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Vitamin E (Systemic)

Generic name: vitamin e systemic

Brand names: Aquasol E, E Pherol, Amino-Opti-E, Vita-Plus E Natural, Alpha E, Nutr-E-Sol, E-400 Clear, Centrum Singles-Vitamin E, Aquavite-E, Aqua-E, Aqua Gem-E, E-600, E-Gems, E-Max-1000

Dosage Forms

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

Pharmacology

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

Pharmacokinetics/Pharmacodynamics

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

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).

Contraindications

Hypersensitivity to vitamin E or any component of the formulation

Dosage and Administration

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)

Administration

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

Protect from light.

Drug 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. Monitor therapy

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

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

Ibrutinib: Vitamin E (Systemic) may enhance the antiplatelet effect of Ibrutinib. 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. 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. Consider therapy modification

Adverse Reactions

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

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.

Monitoring Parameters

Plasma tocopherol concentrations

Pregnancy

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).

Patient Education

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.

Source: Wolters Kluwer Health. Last updated February 4, 2020.