Ascorbic Acid

What is Ascorbic Acid and how is it used?

Ascorbic Acid is an over the counter and prescription medicine used to treat the symptoms of Ascorbic Acid Deficiency (Scurvy), Urinary Acidification and as a nutritional supplement. Ascorbic Acid may be used alone or with other medications.

Ascorbic Acid belongs to a class of drugs called Vitamins, Water-Soluble.

What are the possible side effects of Ascorbic Acid?

Ascorbic Acid may cause serious side effects including:

• nausea,
• vomiting,
• heartburn,
• stomach cramps, and
• headache

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Ascorbic Acid include:

• injection site soreness,
• faintness, and
• dizziness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ascorbic Acid. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

No preservative added.

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 light, it gradually darkens. In the dry state, it is reasonably stable in air, but in solution it rapidly oxidizes. Ascorbic acid (vitamin c) is freely soluble in water; sparingly soluble in alcohol; insoluble in chloroform, in ether, and in benzene. The chemical name of ascorbic acid (vitamin c) is L-ascorbic acid (vitamin c) . The empirical formula is C6H806, and the molecular weight is 176.13. The structure is as follows:

Ascorbic Acid (vitamin c) Injection is a sterile solution. Each mL contains: Ascorbic Acid (vitamin c) 250 mg and Edetate Disodium 0.025% in Water for Injection qs. Prepared with the aid of Sodium Bicarbonate. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.

INDICATIONS

Vitamin C 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 (vitamin c) 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.) increase the need for ascorbic acid (vitamin c) .

Hemovascular disorders, burns, delayed fracture and wound healing are indications for an increase in the daily intake.

DOSAGE AND ADMINISTRATION

Ascorbic acid (vitamin c) is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.

For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.

The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.

To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively 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 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.

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

HOW SUPPLIED

Ascorbic Acid (vitamin c) Injection, USP, 250 mg/mL is available in 2 mL ampules, in cartons of 25.

PROTECT FROM HEAT AND LIGHT. Store at controlled room temperature 15°- 30° C (59°- 86° F).

Pressure may develop within the ampule upon long storage. Precautions should be taken to wrap the container in a protective covering while it is being opened.

CAUTION: Federal law prohibits dispensing without prescription.

Manufactured by: Steris Laboratories, Inc. Phoenix, Arizona 85043, USA. For: Mallinckrodt, Inc. St. Louis, MO 63134. FDA Rev date: n/a

SIDE EFFECTS

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.

DRUG INTERACTIONS

Limited evidence suggests that ascorbic acid (vitamin c) may influence the intensity and duration of action of bishydroxycoumarin.

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 vitamin C over an extended period of time.

PRECAUTIONS

General Precautions

Too-rapid intravenous injection is to be avoided.

Laboratory Tests

Diabetics taking more than 500 mg vitamin C daily may obtain false readings of their urinary glucose test. No exogenous vitamin C should be ingested for 48 to 72 hours before amine-dependent stool occult blood tests are conducted because possible false-negative results may occur.

Usage in Pregnancy

Pregnancy Category C.' Animal reproduction studies have not been conducted with Ascorbic Acid (vitamin c) Injection. It is also not known whether Ascorbic Acid (vitamin c) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ascorbic Acid (vitamin c) Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when Ascorbic Acid (vitamin c) Injection is administered to a nursing woman.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Contraindicated in those persons who have shown hypersensitivity to any component of this preparation.

CLINICAL PHARMACOLOGY

In humans, an exogenous source of ascorbic acid (vitamin c) is required for collagen formation and tissue repair. Ascorbic acid (vitamin c) is reversibly oxidized to dehydroascorbic acid (vitamin c) 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 (vitamin c) deficiency results in scurvy. Collagenous structures are primarily affected, and lesions develop in bones and blood vessels. Administration of ascorbic acid (vitamin c) completely reverses the symptoms of ascorbic acid (vitamin c) deficiency.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.