcare provider if you have any questions about how to mix or give a dose of XURIDEN the right way.

Important Information

• Take XURIDEN exactly as your healthcare provider tells you to.
• Your healthcare provider will prescribe the dose of XURIDEN depending on your body weight. Your healthcare provider will tell you the right dose to take.
• Your healthcare provider will show you how to measure the prescribed dose. The prescribed dose of XURIDEN can be measured using a scale or an adjustable measuring spoon.
• Your healthcare provider may change your dose if needed. Do not change the dose without first talking with your healthcare provider.
• XURIDEN may be taken by mixing XURIDEN with 3 to 4 ounces of applesauce, pudding or yogurt or may be mixed with milk or infant formula.
• XURIDEN mixed with applesauce, pudding or yogurt should be eaten right away. Do not save the mixed applesauce, pudding or yogurt for later use.
• Do notchew the XURIDEN oral granules.

For each dose of XURIDEN given in applesauce, pudding or yogurt, you will need the following (See Figure A):

• paper towels
• XURIDEN packet or packets containing the medicine needed for the prescribed dose
• 1 scale or 1 adjustable measuring spoon
• small spoon for stirring
• 1 small clean container (such as a small cup or bowl)
• 3 to 4 ounces of applesauce, pudding or yogurt
• 4 ounces of drinking water

Figure A

Step 1:	Choose a clean flat work surface. Place a clean paper towel on the work surface. Then place the other supplies on the paper towel.
Step 2:	Wash and dry your hands.
Step 3:	Place 3 to 4 ounces of soft food such as applesauce, pudding, or yogurt in the small clean cup or bowl.
Step 4:	Select the number of XURIDEN packets needed for the prescribed dose.
Step 5:	Measure the dose:
If you are using a scale: Open the packet or packets and measure out the amount needed for the prescribed dose on the scale. Follow the instructions that came with the scale for correct and accurate use. If you are using an adjustable measuring spoon: Open the packet or packets and use the adjustable measuring spoon to measure out the amount needed for the prescribed dose as shown. Throw away any unused XURIDEN in the trash. Do not use any XURIDEN left in the open packet.
Step 6:	Sprinkle the XURIDEN onto the soft food.
Step 7:	Use the small spoon to mix the medicine and the applesauce, pudding, or yogurt together.
Step 8:	Use the small spoon to give or take the soft food and XURIDEN mixture. XURIDEN mixed with soft food should be eaten right away without chewing.To avoid a bitter taste from the medicine, do not chew the granules. Make sure all of the mixture is swallowed. Do notsave the food for later use.
Step 9:	Drink at least 4 ounces of water.
Step 10:	Wash the supplies needed to give the dose as your healthcare provider has told you. Throw away the paper towel and clean the work surface. Wash your hands.

For each dose of XURIDEN given in milk or formula to children receiving up to ¾ teaspoon (2 grams of XURIDEN), you will need the following (See Figure B):

• paper towels
• XURIDEN packet or packets containing the medicine needed for your prescribed dose
• 1 oral dosing syringe (10mL) with a cap
• 1 scale or 1 adjustable measuring spoon
• milk or infant formula (10mL)
• 1 medicine cup (30mL)

Figure B

Step 1:	Choose a clean flat work surface. Place a clean paper towel on the work surface. Then place the other supplies on the paper towel.
If using infant formula, prepare the formula according to the directions on the infant formula package.
Step 2:	Wash and dry your hands.
Step 3:	Open one XURIDEN packet.
Step 4:	Measure the dose:
If you are using a scale: Open the packet and measure out the amount needed for the prescribed dose on the scale. Follow the instructions that came with the scale for correct and accurate use. If you are using an adjustable measuring spoon: Open the packet and use the adjustable measuring spoon to measure out the amount needed for the prescribed dose as shown. Throw away any unused XURIDEN in the trash. Do not use any XURIDEN left in the open packet.
Step 5:	Pour 5 mL of either milk or infant formula into the 30mL medicine cup.
Step 6:	Place the syringe tip into the medicine cup. Pull up on the plunger until all the liquid is removed from the cup and the plunger reaches the 5 mL line on the syringe.
Step 7:	Hold the syringe with the tip pointing upward. Pull down on the plunger until the plunger reaches the 10 mL line on the syringe. This will add air to the syringe.
Step 8:	Place the syringe cap over the tip of the syringe. Now hold the syringe so the tip is pointing down and remove the plunger.
Step 9:	Pour the measured amount of XURIDEN granules into the syringe barrel, and put the plunger back in. Do not push further on the plunger.
Step 10:	Gently swirl the syringe to mix the XURIDEN with the liquid.
Step 11:	Turn the syringe so the syringe tip is pointing up, then remove the syringe cap, and push up on the plunger until the plunger reaches the 5mL line on the syringe. This will remove the air from the syringe.
Step 12:	Give the mixture to the child right awayto avoid a bitter taste from the medicine. Place the tip of the syringe in your child's mouth between the cheek and the gum at the back of the mouth. Gently push the plunger all the way down.
Step 13:	Pour another 5 mL of milk or formula into the medicine cup.
Step 14:	Refill the syringe by placing the syringe tip into the medicine cup. Pull up on the plunger until all the liquid is removed from the cup and the plunger reaches the 5 mL line on the syringe.
Step 15:	Gently swirl the syringe to make sure any medicine remaining in the syringe is mixed with the liquid.
Step 16:	Give the liquid to the child right away. Place the tip of the syringe in your child's mouth between the cheek and the gum at the back of the mouth. Gently push the plunger all the way down.
Step 17:	Give your child a bottle of milk or formula after giving the XURIDEN dose if you wish to.
Step 18:	Remove the plunger from the barrel of the dosing syringe and wash the syringe and mixing cup, with warm water and dish soap. Rinse with water and air dry.
Wash the supplies needed to measure your dose as your healthcare provider has told you. Throw away the paper towel and clean the work surface. Wash your hands.

How should I store XURIDEN?

• Store XURIDEN at room temperature between 59° F to 86°F (15° to 30°C).
• Keep XURIDEN and all medicines out of the reach of children.

General information about the safe and effective use of XURIDEN

This Instructions for Use leaflet summarizes the most important information about XURIDEN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about XURIDEN that is written for healthcare professionals.

For more information, go to www.XURIDEN.com.

What are the ingredients in XURIDEN?

Active ingredient:uridine triacetate

Inactive ingredients:ethylcellulose, hydroxypropylmethylcellulose, Macrogol, natural orange juice flavor

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for and distributed by

BTG International Inc,

West Conshohocken, PA, 19428

XURIDEN ^®is a registered trademark of BTG International Inc.

Issued: 08/2023