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: [20XX]
INDICATIONS AND USAGE
XURIDEN is a pyrimidine analog indicated for uridine replacement in patients with hereditary orotic aciduria. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage (2.1):
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The starting dosage is 60 mg/kg once daily
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Increase the dose by 60 mg/kg increments up to a maximum of 240 mg/kg (not to exceed 8 grams) once daily for insufficient efficacy
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Decrease the dose if diarrhea occurs that persists for 3 or more successive days without another identifiable cause.
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See the full prescribing information for weight-based dosing tables.
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Measure the dose using either a balance accurate to at least 0.1 gram, or a pharmacy-provided graduated teaspoon, accurate to the fraction of the dose to be administered
Administration (2.2)
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Administer the dose in applesauce, pudding or yogurt or in milk/infant formula, see full prescribing information.
DOSAGE FORMS AND STRENGTHS
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Oral granules: 2 gram packets. (3)
CONTRAINDICATIONS
No adverse reactions were reported with XURIDEN in patients with hereditary orotic aciduria (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Wellstat Therapeutics Corporation at (1-800-###-####) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2015
