Ascor® (Ascorbic Acid Injection, USP)
Ascor® is McGuff Pharmaceuticals Inc.'s branded formula of Ascorbic Acid Injection, USP.
Ascor® is vitamin C 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.
Ascor® is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.
McGuff Pharmaceutical's Ascor® consists of a 50mL pharmacy bulk package of sterile, preservative-free, pyrogen-free Ascorbic Acid, USP (500 mg/mL) in a solution containing Edetate Disodium (0.025%), Water for Injection (q.s.) and Sodium Bicarbonate for pH adjustment (pH 5.6 to 6.6).
Storage conditions for Ascorbic Acid Injection are not specified in the USP. McGuff Pharmaceuticals chose to have its product refrigerated to retard the accumulation of pressure and improves stability of product potency for up to 24 months.
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Important Safety Information
- Ascorbic acid has been associated with development of acute or chronic oxalate nephropathy following prolonged use of high doses of ascorbic acid infusion. Patients with renal disease including renal impairment, history of oxalate kidney stones, geriatric patients, and pediatric patients less than 2 years old may be at increased risk.
- Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced dose is recommended.
- Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing.
- Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid.
- Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels and affect excretion and plasma concentrations of other drugs sensitive to urine pH.
- To report SUSPECTED ADVERSE REACTIONS, contact McGuff Pharmaceuticals, Inc., toll free at 1-800-603-4795 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
McGuff Pharmaceuticals maintains a unique combination of technical capabilities, state of the art manufacturing facilities and strong supplier relationships to assure its goal of meeting patient and physician needs for high quality, competitively priced, small volume injectable products. The introduction of Ascor® demonstrates our commitment to these customers.
Ascor® is registered in the United States and may be pending or registered in other jurisdictions.
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