Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
uridine triacetate (UNII: 2WP61F175M) (uridine - UNII:WHI7HQ7H85)
Wellstat Therapeutics Corporation
uridine triacetate
uridine triacetate 951 mg in 1 g
ORAL
PRESCRIPTION DRUG
XURIDEN® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. None 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study, uridine triacetate was administered orally to pregnant rats during the period of organogenesis at doses up to 2000 mg/kg per day (about 2.7 times the maximum recommended human dose (MRHD) of 120
XURIDEN orange-flavored oral granules (95% w/w) are available in single-use packets (NDC 69468-152-02) containing 2 grams of uridine triacetate in cartons of 30 packets each (NDC 69468-152-30). Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
New Drug Application
XURIDEN- URIDINE TRIACETATE GRANULE WELLSTAT THERAPEUTICS CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE XURIDEN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XURIDEN. XURIDEN® (URIDINE TRIACETATE) ORAL GRANULES INITIAL U.S. APPROVAL: 2015 INDICATIONS AND USAGE XURIDEN is a pyrimidine analog for uridine replacement indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. (1) 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. DOSAGE FORMS AND STRENGTHS Oral granules: 2 gram packets. (3) CONTRAINDICATIONS None (4) 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 WELLSTAT THERAPEUTICS CORPORATION AT (1-800-914-0071) OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 12/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Preparation and Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodyn read_full_document