Lumitene

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

Absorption

Bioavailability

Absorption depends on the presence of bile and absorbable fat in the intestinal tract.a e f

Supplemental forms of beta carotene have markedly greater bioavailability than dietary beta carotene.e

Only 20–30% of supplemental beta carotene is absorbed unchanged.a

Onset

Photosensitivity protecting action occurs after at least 2–4 weeks and usually coincides with the development of carotenodermia.a

Duration

Decreased tolerance to light usually is evident within 1–2 weeks after discontinuing beta carotene therapy.a

Plasma Concentrations

Blood carotene concentrations reach a maximum and carotenodermia usually develops about 4–6 weeks after beginning beta carotene therapy.a

Special Populations

Absorption is greatly decreased in patients with steatorrhea and chronic diarrhea.a

Distribution

Extent

Widely distributed in the body.a e Accumulates in the skin and in various tissues, particularly depot fat.a

Not known if distributed into human milk.a f

Elimination

Metabolism

Metabolized, principally in the small intestine, to vitamin A;a f smaller amounts metabolized in the liver.f

Elimination Route

Excreted in fecesf and urine as metabolites.a

Storage

Oral

Tight, light-resistant containers.a

• Inform patients that carotenodermia may develop after 2–6 weeks of therapy; usually first noticed as yellowness of the palms of the hands or soles of the feet and to a lesser extent of the face.a f

• Advise patients against taking supplementary vitamin A because beta carotene will fulfill normal vitamin A requirements.a f

• Advise EPP patients that the protective effect of beta carotene is not total and that they may still develop considerable burning and edema after sufficient exposure to sunlight.a f Explain that each patient must establish his own time limit of exposure to sunlight.a f

• Inform EPP patients not to increase time of exposure to the sun until carotenodermia is evident.a f

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

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.f

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

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. Beta-carotene is converted in the body to vitamin A, which is necessary for healthy eyes and skin.

A lack of vitamin A may cause a rare condition called night blindness (problems seeing in the dark). It may also cause dry eyes, eye infections, skin problems, and slowed growth. Your health care professional may treat these problems by prescribing either beta-carotene, which your body can change into vitamin A, or vitamin A for you.

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

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

Claims that beta-carotene is effective as a sunscreen have not been proven. Although beta-carotene supplements are being studied for their ability to reduce the risk of certain types of cancer and possibly heart disease, there is not enough information to show that this is effective.

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

Beta-carotene is available without a prescription.

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

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

Geriatric

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

Breast Feeding

There are no adequate studies in women for determining 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. Tell 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 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, 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

This section provides information on the proper use of a number of products that contain beta carotene. It may not be specific to Lumitene. Please read with care.

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.

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.

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.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may 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 or are bothersome or if you have any questions about them:

• 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)

• 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.