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Beta-carotene: Drug information

Beta-carotene: Drug information
(For additional information see "Beta-carotene: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • A-Caro-25 [OTC] [DSC];
  • B-Caro-T [OTC];
  • Caroguard [OTC]
Pharmacologic Category
  • Vitamin, Fat Soluble
Dosing: Adult

OTC labeling: Dietary supplement: Oral: One capsule daily

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

A-Caro-25: 25,000 units [DSC] [contains soybean lecithin, soybean oil]

Generic: 25,000 units

Capsule, Oral [preservative free]:

B-Caro-T: 15 mg [dye free]

Caroguard: 15 mg [dye free]

Generic: 25,000 units [DSC]

Generic Equivalent Available: US

Yes

Administration: Adult

May be administered with meals.

Use: Labeled Indications

Dietary supplement: Use as a dietary supplement to increase vitamin A when dietary intake is inadequate

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Dizziness

Dermatologic: Skin discoloration (yellowing of palms, hands, or soles of feet, and to a lesser extent the face)

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment.

Other warnings/precautions:

• Sunscreen use: Not proven effective as a sunscreen.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Maternal intake of beta-carotene influences cord blood concentrations (Scaife 2006).

Breastfeeding Considerations

Beta-carotene is found in breast milk. Concentrations vary by maternal intake (IOM 2000).

Dietary Considerations

Dietary Reference Intake for vitamin A (presented as retinol activity equivalent [RAE]) (IOM 2000):

Adequate intake (AI):

1 to 6 months: 400 mcg/day (1,330 units/day)

7 to 12 months: 500 mcg/day (1,670 units/day)

Recommended dietary allowance (RDA):

1 to 3 years: 300 mcg/day (1,000 units/day)

4 to 8 years: 400 mcg/day (1,330 units/day)

9 to 13 years: 600 mcg/day (2,000 units/day)

Males >13 years: 900 mcg/day (3,000 units/day)

Females >13 years: 700 mcg/day (2,330 units/day)

Pregnant females 14 to 18 years: 750 mcg/day (2,500 units/day)

Pregnant females ≥19 years: 770 mcg/day (2,560 units/day)

Lactating females 14 to 18 years: 1,200 mcg/day (4,000 units/day)

Lactating females ≥19 years: 1,300 mcg/day (4,330 units/day)

Mechanism of Action

The exact mechanism of action in erythropoietic protoporphyria has not as yet been elucidated; although patient must become carotenemic before effects are observed, there appears to be more than a simple internal light screen responsible for the drug's action. A protective effect was achieved when beta-carotene was added to blood samples. The concentrations of solutions used were similar to those achieved in treated patients. Topically applied beta-carotene is considerably less effective than systemic therapy.

Pharmacokinetics

Metabolism: Prior to absorption, converted to vitamin A in the wall of the small intestine, then oxidized to retinoic acid and retinol in the presence of fat and bile acids; small amounts are then stored in the liver; retinol (active) is conjugated with glucuronic acid

Excretion: Urine and feces

Pricing: US

Capsules (Beta Carotene Oral)

25000 unit (per each): $0.03 - $0.05

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Acecap (TR);
  • B-Tene (AU);
  • Bei Xi Di (CN);
  • Betacar-15 (TH);
  • Betavin (CO);
  • Biocarotine (GB);
  • Bronce Sol (AR);
  • Carolin (RU);
  • Carotaben (AT, CH, DE, NO);
  • Carovit (TR);
  • Kalvo (CN);
  • Keratoplastica (IT);
  • Medobiotin (UA);
  • Natural Betacarotene (AU);
  • Oxyma (IN);
  • Tannisol (IT)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. IOM (Institute of Medicine), Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: National Academy Press, 2000.
  2. IOM (Institute of Medicine), Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. A Report of the Panel on Dietary Antioxidants and Related Compounds Food and Nutrition Board, Institute of Medicine. Washington, DC: National Academy Press, 2000.
  3. Lecha M, Puy H, and Deybach JC, "Erythropoietic Protoporphyria," Orphanet J Rare Dis, 2009, 4:19. [PubMed 19744342]
  4. Scaife AR, McNeill G, Campbell DM, et al, "Maternal Intake of Antioxidant Vitamins in Pregnancy in Relation to Maternal and Fetal Plasma Levels at Delivery," Br J Nutr, 2006, 95(4):771-8. [PubMed 16571157]
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