Ascor

1. INDICATIONS AND USAGE ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.

4. CONTRAINDICATIONS None. None.

5. WARNINGS AND PRECAUTIONS ​Oxalate nephropathy and Nephrolithiasis: ​ Ascorbic acid has been associated with development of acute or chronic oxalate nephropathy following prolonged use of high doses of ascorbic acid infusion. Patients with renal disease including renal impairment, history of oxalate kidney stones, geriatric patients, and pediatric patients less than 2 years old may be at increased risk (5.1) . ​Hemolysis: ​ Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced is recommended (5.2) . ​Laboratory Test Interference: ​ Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing (5.3) .

5.1Oxalate Nephropathy and Nephrolithiasis Acute

and chronic oxalate nephropathy have been reported with prolonged administration of high doses of ascorbic acid. Acidification of the urine by ascorbic acid may cause precipitation of cysteine, urate or oxalate stones. Patients with renal disease including renal impairment, history of oxalate kidney stones, and geriatric patients may be at increased risk for oxalate nephropathy while receiving treatment with ascorbic acid.

Pediatric patients less than 2 years of age may be at increased risk for oxalate nephropathy during treatment with ascorbic acid because their kidneys are immature [see Use in Specific Populations ( 8.4 , 8.5 , 8.6 )]. Monitor renal function in patients at increased risk receiving ASCOR. Discontinue ASCOR in patients who develop oxalate nephropathy and treat any suspected oxalate nephropathy. ASCOR is not indicated for prolonged administration (the maximum recommended duration is one week) [see Dosage and Administration ( 2.1 )] .