Beta-Carotene

Beta-carotene is an over-the-counter supplement, which is converted in your body to vitamin A, an essential nutrient. It has antioxidant activity, which helps protect the cells from damage.

Beta-carotene is available under the following different brand names: Lumitene, provitamin A, and Carotene.

Capsule (beadlets)

• 30 mg (Lumitene)

Dosage Considerations – Should be Given as Follows:

Erythropoietic Protoporphyria

Adult:

• Indicated to reduce sun sensitivity in erythropoietic protoporphyria
• 180 mg/day orally 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

Pediatric:

• Indicated to reduce sun sensitivity in erythropoietic protoporphyria
• Administer as either a once-daily dose or divided several times per day
• Children 1-4 years: 60-90 mg/day orally
• Children 5-18 years: 90-120 mg/day orally
• Children 9-12 years: 120-150 mg/day orally
• Children 13-15 years: 150-180 mg/day orally

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

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

Dosing Considerations

Adults and Pediatric:

• The original beta-carotene formula was a prescription called Solatene (now discontinued)
• Lumitene (available over-the-counter) is highly absorbed and is considered the optimal product for erythropoietic protoporphyria (clinical trials were completed using this product)
• Beta-carotene equivalents
  • 1 international unit (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

Side effects of bismuth subsalicylate include:

• diarrhea
• discoloration of the skin
• joint pain
• yellowing of the skin

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Beta-carotene has no known severe interactions with other drugs.

Beta-carotene has no known serious interactions with other drugs.

Moderate interactions of beta-carotene include:

• cholestyramine
• ethanol
• lutein
• mineral oil
• orlistat
• verteporfin
• vitamin A

Beta-carotene has no known minor interactions with other drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains beta-carotene. Do not take Lumitene, provitamin A, or Carotene if you are allergic to beta-carotene or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Beta-Carotene?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Beta-Carotene?"

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 (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 and Lactation

• Beta-carotene is generally acceptable for use during pregnancy. Controlled studies in pregnant women show no evidence of fatal risk (Oral Dosage). Use beta-carotene with caution if doses exceed the recommended daily average.
• Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• Beta-carotene is distributed into breast milk and is safe at recommended daily average dosage.
• Pregnant or breastfeeding women should seek advice of a health professional before using over-the-counter drugs.