Clinical Information
Gen. Code and Des.
77810 ascorbic acid INTRAVEN VIAL 500 MG/ML
GCN and Des.
43957 ascorbic acid INTRAVEN VIAL 500 MG/ML
Strength
500MG-ML
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
88120000 VITAMIN C
Active Ingredients
1010 ascorbic acid 50817
Inactive Ingredients
3785 edetic acid 60004
743 sodium bicarbonate 144558
For: Scurvy
Ascor (ascorbic acid) is an intravenous vitamin C formulation indicated for the short term treatment of scurvy.
ASCOR for intravenous use is a colorless to pale yellow solution supplied as:
NDC 67157-101-50 One 25,000 mg/50 mL (500 mg/mL) Pharmacy Bulk Package vial
NDC 67157-101-51 Tray pack of twenty five 25,000 mg/50 mL (500 mg/mL) Pharmacy Bulk Package vials
Store in a refrigerator at 2° to 8°C (36° to 46°F).
Protect from light. This product contains no preservative. See Dosage and Administration (2.1), for detailed instructions on preparation, dilution, and administration of ASCOR.
Clinical Information
Gen. Code and Des.
77810 ascorbic acid INTRAVEN VIAL 500 MG/ML
Strength
500 mg/mL
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
88120000 VITAMIN C
Active Ingredients
1010 ascorbic acid 50817
Inactive Ingredients
3785 edetic acid 60004
743 sodium bicarbonate 144558
These highlights do not include all the information needed to use ASCOR® safely and effectively. See full prescribing information for ASCOR.
ASCOR (asorbic acid injection), for intravenous use.
Initial U.S. Approval: 1947
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.
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. (2.1)
Must be diluted prior to use (2.1)
Administer as a slow intravenous infusion (2.1)
See Full Prescribing Information for important administration instructions (2.1)
Maximum recommended duration is one week (2.2)
Population (2.2) 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 (2.3, 8.1, 8.2)
Pregnant women, lactating women, patients with glucose-6-phosphate dehydrogenase deficiency Should not exceed the U.S. Recommended Dietary Allowance (RDA)
DOSAGE FORMS AND STRENGTHS
Injection: 25,000 mg/50 mL (500 mg/mL) - Pharmacy Bulk Package
CONTRAINDICATIONS
None.
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).
ADVERSE REACTIONS
Most common adverse reactions are pain and swelling at the site of infusion (6)
To report SUSPECTED ADVERSE REACTIONS, contact McGuff Pharmaceuticals, Inc., toll free at 1-800-603-4795 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Antibiotics: Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid (7.1).
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 (7.2).
Warfarin: Continue standard monitoring (7.3)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 10/2017
