Uridine Triacetate
Generic Name: uridine triacetate
Brand Names:
Xuriden
11 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 C 15 H 18 N 2 O 9 .
Overview
11 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 C 15 H 18 N 2 O 9 .
Uses
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
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.
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS None 4 CONTRAINDICATIONS None None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on XURIDEN use in pregnant women to inform a drug-associated risk. When administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses similar to the maximum recommended human dose (MRHD) of 120 mg/kg per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see Data ] . The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S.
Storage
Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Frequently Asked Questions
What is Uridine Triacetate used for?▼
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 )
What are the side effects of Uridine Triacetate?▼
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.
Can I take Uridine Triacetate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on XURIDEN use in pregnant women to inform a drug-associated risk. When administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses similar to the maximum recommended human dose (MRHD) of 120 mg/kg per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see Data ] . The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S.
What are the important warnings for Uridine Triacetate?▼
5 WARNINGS AND PRECAUTIONS None 4 CONTRAINDICATIONS None None ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.