ASCORBIC ACID injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)

Available from:

American Regent, Inc.

INN (International Name):

ASCORBIC ACID

Composition:

ASCORBIC ACID 500 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

ASCORBIC ACID- ASCORBIC ACID INJECTION, SOLUTION
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ASCORBIC ACID INJECTION, USP
RX ONLY
FOR INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS USE. CONTAINS NO
PRESERVATIVES.
DESCRIPTION
Ascorbic Acid (vitamin C) is a water-soluble vitamin. It occurs as a
white or slightly yellow crystal or
powder with a slight acidic taste. It is an antiscorbutic product. On
exposure to air and light 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.
The chemical name of Ascorbic Acid is L-ascorbic acid. The molecular
formula is C H 0 and the
molecular weight is 176.13. The structural formula is as follows:
Ascorbic Acid Injection, USP is a clear, slightly yellow to yellow
sterile solution of Ascorbic Acid in
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.
6
8
6
CLINICAL PHARMACOLOGY
In humans, an exogenous source of ascorbic acid is required for
collagen formation and tissue repair.
Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the
body. These two forms of 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, carbohydrate
metabolism, 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 reverses the symptoms
of ascorbic acid deficiency