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Drug overview for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e):
Generic name: beta-carotene(vit A) with vitamins C and E
Drug class: Multivitamins
Therapeutic class: Electrolyte Balance-Nutritional Products
Ascorbic acid is the functional and principal in vivo form of vitamin C, an Vitamin A, a fat-soluble vitamin that is present in foods in a variety of Vitamin E is a fat-soluble vitamin and an antioxidant. essential water-soluble vitamin. forms, is available for clinical use as retinol (vitamin A alcohol) or esters of retinol formed from edible fatty acids, principally acetic and palmitic acids.
No enhanced Uses information available for this drug.
Generic name: beta-carotene(vit A) with vitamins C and E
Drug class: Multivitamins
Therapeutic class: Electrolyte Balance-Nutritional Products
Ascorbic acid is the functional and principal in vivo form of vitamin C, an Vitamin A, a fat-soluble vitamin that is present in foods in a variety of Vitamin E is a fat-soluble vitamin and an antioxidant. essential water-soluble vitamin. forms, is available for clinical use as retinol (vitamin A alcohol) or esters of retinol formed from edible fatty acids, principally acetic and palmitic acids.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e):
To avoid toxicity, dietary intake of vitamin A should be estimated and considered when determining the dosage of the vitamin. Vitamin A activity is expressed in terms of the equivalent amount of retinol (i.e., as retinol equivalents (RE) or retinol activity equivalents (RAE)) and is expressed also in USP units or International Units (IU, units). USP units and International Units are equivalent.
One USP vitamin A unit is the specific biologic activity of 0.3 mcg of all-trans-retinol; one retinol equivalent (RE) is the specific biologic activity of 1 mcg of all-trans-retinol; one retinol activity equivalent (RAE) is equal to 1 mcg of all-trans-retinol, 12 mcg of all trans-beta-carotene, or 24 mcg of other provitamin A carotenoids. The use of RAE is preferred when calculating and reporting the amount of total vitamin A in mixed foods or assessing the amount of dietary and supplemental vitamin A consumed.
Vitamin E activity is generally expressed in USP or International Units which are equivalent; the International Unit of vitamin E is no longer officially recognized but continues to be used in the labeling of some preparations. It should be noted that vitamin E preparations are historically and incorrectly labeled as d- or dl-alpha-tocopherol and their respective esters. Vitamin E compounds include the all racemic (all rac)-alpha-tocopherol (dl-alpha-tocopherol (RRR-, RRS-, RSR-, RSS-, SSS-, SRS-, SSR-, and SRR-) or synthetic) form and its esters and the RRR-alpha-tocopherol (d-alpha-tocopherol or natural) form and its esters, and any of these compounds may be present in fortified foods and vitamin preparations.
One unit of vitamin E equals the biologic activity of 1 mg of all rac-alpha-tocopheryl acetate (dl-alpha-tocopheryl acetate), 1.12 mg of all rac-alpha-tocopheryl succinate (dl-alpha-tocopheryl acid succinate), 910 mcg of all rac-alpha-tocopherol (dl-alpha-tocopherol), 735 mcg of RRR-alpha-tocopheryl acetate (d-alpha-tocopheryl acetate), 830 mcg of RRR-alpha-tocopheryl succinate (d-alpha-tocopheryl acid succinate), and 670 mcg of RRR-alpha-tocopherol (d-alpha-tocopherol). However, because the USP potency unit for vitamin E was defined before studies showed a lack of human activity for the 2S-stereoisomers, the National Academy of Sciences (NAS) Food and Nutrition Board recommended in 2000 that the current equivalency defined in the USP standard be redefined based on the R-stereoisomeric forms of alpha-tocopherol, which are the forms that are active in humans. According to the NAS definition, each USP unit of vitamin E is equivalent to the biologic activity of 450 mcg of the synthetic all rac-alpha-forms of tocopherol and its esters or 670 mcg of the RRR-alpha-forms of tocopherol and its esters.
One USP vitamin A unit is the specific biologic activity of 0.3 mcg of all-trans-retinol; one retinol equivalent (RE) is the specific biologic activity of 1 mcg of all-trans-retinol; one retinol activity equivalent (RAE) is equal to 1 mcg of all-trans-retinol, 12 mcg of all trans-beta-carotene, or 24 mcg of other provitamin A carotenoids. The use of RAE is preferred when calculating and reporting the amount of total vitamin A in mixed foods or assessing the amount of dietary and supplemental vitamin A consumed.
Vitamin E activity is generally expressed in USP or International Units which are equivalent; the International Unit of vitamin E is no longer officially recognized but continues to be used in the labeling of some preparations. It should be noted that vitamin E preparations are historically and incorrectly labeled as d- or dl-alpha-tocopherol and their respective esters. Vitamin E compounds include the all racemic (all rac)-alpha-tocopherol (dl-alpha-tocopherol (RRR-, RRS-, RSR-, RSS-, SSS-, SRS-, SSR-, and SRR-) or synthetic) form and its esters and the RRR-alpha-tocopherol (d-alpha-tocopherol or natural) form and its esters, and any of these compounds may be present in fortified foods and vitamin preparations.
One unit of vitamin E equals the biologic activity of 1 mg of all rac-alpha-tocopheryl acetate (dl-alpha-tocopheryl acetate), 1.12 mg of all rac-alpha-tocopheryl succinate (dl-alpha-tocopheryl acid succinate), 910 mcg of all rac-alpha-tocopherol (dl-alpha-tocopherol), 735 mcg of RRR-alpha-tocopheryl acetate (d-alpha-tocopheryl acetate), 830 mcg of RRR-alpha-tocopheryl succinate (d-alpha-tocopheryl acid succinate), and 670 mcg of RRR-alpha-tocopherol (d-alpha-tocopherol). However, because the USP potency unit for vitamin E was defined before studies showed a lack of human activity for the 2S-stereoisomers, the National Academy of Sciences (NAS) Food and Nutrition Board recommended in 2000 that the current equivalency defined in the USP standard be redefined based on the R-stereoisomeric forms of alpha-tocopherol, which are the forms that are active in humans. According to the NAS definition, each USP unit of vitamin E is equivalent to the biologic activity of 450 mcg of the synthetic all rac-alpha-forms of tocopherol and its esters or 670 mcg of the RRR-alpha-forms of tocopherol and its esters.
Vitamin A usually is administered orally. Oral vitamin A capsules containing high strengths (e.g., 50,000 units) no longer are commercially available in the US; however, high-strength oral capsules and solutions may be available from various organizations (e.g., United Nations Children's Fund (UNICEF), the International Dispensary Association (IDA)) for treatment of deficiencies in developing countries. When oral administration is not feasible or when malabsorption is present, the drug may be given IM.
Ascorbic acid is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
Vitamin E is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be given parenterally as a component of a multivitamin injection. Some clinicians use water-miscible oral vitamin E preparations in patients with malabsorption syndromes.
Ascorbic acid is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
Vitamin E is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be given parenterally as a component of a multivitamin injection. Some clinicians use water-miscible oral vitamin E preparations in patients with malabsorption syndromes.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Warfarin/Vitamin E (Alpha Tocopherol) Greater Than or Equal To 800 Units SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Vitamin E may decrease vitamin K-dependent clotting factors, resulting in additive effects with warfarin.(1) CLINICAL EFFECTS: Dose of vitamin E of 800 units/day or more may increase the pharmacologic effects of warfarin.(1-7) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving vitamin E supplements of 800 units/day or more may require lower dosages of warfarin. In patients maintained on warfarin who initiate vitamin E supplements in dosages of 800 units/day or more, measured INR one to two weeks after initiation of vitamin E and also every two to four weeks during the first two months.(2) DISCUSSION: Vitamin E doses up to 400 units/day is believed not to affect the prothrombin time in patients concomitantly receiving warfarin.(2) Vitamin E doses of 800 International Units/day and more have been reported to increase the hypoprothrombinemic effect of warfarin. However, in a double blind clinical trial, with only 13 subjects completing the study, patients who had received chronic warfarin therapy with the addition of vitamin E dose as high as 1,200 IU/day for 1 month saw negligible change in the INR or prothrombin time.(3) Selumetinib capsules contain a significant amount of vitamin E. Each 10 mg capsule contains 32 mg (48 units) and each 25 mg capsule contains (54 units) of vitamin E. The daily dose of selumetinib may contain up to 256 mg (384 units) of vitamin E. Vitamin E supplementation is not recommended if it will result in a daily vitamin E intake exceeding recommended or safe amounts.(4) Agenerase brand of amprenavir capsules and oral solution contain a significant amount of vitamin E. Each 150 mg capsule contains 109 International Units vitamin E, with a total of 1,744 International Units of vitamin E in the recommended daily adult dose. Each mL of oral solution contains 46 International Units of vitamin E.(5) One or more of the drug pairs linked to this monograph have been included in a list of interactions that could be considered for classification as "non-interruptive" in EHR systems. This DDI subset was vetted by an expert panel commissioned by the U.S. Office of the National Coordinator (ONC) for Health Information Technology. |
JANTOVEN, WARFARIN SODIUM |
There are 0 moderate interactions.
The following contraindication information is available for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Hypervitaminosis A |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Increased risk of bleeding due to coagulation disorder |
| Malabsorption states |
| Vitamin K deficiency induced hypoprothrombinemia |
The following adverse reaction information is available for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 0 severe adverse reactions.
There are 5 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Carotenodermia |
None. |
| Rare/Very Rare |
|---|
|
Arthralgia Diarrhea Dizziness Ecchymosis |
The following precautions are available for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Vitamin A is teratogenic in animals; malformations of the CNS, eye, palate, and urogenital tract have been described in several species. Adequate and well-controlled studies in humans are not available. A limited number of reports of human fetal malformations (e.g., cranial neural crest defects) following maternal ingestion of large dosages of vitamin A (10,000 units or more daily) during or both before and during pregnancy suggest potential teratogenicity, at least at high dosages.
The use of vitamin A in excess of the US RDA generally is contraindicated in women who are or may become pregnant. (See Dietary and Replacement Requirements in Dosage and Administration: Dosage.)If vitamin A is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential fetal hazard. It also has been suggested that women of reproductive age should limit their intake of dietary sources (e.g., liver) containing high concentrations of vitamin A; beta-carotene, a precursor of vitamin A, has not been shown to be teratogenic and may be considered as a source of vitamin A supplementation in such women.
Dosages exceeding the RDA may be necessary in women of childbearing age with vitamin A deficiency. There is some evidence suggesting that dosages up to 10,000 units daily or up to 25,000 units weekly may be used safely in women of childbearing age (13-49 years of age), and such dosages are recommended in those with active xerophthalmia. Even higher dosages may be necessary if active corneal lesions are present.
(See Vitamin A Deficiency under Dosage and Administration: Dosage.) Vitamin E has not been shown to be teratogenic. There is no evidence that vitamin E requirements in pregnant women differ from women who are not pregnant. (See Dosage: Dietary and Replacement Requirements, under Dosage and Administration.)
The use of vitamin A in excess of the US RDA generally is contraindicated in women who are or may become pregnant. (See Dietary and Replacement Requirements in Dosage and Administration: Dosage.)If vitamin A is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential fetal hazard. It also has been suggested that women of reproductive age should limit their intake of dietary sources (e.g., liver) containing high concentrations of vitamin A; beta-carotene, a precursor of vitamin A, has not been shown to be teratogenic and may be considered as a source of vitamin A supplementation in such women.
Dosages exceeding the RDA may be necessary in women of childbearing age with vitamin A deficiency. There is some evidence suggesting that dosages up to 10,000 units daily or up to 25,000 units weekly may be used safely in women of childbearing age (13-49 years of age), and such dosages are recommended in those with active xerophthalmia. Even higher dosages may be necessary if active corneal lesions are present.
(See Vitamin A Deficiency under Dosage and Administration: Dosage.) Vitamin E has not been shown to be teratogenic. There is no evidence that vitamin E requirements in pregnant women differ from women who are not pregnant. (See Dosage: Dietary and Replacement Requirements, under Dosage and Administration.)
Vitamin A is distributed into milk. Unless the maternal diet is inadequate, infants can usually obtain sufficient vitamin A from nursing, at least for the first 6 months of life. The effect of large maternal dosages of vitamin A on nursing infants is not known. For information on the currently recommended RDAs of vitamin A for pregnant and lactating women, see Dietary and Replacement Requirements, under Dosage and Administration: Dosage.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for E-400 C-500 AND BETA CAROTENE (beta-carotene(vit a) with vitamins c and e)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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