Key-E (Oral)

Vitamins are substances that are essential for growth and health. You only need them in small amounts, and you can get them from the foods you eat. Vitamin E helps prevent a chemical reaction called oxidation, which can sometimes harm your body. It is also important for the proper functioning of nerves and muscles.

Some conditions may raise your need for vitamin E. These include:

• Intestine disease
• Liver disease
• Pancreas disease
• Surgical removal of stomach

Your health care professional should determine if you need more vitamin E.

Infants on formulas that do not have added vitamin E may be at risk of vitamin E deficiency. Additionally, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E can treat cancer or prevent or treat acne, aging, hair loss, bee stings, liver spots on hands, bursitis, diaper rash, frostbite, stomach ulcers, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being studied for preventing certain types of cancer, there is not enough evidence to confirm its effectiveness.

A lack of vitamin E is very rare, except in people with conditions that prevent its absorption in the body.

Vitamin E can be obtained without a prescription.

For good health, it is important to eat a balanced and varied diet. Follow any diet plan recommended by your health care professional. For specific dietary vitamin and/or mineral needs, ask your health care professional for a list of suitable foods. If you think you are not getting enough vitamins and/or minerals in your diet, you may consider taking a dietary supplement.

Vitamin E is found in various foods, including vegetable oils (like corn, cottonseed, soybean, and safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage can reduce the amount of vitamin E in foods.

Vitamin supplements cannot replace a healthy diet and do not provide energy. Your body also needs other nutrients found in food, such as protein, minerals, carbohydrates, and fat. Vitamins often need the presence of other foods to function properly. For example, small amounts of fat are necessary for your body to absorb vitamin E.

The daily amount of vitamin E required is defined in several ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amounts of vitamins and minerals needed to ensure adequate nutrition for most healthy individuals. RDAs can vary based on a person's age, sex, and physical condition (like pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to show the percent of the recommended daily amount of each nutrient that a serving provides. DV has replaced the previous term United States Recommended Daily Allowances (USRDAs).

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

Vitamin E is available in different forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E was given in Units. This has been changed to alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equal to 1 mg of dl-alpha tocopherol acetate or 0.6 mg of d-alpha tocopherol. Most products sold in stores are still labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E 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

There have been no reported problems in children taking normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may suggest a vitamin E supplement.

Geriatric

There have been no reported problems in older adults taking normal daily recommended amounts.

Breast Feeding

There are no adequate studies in women to determine infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 taking this dietary supplement, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on 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 necessary 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.

• Dicumarol

Using this dietary supplement with any of the following medicines may increase the 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.

• Warfarin

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical problems may affect how you can use this dietary supplement. Make sure you tell your doctor if you have any other medical issues, especially:

• Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may worsen this condition.

Along with its benefits, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

Contact your doctor right away if you experience any of the following side effects:

With doses greater than 400 Units a day and long-term use

• Blurred vision
• diarrhea
• dizziness
• headache
• nausea or stomach cramps
• unusual tiredness or weakness

Other side effects not listed may also happen in some patients. If you notice any other effects, talk to your healthcare professional.

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

In the U.S.

• Alpha-E
• Aqua Gem-E
• Aquasol E
• D-Alpha Gems
• E-400
• E-600
• E-Gems
• Formula E 400
• Gamma E-Gems
• Gamma E Plus
• Key-E
• Natural Vitamin Blend E-400IU
• Nutr-E-Sol

Available Dosage Forms:

• Tablet
• Solution
• Capsule, Liquid Filled
• Liquid
• Oil
• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

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 solution dosage form: To prevent the following deficiencies in infants: Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula. Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used. Infants of normal birthweight—5 Units per 32 ounces of formula.
• For oral dosage forms (capsules, tablets, oral solution): To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day. Adult and teenage females—8 mg alpha-TE or 13 Units per day. Pregnant females—10 mg alpha-TE or 16.7 Units per day. Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day. Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day. Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day. For Canada Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day. Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day. Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day. Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day. Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day. Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day. Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.
• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

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 dietary supplement 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.

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