Ascorbic acid

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.

The exact mechanism of action of ascorbic acid for the treatment of symptoms and signs of scurvy (a disorder caused by severe deficiency in vitamin C) is unknown, however, administration of ascorbic acid in patients with scurvy is thought to restore the body pool of ascorbic acid.

2. DOSAGE AND ADMINISTRATION Supplied in Pharmacy Bulk Package (PBP). Dispense single doses to multiple patients in a pharmacy admixture program, use within 4 hours of puncture. Must be diluted prior to use. Administer as a slow intravenous infusion. See Full Prescribing Information for important administration instructions. Maximum recommended duration is one week. Population ​. Recommended Doses Pediatric patients age 5 months to less than 12 months 50 mg once daily Pediatric patients age 1 year to less than 11 years 100 mg once daily Adults and pediatric patients age 11 years and older 200 mg once daily Specific Populations ​. Pregnant women, lactating women, patients with glucose-6-phosphate dehydrogenase deficiency Should not exceed the U.S. Recommended Dietary Allowance (RDA) Supplied in Pharmacy Bulk Package (PBP).

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. ​Hemolysis: ​ Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis, a reduced is recommended. ​Laboratory Test Interference: ​ Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing.

6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Oxalate nephropathy and Nephrolithiasis Hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency The following adverse reactions associated with the use of ascorbic acid were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Administration site reactions: pain and swelling. ASCOR should not be rapidly administered.

7. DRUG INTERACTIONS ​Antibiotics:​ Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated ​in vitro ​by ascorbic acid. ​Amphetamine and Other Drugs Affected by Urine Acidification:​ Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels affect excretion and plasma concentrations of other drugs sensitive to urine pH. ​Warfarin:​ Continue standard monitoring ​ Bleomycin is inactivated ​in vitro ​by ascorbic acid. ​Amphetamine and Other Drugs Affected by Urine Acidification: ​ Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels affect excretion and plasma concentrations of other drugs sensitive to urine pH. ​Warfarin: ​ Continue standard monitoring ​

Store in a refrigerator at 2° to 8°C (36° to 46°F). Protect from light. Excursions to ambient conditions for up to 30 days during storage or shipping are acceptable.