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Aquasol E

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

Medically reviewed on January 1, 2018

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

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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* 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 2018, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, 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.

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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. http://www.ncbi.nlm.nih.gov/pubmed/3975131?dopt=AbstractPlus

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. http://www.ncbi.nlm.nih.gov/pubmed/3930760?dopt=AbstractPlus

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. http://www.ncbi.nlm.nih.gov/pubmed/6423951?dopt=AbstractPlus

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