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ASCOR (ascorbic acid injection), for intravenous use

PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither NewMedicalTerms Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  

Drug UPDATES:   [Drug information (pdf)]  
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

 

Usual Diluents top of page

D5W, NS

No degradation at 24 hours when D5W used. Review stability data below.

Standard Dilutions   [Amt of drug] [Infusion vol] [Infusion rate] top of page

Sample dilutions:
[1500mg ]   [50 mL ]  [30 minutes]
[3000 mg ]   [100 mL ]  [30-60 minutes]

Rates of infusion may depend on whether or not the patient has a central line and the prescribed dose.  Use our specialized calculator:
https://www.newmedicalterms.com/medcalcs/ascorbic-acid-infusion-data/

Recent studies:

Reference top of page

ClinicalTrials.gov

  • Link
  • Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS.
  • We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19) subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers

Drug: ascorbic acid
50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)

 

Reference top of page

ClinicalTrials.gov

  • Link
  • Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making sepsis the most expensive inpatient disease.

    1. Recent research has described the therapeutic benefits associated with ascorbic acid treatment for sepsis.
    2. Researchers objectives are to perform a randomized-controlled clinical trial investigating the ability of ascorbic acid(vitamin C) administration to decrease organ dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in sepsis leading to tissue hypoxia, mitochondrial dysfunction, and ATP depletion, gives rise to organ failure.
    3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death than patients with organ failure alone. Critically ill patients may have an increased requirement for ascorbic acid in sepsis and these patients frequently have levels below normal. Ascorbic acid administration, has been shown to correlate inversely with organ failure (human literature) and directly with survival (animal studies).
  • Intravenous ascorbic acid therapy decreases organ failure by providing a protective effect on several microvascular functions including improving capillary blood flow, decreasing microvascular permeability, and improving arteriolar responsiveness to vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe sepsis is an important task as investigators continue the institutional focus on sepsis care.

Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.

     

WARNINGS  top of page

DESCRIPTION  top of page

Description:
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.

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:

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.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE:
 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.

CONTRAINDICATIONS top of page

Contraindications:

None.

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS:
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.

ADVERSE REACTIONS top of page

ADVERSE REACTIONS:

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information

DOSAGE AND ADMINISTRATION  top of page

2.1 Important Preparation and Administration Instructions

  • 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.

2.2 Recommended Dosage

Table 1 provides recommended doses of ASCOR based on patient population and infusion rates of diluted ASCOR solution.

 Table 1: Recommended Dose of ASCOR and Infusion Rate of Diluted ASCOR Solution
Patient Population ASCOR
Once Daily Dose
(mg)
Infusion Rate of
Diluted ASCOR
Solution (mg/minute)
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.

2.3 Dosage Reductions in Specific Populations

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.

 

HOW SUPPLIED  top of page

DOSAGE FORMS AND STRENGTHS:

Injection: 25,000 mg/50 mL (500 mg/mL) supplied as a Pharmacy Bulk Package (clear, colorless to pale yellow solution)

Storage and Stability top of page

 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.

Reference top of page

Trissel's™ 2 Clinical Pharmaceutics Database (Parenteral Compatibility

  • Accessed: December 02, 2020
  • Findings: Ascorbic acid: concentrations: 1mg/mL and 10 mg/mL.
    Solution: NS. Compatible. 10 mg/mL:  3 to 6% loss at 24 hours room temperature.
  • Ascorbic acid: concentrations: 1mg/mL and 10 mg/mL.
    Solution: D5W.. Compatible.  10 mg/mL: No ascorbic acid loss occurred within the study period.

Reference top of page

Walker SE, Iazzetta J, Law S, et al. Administration of Intravenous Ascorbic Acid-Practical Considerations for Clinicians. Nutrients. 2019;11(9):1994. Published 2019 Aug 23. doi:10.3390/nu11091994

  • Emerging data suggest that intravenous ascorbic acid (AA) may be beneficial in patients with sepsis. Clinicians require data on stability of diluted AA for safe administration. We evaluated the stability of AA diluted in normal saline (NS) or 5% dextrose in water (D5W) solutions over 14 days at 25 °C and at 4 °C, protected from light, using concentrations of 37 mg/mL and 77 mg/mL (Sandoz) and 40 mg/mL and 92 mg/mL (Mylan). We also assessed stability of a 40 mg/mL solution (Mylan) at 25 °C exposed to light for 75 h.
  • Evaluation of the Need to Protect from Light
    During the 75 h evaluation period, AA exposed to fluorescent room light at 25 °C nominally degraded faster than samples protected from light (Table 3). AA stored in the administration sets degraded to 95.15% remaining when exposed to light, compared to 96.79% remaining when protected from light (p = 0.948 for difference in degradation rate to 75 h). Similar rates of degradation were observed in PVC minibags (p = 0.681 for difference in degradation rate).
  • This study demonstrates that AA solutions at concentrations between 37 and 92 mg/mL, diluted in either NS or D5W and stored in PVC minibags, are physically, chemically and visually stable for at least 14 days refrigerated at 4 °C with protection from light. Clinicians in acute care settings may consider using AA solutions stored under these conditions. By contrast, when stored at room temperature (25 °C), AA solutions remained stable for 10 days, but discolouration was apparent after 2 days, possibly indicating degradation products of uncertain safety.

Ascorbic acid injection