USP-NF Online; PF Online; PF Online (Legacy) Header Navigation. FAQs; USP.org; Contact Us. VITAMIN E - 2013-06-01. Monograph Title. Errata Identifier. Line 1 of Sample: Change 40 mg to: 1.0 g Section. SPECIFIC TESTS/Acidity. Proved products containing Vitamin E TPGS. It is registered as Inactive Ingredient under the name Tocophersolan (UNII: O03S90U1F2). USP: Monograph for Vitamin E TPGS is published in the cur-rent USP-NF. CIR: Expert Panel (US): safe as used in cosmetic formulation. Isochem owns a Type II DMF in the US for Vitamin E TPGS.
Fat-soluble vitamin. Uses for Vitamin A Vitamin A Deficiency Used to treat and prevent symptoms of vitamin A deficiency such as xerophthalmia and night blindness. Used as a dietary supplement to prevent vitamin A deficiency in patients with GI diseases (e.g., malabsorption syndromes) and those with abnormal storage and transport of vitamin A (e.g., abetalipoproteinemia, protein deficiency, diabetes mellitus, hyperthyroidism, fever, liver disease, cystic fibrosis with hepatic involvement). Guidelines from WHO, the United Nations Children's Fund (UNICEF), and the International Vitamin A Consultative Group (IVACG, now the Micronutrient Forum) recommend high-dose vitamin A supplements in the prevention and treatment of severe vitamin A deficiency in certain populations.
In developing countries where vitamin A deficiency is a public health problem, periodic supplementation with high-dose vitamin A (50,000–200,000 units, depending on age) has been recommended in certain high-risk populations (i.e., postpartum women, children), with reduced doses recommended for pregnant women. Such high doses of vitamin A generally are not used in the US except in individuals with vitamin A deficiency. WHO and IVACG consider patients with active xerophthalmia (e.g., night blindness, conjunctival xerosis with Bitot's spots, corneal xerosis, corneal ulceration, keratomalacia) to be in imminent danger of corneal destruction and recommend immediate treatment with high dosages of vitamin A. (See Xerophthalmia under Dosage and Administration.) Children with severe measles have been found to have low serum concentrations of vitamin A; WHO and AAP recommend that vitamin A supplements be given to all children with acute measles, regardless of their country of residence. Dietary Requirements Adequate intake needed to prevent vitamin A deficiency and ocular complications (e.g., xerophthalmia) associated with vitamin A deficiency. Adequate intake of vitamin A usually can be accomplished through consumption of foodstuffs that contain preformed vitamin A (e.g., liver, dairy products, fish) and provitamin A carotenoids (e.g., darkly colored fruits and vegetables).
Adequate intake (AI) established for infants ≤6 months of age based on observed mean vitamin A intake of infants fed principally human milk; AI for infants 7–12 months of age based on the AI for younger infants and the observed mean vitamin A intake from human milk and from solid food. The Estimated Average Requirement (EAR) and Recommended Dietary Allowance (RDA) for children 1–18 years of age based on data in adults. Other Uses Because of the risk of hypervitaminosis A, some clinicians recommend against the use of vitamin A preparations except in vitamin A deficiency and in appropriate preventive situations. Vitamin A Dosage and Administration General. Correct poor dietary habits and consider a multivitamin preparation containing vitamin A in patients with vitamin deficiencies since poor dietary habits often result in concurrent deficiencies.
Risk of irreversible tissue damage from keratomalacia in patients with severe xerophthalmia; therefore, treat immediately. Requirements for vitamin A based on adequate liver stores of vitamin A. Liver storage of vitamin A should be adequate before discontinuing therapy. Administration Administer orally or by IM injection.
Do not administer by IV injection. Oral Administration Oral administration generally preferred over parenteral therapy.
Oral vitamin A capsules containing high strengths (e.g., 50,000 units) no longer commercially available in the US but may be available from various organizations (e.g., UNICEF, the International Dispensary Association IDA) for treatment of deficiencies in developing countries. IM Administration Administer by IM injection when oral administration is not feasible (e.g., anorexia, nausea, vomiting, pre- and postoperative conditions) or when malabsorption syndrome is present. Dosage Available as retinol, vitamin A palmitate, or vitamin A acetate; dosage expressed in terms of retinol (i.e., as retinol equivalents RE or retinol activity equivalents RAE) and in USP units or International Units (IU, units). USP units and International Units are equivalent. One USP vitamin A unit is equivalent to 0.3 mcg of all- trans-retinol; one RE is the specific biologic activity of 1 mcg of all- trans-retinol; one RAE is equal to 1 mcg of all- trans-retinol, 12 mcg of all trans-β-carotene, or 24 mcg of other provitamin A carotenoids. Dosage expressed in 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. Consider the dietary intake of vitamin A when determining the dosage to avoid toxicity.
Pediatric Patients Vitamin A Deficiency Treatment of Deficiency Oral Children 8 years of age: Some manufacturers have recommended a dosage of 100,000 units (30,000 RE) daily for 3 days, followed by 50,000 units (15,000 RE) daily for 2 weeks, then 10,000–20,000 units (3000–6000 RE) daily for 2 months. IM, then Oral Low-birthweight infants: Manufacturer states dosage not established. Infants 8 years of age: 100,000 units IM daily for 3 days, then 50,000 units IM daily for 2 weeks. Follow with 10,000–20,000 units of vitamin A orally daily for 2 months. Xerophthalmia Oral Infants 12 months of age: Initially, 200,000 units daily for 2 days, then 200,000 units at least 2 weeks later (total of 3 doses). Prevention of Deficiency Oral Children living in underdeveloped countries where vitamin A deficiency resulting in keratomalacia and blindness is common: 50,000–200,000 units every 4–6 months have been given.
Consult guidelines from appropriate international organizations (e.g., WHO, IVACG) for additional information. Children with Measles Oral or IM Infants 25,000 units.
Specific Populations Pregnancy Category X. (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Lactation Distributed into milk. Unless the maternal diet is grossly inadequate, infants can usually obtain sufficient vitamin A from nursing; however, the effect of large maternal dosages of vitamin A on nursing infants is not known. Pediatric Use Vitamin A is a well-established and effective treatment of deficiency states in the pediatric population. Polysorbates found in the vitamin A injection have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis) in low birth-weight infants.
Common Adverse Effects Usually nontoxic at therapeutic doses. Interactions for Vitamin A Specific Drugs and Laboratory Tests.
Fat-soluble vitamin; an antioxidant. Uses for Vitamin E Dietary Requirements Adequate intake needed to prevent vitamin E deficiency and peripheral neuropathy associated with vitamin E deficiency. Adequate intake of vitamin E usually can be accomplished through consumption of foodstuffs containing fat. Vitamin E is principally obtained from vegetable oils, unprocessed cereal grains, nuts, fruits, vegetables, and meats (especially those high in fat). Recommended Dietary Allowance (RDA) in adults is based on induced vitamin E deficiency and the correlation between hydrogen peroxide-induced erythrocyte hemolysis and plasma α-tocopherol concentrations. Adequate Intake (AI) established for infants ≤6 months of age is based on observed mean vitamin E intake of infants fed principally human milk; AI for infants 7–12 months of age is based on the AI for younger infants.
Vitamin E Deficiency Treatment of vitamin E deficiency (e.g., patients with genetic abnormalities in α-tocopherol transfer protein, fat malabsorption syndromes, or protein-calorie malnutrition). Alzheimer’s Disease Has been evaluated in a dosage of 2000 units daily for the palliative treatment of moderately severe dementia of the Alzheimer’s type (Alzheimer’s disease, presenile or senile dementia). Not recommended for the treatment of cognitive symptoms of dementia because of limited evidence of efficacy and safety concerns. (See Mortality under Cautions.) Cardiovascular Risk Reduction Current data does not support use of vitamin E supplements to reduce the risk of cardiovascular disease. Macular Degeneration Suggested as a component of high-dose antioxidant supplements with zinc to reduce risk of developing advanced age-related macular degeneration in high-risk patients (i.e., those with intermediate stage age-related macular degeneration or advanced stage macular degeneration in only one eye). Use in Neonates Has been used to prevent vitamin E deficiency in premature neonates.
Pharmacologic doses of vitamin E not recommended for prevention or treatment of retinopathy of prematurity, bronchopulmonary dysplasia, or intraventricular hemorrhage. Cancer Risk Reduction Use of vitamin E alone in conjunction with selenium does not decrease the risk of prostate cancer.
Current data does not support the use of vitamin E supplements to reduce the risk of cancer. Prophylaxis of Tardive Dyskinesia Has been used to reduce the risk of tardive dyskinesia associated with use of antipsychotic agents. Vitamin E Dosage and Administration Administration Usually administered orally; may administer parenterally as a component of a multivitamin injection. Oral Administration Consider water-miscible oral vitamin E preparations for patients with malabsorption syndromes.
Dosage Dosage expressed in terms of USP or International Units (IU). Adequate Intake (AI) and Recommended Dietary Allowance (RDA) are expressed in mg in terms of the 2 R-stereoisomeric forms of α-tocopherol. Pediatric Patients Dietary and Replacement Requirements Oral Infants ≤6 months of age: Recommended AI is 4 mg (0.6 mg/kg) of α-tocopherol daily. Infants 7–12 months of age: Recommended AI is 5 mg (0.6 mg/kg) of α-tocopherol daily.
Children 1–3 years of age: RDA is 6 mg of α-tocopherol daily. Children 4–8 years of age: RDA is 7 mg of α-tocopherol daily.
Children 9–13 years of age: RDA is 11 mg of α-tocopherol daily. Children 14–18 years of age: RDA is 15 mg of α-tocopherol daily. Vitamin E Deficiency Oral 1 unit/kg daily (given as a water-miscible preparation) has been used in children with malabsorption syndromes. Preterm, low-birthweight neonates weighing 1 year) of high doses of vitamin E (≥400 units daily) may increase all-cause mortality. Specific Populations Pregnancy Category A. Lactation Distributed into human milk.
Common Adverse Effects Usually nontoxic at therapeutic doses. Interactions for Vitamin E Specific Drugs.