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Aquasol E

Generic Name: Vitamin E
Class: Vitamin E
ATC Class: A11HA03
VA Class: VT600
CAS Number: 1406-18-4

Introduction

Fat-soluble vitamin; an antioxidant.a

Uses for Aquasol E

Dietary Requirements

Adequate intake needed to prevent vitamin E deficiency and peripheral neuropathy associated with vitamin E deficiency.159

Adequate intake of vitamin E usually can be accomplished through consumption of foodstuffs containing fat.159 Vitamin E is principally obtained from vegetable oils, unprocessed cereal grains, nuts, fruits, vegetables, and meats (especially those high in fat).b

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.159

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.159

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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).159

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).146 147 148 149 Not recommended for the treatment of cognitive symptoms of dementia because of limited evidence of efficacy and safety concerns.f (See Mortality under Cautions.)

Cardiovascular Risk Reduction

Current data does not support use of vitamin E supplements to reduce the risk of cardiovascular disease.168 169 171 172

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).164 165

Use in Neonates

Has been used to prevent vitamin E deficiency in premature neonates.108

Pharmacologic doses of vitamin E not recommended for prevention or treatment of retinopathy of prematurity, bronchopulmonary dysplasia, or intraventricular hemorrhage.108

Cancer Risk Reduction

Use of vitamin E alone in conjunction with selenium does not decrease the risk of prostate cancer.175

Current data does not support the use of vitamin E supplements to reduce the risk of cancer.168 169 172

Prophylaxis of Tardive Dyskinesia

Has been used to reduce the risk of tardive dyskinesia associated with use of antipsychotic agents.173

Aquasol E Dosage and Administration

Administration

Usually administered orally; may administer parenterally as a component of a multivitamin injection.a

Oral Administration

Consider water-miscible oral vitamin E preparations for patients with malabsorption syndromes.a

Dosage

Dosage expressed in terms of USP or International Units (IU).a

Adequate Intake (AI) and Recommended Dietary Allowance (RDA) are expressed in mg in terms of the 2R-stereoisomeric forms of α-tocopherol.159

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.159

Infants 7–12 months of age: Recommended AI is 5 mg (0.6 mg/kg) of α-tocopherol daily.159

Children 1–3 years of age: RDA is 6 mg of α-tocopherol daily.159

Children 4–8 years of age: RDA is 7 mg of α-tocopherol daily.159

Children 9–13 years of age: RDA is 11 mg of α-tocopherol daily.159

Children 14–18 years of age: RDA is 15 mg of α-tocopherol daily.159

Vitamin E Deficiency
Oral

1 unit/kg daily (given as a water-miscible preparation) has been used in children with malabsorption syndromes.a

Preterm, low-birthweight neonates weighing <1 kg at birth: 6–12 units/kg daily has been used to prevent vitamin E deficiency.108

Adults

Dietary and Replacement Requirements
Oral

Men and women ≥19 years of age: RDA is 15 mg of α-tocopherol daily.159

Vitamin E Deficiency
Oral

60–75 units daily.a

Macular Degeneration
Oral

400 units in combination with ascorbic acid 500 mg, beta carotene 15 mg, and zinc (as zinc oxide) 80 mg, with copper (as cupric oxide) 2 mg (to prevent anemia) daily has been used.164 165

Tardive Dyskinesia
Oral

400–800 units daily has been recommended.173

Prescribing Limits

Adults

Oral

≥400 units daily generally not recommended.166 (See Mortality under Cautions.)

Special Populations

Pregnant Women

RDA for pregnant women 14–50 years of age is 15 mg of α-tocopherol daily.159

Lactating Women

RDA for lactating women 14–50 years of age is 19 mg of α-tocopherol daily.159

Cautions for Aquasol E

Contraindications

No known contraindications.a

Warnings/Precautions

Warnings

Mortality

Long-term administration (>1 year) of high doses of vitamin E (≥400 units daily) may increase all-cause mortality.166 d

Specific Populations

Pregnancy

Category A.c

Lactation

Distributed into human milk.c

Common Adverse Effects

Usually nontoxic at therapeutic doses.a

Interactions for Aquasol E

Specific Drugs

Drug

Interaction

Comments

Anticoagulants, oral

Risk of hemorrhage with large doses of vitamin Ea

Iron supplements

Vitamin E dosages ≥10 units/kg daily may delay response to iron therapy in children a

Mineral oil

Possible impaired absorption of vitamin Ea

Orlistat

Possible impaired absorption of fat-soluble vitamins, including vitamin E150

Administer orlistat ≥2 hours before or after vitamin E150 152 156 158

Vitamin A

Potential increase in absorption, utilization, and storage of vitamin Aa

Aquasol E Pharmacokinetics

Absorption

Bioavailability

Absorption from the GI tract depends on biliary and pancreatic secretions, micelle formation, uptake into erythrocytes, and chylomicron secretion.a b Not well absorbed; 20–60% absorbed from dietary sources.a Fraction absorbed decreases as dosage increases.a

Distribution

Extent

Readily distributed into all tissues and stored in adipose tissue.a

Crosses the placenta.c Distributed into human milk.c

Secreted from the liver in very-low-density lipoproteins (VLDLs); only the R-stereoisomer of α-tocopherol is secreted by the liver.159

Elimination

Metabolism

Extensively metabolized, principally in the liver, to glucuronides of tocopheronic acid and its γ-lactone.a

Elimination Route

Excreted principally in the feces via biliary excretion; also excreted in urine.a 159

Stability

Storage

Oral

Cool dry place.e

Actions

  • Chain-breaking antioxidant that prevents propagation of free-radical reactions (e.g., lipid peroxidation);159 scavenges peroxyl radicals;159 protects polyunsaturated fatty acids (PUFAs) and other oxygen-sensitive substances such as vitamin A and ascorbic acid from oxidation.a 159

  • Has been suggested that the antioxidant effects of the vitamin may have beneficial effects in delaying the onset or slowing the progress of Alzheimer’s changes.118 146 147 149

  • May enhance immune response in healthy geriatric individuals.142 143 159

Advice to Patients

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a

  • Importance of proper dietary habits, including taking appropriate AI or RDA of vitamin E.a

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Vitamin E

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

oil*

Oral

Capsules, liquid-filled

100 units*

200 units*

400 units*

600 units*

1000 units*

Capsules, water-miscible

100 units*

200 units*

400 units*

Liquid, dye-free

4600 units/5 mL*

Solution, water-miscible

50 units/mL

Solution, aqueous drops

15 units/0.3 mL

Aquasol E Drops (as dl-α-tocopheryl acetate; with propylene glycol)

Hospira

Tablets

100 units*

200 units*

400 units*

500 units*

600 units*

1000 units*

Vitamin E is also commercially available in combination with other vitamins, minerals, protein supplements, and infant formulas.

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. American Academy of Pediatrics Committee on Fetus and Newborn. Vitamin E and the prevention of retinopathy of prematurity. Pediatrics. 1985; 76:315-6. [IDIS 203265] [PubMed 3895151]

101. Lorch V, Murphy MD, Hoersten LR et al. Unusual syndrome among premature infants: association with a new intravenous vitamin E product. Pediatrics. 1985; 75:598-602. [IDIS 196841] [PubMed 3975131]

102. Bove KE, Kosmetatos N, Wedig KE et al. Vasculopathic hepatotoxicity associated with E-Ferol syndrome in low-birth-weight infants. JAMA. 1985; 254:2422-30. [IDIS 205846] [PubMed 3930760]

103. Centers for Disease Control. Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984; 33:198-9. [IDIS 184132] [PubMed 6423951]

104. Butler J, Hutchison M, Sandlin M. Deaths in preterm infants associated with intravenous vitamin E supplement. Am J Hosp Pharm. 1984; 41:1514-6. [PubMed 6475969]

105. Bodenstein CJ. Intravenous vitamin E and deaths in the intensive care unit. Pediatrics. 1984; 73:733. [IDIS 215801] [PubMed 6718133]

106. Phelps DL. E-Ferol: what happened and what now? Pediatrics. 1984; 74:1114-6. Editorial.

107. Lemons JA, Maisels MJ. Vitamin E—how much is too much? Pediatrics. 1985; 76:625-7. Editorial.

108. American Academy of Pediatrics Committee on Nutrition. Pediatric nutrition handbook. 5th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2004:35.

109. Committee on Dietary Allowances, Food and Nutrition Board, National Research Council. Recommended dietary allowances. 9th rev ed. Washington, DC: National Academy of Sciences; 1980:63-9.

110. Finer NN, Peters KL, Hayek Z et al. Vitamin E and necrotizing enterocolitis. Pediatrics. 1984; 73:387-93. [IDIS 182165] [PubMed 6546616]

111. Bhat R. Serum, retinal, choroidal vitreal vitamin E concentrations in human infants. Pediatrics. 1986; 78:866-70. [PubMed 3763301]

112. Conyers RAJ, Bais R, Rofe AM. Oxalosis and the E-Ferol toxicity syndrome. JAMA. 1986; 256:2677-8. [IDIS 222794] [PubMed 3773173]

113. Brown RE, Alade SL, Krouse MA. Polysorbates and renal oxalate crystals in the E-Ferol syndrome. JAMA. 1986; 255:2445. [IDIS 214825] [PubMed 3701955]

114. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986; 77:593-7. [PubMed 3960626]

115. Balistreri WF, Farrel MK, Bove KE. Lessons from the E-Ferol tragedy. Pediatrics. 1986; 78:503-6. [IDIS 220419] [PubMed 3748688]

116. Phelps DL, Rosenbaum AL, Isenberg SJ et al. Tocopherol efficacy and safety for preventing retinopathy of prematurity: a randomized, controlled, double-masked trial. Pediatrics. 1987; 79:489-500. [IDIS 227996] [PubMed 3547300]

117. National Research Council Food and Nutrition Board Subcommittee on the Tenth Edition of the RDAs. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press; 1989:99-107.

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121. Stampfer MJ, Hennekens CH, Manson JE et al. Vitamin E consumption and the risk of coronary disease in women. N Engl J Med. 1993; 328:1444-9. [IDIS 314550] [PubMed 8479463]

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123. Kushi LH, Folsom AR, Prineas RJ et al. Dietary antioxidant vitamins and death from coronary heart disease in postmenopausal women. N Engl J Med. 1996; 334:1156-62. [IDIS 363830] [PubMed 8602181]

124. Stephens NG, Parsons A, Schofield PM et al. Randomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS). Lancet. 1996; 347:781-6. [IDIS 362408] [PubMed 8622332]

125. Hennekens CH. Platelet inhibitors and antioxidant vitamins in cardiovascular disease. Am Heart J. 1994; 128:1333-6. [IDIS 340011] [PubMed 7977015]

126. Mosca L, Rubenfire M, Mandel C et al. Antioxidant nutrient supplementation reduces the susceptibility of low density lipoprotein to oxidation in patients with coronary artery disease. J Am Coll Cardiol. 1997; 30:392-9. [IDIS 390734] [PubMed 9247510]

127. Freedman JE, Farhat JH, Loscalzo J et al. α-Tocopherol inhibits aggregation of human platelets by a protein kinase C-dependent mechanism. Circulation. 1996; 94:2434-40. [PubMed 8921785]

128. Hodis HN, Mack WJ, LaBree L et al. Serial coronary angiographic evidence that antioxidant vitamin intake reduces progression of coronary artery atherosclerosis. JAMA. 1995; 273:1849-54. [IDIS 348149] [PubMed 7776501]

129. Tardif JC, Cote G, Lesperance J et al. Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. N Engl J Med. 1997; 337:365-72. [IDIS 389178] [PubMed 9241125]

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131. Stephens N. Anti-oxidant therapy for ischaemic heart disease: where do we stand? Lancet. 1997; 349:1710-1. Editorial.

132. Rapola JM, Virtamo J, Ripatti S et al. Randomised trial of α-tocopherol and β-carotene supplements on incidence of major coronary events in men with previous myocardial infarction. Lancet. 1997; 349:1715-20. [IDIS 386567] [PubMed 9193380]

133. Greenberg ER. Antioxidant vitamins, cancer, and cardiovascular disease. N Engl J Med. 1996; 334:1189-90. [IDIS 363832] [PubMed 8602188]

134. National Research Council, Committee on Diet and Health, Food and Nutrition Board, Commission on Life Sciences. Diet and health: implications for reducing chronic disease risk. Washington, D.C.: National Academy Press, 1989.

135. The Alpha-tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994; 330:1029-35. [IDIS 328112] [PubMed 8127329]

136. Greenberg ER, Baron JA, Tosteson TD et al. A clinical trial of antioxidant vitamins to prevent colorectal adenoma. N Engl J Med. 1994; 331:141-7. [IDIS 332766] [PubMed 8008027]

137. Hunter DJ, Manson JE, Colditz GA et al. A prospective study of the intake of vitamins C, E, and A and the risk of breast cancer. N Engl J Med. 1993; 329:234-40. [IDIS 317963] [PubMed 8292129]

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140. Hennekens CH, Buring JE, Peto R. Beta carotene, vitamin E, and lung cancer. N Engl J Med. 1994; 331:613-4.

141. Meydani SN, Meydani M, Verdon CP et al. Vitamin E supplementation suppresses prostaglandin E2 synthesis and enhances the immune response of aged mice. Mech Ageing Dev. 1986; 34:191-201. [PubMed 3487685]

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143. Meydani SN, Barklund PM, Liu S et al. Effect of vitamin E supplementation on immune responsiveness of healthy elderly subjects. Am J Clin Nutr. 1990; 52:557-63. [IDIS 302012] [PubMed 2203257]

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147. Drachman DA, Leber P. Treatment of Alzheimer’s disease—searching or a breakthrough, settling for less. N Engl J Med. 1997; 336:1245-7. [IDIS 383383] [PubMed 9110915]

148. Small GW, Rabins PV, Barry PP et al. Diagnosis and treatment of Alzheimer disease and related disorders: consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer’s Association, and the American Geriatric Society. JAMA. 1997; 278:1363-71. [IDIS 393115] [PubMed 9343469]

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155. Zhi J, Melia AT, Koss-Twardy SG et al. The effect of orlistat, an inhibitor of dietary fat absorption, on the pharmacokinetics of β-carotene in healthy volunteers. J Clin Pharmacol. 1996; 36:152-9. [IDIS 364805] [PubMed 8852391]

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a. AHFS drug information 2007. McEvoy GK, ed. Vitamin E. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3645-9.

b. Dietary reference intakes: the essential guide to nutrient requirements. Institute of Medicine of the National Academies. Washington, D.C.: National Academies Press, 2006: 235–43.

c. Vitamin E. In: Briggs GG, Freeman RK, Yaffe SJ, eds. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 7th ed.Philadelphia: Lippincott, Williams & Wilkins; 2005:1735-7.

d. Bjelakovic F, Nikolova D, Gluud LL et al. Mortality in randomized trials of antioxidant supplements for primary or secondary prevention: systematic review and meta-analysis. JAMA. 2007; 297:842-57. [PubMed 17327526]

e. Nature's Bounty 100% natural vitamin E 400 IU, softgels product information. From Walgreen's website. Accessed 24 Mar 2008.

f. American Psychiatric Association. Practice Guideline for the treatment of patients with Alzheimer's disease and other dementias. 2007 Oct. From the American Psychiatric Association website.

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