XURIDEN Oral granules Ref.[10388] Active ingredients: Uridine triacetate

2.1 Recommended Dosage

The recommended starting dosage of oral XURIDEN is 60 mg/kg once daily. Increase the dosage of XURIDEN to 120 mg/kg (not to exceed 8 grams) once daily 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

The XURIDEN dose to be administered at the 60 mg/kg and 120 mg/kg dose levels by body-weight is presented in Tables 1 and 2.

A 2 gram packet of XURIDEN contains approximately ¾ teaspoon of XURIDEN. Therefore, in the tables below for patients requiring doses in multiples of 2 grams (¾ teaspoon) an entire packet(s) may be administered without weighing or measuring.

XURIDEN Daily Dose Based on Body Weight (kg)

Table 1. XURIDEN 60 mg/kg?footnote? Dose Level:

* total daily dose by weight category in the tables was rounded to achieve the approximate dose level
^† may use 1 entire 2 gram packet without weighing or measuring
^‡ may use 2 entire 2 gram packets without weighing or measuring
^§ may use 3 entire 2 gram packets without weighing or measuring

Table 2. XURIDEN 120 mg/kg?footnote? Dose Level:

* total daily dose by weight category in the tables was rounded to achieve the approximate dose level
^† may use 2 entire 2 gram packets without weighing or measuring
^‡ may use 3 entire 2 gram packets without weighing or measuring
^§ may use 4 entire 2 gram packets without weighing or measuring

2.2 Preparation and Administration

Preparation

Measure the dose using either a scale accurate to at least 0.1 gram, or a graduated teaspoon, accurate to the fraction of the dose to be administered.

Once the measured dose has been removed from the XURIDEN packet, discard the unused portion of granules. Do not use any granules left in the open packet.

Administration with Food

1. Place 3 to 4 ounces of applesauce, pudding or yogurt in a small clean container.
2. Mix the measured amount of granules in the applesauce, pudding or yogurt
3. Swallow applesauce/pudding/yogurt immediately. Do not chew the granules. Do not save the applesauce/pudding/yogurt for later use.
4. Drink at least 4 ounces of water.

Administration in Milk or Infant Formula

XURIDEN can be mixed with milk or infant formula instead of the soft foods described above for patients receiving up to ¾ teaspoon (2 grams) of XURIDEN. After weighing the dose of XURIDEN:

1. Pour 5 mL of milk or infant formula into a 30 mL medicine cup.
2. Insert the tip of the oral syringe into the medicine cup and draw up 5 mL of milk/infant formula into the syringe.
3. Hold the syringe with the tip pointing upward. Pull down on the plunger until the plunger reaches 10 mL. This will add air to the syringe.
4. Place the cap over the tip of the syringe. Then invert the syringe so the syringe tip is pointing down, and remove the plunger.
5. Pour the measured amount of XURIDEN granules into the syringe barrel and reinsert the syringe plunger. Do not push up on the plunger.
6. Gently swirl the syringe to mix the XURIDEN granules with the liquid.
7. 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 5 mL mark. This will remove air from the syringe.
8. 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.
9. Refill the syringe with another 5 mL of milk/infant formula.
10. Gently swirl the syringe to rinse any remaining XURIDEN granules from the syringe barrel.
11. 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.
12. Follow with a bottle of milk or infant formula, if desired.

Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).