Ascorbic Acid (Systemic)

This monograph includes information on the following:

1) Ascorbic Acid
2) Sodium Ascorbate  

VA CLASSIFICATION
Ascorbic acid
Primary: VT400
Secondary: AD900; DX900

Sodium Ascorbate
Primary: VT400
Secondary: AD900


Commonly used brand name(s): Apo-C1; Ascorbicap1; Cebid Timecelles1; Cecon1; Cecore 5001; Cee-5001; Cemill1; Cenolate2; Cetane1; Cevi-Bid1; Flavorcee1; Mega-C/A Plus1; Ortho/CS2; Sunkist1.

Another commonly used name is
vitamin C .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:

Note: Ascorbic acid (vitamin C) is a water-soluble vitamin.



Nutritional supplement (vitamin)—Ascorbic Acid; Sodium Ascorbate;

Diagnostic aid adjunct (red blood cell disease)—Ascorbic Acid Injection{32}{33};

Deferoxamine adjunct (chronic iron overdose)—Ascorbic Acid; Sodium Ascorbate{09}{41}{43};

Methemoglobinemia (idiopathic) therapy adjunct—Ascorbic Acid{52};

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Vitamin C deficiency (prophylaxis and treatment)—Ascorbic acid and sodium ascorbate are indicated for prevention and treatment of ascorbic acid deficiency states. Ascorbic acid deficiency may occur as a result of inadequate nutrition but does not occur in healthy individuals receiving an adequate balanced diet. For prophylaxis of ascorbic acid deficiency, dietary improvement rather than supplementation is advisable. For treatment of vitamin C deficiency, supplementation is preferred.
—Deficiency of ascorbic acid may lead to scurvy. {43}
—Requirements may be increased and/or supplementation may be necessary in the following persons or conditions (based on documented ascorbic acid deficiency):

• AIDS (acquired immune deficiency syndrome) {72}


• Alcoholism {50}


• Burns {53}


• Cancer {53}


• Exposure to cold temperatures, prolonged {09}


• Fever, prolonged {09}


• Gastrectomy {53}


• Hemodialysis, chronic {19}


• Hyperthyroidism {22}


• Infants receiving unfortified formulas


• Infection, continuing {53}


• Intestinal diseases—diarrhea, prolonged; ileal resection


• Peptic ulcer {53}


• Smokers {40}


• Stress, continuing {22}


• Surgery


• Trauma, continuing {09}


• Tuberculosis {09} {53}

—Some unusual diets (e.g., reducing diets that drastically restrict food selection) may not supply minimum daily requirements for ascorbic acid. Supplementation is necessary in patients receiving total parenteral nutrition (TPN) {09} or undergoing rapid weight loss or in those with malnutrition, because of inadequate dietary intake.
—Recommended intakes for all vitamins and most minerals are increased during pregnancy. Many physicians recommend that pregnant women receive multivitamin and mineral supplements, especially those pregnant women who do not consume an adequate diet and those in high-risk categories (i.e., women carrying more than one fetus, heavy cigarette smokers, and alcohol and drug abusers). Taking excessive amounts of a multivitamin and mineral supplement may be harmful to the mother and/or fetus and should be avoided. {51}
—Recommended intakes for all vitamins and most minerals are increased during breast-feeding.

Red blood cells, labeling of, adjunct—Ascorbic acid injection is used as a reducing agent in the preparation of sodium chromate Cr 51 injection for the in vitro labeling of red blood cells. {32} {33}

[Toxicity, iron, chronic (treatment adjunct)]1—Ascorbic acid or sodium ascorbate has been used to increase iron excretion by improving chelation during deferoxamine therapy. {09} {41} {43}

—Ascorbic acid has been used as treatment adjunct for idiopathic methemoglobinemia; however, its use has generally been replaced by more effective agents. {52} {71}

Acceptance not established
There are insufficient data to show that ascorbic acid may reduce the risk of cardiovascular disease and certain types of cancer.

Unaccepted
{22}A potential role for ascorbic acid in the treatment of cancer has not been proven. {13} {14} Ascorbic acid is not useful for treatment of pyorrhea or gingival infections, {16} hemorrhagic states, hematuria, retinal hemorrhages, immune system dysfunction, {14} {43} or mental depression not related to ascorbic acid deficiency. Ascorbic acid has not been proven effective for treatment of dental caries, anemia, acne, asthma, {17} {43} infertility, {43} aging, atherosclerosis {14}, peptic ulcer, tuberculosis, schizophrenia, {12} dysentery, collagen disorders, fractures, skin ulcers, hay fever, or drug toxicity, nor for prevention of vascular thrombosis or the common cold. {11} {12} {43}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Ascorbic acid: 176.13 {28}
    Sodium ascorbate: 198.11 {28}

pKa—
    4.2 and 11.6

Mechanism of action/Effect:

Nutritional supplement (vitamin)—Ascorbic acid is necessary for collagen formation and tissue repair in the body and may be involved in some oxidation-reduction reactions. {23} It is also involved in metabolism of phenylalanine, tyrosine, folic acid, norepinephrine, {09} {11} histamine, {31} iron, and some drug enzyme systems; {09} {31} utilization of carbohydrates; synthesis of lipids, proteins, and carnitine {09} {31}; immune function; {31} hydroxylation of serotonin; {09} {11} and preservation of blood vessel integrity. In addition, ascorbic acid enhances the absorption of nonheme iron. {40}

Diagnostic aid adjunct (red blood cell disease)—Ascorbic acid reduces unbound dianionic chromium 51 to the anionic state, which does not penetrate red blood cells, thereby terminating the in vitro labeling of red blood cells. {32} {33}

Deferoxamine adjunct (chronic iron overdose)—Complex interaction; {02} vitamin C given orally in small doses (150 to 250 mg per day) may improve the chelating action of deferoxamine and increase the amount of iron excreted. {09} {21} {43}

Absorption:

Readily absorbed from gastrointestinal tract (jejunum); may be reduced with large doses. {10}

Protein binding:

Low (25%). {22}


Storage

Ascorbic acid is taken up by all cells of the body. {10} {11} The highest concentrations are found in glandular tissues, {11} leukocytes, {10} the liver, {11} and the lens of the eye. {11} The body stores up to approximately 1500 mg of ascorbic acid {10} {74} with intake of the recommended daily amount, and 2500 mg with an intake of 200 mg a day. {10}

Biotransformation:

Hepatic.

Elimination:
    Renal, {10} very little as unchanged vitamin and metabolites except with high doses; urinary excretion increases with plasma concentrations of greater than 1.4 mg per 100 mL. {11}
    In dialysis—Removable by hemodialysis. {43}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans. Problems in humans have not been documented with intake of normal daily recommended amounts. Ascorbic acid crosses the placenta. Ingestion of large quantities of ascorbic acid daily throughout pregnancy may possibly harm the fetus. {30} {53}

Studies have not been done in animals. {53}

FDA Pregnancy Category C (parenteral ascorbic acid). {53}

Breast-feeding

Problems in humans have not been documented with intake of normal daily recommended amounts. Ascorbic acid is distributed into breast milk. {04} {43}

Pediatrics

Problems in pediatrics have not been documented with intake of normal daily recommended amounts.


Geriatrics


Problems in geriatrics have not been documented with intake of normal daily recommended amounts.


Dental

Excessive use of chewable ascorbic acid tablets has been reported to cause breakdown of tooth enamel. {55} {78}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Large doses of ascorbic acid (but not sodium ascorbate) may lower urinary pH and cause renal tubular reabsorption of acidic medications with concurrent administration; alkaline medications may exhibit decreased reabsorption. {08}

Anticoagulants, coumarin- or indandione-derivative    (doses of 10 grams or more a day of ascorbic acid have been reported to impair gastrointestinal absorption of the anticoagulant {41} {46} {53})


Cellulose sodium phosphate    (concurrent use may result in metabolism of ascorbic acid to oxalate {37} {38})


» Deferoxamine    (concurrent use with ascorbic acid may enhance tissue iron toxicity, especially in the heart, causing cardiac decompensation; therefore, this regimen should be used with caution in older patients; the need for ascorbic acid supplementation should be completely documented by measurements of iron excretion before and after supplements, and the oral dose of ascorbic acid should be given an hour or two after the deferoxamine infusion has been initiated when adequate concentrations of deferoxamine have been achieved {01} {39} {43})


Disulfiram{25}    (concurrent use with ascorbic acid, especially with chronic use or high doses, may interfere with the disulfiram-alcohol interaction)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Because ascorbic acid is a strong reducing agent, it interferes with laboratory tests based on oxidation-reduction reactions. {43}

With diagnostic test results
Glucose determinations, urine, by cupric sulfate (Benedict's) reagent    (concentration may be falsely increased {54})


Glucose determinations, urine, by glucose oxidase ( Tes-Tape) method    (concentration may be falsely decreased {54})


Lactate dehydrogenase (LDH) and
Transaminase, hepatic    (serum concentrations as measured by auto-analyzer may be decreased with doses of ascorbic acid greater than 200 mg a day {70} {73})


Occult blood in stool    (large doses may cause false-negative results {09})

With physiology/laboratory test values
Bilirubin    (serum concentrations may be elevated {07} {54} {70})


pH, urine{64}{20}    (may be decreased by large doses of ascorbic acid, but not by sodium ascorbate)


Uric acid and{07}{54}{56}
Oxalate, urine{03}    (concentrations may be increased in patients receiving large doses of ascorbic acid)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Diabetes mellitus    (possible interference with glucose determinations by very high doses of ascorbic acid {54})


Glucose-6-phosphate dehydrogenase (G6PD) deficiency    (high doses of ascorbic acid may cause hemolytic anemia {09} {44} {45})


Hemochromatosis or
Sideroblastic anemia or
Thalassemia    (high doses of ascorbic acid may increase iron absorption {12} {45} {71})


Hyperoxaluria or oxalosis or
Renal stones, history of    (risk of hyperoxaluria and possible precipitation of oxalate stones in urinary tract after high doses of ascorbic acid {03} {27} {45})


Sensitivity to ascorbic acid or sodium ascorbate

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Ascorbic acid determinations, buffy coat, plasma, or serum{09}{11}{68}    (recommended to determine ascorbic acid deficiency; {09} {11} buffy coat levels are used to determine ascorbic acid stores {68})




Side/Adverse Effects

Note: Withdrawal scurvy may occur after prolonged administration of 2 to 3 grams per day {05} {30}.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence dose-related
    
Kidney stones, oxalate (side or lower back pain)
Note: Occasionally, prolonged doses of ascorbic acid in excess of 1 g per day have been reported to cause an increase in urinary oxalate, which may cause precipitation of oxalate stones in the urinary tract in patients with renal disease, especially those on hemodialysis, or in patients with a history of renal stones. {03} {22} {27} However, studies have not found an increase in urinary oxalate formation with high doses of ascorbic acid. {75} {76} {77}





Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
    
Dizziness or faintness —with rapid intravenous administration{53}

With high doses
    
Diarrhea —with oral doses greater than 1 gram per day{43}
    
flushing or redness of skin {22}{36}
    
headache {22}{36}
    
increase in urination, mild —with doses greater than 600 mg per day{22}
    
nausea or vomiting {22}{36}
    
stomach cramps {09}{22}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Ascorbic Acid (Vitamin C) (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Description should include function in the body, signs of deficiency, conditions that may cause deficiency, and unproven uses


Importance of diet
Importance of proper nutrition; supplement may be needed because of inadequate dietary intake

Food sources of ascorbic acid; effects of processing

Not using vitamins as substitute for balanced diet

Recommended daily intake for ascorbic acid

Before using this dietary supplement
»   Conditions affecting use, especially:

Pregnancy—Crosses placenta; large quantities during pregnancy may be harmful to the fetus





Breast-feeding—Distributed into breast milk





Dental—Breakdown of enamel has been reported with excessive use of chewable tablets
Other medications, especially deferoxamine

Proper use of this dietary supplement

» Proper dosing
Missed dose: No cause for concern because of length of time necessary for depletion; remembering to take as directed
Proper administration of oral solution:Taking by mouth even though it comes in dropper bottle

May be dropped directly into the mouth or mixed with cereal, fruit juice, or other food

» Proper storage

Precautions while using this dietary supplement
Ascorbic acid not stored; excessive amounts excreted in urine; very high doses may interfere with glucose determinations and diagnostic tests for occult blood in stool


Side/adverse effects
Signs of potential side effects, especially increase in urinary oxalate and possible precipitation of oxalate kidney stones


General Dosing Information

For parenteral dosage forms
The intramuscular route is usually preferred because ascorbic acid is absorbed and utilized more efficiently with this method of administration.

Diet/Nutrition
Recommended dietary intakes for ascorbic acid are defined differently worldwide.



For U.S.:
The Recommended Dietary Allowances (RDAs) for vitamins and minerals are determined by the Food and Nutrition Board of the National Research Council and are intended to provide adequate nutrition in most healthy persons under usual environmental stresses. In addition, a different designation may be used by the FDA for food and dietary supplement labeling purposes, as with Daily Value (DV). DVs replace the previous labeling terminology United States Recommended Daily Allowances (USRDAs). {58}



For Canada:
Recommended Nutrient Intakes (RNIs) for vitamins, minerals, and protein are determined by Health and Welfare in Canada and provide recommended amounts of a specific nutrient while minimizing the risk of chronic diseases. {59}

Daily recommended intakes for ascorbic acid are generally defined as follows: {40} {59}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
30–40
20
4 to 6 years of age
45
25
7 to 10 years of age
45
25
Adolescent and adult males
50–60
25–40
Adolescent and adult females
50–60
25–30
Pregnant females
70
30–40
Breast-feeding females
90–95
55
Smokers
100
45–60


These are usually provided by nutritionally adequate diets.

Best dietary sources of ascorbic acid include citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. {09} {11} Gradual loss of ascorbic acid occurs in fresh foods with storage, {09} but not when frozen(except over prolonged periods). Ascorbic acid in foods is rapidly destroyed by exposure to air (oxygen), {09} drying, salting, and ordinary cooking {43} (30 to 50%, especially in copper pots). Mincing of fresh vegetables and mashing of potatoes also reduces the ascorbic acid content.


ASCORBIC ACID


Oral Dosage Forms

ASCORBIC ACID EXTENDED-RELEASE CAPSULES

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes: {40} {59}

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
50–60
25–40
Adolescent and adult females
50–60
25–30
Pregnant females
70
30–40
Breast-feeding females
90–95
55
Smokers
100
45–60


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency. The following dosage has been established: Scurvy—Oral, 500 mg a day for at least 2 weeks. {36} {64} {80}


Usual pediatric dose
Dosage form not appropriate for pediatric patients.

Strength(s) usually available
U.S.—


500 mg (OTC) [Ascorbicap (tartrazine)] [Cebid Timecelles] [Cetane] [Cevi-Bid][Generic]

Canada—
Not commercially available.

Note: The strength of these ascorbic acid preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light.


ASCORBIC ACID ORAL SOLUTION USP

Usual adult and adolescent dose
See Ascorbic Acid Extended-release Capsules.

Usual pediatric dose
Deficiency(prophylaxis)
Oral, amount based on intake of normal daily recommended intakes: {40} {59}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
30–40
20
4 to 6 years of age
45
25
7 to 10 years of age
45
25


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency. The following dosage has been established: Scurvy—Oral, 100 to 300 mg a day for at least 2 weeks. {36} {64}


Strength(s) usually available
U.S.—


50 mg per mL (OTC)[Generic]{65}


100 mg per mL (OTC) [Cecon]

Canada—
Not commercially available.

Note: The strength of these ascorbic acid preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.


ASCORBIC ACID SYRUP

Usual adult and adolescent dose
See Ascorbic Acid Extended-release Capsules.

Usual pediatric dose
See Ascorbic Acid Oral Solution USP.

Strength(s) usually available
U.S.—


250 mg per 5 mL (OTC)[Generic]{65}


500 mg per 5 mL (OTC)[Generic]

Canada—
Not commercially available.

Note: Some strengths of these ascorbic acid preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light. Protect from freezing.


ASCORBIC ACID TABLETS USP

Usual adult and adolescent dose
See Ascorbic Acid Extended-release Capsules.

Usual pediatric dose
See Ascorbic Acid Oral Solution USP.

Strength(s) usually available
U.S.—


25 mg (OTC)[Generic]{66}


50 mg (OTC)[Generic]


100 mg (OTC)[Generic]


125 mg (OTC)[Generic]{65}


250 mg (OTC)[Generic]


500 mg (OTC) [Sunkist][Generic]


1 gram (OTC)[Generic]


1.5 grams (OTC)[Generic]

Canada—


100 mg (OTC) [Apo-C (scored)]


250 mg (OTC) [Apo-C (scored)]


500 mg (OTC) [Apo-C]


1 gram (OTC) [Apo-C][Generic]

Note: Some strengths of these ascorbic acid preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container.


ASCORBIC ACID TABLETS (CHEWABLE) USP

Usual adult and adolescent dose
See Ascorbic Acid Extended-release Capsules.

Usual pediatric dose
See Ascorbic Acid Oral Solution USP.

Strength(s) usually available
U.S.—


60 mg (OTC) [Sunkist][Generic]


100 mg (OTC) [Flavorcee][Generic]


250 mg (OTC) [Flavorcee] [Sunkist][Generic]


500 mg (OTC) [Flavorcee{66}] [{66}Sunkist][Generic]


1 gram (OTC)[Generic]

Canada—


60 mg (OTC)[Generic]


250 mg (OTC)[Generic]{60}


500 mg (OTC)[Generic]{60}

Note: Some chewable ascorbic acid tablets may also contain sodium ascorbate.
Some strengths of these ascorbic acid preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container.


ASCORBIC ACID TABLETS (EFFERVESCENT) USP

Usual adult and adolescent dose
See Ascorbic Acid Extended-release Capsules.

Usual pediatric dose
See Ascorbic Acid Oral Solution USP.

Strength(s) usually available
U.S.—


1 gram (OTC)[Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container.

Preparation of dosage form:
Ascorbic acid effervescent tablets should be dissolved in a glass of water immediately prior to ingestion.


ASCORBIC ACID EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
See Ascorbic Acid Extended-release Capsules.

Usual pediatric dose
Dosage form not appropriate for pediatric patients.

Strength(s) usually available
U.S.—


500 mg (OTC) [Cemill][Generic]


1 gram (OTC) [Cemill][Generic]


1.5 gram (OTC)[Generic]

Canada—


500 mg (OTC)[Generic]

Note: Some strengths of these ascorbic acid preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light.



Parenteral Dosage Forms

ASCORBIC ACID INJECTION USP

Usual adult and adolescent dose
Deficiency (prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.
{24}
Deficiency (treatment)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.
Intramuscular, 100 to 500 mg a day for at least 2 weeks. {79}

Diagnostic aid adjunct (red blood cell disease)
For use in labeling of red blood cells, 100 mg of ascorbic acid injection injected into the vial of sodium chromate Cr 51 injection.


Usual pediatric dose
Deficiency(prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.

Deficiency (treatment)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.
Intramuscular, 100 to 300 mg a day for at least 2 weeks. {36} {64}


Strength(s) usually available
U.S.—


222 mg per mL (Rx)[Generic]{65}


250 mg per mL (Rx)[Generic]


500 mg per mL (Rx) [Cecore 500] [Cee-500] [Mega-C/A Plus][Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a light-resistant container. Protect from freezing.

Stability:
Ascorbic acid is oxidized rapidly, {63} especially in the presence of catalyzing metal ions such as copper. {60} {62} Loss of ascorbic acid is greatest from admixtures stored in plastic containers, especially for longer than 48 hours. {69} Exposure to light causes degradation of ascorbic acid; however, the slight color that develops during storage does not impair therapeutic activity. {61} Some clinicians recommend that total parenteral nutrition solutions that contain ascorbic acid should be protected from light. {71}

Incompatibilities:
Ascorbic acid injection is physically incompatible with aminophylline, {60} {61} bleomycin, {60} cefazolin sodium, {60} cephapirin, {60} chlordiazepoxide, {05} conjugated estrogen, {61} dextran, {61} doxapram hydrochloride, {60} erythromycin lactobionate, {60} {61} methicillin sodium, {61} nafcillin sodium, {60} penicillin G potassium, {61} phytonadione, {61} sodium bicarbonate, {15} and warfarin {60}.


SODIUM ASCORBATE


Parenteral Dosage Form

SODIUM ASCORBATE INJECTION

Usual adult and adolescent dose
See Ascorbic Acid Injection USP.

Usual pediatric dose
See Ascorbic Acid Injection USP.

Strength(s) usually available
U.S.—
{08}

250 mg (222 mg ascorbic acid) per mL (Rx) [Ortho/CS{65}][Generic]


562.5 mg (500 mg ascorbic acid) per mL (Rx) [Cenolate (0.5% sodium hydrosulfate)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), protected from light, unless otherwise specified by manufacturer. Protect from freezing.

Stability:
Ascorbic acid is oxidized rapidly, {63} especially in the presence of catalyzing metal ions such as copper. {60} {62} Loss of ascorbic acid is greatest from admixtures stored in plastic containers, especially for longer than 48 hours. {69} Exposure to light causes degradation of ascorbic acid; however, the slight color that develops during storage does not impair therapeutic activity. {61} Some clinicians recommend that total parenteral nutrition solutions that contain ascorbic acid should be protected from light. {71}

Incompatibilities:
Ascorbic acid injection is physically incompatible with aminophylline, {60} {61} bleomycin, {60} cefazolin sodium, {60} cephapirin, {60} chlordiazepoxide, {05} conjugated estrogen, {61} dextran, {61} doxapram hydrochloride, {60} erythromycin lactobionate, {60} {61} methicillin sodium, {61} nafcillin sodium, {60} penicillin G potassium, {61} phytonadione, {61} sodium bicarbonate, {15} and warfarin {60}.

Additional information:
Each gram of sodium ascorbate contains approximately 5 mEq of sodium.



Revised: 05/01/1995



References
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  1. The vitamin book, Vitamin C (Ascorbic Acid), 1979: 120-30.
  1. Ponha A, Kuhlback B. Serum ascorbic acid in patients undergoing chronic hemodialysis. Acta Med Scand 1983; 213: 305-7.
  1. Nahata M, Cummins B, McLeod D. Effect of ascorbic acid on urine pH. J Hosp Pharm 1981; 38: 33-4.
  1. Hansten PD, Horn JR. Drug interactions. 5th ed. Philadelphia: Lea & Febiger, 1985: 357.
  1. McEvoy GK, editor. AHFS Drug information 89. Bethesda, MD: American Society of Hospital Pharmacists, 1989: 2108-10.
  1. Linder M, editor. Nutritional biochemistry and metabolism with clinical applications. New York: Elsevier, 1991: 146-7.
  1. Ascorbic Acid product information (LyphoMed—US), Rec 6/86.
  1. Antabuse product information, (Ayerst—US), Rev 4/86, Rec 5/87.
  1. Medical Letter-Vitamin Supplements; 1985 Feb 2; 27.
  1. Swartz R. Hyperoxaluria and renal insufficiency due to ascorbic acid administration during total parenteral nutrition. Ann Intern Med 1984; 100(4): 530-1.
  1. Fleeger CA, editor. USP dictionary of USAN and international drug names 1995. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1994: 60, 616.
  1. Chatterjie I. Ascorbic acid metabolism. World Rev Nutr Diet 1978; 30: 69-87.
  1. Council on Scientific Affairs, American Medical Association. Vitamin preparations as dietary supplements and as therapeutic agents. JAMA 1987; 257 (14): 1929-36.
  1. Olson J, Hodges R. Recommended dietary intake (RDI) of vitamin C in humans. Am J Clin Nut 1987; 45: 693-703.
  1. Reviewer comment, 1990.
  1. Chromitrope product information (Squibb—US), Rev 10/83.
  1. To be reused.
  1. To be reused.
  1. Johnson K, editor. The Harriet Lane handbook. 13th ed. St Louis, MO: Mosby, 1993: 389.
  1. Calcibind product information (Mission Pharmacol—US).
  1. Lake K, Brown D. New drug therapy for kidney stones: a review of cellulose sodium phosphate, acetohydroxamic acid, and potassium citrate. DICP 1985; 19: 530-9.
  1. Drug evaluations subscription. Chicago: American Medical Association, Spring 1990.
  1. National Research Council. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press, 1989: 115-24.
  1. Simon J. Vitamin C and cardiovascular disease-a review. J Am Coll Nutr 1992; 11(2): 107-25.
  1. Escobar G, Heyman M, Smith W, Thaler M. Primary hemochromatosis in childhood. Pediatrics 1987; 80(4): 549-54.
  1. Reynolds JEF, editor. Martindale, the extra pharmacopeia. 30th ed. London: The Pharmaceutical Press, 1993: 1057-8.
  1. Rees D, Kelsey H, Richards J. Acute haemolysis induced by high dose ascorbic acid in glucose-6-phosphate dehydrogenase deficiency. Br Med J 1993; 306: 841-2.
  1. Ellenhorn MJ, Barceloux DG. Medical toxicology. Diagnosis and treatment of human poisoning. New York: Elsevier, 1988: 557.
  1. PDR Physicians' desk reference. 44th ed. 1990. Oradell, NJ: Medical Economics Company, 1990: 922.
  1. Mexitil product information (Boehringer Ingelheim—US), Rec 3/90, Rev 12/89.
  1. Herbert V, Jacob E. Destruction of vitamin B 1 2 by ascorbic acid. J Am Med Assoc 1974: 230(2); 241-2.
  1. Hines J. Ascorbic acid and vitamin B 1 2 deficiency. J Am Med Assoc 1975; 234(1): 24.
  1. Lieber C. The influence of alcohol on nutritional status. Nutr Rev 1988; 46(7): 241-54.
  1. Institute of Medicine. Nutrition during pregnancy. Washington, DC: National Academy Press, 1990: 1-23.
  1. Wilson JD, Braunwald E, Isselbacher KJ, Petersdorf RG, Martin JB, Fauci AS, Root RK, editors. Harrison's principles of internal medicine. 12th ed. New York: McGraw-Hill, Inc., 1991: 1549.
  1. Cenolate product information (Abbott—US), Rec 9/94, Rev 12/91.
  1. Knoben J, Anderson P. Handbook of clinical drug data. Hamilton, IL: Drug Intelligence Publications, Inc., 1993: 248-51.
  1. Guinta J. Dental erosion resulting from chewable vitamin C tablets. J Am Dent Assoc 1983; 107: 253-6.
  1. Stein H, Hasan A, Fox I. Ascorbic acid-induced uricosuria, a consequence of megavitamin therapy. Ann Intern Med 1976; 84: 385-8.
  1. Levine M. New concepts in the biology and biochemistry of ascorbic acid. N Engl J Med 1986; 314(14): 892-902.
  1. Food and Drug Administration. Focus on food labeling. FDA Consum 1993, May.
  1. Health and Welfare Canada. Nutrition recommendations, the report of the scientific committee. Ottawa Canada: Canadian Government Publishing Centre, 1990: 11-5, 204.
  1. Trissel LA. ASHP handbook on injectable drugs. 8th ed. Bethesda, MD: American Society of Hospital Pharmacists, 1994: 91-5.
  1. King J. Guide to parenteral admixtures. St. Louis, MO: Pacemarq, 1991.
  1. Burge J, Flancbaum L, Holcombe B. Copper decreases ascorbic acid stability in total parenteral nutrition solutions. J Am Diet Assoc 1994; 94(7): 777-9.
  1. Allwood M, Brown P, Ghedini C, Hardy G. The stability of ascorbic acid in TPN mixtures stored in a multilayered bag. Clin Nutr 1992; 11: 284-8.
  1. Benitz WE, Tatro DS. The pediatric drug handbook. 2nd ed. Chicago: Year Book Medical Publishers, Inc., 1988: 374.
  1. Red book 1994. Montvale, NJ: Medical Economics Data, 1993: 108, 109, 361, 418.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1991: 10a-c.
  1. Per phone call to Ciba/Canada: all Sunkist products discontinued and Webber Vitamin C now made.
  1. Rakel RE, editor. Conn's current therapy 1992. Philadelphia: W.B. Saunders Company, 1992: 518.
  1. Smith J, Canham J, Kirkland W, Wells P. Effect of intralipid, amino acids, container, temperature, and duration of storage on vitamin stability in total parenteral nutrition admixtures. JPEN 1988; 12(5):478-83.
  1. vanSteirteghem A, Robertson E, Young D. Influence of large doses of ascorbic acid on laboratory test results. Clin Chem 1978; 24: 54-7.
  1. Panel consensus, 1994.
  1. Panelist comment, 1994.
  1. Panelist comment, 1994.
  1. Panelist comment, 1994.
  1. Wandzilak T, D'Andre S, Davis P, et al. Effect of high dose vitamin C on urinary oxalate levels. J Urol 1994; 151: 834–7.
  1. Gerster H. Do high doses of vitamin C cause kidney stones? Nutrition 1986; 10: 1–4.
  1. Gaby S, Singh V. Safety of oral intake of vitamin C. Human Nitrition Research and Communications, page 1.
  1. Panelist comment
  1. Panelists comments.
  1. Panelist comment.
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