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:

Raw Materials International Overseas LLC

INN (International Name):

ASCORBIC ACID

Composition:

ASCORBIC ACID 500 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Symptoms of mild deficiency may include faulty bone and tooth development, gingivitis, bleeding gums, and loosened teeth. Febrile states, chronic illness, and infection (pneumonia, whooping cough, tuberculosis, diphtheria, sinusitis, rheumatic fever, etc.) increases the need for ascorbic acid. Hemovascular disorders, burns, delayed fracture and wound healing are indications for an increase in the daily intake. There are no contraindications to the administration of ascorbic acid.

Product summary:

Ascorbic Acid for Injection, USP (500mg/mL) NDC 69877-017-01 50mL Sterile Dispensing Vial, individually boxed, Rx only NDC 69877-017-10 50 mL Sterile Dinspensing Vial, packaged in boxes of 10 vials, Rx only PROTECT FROM LIGHT. STORE IN CARTON UNTIL TIMEOF USE: Store between 2° to 8°C (36° to 46°F). Rev. 07/15

Authorization status:

unapproved drug other

Summary of Product characteristics

ASCORBIC ACID- ASCORBIC ACID INJECTION, SOLUTION
RAW MATERIALS INTERNATIONAL OVERSEAS LLC
_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 BOX OF 10 REVISED
FOR INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS USE.
CONTAINS NO PRESERVATIVES.
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 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:
6
8
6
Ascorbic Acid injection is a clear, colorless to slightly 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 0.25 mg, Water for Injection q.s. pH
(range 5.5-7.0) adjusted with
Sodium Bicarbonate and Sodium Hydroxide. Contains no preservatives.
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 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, lesions
develop in bones and blood vessels. Administration of ascorbic acid
completely reverses the symptoms
of asco