ASCOR (ascorbic acid injection), for intravenous use
Drug UPDATES: [Drug information (pdf)]
PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)
No degradation at 24 hours when D5W used. Review stability data below.
[1500mg ] [50 mL ] [30 minutes]
[3000 mg ] [100 mL ] [30-60 minutes]
ASCOR (ascorbic acid injection) for intravenous use is a colorless to pale yellow, preservative-free, hypertonic, sterile, non-pyrogenic solution of ascorbic acid. ASCOR must be diluted with an appropriate infusion solution.
Each ASCOR, 50 mL, Pharmacy Bulk Package vial contains 25,000 mg ascorbic acid, equivalent to 28,125 mg sodium ascorbate.
Each mL of ASCOR contains 500 mg of ascorbic acid (equivalent to 562.5 mg of sodium ascorbate which amounts to 65 mg sodium/mL of ASCOR), 0.25 mg of edetate disodium, and water for injection. Sodium hydroxide and sodium bicarbonate are added for pH adjustment (pH range 5.6 to 6.6). It contains no bacteriostatic or antimicrobial agent.
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.
ASCOR ® is 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 the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.
Several unlabled uses have been studied. Please review the recent literature for updated guidelines.
5.1 Oxalate 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)
5.2 Hemolysis in Patients with Glucose-6-Phosphate Dehydrogenase Deficiency
Hemolysis has been reported with administration of ascorbic acid in patients with glucose-6-phosphate dehydrogenase deficiency. Patients with glucose-6-phosphate dehydrogenase may be at increased risk for severe hemolysis during treatment with ascorbic acid. Monitor hemoglobin and blood count and use a reduced dose of ASCOR in patients with glucose-6-phosphate dehydrogenase deficiency. Discontinue treatment with ASCOR if hemolysis is suspected and treat as needed.
5.3 Laboratory Test Interference
Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing, nitrite and bilirubin levels, and leucocyte count testing. If possible, laboratory tests based on oxidation-reduction reactions should be delayed until 24 hours after infusion of ASCOR.
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information
- ASCOR vials contain 25, 000 mg of ascorbic acid and the largest recommended single dose is 200 mg. Do not give the entire contents of the vial to a single patient.
- Do not administer ASCOR as an undiluted intravenous sensitive.
- Minimize exposure to light because ASCOR is light sensitive.
- ASCOR is supplied as a Pharmacy Bulk Package (PBP) which is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion:
a. Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area)
b. Penetrate each PBP vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. Given that pressure may develop within the vial during storage, excercise caution when withdrawing contents from the vial.
c. Once the closure system has been penetrated, complete all dispensing from the PBP vial within 4 hours. Each dose must be used immediately. Discard unused portion.
d. Prior to administration, ASCOR must be diluted in a suitable infusion solution and the final solution for infusion must be isotonic (undiluted the osmolarity of ASCOR is approximately 5,900 mOsmol/L). Prior to preparing the admixture for infusion, calculate the osmolarity of the intended admixture for infusion. Add one daily dose of ASCOR directly to an appropriate volume of a suitable infusion solution (e.g., 5% Dextrose Injection, Sterile Water for Injection) and add appropriate solutes, as necessary, to make final solution isotonic. Sterile Water for Injection is highly hypotonic; adjust solute content, as necessary, to make thet final infusion solution isotonic prior to injection. Do not mix ASCOR with solutions containing elemental compounds that can be reduced (e.g., copper). The concentration of ascorbic acid in the final, admixture solution for infusion is to be the range of 1 to 25 mg of ascorbic acid per mL. For example, for the largest recommended dose:
Add 200 mg of ascorbic acid (equivalent to 0.4 mL of ASCOR) to 7.5 mL of Sterile Water for Injection to produce an infusion solution having an approximate osmolarity of 290 mOsmol/L. In this specific example, addition of solute is NOT necessary because the solution is isotonic.
e. Prepare the recommended dose based on the patient population.
f. Visually inspect for particulate matter and discoloration prior to administration (the diluted ASCOR solution should appear colorless to pale yellow).
g. Immediately administer the admixture for infusion as a slow intravenous infusion.
Table 1 provides recommended doses of ASCOR based on patient population and infusion rates of diluted ASCOR solution.
Once Daily Dose
|Infusion Rate of
|Pediatric Patients age 5 months to less than 12 months||50||1.3|
|Pediatric Patients age 1 year to less than 11 years||100||3.3|
|Adults and Pediatric Patients 11 years and older||200||33|
The recommended maximum duration of daily treatment with ASCOR is seven days. If no improvement in scorbutic symptoms is observed after one week of treatment, retreat until resolution of scorbutic symptoms is observed.
Repeat dosing is not recommended in pediatric patients less than 11 years of age.
Women who are pregnant or lactating and patients with glucose-6-dehydrogenase deficiency should not exceed the U.S. Recommended Dietary Allowance (RDA) or daily Adequate Intake (AI) level for ascorbic acid for their age group and condition and Use in Specific Populations.
Injection: 25,000 mg/50 mL (500 mg/mL) supplied as a Pharmacy Bulk Package (clear, colorless to pale yellow solution)
Protect from light. This product contains no preservative.
See Dosage and Administration (2.1), for detailed instructions on preparation, dilution, and administration of ASCOR.