Pronunciation:

pir-i-DOX-een

Brand Names:

• Aminoxin
• Pyri-500
• Rodex
• Vitabee 6

Dosage Forms:

• Tablet
• Tablet, Extended Release
• Solution
• Capsule
• Powder

Classifications:

Therapeutic—

Nutritive Agent

Pharmacologic—

Vitamin B (class)

Uses of This Medicine:

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. Pyridoxine (vitamin B 6) is necessary for normal breakdown of proteins, carbohydrates, and fats.

Some conditions may increase your need for pyridoxine. These include:

• Alcoholism
• Burns
• Diarrhea
• Dialysis
• Heart disease
• Intestinal problems
• Liver disease
• Overactive thyroid
• Stress, long-term illness, or serious injury
• Surgical removal of stomach

In addition, infants receiving unfortified formulas such as evaporated milk may need additional pyridoxine.

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

Lack of pyridoxine may lead to anemia (weak blood), nerve damage, seizures, skin problems, and sores in the mouth. Your doctor may treat these problems by prescribing pyridoxine for you.

Claims that pyridoxine is effective for treatment of acne and other skin problems, alcohol intoxication, asthma, hemorrhoids, kidney stones, mental problems, migraine headaches, morning sickness, and menstrual problems, or to stimulate appetite or milk production have not been proven.

Injectable pyridoxine is given by or under the supervision of a health care professional. Other forms of pyridoxine 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.

Pyridoxine is found in various foods, including meats, bananas, lima beans, egg yolks, peanuts, and whole-grain cereals. Pyridoxine is not lost from food during ordinary cooking, although some other forms of vitamin B 6 are.

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 pyridoxine needed is defined in several different ways.

• 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).

• 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 pyridoxine are generally defined as follows:

• Infants and children—
  • Birth to 3 years of age: 0.3 to 1 milligram (mg).
  • 4 to 6 years of age: 1.1 mg.
  • 7 to 10 years of age: 1.4 mg.
• Adolescent and adult males—1.7 to 2 mg.
• Adolescent and adult females—1.4 to 1.6 mg.
• Pregnant females—2.2 mg.
• Breast-feeding females—2.1 mg.

Before Using This Medicine:

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.

Children—

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

Older adults—

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

Breast-feeding—

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

Other 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.

• Altretamine

Other interactions—

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, tablets, oral solution):
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    • Adult and teenage males—1.7 to 2 milligrams (mg) per day.
    • Adult and teenage females—1.4 to 1.6 mg per day.
    • Pregnant females—2.2 mg per day.
    • Breast-feeding females—2.1 mg per day.
    • Children 7 to 10 years of age—1.4 mg per day.
    • Children 4 to 6 years of age—1.1 mg per day.
    • Children birth to 3 years of age—0.3 to 1 mg per day.
  • To treat deficiency:
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

To use the extended-release capsule form of this dietary supplement:

• Swallow the capsule whole.
• Do not crush, break, or chew before swallowing.
• If the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

To use the extended-release tablet form of this dietary supplement:

• Swallow the tablet whole.
• Do not crush, break, or chew before swallowing.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

With large doses

Clumsiness

numbness of hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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