beta carotene (OTC)

Brand and Other Names:Lumitene, provitamin A, more...carotene
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule (beadlets)

  • 30mg (Lumitene)

Erythropoietic Protoporphyria

Indicated to reduce sun sensitivity in erythropoietic protoporphyria

180 mg/day PO as a once daily dose or divided several times per day

If sun sensitivity still exists, may increase by 30-60 mg/day; not to exceed 300 mg/day

Dosing Considerations

The original beta carotene formula was a prescription called Solatene (now discontinued)

Lumitene (available OTC) is highly absorbed and is considered the optimal product for erythropoietic protoporphyria (clinical trials were completed using this product)

Beta carotene equivalents

  • 1 IU beta carotene = 0.6 mcg beta carotene
  • 1 retinol equivalent (RE expressed as vitamin A equivalent) = 6 mcg beta carotene

Administration

Content of capsules may be mixed with orange or tomato juice for individuals who are unable to swallow capsule

Dosage Forms & Strengths

capsule (beadlets)

  • 30mg (Lumitene)

Erythropoietic Protoporphyria

Indicated to reduce sun sensitivity in erythropoietic protoporphyria

Administer as either a once-daily dose or divided several times per day

1-4 years: 60-90 mg/day PO

5-18 years: 90-120 mg/day PO

9-12 years: 120-150 mg/day PO

13-15 years: 150-180 mg/day PO

If sun sensitivity still remains after using the above doses, may increase dose by 30-60 mg/day for children younger than 16 years

≥16 years: 180 mg/day PO; if sun sensitivity still exists, may increase by 30-60 mg/day; not to exceed 300 mg/day

Dosing Considerations

The original beta carotene formula was a prescription called Solatene (now discontinued)

Lumitene (available OTC) is highly absorption and is considered the optimal product for erythropoietic protoporphyria (clinical trials were completed using this product)

Beta carotene equivalents

  • 1 IU beta carotene = 0.6 mcg beta carotene
  • 1 retinol equivalent (RE expressed as vitamin A equivalent) = 6 mcg beta carotene

Administration

Content of capsules may be mixed with orange or tomato juice for individuals who are unable to swallow capsule

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Interactions

Interaction Checker

and beta carotene

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (7)

                • cholestyramine

                  cholestyramine decreases levels of beta carotene by drug binding in GI tract. Use Caution/Monitor.

                • ethanol

                  beta carotene, ethanol. Other (see comment). Use Caution/Monitor. Comment: Excessive alcohol ingestion decreases beta carotene levels in the body.

                • lutein

                  beta carotene, lutein. Either decreases levels of the other by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                • mineral oil

                  mineral oil decreases levels of beta carotene by drug binding in GI tract. Use Caution/Monitor.

                • orlistat

                  orlistat decreases levels of beta carotene by drug binding in GI tract. Use Caution/Monitor.

                • verteporfin

                  beta carotene decreases effects of verteporfin by pharmacodynamic antagonism. Use Caution/Monitor. Drugs that reduce active oxygen species or scavenge radicals are expected to decrease verteporfin's therapeutic effect .

                • vitamin A

                  vitamin A, beta carotene. Either increases levels of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Administration of beta-carotene with vitamin A usually is not necessary and should be avoided to prevent the development of hypervitaminosis A.

                Minor (0)

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                  Adverse Effects

                  Frequency Not Defined

                  Diarrhea

                  Ecchymoses

                  Arthralgia

                  Carotenoderma

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                  Warnings

                  Contraindications

                  Hypersensitivity

                  Cautions

                  Renal or hepatic impairment (not studied in these conditions)

                  Carotenoderma (yellowing of the skin) reported 4-6 weeks after initiating high doses

                  When antioxidant vitamins, including beta-carotene, are used together, they might interfere with healing following angioplasty

                  May increase cardiovascular risk (eg, coronary artery disease, cardiovascular mortality), especially in current smokers

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

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                  Pregnancy & Lactation

                  Pregnancy Category: A (oral); C (doses exceeding RDA)

                  Lactation: Distributed into milk; safe at RDA levels

                  Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Beta carotene is 1 of a group of red, orange, and yellow pigments called carotenoids; beta carotene and other carotenoids provide ~50% of the vitamin A needed in the American diet

                  Dietary sources include fruits, vegetables, and whole grains

                  Photoprotective effects: Exact mechanism unknown; in vitro studies suggest antioxidant effects and that beta carotene reduces free radicals and singlet oxygen, which are produced when porphyrin is exposed to light and air

                  Absorption

                  ~20-30% is absorbed unchanged

                  Onset: Photoprotection occurs after 4-6 weeks, when plasma concentrations reach a maximum

                  Peak plasma time: ~4-6 weeks

                  Therapeutic plasma concentration: 4-6 mcg/mL

                  Distribution

                  Widely distributed, with accumulation in the skin and depot fat

                  Metabolism

                  Absorbed into small intestine wall where it is metabolized to vitamin A

                  Small amount converted to vitamin A in liver

                  Beta carotene is cleaved into 2 molecules of retinal, which are then reduced to retinol

                  Oxidation of retinal to retinoic acid may occur

                  Elimination

                  Retinol is conjugated and excreted in the urine and feces

                  Retinoic acid metabolites are excreted via the bile

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                  Images

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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.