Xuriden

Generic name: Uridine Triacetate (Xuriden)
Drug classes: Antidotes, Miscellaneous metabolic agents

What is Xuriden?

Xuridenis a prescription medicine that is used to treat a rare metabolism health problem called orotic aciduria.

Description

XURIDEN (uridine triacetate) oral granules is a pyrimidine analog indicated for uridine replacement therapy. Uridine triacetate has the chemical designation (2′,3′,5′-tri-O-acetyl-β-D-ribofuranosyl)-2,4(1H,3H)-pyrimidinedione. The molecular weight is 370.3 and it has an empirical formula of C15H18N2O9. The structural formula is:

Each single-use 2-gram packet of XURIDEN orange-flavored oral granules (95% w/w) contains 2 grams of uridine triacetate and the following inactive ingredients: ethylcellulose (0.062 grams), Opadry Clear [proprietary dispersion of hydroxypropylmethylcellulose and Macrogol] (0.015 grams), and natural orange juice flavor (0.026 grams).

Mechanism of Action

Uridine triacetate is an acetylated form of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation (Figure 1).

Figure 1: Uridine Triacetate Conversion to Uridine

XURIDEN provides uridine in the systemic circulation of patients with hereditary orotic aciduria who cannot synthesize adequate quantities of uridine due to a genetic defect in uridine nucleotide synthesis.

Before taking Xuriden, tell your doctor:

• If you are allergic to Xuriden; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xuriden with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Xuriden?

• Tell all of your health care providers that you take Xuriden. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Xuriden while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• Have your urine checked as you have been told by your doctor.

How is Xuriden best taken?

Use Xuriden as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will tell you how to take Xuriden. Be sure you know how much to take, how often to take Xuriden, and how to store Xuriden. If your doctor does not tell you how to use Xuriden or if you are not sure how to use it, talk with your doctor.
• Throw away any part of the packet not used after use.
• Mix granules with 3 to 4 ounces (90 to 120 mL) of applesauce, pudding, or yogurt.
• Do not chew Xuriden.
• Drink at least 4 ounces (120 mL) of water.
• Keep taking Xuriden as you have been told by your doctor or other health care provider, even if you feel well.
• Some doses of Xuriden may be mixed with milk or infant formula. If you are mixing Xuriden with milk or infant formula, follow what the doctor has told you or read the package insert.
• Swallow the mixture right away. Do not store for use at a later time.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Xuriden that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Xuriden?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Xuriden?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 2 g Packet Carton

• NDC 69468-152-30
  Rx Only
• Xuriden® 2 g
  (uridine triacetate)
• Oral Granules
• Carton contains 30 x 2 gram packets
• Wellstat Therapeutics™
  CORPORATION

SRC: NLM .