Drug information of Betacarotene

A carotenoid pigment that occurs naturally in green and yellow vegetables

Precise mechanism by which beta carotene exerts photoprotection has not been established; may quench the formation of singlet excited oxygen

No effect on the basic biochemical abnormality of EPP (i.e., erythrocyte, plasma, and stool concentrations of protoporphyrins are not altered by the drug

Absorption
Bioavailability
Absorption depends on the presence of bile and absorbable fat in the intestinal tract
Supplemental forms of beta carotene have markedly greater bioavailability than dietary beta carotene
Only 20–30% of supplemental beta carotene is absorbed unchanged
Onset of Action
Photosensitivity protecting action occurs after at least 2–4 weeks and usually coincides with the development of carotenodermia
Duration
Decreased tolerance to light usually is evident within 1–2 weeks after discontinuing beta carotene therapy
Plasma Concentrations
Blood carotene concentrations reach a maximum and carotenodermia usually develops about 4–6 weeks after beginning beta carotene therapy
Distribution
Extent
Widely distributed in the body. Accumulates in the skin and in various tissues, particularly depot fat
Not known if distributed into human milk
Metabolism
Metabolized, principally in the small intestine, to vitamin A; smaller amounts metabolized in the liver
Elimination Route
Excreted in fecesf and urine as metabolites

Erythropoietic Protoporphyria
Used to reduce the severity of photosensitivity reactions in patients with erythropoietic protoporphyria (EPP

Increases the development time for minimal erythema in EPP patients exposed to artificial light and sunlight

Macular Degeneration
Has been used in high-dose antioxidant supplements containing ascorbic acid and vitamin E with zinc in high-risk patients with age-related macular degeneration

Other Photosensitivity Reactions
Has been used in the management of polymorphous light eruption and photosensitivity caused by diseases other than EPP; further studies are required

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

1
IU beta carotene is equivalent to 0.6 mcg beta carotene
1
RE is equivalent to 6 mcg of dietary beta carotene

Pediatric Patients
Erythropoietic Protoporphyria
Oral
Children <14 years of age: Usually, 30–150 mg (50,000–250,000 IU beta carotene) daily

Adults
Erythropoietic Protoporphyria
Oral
Usually, 30–300 mg (50,000–500,000 IU beta carotene) daily

Macular Degeneration
Oral
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

Special Populations
No special populations dosage recommendations at this time

 

Known hypersensitivity to beta carotene or any ingredient in the formulation

Side effects requiring immediate medical attention
Along with its needed effects, beta-carotene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention

Side effects not requiring immediate medical attention
Some side effects of beta-carotene 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

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

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat

Store at room temperature
Store in a dry place. Do not store in a bathroom

If your symptoms or health problems do not get better or if they become worse, call your doctor

Do not share your drugs with others and do not take anyone else's drugs

Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about beta-carotene, please talk with your doctor, nurse, pharmacist, or other health care provider

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened

Increased incidence of lung cancer following beta carotene supplementation has been reported in clinical trials of adult smokers and those exposed to asbestos
Carcinogenic potential of beta carotene supplementation has not been determined to date. However, beta carotene supplementation was not carcinogenic in animal studies

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

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

What are some things I need to know or do while I take Beta-Carotene

Tell all of your health care providers that you take beta-carotene. This includes your doctors, nurses, pharmacists, and dentists

Avoid other sources of vitamin A

Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby

Use beta-carotene as ordered by your doctor. Read all information given to you. Follow all instructions closely
Take beta-carotene with food
Take with a full glass of water

Absorption is greatly decreased in patients with steatorrhea and chronic diarrhea

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

Advise patients against taking supplementary vitamin A because beta carotene will fulfill normal vitamin A requirements

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

Inform EPP patients not to increase time of exposure to the sun until carotenodermia is evident

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

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

Importance of informing patients of other important precautionary information

Not effective as a sunscreen

Not recommended to reduce cardiovascular risk

Beta carotene supplementation has not been shown to reduce the risk for developing lung or other cancers

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

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

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

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

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

Category C