Ascorbic Acid

2 DOSAGE AND ADMINISTRATION • Supplied in a Pharmacy Bulk Package (PBP). Dispense single doses to multiple patients in a pharmacy admixture program; use within 4 hours of puncture. S. 1 Important Preparation and Administration Instructions • Ascorbic acid injection 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 ascorbic acid injection as an undiluted intravenous injection. • Minimize exposure to light because ascorbic acid injection is light sensitive. • Ascorbic acid injection 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, exercise 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 , ascorbic acid injection must be diluted in a suitable infusion solution and the final solution for infusion must be isotonic (undiluted the osmolarity of ascorbic acid injection is approximately 5,900 mOsmol/L).

Prior to preparing the admixture for infusion, calculate the osmolarity of the intended admixture for infusion. , 5% Dextrose Injection, Sterile Water for Injection) and add appropriate solutes, as necessary, to make the final solution isotonic.

Sterile Water for Injection is highly hypotonic; adjust solute content, as necessary, to make the final infusion solution isotonic prior to injection. , copper). The concentration of ascorbic acid in the final, admixture solution for infusion is to be in the range of 1 to 25 mg of ascorbic acid per mL.

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. 3) ]. f. Visually inspect for particulate matter and discoloration prior to administration (the diluted ascorbic acid injection solution should appear colorless to pale yellow).

g. 2 Recommended Dosage Table 1 provides recommended doses of ascorbic acid injection based on patient population and infusion rates of diluted ascorbic acid injection solution. 3 Adults and Pediatric Patients 11 years and older 200 33 The recommended maximum duration of daily treatment with ascorbic acid injection 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. S. 2) ]. 1 Important Preparation and Administration Instructions • Ascorbic acid injection 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 ascorbic acid injection as an undiluted intravenous injection. • Minimize exposure to light because ascorbic acid injection is light sensitive. • Ascorbic acid injection 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, exercise 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 , ascorbic acid injection must be diluted in a suitable infusion solution and the final solution for infusion must be isotonic (undiluted the osmolarity of ascorbic acid injection is approximately 5,900 mOsmol/L).

Prior to preparing the admixture for infusion, calculate the osmolarity of the intended admixture for infusion. , 5% Dextrose Injection, Sterile Water for Injection) and add appropriate solutes, as necessary, to make the final solution isotonic.

Sterile Water for Injection is highly hypotonic; adjust solute content, as necessary, to make the final infusion solution isotonic prior to injection. , copper). The concentration of ascorbic acid in the final, admixture solution for infusion is to be in the range of 1 to 25 mg of ascorbic acid per mL.

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. 3) ]. f. Visually inspect for particulate matter and discoloration prior to administration (the diluted ascorbic acid injection solution should appear colorless to pale yellow).

g. 2 Recommended Dosage Table 1 provides recommended doses of ascorbic acid injection based on patient population and infusion rates of diluted ascorbic acid injection solution. 3 Adults and Pediatric Patients 11 years and older 200 33 The recommended maximum duration of daily treatment with ascorbic acid injection 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. S. 2) ].

1) ]. 2) ]. 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.

Ascorbic acid injection should not be rapidly administered. 2) ]). 1) ]. 2) ]. gov/medwatch.

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. 1 ). 2 ).

3 ). 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. 6) ] . Monitor renal function in patients at increased risk receiving ascorbic Acid Injection.

Discontinue ascorbic acid injection in patients who develop oxalate nephropathy and treat any suspected oxalate nephropathy. 1) ]. 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 deficiency may be at increased risk for severe hemolysis during treatment with ascorbic acid. 3) ] . Discontinue treatment with ascorbic acid injection if hemolysis is suspected and treat as needed.

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. 4) ]. 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.

6) ] . Monitor renal function in patients at increased risk receiving ascorbic Acid Injection. Discontinue ascorbic acid injection in patients who develop oxalate nephropathy and treat any suspected oxalate nephropathy. 1) ]. 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 deficiency may be at increased risk for severe hemolysis during treatment with ascorbic acid. 3) ] . Discontinue treatment with ascorbic acid injection if hemolysis is suspected and treat as needed.

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. 4) ].

4 CONTRAINDICATIONS None. None.