Beta Carotene

Weak antioxidant; precursor of vitamin A.a e f

General

Erythropoietic Protoporphyria

• Adjust dosage according to individual requirements and response.a f Adjust dosage to maintain blood carotene concentrations of 4–6 mcg/mL.a

• Several weeks of therapy are often required before enough beta carotene has accumulated in the skin to exert a protective effect.a f

• Patients should not increase time of exposure to the sun until carotenodermia is evident (e.g., yellowness of palms and soles).a f When carotenodermia occurs, cautiously and gradually increase exposure to the sun.a f

Administration

Oral Administration

Administer orally as a single daily dose or in divided doses, preferably with meals.a f h

Contents of capsules may be mixed with orange or tomato juice to facilitate administration to children.a f

Dosage

Dosage expressed in terms of beta carotene; may also be expressed in terms of vitamin A in international units (IU) or retinol equivalents (RE).d f g h

1 IU beta carotene is equivalent to 0.6 mcg beta carotene.g

1 RE is equivalent to 6 mcg of dietary beta carotene.f g

Pediatric Patients

Children <14 years of age: Usually, 30–150 mg (50,000–250,000 IU beta carotene) daily.a f

Adults

Usually, 30–300 mg (50,000–500,000 IU beta carotene) daily.a e f

15 mg daily in combination with ascorbic acid 500 mg daily, vitamin E 400 units daily, and zinc (as zinc oxide) 80 mg daily, with copper (as cupric oxide) 2 mg daily (to prevent anemia).128 130

Special Populations

No special populations dosage recommendations at this time.f

Contraindications

• Known hypersensitivity to beta carotene or any ingredient in the formulation.a f

Warnings/Precautions

Warnings

Increased incidence of lung cancer following beta carotene supplementation has been reported in clinical trials of adult smokers and those exposed to asbestos.113 129 e

Carcinogenic potential of beta carotene supplementation has not been determined to date.a However, beta carotene supplementation was not carcinogenic in animal studies.e

Beta carotene supplementation may increase cardiovascular risk (e.g., coronary artery disease, cardiovascular mortality), especially in current smokers.101 105 106 e

Sensitivity Reactions

Some preparations of beta carotene (Lumitene) contain peanut oil.f

General Precautions

Excessive beta carotene ingestion may cause reversible carotenodermia (yellowish skin discoloration); carotenodermia usually disappears when beta carotene is reduced or discontinued.f

Specific Populations

Category C.b f

Not known whether beta carotene is distributed into milk.a f Use with caution.a f

Safety not established; use with caution.a f

Safety not established; use with caution.a f

Common Adverse Effects

Reversible carotenodermia,a e f loose stools.a f

Storage

Oral

Tight, light-resistant containers.a

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.

It is documented that people who consume diets high in fruits and vegetables have a reduced risk of heart disease and certain cancers. Fruits and vegetables are rich in beta-carotene and other nutrients that may be beneficial.

Beta-carotene is found in carrots; dark-green leafy vegetables, such as spinach and green leaf lettuce; sweet potatoes; broccoli; cantaloupe; and winter squash. The body converts beta-carotene into vitamin A. Ordinary cooking does not destroy beta-carotene.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body 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, some fat is needed so that beta-carotene can be absorbed into the body.

Use of beta-carotene has been associated with an increased risk of lung cancer in people who smoke or who have been exposed to asbestos. One study of 29,000 male smokers found an 18% increase in lung cancer in the group receiving 20 mg of beta-carotene a day for 5 to 8 years. Another study of 18,000 people found 28% more lung cancers in people with a history of smoking and/or asbestos exposure. These people took 30 mg of beta-carotene in addition to 25,000 Units of retinol (a form of vitamin A) a day for 4 years. However, one study of 22,000 male physicians, some of them smokers or former smokers, found no increase in lung cancer. These people took 50 mg of beta-carotene every other day for 12 years. If you smoke or have a history of smoking or asbestos exposure, you should not take large amounts of beta-carotene supplements for long periods of time. However, foods that are rich in beta-carotene are considered safe and appear to lower the risk of some types of cancer and possibly heart disease.

• If you have an allergy to beta-carotene or any other part of beta-carotene.
• 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.
• If you are taking acitretin.

This is not a list of all drugs or health problems that interact with this medicine.

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 beta-carotene with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking beta-carotene as you have been told by your doctor or other health care provider, even if you feel well.
• Take this medicine with food.
• Take with a full glass of water.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• 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.