Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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)
Adverse Effects
Frequency Not Defined
Diarrhea
Ecchymoses
Arthralgia
Carotenoderma
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
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.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
