Aquasol E

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.

Dietary Requirements

Adequate intake needed to prevent vitamin E deficiency and peripheral neuropathy associated with vitamin E deficiency.159

Adequate intake of vitamin E usually can be accomplished through consumption of foodstuffs containing fat.159 Vitamin E is principally obtained from vegetable oils, unprocessed cereal grains, nuts, fruits, vegetables, and meats (especially those high in fat).b

Recommended Dietary Allowance (RDA) in adults is based on induced vitamin E deficiency and the correlation between hydrogen peroxide-induced erythrocyte hemolysis and plasma α-tocopherol concentrations.159

Adequate Intake (AI) established for infants ≤6 months of age is based on observed mean vitamin E intake of infants fed principally human milk; AI for infants 7–12 months of age is based on the AI for younger infants.159

Vitamin E Deficiency

Treatment of vitamin E deficiency (e.g., patients with genetic abnormalities in α-tocopherol transfer protein, fat malabsorption syndromes, or protein-calorie malnutrition).159

Alzheimer’s Disease

Has been evaluated in a dosage of 2000 units daily for the palliative treatment of moderately severe dementia of the Alzheimer’s type† (Alzheimer’s disease, presenile or senile dementia).146 147 148 149 Not recommended for the treatment of cognitive symptoms of dementia because of limited evidence of efficacy and safety concerns.f (See Mortality under Cautions.)

Cardiovascular Risk Reduction

Current data does not support use of vitamin E supplements to reduce the risk of cardiovascular disease†.168 169 171 172

Macular Degeneration

Suggested as a component of high-dose antioxidant supplements with zinc to reduce risk of developing advanced age-related macular degeneration† in high-risk patients (i.e., those with intermediate stage age-related macular degeneration or advanced stage macular degeneration in only one eye).164 165

Use in Neonates

Has been used to prevent vitamin E deficiency in premature neonates†.108

Pharmacologic doses of vitamin E not recommended for prevention or treatment of retinopathy of prematurity†, bronchopulmonary dysplasia†, or intraventricular hemorrhage†.108

Cancer Risk Reduction

Use of vitamin E alone in conjunction with selenium does not decrease the risk of prostate cancer†.175

Current data does not support the use of vitamin E supplements to reduce the risk of cancer†.168 169 172

Prophylaxis of Tardive Dyskinesia

Has been used to reduce the risk of tardive dyskinesia† associated with use of antipsychotic agents.173

Contraindications

No known contraindications.a

Warnings/Precautions

Warnings

Long-term administration (>1 year) of high doses of vitamin E (≥400 units daily) may increase all-cause mortality.166 d

Specific Populations

Category A.c

Distributed into human milk.c

Common Adverse Effects

Usually nontoxic at therapeutic doses.a

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a

• Importance of proper dietary habits, including taking appropriate AI or RDA of vitamin E.a

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

• Importance of informing patients of other important precautionary information. (See Cautions.)

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

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

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

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

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, 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 used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

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

Vitamin supplements 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. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E 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.

Vitamin E is available in various 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 have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be 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 have an allergy to Aquasol E (vitamin E solution) or any part of this medicine.
• 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 Aquasol E with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.