Dosage and Administration

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)

DOSAGE AND ADMINISTRATION

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 injection.
• 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:
  • Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area).
  • 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.
  • 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.
  • 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 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. 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 in 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.
  • Prepare the recommended dose based on the patient population.
  • Visually inspect for particulate matter and discoloration prior to administration (the diluted ASCOR^® solution should appear colorless to pale yellow).
  • Immediately administer the admixture for infusion as a slow intravenous infusion.

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 age 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.

Dose Reduction 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.