Vitamin C

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

No information provided.

Ascorbic acid (vitamin C) occurs naturally in foods such as citrus fruit, tomatoes, potatoes, and leafy vegetables. Vitamin C is important for bones and connective tissues, muscles, and blood vessels. Vitamin C also helps the body absorb iron, which is needed for red blood cell production.

Ascorbic acid is used to treat and prevent vitamin C deficiency.

Ascorbic acid may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

The recommended dietary allowance of vitamin C (ascorbic acid) increases with age. Follow your healthcare provider's instructions. You may also consult the Office of Dietary Supplements of the National Institutes of Health, or the U.S. Department of Agriculture (USDA) Nutrient Database (formerly "Recommended Daily Allowances") listings for more information.

Drink plenty of liquids while you are taking ascorbic acid.

The chewable tablet must be chewed before you swallow it.

Ascorbic acid gum may be chewed as long as desired and then thrown away.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Keep the orally disintegrating tablet in the package until you are ready to take it. Use dry hands to remove the tablet and place it in your mouth. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.

Store ascorbic acid at room temperature away from moisture and heat.

Do not stop using ascorbic acid suddenly after long-term use at high doses, or you could have "conditional" vitamin C deficiency. Symptoms include bleeding gums, feeling very tired, and red or blue pinpoint spots around your hair follicles. Follow your doctor's instructions about tapering your dose. Conditional vitamin C deficiency can be difficult to correct without medical supervision.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ascorbic acid and call your doctor at once if you have:

• joint pain, weakness or tired feeling, weight loss, stomach pain;

• chills, fever, increased urge to urinate, painful or difficult urination; or

• severe pain in your side or lower back, blood in your urine.

Common side effects may include:

• heartburn, upset stomach; or

• nausea, diarrhea, stomach cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to ascorbic acid: oral capsule, oral capsule extended release, oral capsule liquid filled, oral granule, oral liquid, oral lozenge/troche, oral powder, oral powder for solution, oral powder for suspension, oral solution, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release, oral wafer

Along with its needed effects, ascorbic acid (the active ingredient contained in Vitamin C) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking ascorbic acid:

• Side or lower back pain

Some side effects of ascorbic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dizziness or faintness (with the injection only)
• flushing or redness of skin
• headache
• increase in urination (mild)
• nausea or vomiting
• stomach cramps

Applies to ascorbic acid: compounding powder, injectable solution, oral capsule, oral gum, oral liquid, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release

Renal

Renal side effects have included oxalate and urate kidney stones.[Ref]

Hyperoxaluria appears to be dose-related.[Ref]

Nervous system

Migraine headache has been reported with a daily dose of 6 grams.

The manufacturer reports temporary dizziness and faintness may be associated with too rapid of a rate during intravenous administration.[Ref]

Nervous system side effects have included dizziness, faintness, fatigue, and headache in less than 1% of patients. Migraine headache has also been reported.[Ref]

Other

Conditional scurvy is reported to occur following excessive doses of ascorbic acid (the active ingredient contained in Vitamin C) over a prolonged period of time. The mechanism of action for this condition is thought to be that large doses of ascorbic acid condition the patient over time for rapid clearance of ascorbic acid resulting in scurvy. The plasma levels of ascorbic acid appear to remain within normal limits. The actual existence of conditional scurvy remains controversial.[Ref]

Other side effects have included flank pain in less than 1% of patients. Conditional scurvy has also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, abdominal cramps, and esophagitis.[Ref]

Nausea, diarrhea, and abdominal cramps appears to be associated with doses exceeding 2 g per day, although there have been some reports with as little as 1 g per day.

Esophagitis appears to be associated with prolonged or increased contact of ascorbic acid tablets with the esophageal mucosa.[Ref]

Hematologic

The majority of hemolysis reports have been associated with patients who have concurrent glucose-6-phosphate dehydrogenase deficiency.[Ref]

Hematologic side effects have included hemolysis.[Ref]

Local

Local side effects have included transient mild soreness at the site of injection.[Ref]

Some side effects of Vitamin C may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.