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

In a single pharmacokinetic study, healthy male and female adults (n=8) were given a single intravenous dose of 1000 mg ascorbic acid (5 times the largest recommended single dose) infused over a 30 minute period. The mean peak exposure to ascorbic acid was 436.2 µM and occurred at the end of the 30 minute infusion.

Distribution

Ascorbic acid is distributed widely in the body, with large concentrations found in the liver, leukocytes, platelets, glandular tissues, and lens of the eye. Based on data from oral exposure, ascorbic acid is known to be distributed into breast milk and crosses the placental barrier.

Elimination

When the body is saturated with ascorbic acid, the plasma concentration will be about the same as that of the renal threshold; if further amounts are then administered, most of it is excreted in the urine. When body tissues are not saturated and plasma concentration is low, administration of ascorbic acid results in little or no renal excretion. The mean±SD (N=3) half-life observed in the single dose PK study as described above, was 7.4±1.4 h.

Metabolism

A major route of metabolism of ascorbic acid involves its conversion to urinary oxalate, presumably through intermediate formation of its oxidized product, dehydroascorbic acid.

Excretion

There is a renal threshold for ascorbic acid (Vitamin C); the vitamin is excreted by the kidney in large amounts only when the plasma concentration exceeds this threshold, which is approximately 1.4 mg/100 mL.

Carcinogenicity, mutagenicity, and fertility studies have not been performed with ASCOR.