XURIDEN 951 mg/g
uridine triacetate · GRANULE · BTG International Inc
XURIDEN is a granule containing uridine triacetate at 951 mg/g, taken oral. Manufactured by BTG International Inc.
Key Facts
- Brand Name
- XURIDEN
- Generic Name
- uridine triacetate
- NDC Code (Product)
50633-330- Manufacturer
- BTG International Inc
- Strength
- 951 mg/g
- Dosage Form
- GRANULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA208169
- Marketing Start
- 05/31/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE XURIDEN ® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. XURIDEN is a pyrimidine analog for uridine replacement indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Dosage ( 2.1 ): The starting dosage is 60 mg/kg once daily; the dose may be increased to120 mg/kg (not to exceed 8 grams) once daily for insufficient efficacy. See the full prescribing information for 60 mg/kg and 120 mg/kg weight-based dosing tables. Preparation and Administration ( 2.2 ) 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. Administer the dose with food (applesauce, pudding or yogurt) or in milk or infant formula. See full prescribing information for preparation and administration instructions. 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…
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS No adverse reactions were reported in clinical trials with XURIDEN in patients with hereditary orotic aciduria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BTG International Inc. at (1-877-377-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and using a wide range of doses, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of XURIDEN was assessed in 4 patients with hereditary orotic aciduria ranging in age from 3 to 19 years (3 male, 1 female) who received 60 mg/kg of XURIDEN once daily for six weeks. All patients continued to receive XURIDEN for at least 24 months at dosages of up to 120 mg/kg once daily. No adverse reactions were reported with XURIDEN.
Frequently Asked Questions
What is XURIDEN used for?
XURIDEN contains uridine triacetate. It is a granule taken oral. Consult your doctor for specific uses.
Is XURIDEN a controlled substance?
XURIDEN is not classified as a controlled substance by the DEA.
What is the generic name for XURIDEN?
The generic name for XURIDEN is uridine triacetate. There are 1 other brand versions of uridine triacetate.
What is the NDC code for XURIDEN 951 mg/g?
The NDC (National Drug Code) for XURIDEN 951 mg/g is 50633-330, listed by BTG International Inc.