Cevi-Bid

In the U.S.

• Ascocid
• C-500
• Cecon
• Cemill 1000
• Cemill 500
• Cevi-Bid
• C-Time w/Rose Hips
• Mega-C
• One-Gram C
• Protexin
• Sunkist Vitamin C

In Canada

• Ce-Vi-Sol
• Revitalose-C-1000
• Revitonus C-1000 Yellow Ampule
• Vitamin C Powder

Available Dosage Forms:

• Tablet
• Powder
• Powder for Solution
• Capsule, Liquid Filled
• Tablet, Chewable
• Solution
• Granule
• Capsule
• Syrup
• Powder for Suspension
• Liquid
• Tablet, Extended Release
• Lozenge/Troche
• Capsule, Extended Release
• Wafer

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin C (class)

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Ascorbic acid, also known as vitamin C, is necessary for wound healing. It is needed for many functions in the body, including helping the body use carbohydrates, fats, and protein. Vitamin C also strengthens blood vessel walls.

Lack of vitamin C can lead to a condition called scurvy, which causes muscle weakness, swollen and bleeding gums, loss of teeth, and bleeding under the skin, as well as tiredness and depression. Wounds also do not heal easily. Your health care professional may treat scurvy by prescribing vitamin C for you.

Some conditions may increase your need for vitamin C. These include:

• AIDS (acquired immune deficiency syndrome)
• Alcoholism
• Burns
• Cancer
• Diarrhea (prolonged)
• Fever (prolonged)
• Infection (prolonged)
• Intestinal diseases
• Overactive thyroid (hyperthyroidism)
• Stomach ulcer
• Stress (continuing)
• Surgical removal of stomach
• Tuberculosis

Also, the following groups of people may have a deficiency of vitamin C:

• Infants receiving unfortified formulas
• Smokers
• Patients using an artificial kidney (on hemodialysis)
• Patients who undergo surgery
• Individuals who are exposed to long periods of cold temperatures

Increased need for vitamin C should be determined by your health care professional.

Vitamin C may be used for other conditions as determined by your health care professional.

Claims that vitamin C is effective for preventing senility and the common cold, and for treating asthma, some mental problems, cancer, hardening of the arteries, allergies, eye ulcers, blood clots, gum disease, and pressure sores have not been proven. Although vitamin C is being used to reduce the risk of cardiovascular disease and certain types of cancer, there is not enough information to show that these uses are effective.

Injectable vitamin C is given by or under the supervision of a health care professional. Other forms of vitamin C are available without a prescription.

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin C is found in various foods, including citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, exposure to air, drying, salting, or cooking (especially in copper pots), mincing of fresh vegetables, or mashing potatoes may reduce the amount of vitamin C in foods. Freezing does not usually cause loss of vitamin C unless foods are stored for a very long time.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of vitamin C needed is defined in several different ways.

For U.S.—
• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for vitamin C are generally defined as follows:

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amygdalin
• Deferoxamine

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Indinavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems—High doses of vitamin C may cause certain blood problems

• Type 2 diabetes mellitus—Very high doses of vitamin C may interfere with tests for sugar in the urine

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency—High doses of vitamin C may cause hemolytic anemia

• Kidney stones (history of)—High doses of vitamin C may increase risk of kidney stones in the urinary tract

Vitamin C is not stored in the body. If you take more than you need, the extra vitamin C will pass into your urine. Very large doses may also interfere with tests for sugar in diabetics and with tests for blood in the stool.

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

• If you have an allergy to ascorbic acid or any other part of Cevi-Bid (ascorbic acid (vitamin C) controlled-release caps & controlled-release tabs).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Cevi-Bid. 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 Cevi-Bid while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Store at room temperature.
• Protect from light.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• 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.

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