Ascorbic acid (vitamin C), plain

Ascorbic Acid

Approved 7 Aug 2025IntravenousSolution

Indications

Ascorbic acid injection is 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. Limitations of Use Ascorbic acid injection is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. Ascorbic acid injection 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.

Limitations of Use Ascorbic acid injection is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.

Contraindications

None. None.

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. 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 ( 5.1 ).
Hemolysis : Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced dose is recommended ( 5.2 ).
Laboratory Test Interference: Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing ( 5.3 ).

5.1Oxalate 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.

Pediatric patients less than 2 years of age may be at increased risk for oxalate nephropathy during treatment with ascorbic acid because their kidneys are immature [see Use in Specific Populations (8.4, 8.5, 8.6) ] . 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.

At a glance

Brand name: Ascorbic Acid
Drug class: Ascorbic acid (vitamin C), plain, Organic acids, Other ophthalmologicals
Route: Intravenous
Dosage form: Solution
Applicant: Fresenius Kabi USA
Status: Prescription
FDA approval: 7 Aug 2025
Application: ANDA217131-001
RxCUI: 1151

Indications

Limitations of Use Ascorbic acid injection is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.

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. 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 ( 5.1 ).
Hemolysis : Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced dose is recommended ( 5.2 ).
Laboratory Test Interference: Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing ( 5.3 ).

5.1Oxalate Nephropathy and Nephrolithiasis Acute

Interactions

Antibiotics: Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid ( 7.1 ).
Amphetamine and Other Drugs Affected by Urine Acidification: 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 ( 7.2 ).
Warfarin: Continue standard monitoring ( 7.3 ).

7.1Antibiotics

Ascorbic acid may decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid. If the antibiotic efficacy is suspected to be decreased by concomitant administration of ascorbic acid injection, discontinue ascorbic acid injection administration.

7.2 Amphetamines & Other Drugs Affected by Urine Acidification Ascorbic acid may acidify the urine and lower serum concentrations of amphetamine by increasing renal excretion (as reflected by changes in amphetamine urine recovery rates). In case of decreased amphetamine efficacy, discontinue ascorbic acid injection administration. Standard monitoring of therapy is warranted. In addition, acidification of urine by ascorbic acid will alter the excretion of certain drugs affected by the pH of the urine (e.g., fluphenazine) when administered concurrently.

It has been reported that concurrent administration of ascorbic acid and fluphenazine has resulted in decreased fluphenazine plasma concentrations. Standard monitoring of therapy is warranted.

7.3Warfarin

Limited case reports have suggested interference of ascorbic acid with the anticoagulation effects of warfarin; however, for patients on warfarin therapy treated with ascorbic acid doses up to 1000 mg/day (5 times the largest recommended single dose) for 2 weeks (twice the maximum recommended duration), no effect was observed. Standard monitoring for anti-coagulation therapy should continue during ascorbic acid treatment, as per standard of care.

7.4Laboratory Test Interference

Because ascorbic acid is a strong reducing agent, it can interfere with numerous laboratory tests based on oxidation-reduction reactions (e.g., glucose, nitrite and bilirubin levels, leukocyte count, etc.). Chemical detecting methods based on colorimetric reactions are generally those tests affected. Ascorbic acid may lead to inaccurate results (false negatives) obtained for checking blood or urinary glucose levels, nitrite, bilirubin, and leukocytes if tested during or within 24 hours after infusion [see Warnings and Precautions (5.3) ].

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on use of ascorbic acid injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes; however, use of ascorbic acid (vitamin C) has been used during pregnancy for several decades and no adverse developmental outcomes are reported in the published literature [see Data]. There are dose adjustments for ascorbic acid (vitamin C) use during pregnancy [see Clinical Considerations].

Animal reproduction studies have not been conducted with ascorbic acid injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Dose Adjustments During Pregnancy and Post-Partum Period Follow the U.S. Recommended Dietary Allowances (RDA) for pregnant women when considering use of Ascorbic acid injection for treatment of scurvy [see Dosage and Administration (2.3)]. Data Human Data There are no available data on use of ascorbic acid injection or another ascorbic acid injection in pregnant women. However, a published meta–analysis of randomized studies evaluating a large number of pregnant women who took oral ascorbic acid (vitamin C) (through diet and supplementation) at doses ranging from 500 to 1000 mg/day (2.5 to 5 times the recommended daily intravenous dose, respectively) [see Dosage and Administration (2.3) ] between the 9th and 16th weeks of pregnancy showed no increased risk of adverse pregnancy outcomes such as miscarriage, preterm premature rupture of membranes, preterm delivery or pregnancy induced hypertension when compared to placebo.

These data cannot definitively establish or exclude the absence of a risk with ascorbic acid (vitamin C) during pregnancy.

Ascorbic Acid

Indications

Contraindications

Warnings and precautions

5.1Oxalate Nephropathy and Nephrolithiasis Acute

At a glance

Two medicines in one question?

Ascorbic Acid

Indications

Contraindications

Warnings and precautions

5.1Oxalate Nephropathy and Nephrolithiasis Acute

At a glance

Two medicines in one question?

5.2Hemolysis in Patients with Glucose-6-Phosphate Dehydrogenase Deficiency

5.3Laboratory Test Interference

Interactions

7.1Antibiotics

7.3Warfarin

7.4Laboratory Test Interference

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information