Vitamin E

Pharmacologic Category

Vitamin, Fat Soluble

Dosing: Adult

Vitamin E may be expressed as alpha-tocopherol equivalents (ATE), which refer to the biologically-active (R) stereoisomer content.

Dietary supplement: Oral:

Capsule, tablet: Varies by product. Dosages range from 100 to 400 units/day

Aqueous Oral Drops: 30 units/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Cholestasis, chronic; supplementation: Oral:

Infants: 20 to 50 units/kg/day; in the trials, a water soluble formulation was used (Corkins 2010; Sokol 1993)

Biliary atresia, post-hepatoportoenterostomy (HPE): Initial: 100 units/day using AquaADEK (2 mL); titrate dose based upon serum concentrations in 25 units/kg/day increments up to 100 units/kg/day to target alpha-tocopherol serum concentration range: 3.8 to 20.3 mcg/mL, vitamin E: Total serum lipids ratio of 0.6 mg/g; patients with a total bilirubin <2 mg/dL may require lower doses (Schneider 2012)

Children: 1 unit/kg/day; a water soluble formulation is preferred (Kliegman 2011)

Deficiency, vitamin E: Oral: Treatment (associated with malabsorption): Children: 1 unit/kg/day; adjust dose based on serum concentrations; a water soluble formulation is preferred (Kliegman 2016)

Cystic fibrosis supplementation (Borowitz 2002): Oral:

1 to 12 months: 40 to 50 units/day

1 to 3 years: 80 to 150 units/day

4 to 8 years: 100 to 200 units/day

>8 years: 200 to 400 units/day

Dietary supplement/deficiency, prevention: Aqueous Oral Drops (50 units/mL): Oral:

Infants: 5 units daily (0.1 mL)

Children <4 years: 10 units daily (0.2 mL)

Children ≥4 years and Adolescents: 30 units daily (0.6 mL)

Use: Labeled Indications

Dietary supplement

Note: According to the 2014 USPSTF recommendations for the primary prevention of cardiovascular disease and cancer, the use of vitamin E supplements are not recommended (Moyer 2014).

Use: Unsupported: Adult

Alzheimer disease

Data from a randomized, double-blind, placebo-controlled, parallel-group trial using high-dose vitamin E demonstrated some delay in clinical progression of Alzheimer disease (Dysken 2014); however, doses this high are not recommended because of a possible association with increased mortality. (AAGP [Lyketsos 2006])

According to European Federation of Neurological Societies (EFNS) guidelines for the diagnosis and management of Alzheimer disease, vitamin E should not be used as treatment for Alzheimer disease. (EFNS [Hort 2010]) In a guideline watch from the American Psychiatric Association (APA), the authors concluded that there was not enough evidence to revise the 2007 guideline statement that alternative agents such as vitamin E are not generally recommended because of uncertain efficacy and safety. (APA [Rabins 2014]) American Academy of Neurology (AAN) guidelines state that vitamin E can be considered to slow progression of Alzheimer disease but should not be used concurrently with selegiline because there is no additive benefit. (AAN [Doody 2001]) In a position statement, the American Association for Geriatric Psychiatry (AAGP) states that vitamin E can still be considered an option for the treatment of Alzheimer disease, but that dosages should not exceed 400 units daily. (AAGP [Lyketsos 2006]) Access Full Off-Label Monograph

Postherpetic neuralgia

Use of vitamin E for treatment of PHN has only been studied in case series that showed inconsistent results. American Academy of Neurology clinical practice guidelines state that vitamin E is of no benefit in patients with PHN (level B, class II). Access Full Off-Label Monograph

Prevention of cardiovascular disease

The majority of studies show that supplemental vitamin E has no beneficial effect on reducing cardiovascular risk and therefore cannot be recommended for routine use in the primary and secondary prevention of cardiovascular disease.

Administration: Oral

Swallow capsules whole; do not crush or chew.

Administration: Pediatric

Oral: May administer with or without food. Swallow capsules whole; do not crush or chew.

Dietary Considerations

Adequate intake (AI) (IOM 2000):

1 to 6 months: 4 mg

7 to 12 months: 5 mg

Recommended daily allowance (RDA) (IOM 2000):

1 to 3 years: 6 mg; upper limit of intake should not exceed 200 mg/day

4 to 8 years: 7 mg; upper limit of intake should not exceed 300 mg/day

9 to 13 years: 11 mg; upper limit of intake should not exceed 600 mg/day

14 to 18 years: 15 mg; upper limit of intake should not exceed 800 mg/day

>18 years: 15 mg; upper limit of intake should not exceed 1,000 mg/day

Pregnant female:

≤18 years: 15 mg; upper level of intake should not exceed 800 mg/day

19 to 50 years: 15 mg; upper level of intake should not exceed 1,000 mg/day

Lactating female:

≤18 years: 19 mg; upper level of intake should not exceed 800 mg/day

19 to 50 years: 19 mg; upper level of intake should not exceed 1,000 mg/day

Storage/Stability

Protect from light.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• Vitamins are needed for growth and good health.

Frequently reported side effects of this drug

• Asthenia

• Dyspepsia

• Diarrhea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Ecchymosis

• Hemorrhaging

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Contraindications

Hypersensitivity to vitamin E or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Vitamin K deficiency: May induce vitamin K deficiency (Corkins 2010).

Special populations:

• Low birth weight infants: Necrotizing enterocolitis has been associated with oral administration of large dosages (eg, >200 units/day) of a hyperosmolar vitamin E preparation in low birth weight infants.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Geriatric Considerations

Elderly may have vitamin E prescribed for those with cardiovascular disease. Elderly should be advised not to take more than prescribed.

Warnings: Additional Pediatric Considerations

Excessive intake of vitamin E may be associated with adverse effects, including hemorrhagic effects; use caution when total daily intake from all sources exceeds the recommended age-based daily upper limit: 1 to 3 years: 200 mg; 4 to 8 years: 300 mg; 9 to 13 years: 600 mg; 14 to 18 years: 800 mg; ≥19 years: 1,000 mg; monitor serum concentrations (IOM 2000).

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Pregnancy Considerations

Vitamin E crosses the placenta. Maternal serum concentrations of α tocopherol increase with lipid concentrations as pregnancy progresses; however, placental transfer remains constant. Additional supplementation is not needed in pregnant women without deficiency (IOM 2000).

Breast-Feeding Considerations

Vitamin E is found in breast milk; concentrations decrease over time and are highest immediately postpartum. Breast milk concentrations may be affected by maternal intake; however, additional supplementation is not needed in nursing women (IOM 2000).

Briggs' Drugs in Pregnancy & Lactation

• Vitamin E

Adverse Reactions

There are no adverse reactions listed in the manufacturer’s labeling.

Toxicology

• Vitamin E (Systemic)

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Vitamin E (Systemic) may enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Anticoagulants: Vitamin E (Systemic) may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

CycloSPORINE (Systemic): Vitamin E (Systemic) may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

Ibrutinib: Vitamin E (Systemic) may enhance the antiplatelet effect of Ibrutinib. Risk C: Monitor therapy

Orlistat: May decrease the serum concentration of Vitamins (Fat Soluble). Management: Administer oral fat soluble vitamins at least 2 hours before or after the administration of orlistat. Similar precautions do not apply to parenterally administered fat soluble vitamins. Risk D: Consider therapy modification

Selumetinib: May enhance the adverse/toxic effect of Vitamin E (Systemic). Management: If selumetinib is combined with additional vitamin E supplements, ensure that the total daily intake of vitamin E (including the amount of vitamin E in selumetinib and the supplement) does not exceed the recommended or safe limits. Risk D: Consider therapy modification

Tipranavir: May enhance the adverse/toxic effect of Vitamin E (Systemic). Management: Patients taking tipranavir oral solution are advised to avoid taking additional vitamin E, beyond the amounts contained in a multivitamin product. This interaction does not apply to tipranavir capsules. Risk D: Consider therapy modification

Monitoring Parameters

Plasma tocopherol concentrations

Reference Range

Therapeutic: 0.8 to 1.5 mg/dL (SI: 19 to 35 micromole/L), some method variation

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Alph-E: 400 units

Alph-E-Mixed 1000: 1000 units

Alph-E-Mixed: 200 units

Alph-E-Mixed: 400 units [corn free, milk free, sugar free, wheat free, yeast free]

Formula E 400: 400 units

Vita-Plus E: 400 units [DSC]

Generic: 100 units, 400 units, 1000 units, 200 units

Capsule, Oral [preservative free]:

E-400: 400 units [DSC] [corn free, gluten free, milk derivatives/products, no artificial color(s), no artificial flavor(s), sodium free, soy free, starch free, sugar free, yeast free]

E-400-Clear: 400 units [dye free]

E-400-Mixed: 400 units [dye free]

E-Max-1000: 1000 units [dye free]

Generic: 100 units, 400 units

Liquid, Oral:

Nutr-E-Sol: 400 units/15 mL (473 mL) [color free, starch free, sugar free]

Solution, Oral:

Aqueous Vitamin E: 15 units/0.3 mL (30 mL) [anise-butterscotch flavor]

SoluVita E: 50 units/mL (30 mL) [dye free, gluten free, lactose free, sugar free; contains methylparaben, polysorbate 80, propylene glycol, saccharin sodium]

Generic: 15 units/0.3 mL (12 mL, 30 mL)

Tablet, Oral:

E-Pherol: 400 units [DSC]

Natural Vitamin E: 200 units, 400 units [animal products free, gelatin free, gluten free, kosher certified, lactose free, no artificial color(s), no artificial flavor(s), starch free, sugar free, yeast free]

Generic: 100 units, 200 units, 400 units

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Oil, Injection:

Generic: 100 units/mL (10 mL, 30 mL)

Generic Available (US)

May be product dependent

Pricing: US

Capsules (Vitamin E Oral)

100 unit (per each): $0.03

200 unit (per each): $0.04 - $0.08

400 unit (per each): $0.05 - $0.12

1000 unit (per each): $0.10 - $0.18

Liquid (Nutr-E-Sol Oral)

400 unit/15 mL (per mL): $0.08

Solution (SoluVita E Oral)

50 units/mL (per mL): $1.17

Solution (Vitamin E Oral)

15 unit/0.3 mL (per mL): $0.82

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Prevents oxidation of vitamin A and C; protects polyunsaturated fatty acids in membranes from attack by free radicals and protects red blood cells against hemolysis

Pharmacodynamics/Kinetics

Absorption: Depends on presence of bile; reduced in conditions of malabsorption, in low birth weight premature infants, and as dosage increases; water miscible preparations are better absorbed than oil preparations

Distribution: To all body tissues, especially adipose tissue, where it is stored

Metabolism: Hepatic to glucuronides

Excretion: Feces

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

High doses of vitamin E (800 to 1,200 int. units/day) may increase the overall risk of bleeding. Although the mechanism is unknown, it may affect the coagulation cascade and has the potential to enhance the anticoagulant effects of various anticoagulants.

Related Information

• Multivitamin Product Table

Pharmacotherapy Pearls

The 2R-stereoisomeric forms of α-tocopherol are used to define vitamin E intake and RDA. While international units are no longer recognized, many fortified foods and supplements continue to use this term although USP units are now used by the pharmaceutical industry when labeling vitamin E supplements. Both IUs and USP units are based on the same equivalency. The following can be used to convert international units (IU) of vitamin E (and esters) to milligrams α-tocopherol in order to meet recommended daily intake:

Synthetic (eg, all-racemic α-tocopherol):

dl-α-tocopherol:

USP: 1.10 IU / mg; 0.91 mg / IU

Molar: 2.12 μmol / IU

α-tocopherol: 0.45 mg / IU

dl-α-tocopherol acetate:

USP: 1 IU / mg; 1 mg / IU

Molar: 2.12 μmol / IU

α-tocopherol: 0.45 mg / IU

dl-α-tocopherol succinate:

USP: 0.89 IU / mg; 1.12 mg / IU

Molar: 2.12 μmol / IU

α-tocopherol: 0.45 mg / IU

Natural (eg, RRR-α-tocopherol):

d-α-tocopherol:

USP: 1.49 IU / mg; 0.67 mg / IU

Molar: 1.56 μmol / IU

α-tocopherol: 0.67 mg / IU

d-α-tocopherol acetate:

USP: 1.36 IU / mg; 0.74mg / IU

Molar: 1.56 μmol / IU

α-tocopherol: 0.67 mg / IU

d-α-tocopherol succinate:

USP: 1.21 IU / mg; 0.83 mg / IU

Molar: 1.56 μmol / IU

α-tocopherol: 0.67 mg / IU

Historically, vitamin E supplements have been labeled (incorrectly) as d- or dl-α-tocopherol. Synthetic vitamin E compounds are racemic mixtures, and may be designated as all-racemic (all rac-α-tocopherol). The natural form contains the only RRR-α-tocopherol. All of these compounds may be present in fortified foods and multivitamins. Not all stereoisomers are capable of performing physiological functions in humans; therefore, cannot be considered to meet vitamin E requirements.

Index Terms

d-Alpha Tocopherol; dl-Alpha Tocopherol

References

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Vitamin E 200 (vitamin E systemic) [prescribing information]. Woonsocket, RI: CVS Pharmacy, Inc.

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Brand Names: International

Altocaps-400 (AE); Armilla (IT); Auxina E (ES); Best (VE); Bio E (BR); Bio-E (DK, IN, NO, TH); E Natural (EG); E Viton (EG); E-400 (PY); E-Cap (LK); E-Drops (TH); E-Fertoc (MX); E-Tabs (BR); E-vicotrat (GR); E-vimin (SE); E-Viton (QA); Egogyn (CL, CO, PE, PY, VE); Enat (MY, PE, PH, SG, UA); Enervon-E (PH); Ephynal (AE, AR, BR, CH, ES, GB, GR, IN, IT, PK, TR, UY); Epol (VE); Erevit (CZ, SK); Etec (AR, CL, EC, PY); Etocovit (AT); Eugerminol (MX); Eusovit (DE); Eviol (GR); Evion (IN, IT, LK); Evit (CH, UY); Evitol (IL, RU); Evon (TR); Grandpherol (KR); Hijuven (AE); Ixopalet (MX); Livingpherol (KR); Nat E (TH); Natopherol (MY); Naturee (SG); Nuenat (LK); Optovit E (BE); Su Le Kang (CN); Vedrop (AT); Vieta (BR); Zyme (PH)

Last Updated 4/24/20