Ascorbic Acid
Generic Name: ascorbic acid
Brand Names:
Ascorbic Acid
11 DESCRIPTION Ascorbic acid injection, USP for intravenous use is a colorless to pale yellow, preservative-free, hypertonic, sterile, non-pyrogenic solution of ascorbic acid. Ascorbic acid injection must be diluted with an appropriate infusion solution (e.g., 5% Dextrose Injection, USP; Sterile Water for Injection, USP) [see Dosage and Administration (2.1) ] . The chemical name of ascorbic acid, USP is L -ascorbic acid. The molecular formula is C 6 H 8 O 6 .
Overview
11 DESCRIPTION Ascorbic acid injection, USP for intravenous use is a colorless to pale yellow, preservative-free, hypertonic, sterile, non-pyrogenic solution of ascorbic acid. Ascorbic acid injection must be diluted with an appropriate infusion solution (e.g., 5% Dextrose Injection, USP; Sterile Water for Injection, USP) [see Dosage and Administration (2.1) ] . The chemical name of ascorbic acid, USP is L -ascorbic acid. The molecular formula is C 6 H 8 O 6 .
Uses
1 INDICATIONS AND USAGE 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.
Dosage
2 DOSAGE AND ADMINISTRATION • Supplied in a 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 ) Population ( 2.2 ) 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 ( 2.3, 8.1, 8.2 ) Pregnant women, lactating women, patients with glucose-6-phosphate dehydrogenase deficiency Sho...
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Oxalate nephropathy and Nephrolithiasis [see Warnings and Precautions (5.1) ]. • Hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency [see Warnings and Precautions (5.2) ]. The following adverse reactions associated with the use of ascorbic acid were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Administration site reactions: pain and swelling. Ascorbic acid injection should not be rapidly administered.
Interactions
7 DRUG 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 ). 7.1 Antibiotics Ascorbic acid may decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid.
Warnings
5 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 ). 4 CONTRAINDICATIONS None. None.
Pregnancy
8.1 Pregnancy 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Ascorbic acid injection, USP for intravenous use is a colorless to pale yellow solution supplied as: Product Code Unit of Sale Strength (Concentration) Each 207755 NDC 65219-027-55 Unit of 1 25,000 mg per 50 mL (500 mg per mL) NDC 65219-027-55 50 mL Pharmacy Bulk Package vial 207750 NDC 65219-027-50 Unit of 25 25,000 mg per 50 mL (500 mg per mL) NDC 65219-027-0...
Frequently Asked Questions
What is Ascorbic Acid used for?▼
1 INDICATIONS AND USAGE 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.
What are the side effects of Ascorbic Acid?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Oxalate nephropathy and Nephrolithiasis [see Warnings and Precautions (5.1) ]. • Hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency [see Warnings and Precautions (5.2) ]. The following adverse reactions associated with the use of ascorbic acid were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Administration site reactions: pain and swelling. Ascorbic acid injection should not be rapidly administered.
Can I take Ascorbic Acid during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Ascorbic Acid?▼
5 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 ). 4 CONTRAINDICATIONS None. None.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.