Lumitene (Oral)

Vitamins are essential compounds for your growth and health. You only need them in small amounts, and they are usually found in the foods you eat. Beta-carotene is turned into vitamin A in your body, which is important for keeping your eyes and skin healthy.

Not having enough vitamin A may lead to a rare condition called night blindness (difficulty seeing in the dark). It can also cause dry eyes, eye infections, skin issues, and slow growth. Your health care professional may treat these issues by prescribing either beta-carotene, which your body can convert to vitamin A, or vitamin A directly.

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

• Cystic fibrosis
• Diarrhea, continuing
• Illness, long-term
• Injury, serious
• Liver disease
• Malabsorption problems
• Pancreas disease

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

There is no proof that beta-carotene works as a sunscreen. While beta-carotene supplements are being researched for their potential to lower the risk of certain cancers and possibly heart disease, there is not enough evidence to show that they are effective.

Beta-carotene may also be used to treat other conditions as decided by your doctor.

Beta-carotene is available without a prescription.

For good health, it's important to eat a balanced and varied diet. Follow any diet plan your health care professional recommends carefully. If you have specific dietary needs for vitamins and/or minerals, ask your health care professional for a list of suitable foods. If you think you are not getting enough vitamins and/or minerals from your diet, you might consider taking a dietary supplement.

Research shows that people who eat a lot of fruits and vegetables have a lower risk of heart disease and certain cancers. Fruits and vegetables are high in beta-carotene and other beneficial nutrients.

Beta-carotene can be 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, and normal cooking does not destroy it.

Vitamins by themselves cannot replace a healthy diet and do not provide energy. Your body also needs other substances found in food, like protein, minerals, carbohydrates, and fat. Vitamins often cannot function without other foods. For instance, some fat is needed for your body to absorb beta-carotene.

Use of beta-carotene has been linked to a higher risk of lung cancer in people who smoke or who have been exposed to asbestos. One study involving 29,000 male smokers found an 18% increase in lung cancer among those taking 20 mg of beta-carotene each day for 5 to 8 years. Another study with 18,000 people found 28% more lung cancers in individuals with a history of smoking and/or asbestos exposure. These participants took 30 mg of beta-carotene along with 25,000 Units of retinol (a form of vitamin A) each day for 4 years. However, a study of 22,000 male physicians, some of whom were smokers or former smokers, showed no increase in lung cancer. These individuals 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 high in beta-carotene are considered safe and may lower the risk of some types of cancer and possibly heart disease.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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 documented problems in children when taking normal daily recommended amounts.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this dietary supplement. Be sure to inform your doctor if you have any other medical issues, especially:

• Eating disorders or
• Kidney disease or
• Liver disease—These conditions may cause high blood levels of beta-carotene, which may increase the chance of side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Yellowing of palms, hands, or soles of feet, and to a lesser extent the face (this may be a sign that your dose of beta-carotene as a nutritional supplement is too high)

Rare

• Diarrhea
• dizziness
• joint pain
• unusual bleeding or bruising

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.

In the U.S.

• A-Caro-25
• Lumitene

Available Dosage Forms:

• Capsule
• Capsule, Liquid Filled
• Tablet

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin A (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 use as a dietary supplement:

• For oral dosage forms (capsules or chewable tablets): Adults and teenagers: 6 to 15 milligrams (mg) of beta-carotene (the equivalent of 10,000 to 25,000 Units of vitamin A activity) per day. Children: 3 to 6 mg of beta-carotene (the equivalent of 5,000 to 10,000 Units of vitamin A activity) per day.

For other uses:

• For oral dosage forms (capsules or tablets): To treat or prevent a reaction to sun in patients with erythropoietic protoporphyria: Adults and teenagers—30 to 300 milligrams (mg) of beta-carotene (the equivalent of 50,000 to 500,000 Units of vitamin A activity) a day. Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day. To treat or prevent a reaction to sun in patients with polymorphous light eruption: Adults and teenagers—75 to 180 mg of beta-carotene (the equivalent of 125,000 to 300,000 Units of vitamin A activity) a day. Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day.

If you have high blood levels of vitamin A, your body will convert less beta-carotene to vitamin A.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this vitamin, try to remember to take it as directed every day.

If you miss a dose and you are using it as medicine, take it as soon as possible. However, if it is almost time for your next dose, 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. Do not refrigerate. Keep from freezing.

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.

• What are antioxidants and should you take supplements?