Ascorbic Acid Injection

8/13/2019 Ascorbic Acid Injection

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Ascorbic Acid Injection

Pronunciation

Dosage Form:injection, solution

For ProfessionalsIndicationsSide EffectsDosageInteractionsMore...

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Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling hasnot been approved by FDA.For further information about unapproved drugs, click here.

FOR INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS USE.

CONTAINS NO PRESERVATIVES.

Ascorbic Acid Injection Description

Ascorbic Acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellow

crystal or powder with a light acidic taste. It is an antiscorbutic product. On exposure to air andlight it gradually darkens. In the dry state it is reasonably stable in air, but in solution it rapidly

oxidizes. Ascorbic Acid is freely soluble in water; sparingly soluble in alcohol; insoluble in

chloroform, ether, and benzene.

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The chemical name of Ascorbic Acid is L-ascorbic acid. The molecular formula is C6H806 and

the molecular weight is 176.13. The structural formula is as follows:

Ascorbic Acid Injection is a clear, colorless to slightly yellow sterile solution of Ascorbic Acidin Water for Injection, for intravenous, intramuscular or subcutaneous use. Each mL contains:

Ascorbic Acid 500 mg, Edetate Disodium 0.025%, Water for Injection q.s. pH (range 5.5-7.0)

adjusted with Sodium Bicarbonate.

Ascorbic Acid Injection - Clinical Pharmacology

In humans, an exogenous source of ascorbic acid is required for collagen formulation and tissue

repair. Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body. These two formsof the vitamin are believed to be important in oxidation-reduction reactions. The vitamin is

involved in tyrosine metabolism, conversion of folic acid to folinic acid, carbohydratemetabolism, synthesis of lipids and proteins, iron metabolism, resistance to infections, and

cellular respiration.

Ascorbic acid deficiency results in scurvy. Collagenous structures are primarily affected, and

lesions develop in bones and blood vessels. Administration of ascorbic acid completely reversesthe symptoms of ascorbic acid deficiency.

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Indications and Usage for Ascorbic Acid Injection

Ascorbic acid is recommended for the prevention and treatment of scurvy. Its parenteral

administration is desirable for patients with an acute deficiency or for those whose absorption of

orally ingested ascorbic acid is uncertain.
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Symptoms of mild deficiency may include faulty bone and tooth development, gingivitis,

bleeding gums, and loosened teeth. Febril states, chronic illness, and infection (pneumonia,

whooping cough, tuberculosis, diphtheria, sinusitis, rheumatic fever, etc.) increases the need forascorbic acid.

Contraindications

There are no contraindications to the administration of ascorbic acid.

Warnings

Diabetics, patients prone to recurrent renal calculi, those undergoing stool occult blood tests and

those on sodium restricted diets or anticoagulant therapy should not take excessive doses of

ascorbic acid over an extended period of time.

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with

prolonged parenteral administration if kidney function is impaired. Premature neonates areparticularly at risk because their kidneys are immature, and they require large amounts ofcalcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates,

who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate

aluminum at levels associated with central nervous system and bone toxicity. Tissue loading mayoccur at even lower rates of administration.

PRECAUTIONS

General Precautions

Too-rapid intravenous injection is to be avoided.

Laboratory Tests

Diabetics taking more than 500 mg of ascorbic acid daily, may obtain false reading of the urinary

glucose test. No exogenous ascorbic acid should be ingested for 48 to 72 hours before aminedependent stool occult blood tests are conducted because possible false negative results may

occur.

Drug Interactions

Limited evidence suggests that ascorbic acid may influence the intensity and duration of action

of bishydroxycoumarin.

Usage in Pregnancy

Pregnancy Category C


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Animal reproduction studies have not been conducted with Ascorbic Acid Injection. It is also not

known whether Ascorbic Acid Injection can cause fetal harm when administered to a pregnant

woman or can affect reproduction capacity. Ascorbic Acid Injection should be given to apregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when Ascorbic Acid Injection is administered to a nursing woman.

Adverse Reactions

Transient mild soreness may occur at the site of intramuscular or subcutaneous injection. Too-

rapid intravenous administration of the solution may cause temporary faintness or dizziness.

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Ascorbic Acid Injection Dosage and Administration

Ascorbic acid is usually administered orally. When oral administration is not feasible or when

malabsorption is suspected, the drug may be administered intramuscularly, intravenously orsubcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM

administration, which is the preferred parenteral route.

For intravenous injection, dilution into a large volume parenteral such as Normal Saline or

Glucose is recommended to minimize the adverse reactions associated with intravenousinjection.

The average protective dose of ascorbic acid for adults is 70 to 150 mg daily. In the presence of

scurvy, doses of 300 mg to 1 gram daily are recommended. However, as much as 6 grams havebeen administered parenterally to normal adults without evidence of toxicity.

To enhance wound-healing, doses of 300 to 500 mg daily for a week to ten days, bothpreoperatively and postoperatively, are generally considered adequate, although considerably

larger amounts have been recommended. In the treatment of burns, doses are governed by the

extent of tissue injury. For severe burns, daily doses of 1 to 2 grams are recommended. In other

conditions in which the need for ascorbic acid is increased, three to five times the daily optimumallowances appear to be adequate.

Warning

PRESSURE MAY DEVELOP WITHIN THE VIAL UPON STORAGE.
http://www.google.com/url?ct=abg&q=https://www.google.com/adsense/support/bin/request.py%3Fcontact%3Dabg_afc%26url%3Dhttp://www.drugs.com/pro/ascorbic-acid-injection.html%26gl%3DPH%26hl%3Den%26client%3Dca-drugsite%26ai0%3DCypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&usg=AFQjCNFdozBZ8HPuqDbv8XDBUYCZGhMsKQhttp://www.google.com/url?ct=abg&q=https://www.google.com/adsense/support/bin/request.py%3Fcontact%3Dabg_afc%26url%3Dhttp://www.drugs.com/pro/ascorbic-acid-injection.html%26gl%3DPH%26hl%3Den%26client%3Dca-drugsite%26ai0%3DCypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&usg=AFQjCNFdozBZ8HPuqDbv8XDBUYCZGhMsKQhttp://www.googleadservices.com/pagead/aclk?sa=L&ai=CypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&num=1&cid=5Gj1oqv88QshaJnHa6WkUAeu&sig=AOD64_3csoBqzgC0kqXOFCJjU5oa-kIVIA&client=ca-drugsite&adurl=http://w3.newsmax.com/newsletters/crandall/video_intl.cfm%3Fpromo_code%3D1471F-1http://www.googleadservices.com/pagead/aclk?sa=L&ai=CypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&num=1&cid=5Gj1oqv88QshaJnHa6WkUAeu&sig=AOD64_3csoBqzgC0kqXOFCJjU5oa-kIVIA&client=ca-drugsite&adurl=http://w3.newsmax.com/newsletters/crandall/video_intl.cfm%3Fpromo_code%3D1471F-1http://www.googleadservices.com/pagead/aclk?sa=L&ai=CypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&num=1&cid=5Gj1oqv88QshaJnHa6WkUAeu&sig=AOD64_3csoBqzgC0kqXOFCJjU5oa-kIVIA&client=ca-drugsite&adurl=http://w3.newsmax.com/newsletters/crandall/video_intl.cfm%3Fpromo_code%3D1471F-1http://www.googleadservices.com/pagead/aclk?sa=L&ai=CypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&num=1&cid=5Gj1oqv88QshaJnHa6WkUAeu&sig=AOD64_3csoBqzgC0kqXOFCJjU5oa-kIVIA&client=ca-drugsite&adurl=http://w3.newsmax.com/newsletters/crandall/video_intl.cfm%3Fpromo_code%3D1471F-1http://www.googleadservices.com/pagead/aclk?sa=L&ai=CypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&num=1&cid=5Gj1oqv88QshaJnHa6WkUAeu&sig=AOD64_3csoBqzgC0kqXOFCJjU5oa-kIVIA&client=ca-drugsite&adurl=http://w3.newsmax.com/newsletters/crandall/video_intl.cfm%3Fpromo_code%3D1471F-1http://www.google.com/url?ct=abg&q=https://www.google.com/adsense/support/bin/request.py%3Fcontact%3Dabg_afc%26url%3Dhttp://www.drugs.com/pro/ascorbic-acid-injection.html%26gl%3DPH%26hl%3Den%26client%3Dca-drugsite%26ai0%3DCypbcmChzUuKIDoWwmQX95YCYB_T6iusEjKXJ_2rAjbcBEAEg8f7IH1DFwOIGYOEEoAGBp4n_A8gBAagDAaoEhwFP0OJC4Xfagjey0EEqzf1aytGt4yGILgsacRSQ6pmBIUtFYH6swVmzLr_bjKZv-fNfwnnN8yOOBXwqm--neBoD_ltLruRojJrjtty9Q-DVJdFhwrErnjMMTv-EnRQJVHliBFcKq_wWKKXoE0r3og5vVsxtrm9cYk956DfU5rL26uviigQD07aIBgGAB-fYdg&usg=AFQjCNFdozBZ8HPuqDbv8XDBUYCZGhMsKQ


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Exercise care when withdrawing and/or relieve pressure by first inserting sterile empty syringe

into vial thus allowing pressure to equilibrate.

When using dispensing vials use aseptic technique. Dispense entire contents in aliquots under a

laminar flow hood without delay or within 4 hours after entry or discard remaining content after

first withdrawal. Prepare stoppers with a suitable antiseptic solution. Do not use unless solutionis clear and seal is intact.

Parenteral drug products should be inspected visually for particulate matter and discolorationprior to administration, whenever the solution and container permit.

How is Ascorbic Acid Injection Supplied

Ascorbic Acid for Injection, USP (500 mg/mL)

50 mL Sterile Dispensing VialBoxed 50's

RX only

PROTECT FROM LIGHT. STORE IN CARTON UNTIL TIME OF USE: Store below

23C (73F).

Revised: 07/11

Manufactured for:

THE TORRANCE COMPANYPortage, Michigan, 49024

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


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Ascorbic Acid Injection

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