Beta Carotene (Monograph)

Brand name: Lumitene
Drug class: Vitamin A
ATC class: A11HA
VA class: VT050
Molecular formula: C₄₀H₅₆
CAS number: 7235-40-7

Medically reviewed by Drugs.com on Sep 9, 2024. Written by ASHP.

Introduction

Weak antioxidant; precursor of vitamin A.

Uses for Beta Carotene

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^{† [off-label]}.

Other Photosensitivity Reactions

Has been used in the management of polymorphous light eruption^{† [off-label]} and photosensitivity caused by diseases other than EPP; further studies are required.

Other Uses

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.

Beta Carotene Dosage and Administration

General

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.

Administration

Oral Administration

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.

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).

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† [off-label]

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.

Cautions for Beta Carotene

Contraindications

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

Warnings/Precautions

Warnings

Lung Cancer

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.

Cardiovascular Disease

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

Sensitivity Reactions

Peanut Hypersensitivity

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

General Precautions

Skin Discoloration

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

Specific Populations

Pregnancy

Category C.

Lactation

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

Hepatic Impairment

Safety not established; use with caution.

Renal Impairment

Safety not established; use with caution.

Common Adverse Effects

Reversible carotenodermia, loose stools.

Drug Interactions

Specific Drugs

Beta Carotene Pharmacokinetics

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

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.

Special Populations

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

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.

Elimination

Metabolism

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

Elimination Route

Excreted in feces and urine as metabolites.

Stability

Storage

Oral

Capsules

Tight, light-resistant containers.

Actions

• 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).

Advice to Patients

• 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. 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. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

• What are antioxidants and should you take supplements?

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