U.S. Brand Names:
A-Caro-25®; B-Caro-T™; Lumitene™
Generic Available:
Yes
Use - Unlabeled/Investigational:
Prophylaxis and treatment of polymorphous light eruption; prophylaxis against photosensitivity reactions in erythropoietic protoporphyria
Pregnancy Risk Factor:
C
Lactation:
Excretion in breast milk unknown/use caution
Contraindications:
Hypersensitivity to beta-carotene or any component of the formulation
Warnings/Precautions:
Use with caution in patients with renal or hepatic impairment; not proven effective as a sunscreen
Adverse Reactions:
>10%: Dermatologic: Carotenodermia (yellowing of palms, hands, or soles of feet, and to a lesser extent the face)
<1%: Dizziness, bruising, diarrhea, arthralgia
Drug Interactions:
Fulfills vitamin A requirements, do not prescribe additional vitamin A
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.
Pharmacodynamics/Kinetics:
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
Dosage:
Oral:
Children <14 years: 30-150 mg/day
Adults: 30-300 mg/day
Dietary Considerations:
May be taken with meals.
Patient Education:
Take exactly as directed; do not take more than the recommended dose. Take with meals. Do not take additional vitamins without consulting prescriber. Skin may appear slightly yellow-orange. Not a proven sunblock. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Nursing Implications:
Skin may appear slightly yellow-orange; not a proven sunscreen
Cardiovascular Considerations:
There is no compelling evidence that supplemental antioxidant therapy has a role in the primary prevention of cardiovascular disease. The role of antioxidant therapy in secondary prevention has also not been established, in part, because of a lack of concordance between studies, reports of increased risk with specific antioxidants (eg, beta-carotene), not fully understanding the underlying pathophysiologic mechanisms, and the use of different doses or combinations of antioxidants. In general, secondary prevention trials evaluating vitamin E have shown the most promise. However, a recent trial (HOPE) demonstrated no cardiovascular benefit from the use of vitamin E in patients with or at risk for coronary artery disease. Until further outcome trials establish the role of vitamin E and possible other antioxidants for the secondary prevention of cardiovascular disease, patients should be encouraged to follow a balanced diet that is rich in antioxidants (eg, citrus fruits, vegetables, whole grains).
Dental Health: Effects on Dental Treatment:
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions:
No information available to require special precautions
Mental Health: Effects on Mental Status:
None reported
Mental Health: Effects on Psychiatric Treatment:
None reported
Dosage Forms:
Capsule: 10,000 int. units (6 mg); 25,000 int. units (15 mg)
A-Caro-25®, B-Caro-T™: 25,000 int. units (15 mg)
Lumitene™: 50,000 int. units (30 mg)
Tablet: 10,000 int. units
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