ASCOR Solution for injection Ref.[50377] Active ingredients: Vitamin C

• 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)

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 [see Dosage and Administration (2.2), (2.3)].

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 [see Recommended Dosage, (2.2)].

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:

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 [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.2)].

Overdose with ascorbic acid may cause nausea, vomiting, diarrhea, facial flushing, rash, headache, fatigue or disturbed sleep. If overdose of ASCOR occurs, immediately discontinue administration and treat symptoms and signs of overdose, avoiding additional intake of ascorbic acid.

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. Excursions to ambient conditions for up to 30 days during storage or shipping are acceptable.