Ascor L 500

• It is used to treat or prevent vitamin C deficiency.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take Ascor L 500. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you have high blood sugar (diabetes), talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• Kidney stones may rarely happen.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ascor L 500 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Back pain, belly pain, or blood in the urine. May be signs of a kidney stone.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Ascor L 500 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ascor L 500. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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 Ascor L 500) 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 Ascor L 500 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.