Professional Drug Information > E-1000 I.U. Softgels

Vitamin E (Systemic)

VA CLASSIFICATION
Primary: VT600

Commonly used brand name(s): Amino-Opti-E; Aquasol E; E-1000 I.U. Softgels; E-200 I.U. Softgels; E-400 I.U. in a Water Soluble Base; E-Complex-600; E-Vitamin Succinate; Liqui-E; Pheryl E; Vita-Plus E; Webber Vitamin E.

Another commonly used name is
alpha tocopherol .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Nutritional supplement (vitamin)—
Note: Vitamin E is a fat-soluble vitamin.



Indications

Accepted

Vitamin E deficiency (prophylaxis and treatment)—Vitamin E (also known as alpha tocopherol) is indicated for prevention and treatment of vitamin E deficiency. For prophylaxis of vitamin E deficiency, dietary improvement, rather than supplementation, is advisable. For treatment of vitamin E deficiency, supplementation is preferred. ^{48} Although dietary vitamin E deficiency usually does not occur, even with inadequate nutrition, it may occur rarely in newborn, premature, or low-birthweight babies fed unfortified formulas ^{{05} {22}} or when transfer from the mother to the fetus is insufficient, and in severe fat malabsorption. ^{{02} {06}}
—Deficiency of vitamin E may lead to peripheral neuropathy, ^{14} decreased proprioception, ophthalmoplegia, and necrotizing myopathy. ^{{07} {09}}
—Recommended intakes may be increased and/or supplementation may be necessary in the following persons or conditions (based on documented vitamin E deficiency):

• Abetalipoproteinemia ^{{06} {09} {18} {24}}


• Acanthocytosis ^{09}


• Gastrectomy


• Hepatic-biliary tract disease—chronic cholestasis, ^{{25} {26} {28}} hepatic cirrhosis, ^{15} biliary atresia, ^{27} obstructive jaundice ^{{05} {15}}


• Infants receiving formula not sufficiently fortified with vitamin E ^{{05} {22}}


• Intestinal diseases—celiac, tropical sprue, regional enteritis ^{10}


• Malabsorption syndromes associated with pancreatic insufficiency—cystic fibrosis ^{{02} {13} {16}}

—In general, vitamin E absorption will be impaired in any condition in which fat malabsorption (steatorrhea) occurs. ^{06}
—Vitamin E supplementation may be necessary in patients receiving total parenteral nutrition (TPN). ^{{07} {23}}
—Recommended intakes for all vitamins and most minerals are increased during pregnancy. Many physicians recommend that pregnant women receive multivitamin and mineral supplements, especially those pregnant women who do not consume an adequate diet and those in high-risk categories (i.e., women carrying more than one fetus, heavy cigarette smokers, and alcohol and drug abusers). ^{20} Taking excessive amounts of a multivitamin and mineral supplement may be harmful to the mother and/or fetus and should be avoided.
—Recommended intakes for all vitamins and most minerals are increased during breast-feeding. ^{02}
—Recommended intakes may be increased by the following medications: Cholestyramine, ^{03} colestipol, ^{04} mineral oil, ^{06} and iron supplements. ^{05}
—Recommended intakes for vitamin E are directly related to amounts of polyunsaturated fatty acids (PUFA) in the diet. ^{02} A high intake of PUFA may increase vitamin E requirements.
—Recommended intakes may be decreased in diets containing selenium, ^{07} sulfur-containing amino acids, or antioxidants. ^{09}

—Routine administration of vitamin E to low-birthweight premature infants is being recommended by some clinicians for prevention of hemolytic anemia ^{02} due to vitamin E deficiency and to reduce the severity of retrolental fibroplasia ^{17} (which may cause blindness) and bronchopulmonary dysplasia due to oxygen toxicity. ^{09} However, benefits of routine prophylactic use have not been conclusively proven, and there are significant potential risks, such as necrotizing enterocolitis, ^{11} associated with its use. Further study is necessary.

Acceptance not established
There are insufficient data to show that vitamin E may prevent the occurrence of certain types of cancer. ^{41}

Unaccepted
Although a large number of unsubstantiated claims for vitamin E have been made, it has not been proven effective for treatment of beta-thalassemia, cancer, ^{38} fibrocystic disease of the breast, ^{08} inflammatory skin disorders, ^{{05} {06}} loss of hair, habitual abortion, ^{{06} {09} {21}} heart disease, ^{21} intermittent claudication, menopausal syndrome, ^{09} infertility, ^{09} peptic ulcer, sickle cell disease, burns, porphyria, ^{06} neuromuscular disorders, ^{21} thrombophlebitis, impotence, ^{{09} {21}} bee stings, liver spots on the hands, bursitis, diaper rash, lung toxicity from air pollution, or for prevention of arteriosclerosis, ^{06} or deterioration from aging. Vitamin E has also not been shown ^{05} to increase physical endurance or sexual ability.


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Vitamin E is considered an essential nutritional element, although its exact function is unknown. As an antioxidant, in conjunction with dietary selenium, vitamin E protects polyunsaturated fatty acids in membranes and other cellular structures from attack by free radicals ^{{07} {28}} and protects red blood cells against hemolysis. ^{02} Protection against oxygen radical damage appears to be important for the development and maintenance of nerve and muscle function. ^{28} Vitamin E may also act as a cofactor in some enzyme systems.

Absorption:

50 ^{10} to 80% absorbed from gastrointestinal tract (duodenum); requires presence of bile salts, ^{02} dietary fat, and normal pancreatic function ^{02} for efficient absorption.

Protein binding:

Bound to betalipoproteins in blood. ^{09}


Storage

All body tissues, especially fatty tissues ^{02}.

Biotransformation:

Hepatic. ^{09}

Elimination:
    Biliary/renal. ^{09}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented with intake of normal daily recommended amounts. Placental transfer is incomplete; neonates receive 20 to 30% of maternal concentrations. ^{09} Low-birthweight infants may be deficient in vitamin E because of low stores at birth.

Breast-feeding

Vitamin E is distributed into breast milk; ^{{12} {29}} however, problems in humans have not been documented with intake of normal daily recommended amounts. ^{12}

Pediatrics

Problems in pediatrics have not been documented with intake of normal daily recommended amounts. Plasma vitamin E concentrations in newborn infants are about one-third those of adults and are even lower in premature or low-birthweight infants. The Committee on Nutrition of the American Academy of Pediatrics recommends that the full-term infant receive 0.3 U of vitamin E per 100 kilocalories and at least 1 U of vitamin E per gram of linoleic acid; ^{39} it also recommends that formula fed to premature infants provide 0.7 U of vitamin E per 100 kilocalories and at least 1 U of vitamin E per gram of linoleic acid. In addition, it has been suggested that premature infants receive 5 to 25 U of supplemental vitamin E per day because of concerns about the adequacy of its intestinal absorption. ^{31}


Geriatrics


Problems in geriatrics have not been documented with intake of normal daily recommended amounts.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following, depending on the amount present, may also interact with vitamin E supplements.

Anticoagulants, coumarin- or indandione-derivative^{10}    (concurrent use with doses of vitamin E greater than 400 U a day should be avoided to prevent a possible hypoprothrombinemic response ^{{05} {07} {32} {33}})


Cholestyramine or^{03}
Colestipol or^{04}
Mineral oil^{06}{10}    (may interfere with absorption of vitamin E; recommended intakes for vitamin E may be increased in patients receiving these medications)


Iron supplements    (large doses of iron may catalyze the oxidation ^{40} of and possibly increase daily requirements for vitamin E ^{{05} {10}}; observation of individuals receiving both is recommended)


Vitamin A^{02}{06}    (vitamin E may facilitate absorption, hepatic storage, and utilization, and reduce toxicity of vitamin A; excessive doses of vitamin E may deplete vitamin A stores ^{06})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Hypoprothrombinemia due to vitamin K deficiency    (may be aggravated by doses of vitamin E greater than 400 U a day ^{{07} {33}})


Sensitivity to vitamin E


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention only if they continue or are bothersome
With large doses (between 400 and 800 Units per day for prolonged periods)
    
Blurred vision ^{10}{35}
    
diarrhea ^{35}
    
dizziness ^{35}
    
headache ^{10}
    
nausea or stomach cramps ^{10}{34}
    
unusual tiredness or weakness ^{10}{34}


Note: Although data have not been established, very high doses of vitamin E (greater than 800 Units per day for prolonged periods) have been reported to increase bleeding tendencies in vitamin K-deficient patients, ^{34} alter metabolism of thyroid hormones, ^{{34} {36}} impair sexual function, ^{10} and may increase the risk of thrombophlebitis ^{{34} {37}} or thromboembolism in susceptible patients.





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Vitamin E (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Description should include function in the body, signs of deficiency, and unproven uses


Importance of diet
Importance of proper nutrition; supplement may be needed because of inadequate intake

Food sources of vitamin E; effects of processing

Not using vitamins as substitute for balanced diet

Recommended daily intake for vitamin E

Before using this dietary supplement
»   Conditions affecting use, especially:
Sensitivity to vitamin E





Use in children—Premature infants may need additional supplementation


Proper use of this dietary supplement

» Proper dosing
Proper administration of oral solution dosage form: Taking by mouth even though dietary supplement comes in a dropper bottle; may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food
Missed dose: No cause for concern because of length of time necessary for depletion; remembering to take as directed

» Proper storage


General Dosing Information
In spite of the infrequency of vitamin E deficiency, ^{07} combinations of vitamins may contain vitamin E. Many commercial vitamin complexes are available.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. The synthetic form of vitamin E is dl-alpha tocopherol, while the natural form of vitamin E is d-alpha tocopherol. ^{02}

For oral dosage forms only
Water-miscible preparations may be useful for prevention of vitamin E deficiency in individuals with fat malabsorption ^{13}; if bile acid depletion is present, high doses of vitamin E may still be necessary.

Diet/Nutrition
Recommended dietary intakes for vitamin E are defined differently worldwide.



For U.S.:
The Recommended Dietary Allowances (RDAs) for vitamins and minerals are determined by the Food and Nutrition Board of the National Research Council and are intended to provide adequate nutrition in most healthy persons under usual environmental stresses. In addition, a different designation may be used by the FDA for food and dietary supplement labeling purposes, as with Daily Value (DV). DVs replace the previous labeling terminology United States Recommended Daily Allowances (USRDAs). ^{{02} {30} {49}}



For Canada:
Recommended Nutrient Intakes (RNIs) for vitamins, minerals, and protein are determined by Health and Welfare Canada and provide recommended amounts of a specific nutrient while minimizing the risk of chronic diseases. ^{49}

The expression of vitamin E activity has changed from Units to alpha tocopherol equivalents (alpha-TE), with 1 alpha-TE equal to the activity of 1 mg of d-alpha tocopherol, 1.4 mg dl-alpha tocopherol, 1.7 mg dl-alpha tocopheryl acid succinate, 1.1 mg d-alpha tocopheryl acetate, 1.5 mg dl-alpha tocopheryl acetate, or 1.2 mg d-alpha tocopheryl acid succinate ^{40}. One Unit of vitamin E is equal to 1 mg of dl-alpha tocopherol acetate, 0.7 mg of d-alpha tocopherol, 0.9 mg dl-alpha tocopherol, 1.1 mg dl-alpha tocopherol acid succinate, 0.7 mg d-alpha tocopheryl, or 0.8 mg d-alpha tocopheryl acid succinate ^{40}. This change was made to reflect the total activity of all forms of vitamin E. ^{{02} {19}} Most commercially available vitamin E products continue to be labeled in Units.

Daily recommended intakes for vitamin E are generally defined as follows: ^{{02} {49}}

Persons	U.S.		Canada
	mg alpha-TE	Units	mg alpha-TE	Units
Infants and children Birth to 3 years of age	3–6	5–10	3–4	5–6.7
4 to 6 years of age	7	11.7	5	8.3
7 to 10 years of age	7	11.7	6–8	10–13
Adolescent and adult males	10	16.7	6–10	10–16.7
Adolescent and adult females	8	13	5–7	8.3–11.7
Pregnant females	10	16.7	8–9	13–15
Breast-feeding females	11–12	18–20	9–10	15–16.7

These are usually provided by adequate diets.

The best dietary sources of vitamin E include vegetable oils ^{28} (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, ^{28} and green leafy vegetables. ^{02} Foods may lose significant amounts of vitamin E activity during cooking and storage. ^{{07} {28}}



Oral Dosage Forms

Note: Dosages and strengths are expressed in terms of USP Units of vitamin E activity.


VITAMIN E CAPSULES USP

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes: ^{{02} {49}}

Persons	U.S.		Canada
	mg alpha-TE	Units	mg alpha-TE	Units
Adolescent and adult males	10	16.7	6–10	10–16.7
Adolescent and adult females	8	13	5–7	8.3–11.7
Pregnant females	10	16.7	8–9	13–15
Breast-feeding females	11–12	18–20	9–10	15–16.7

Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Usual pediatric dose
Dosage form not appropriate for use in children.

Strength(s) usually available
U.S.—


100 Units (OTC) [Aquasol E (d-alpha tocopheryl acetate)][Generic]


200 Units (OTC) [Amino-Opti-E (d-alpha tocopheryl acid succinate)^{46}] [E-200 I.U. Softgels (d-alpha tocopheryl acetate)^{46}] [E-Vitamin Succinate (d-alpha tocopheryl acid succinate)][Generic]


400 Units (OTC) [Aquasol E (d-alpha tocopheryl acetate)] [E-Vitamin Succinate (d-alpha tocopheryl acid succinate)] [E-400 I.U. in a Water Soluble Base^{46}] [Vita-Plus E (d-alpha tocopheryl acetate)][Generic]


500 Units (OTC)[Generic]^{46}


600 Units (OTC) [E-Complex-600^{46}][Generic]


1000 Units (OTC) [E-1000 I.U. Softgels^{46}][Generic]

Canada—


100 Units (OTC) [Aquasol E (d-alpha tocopheryl acetate)][Generic]


200 Units (OTC)[Generic]


400 Units (OTC)[Generic]


800 Units (OTC)[Generic]


1000 Units (OTC)[Generic]

Note: A water-miscible dosage form is available.
Some strengths of these vitamin E preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light.


VITAMIN E ORAL SOLUTION

Usual adult and adolescent dose
See Vitamin E Capsules USP .

Usual pediatric dose
Deficiency (prophylaxis)
Premature infants receiving formulas high in polyunsaturated fatty acids (PUFA)—Oral, 15 to 25 Units per day, or 7 Units per Liter of formula. ^{07}
Infants with chronic cholestasis—Oral, 15 to 25 Units of a water-miscible preparation per kg of body weight per day. ^{{42} {43}}
Normal birthweight infants—Oral, 5 Units per Liter of formula. ^{07}

Other children—Oral, amount based on normal daily recommended intakes:

Persons	U.S.		Canada
	mg alpha-TE	Units	mg alpha-TE	Units
Infants and children Birth to 3 years of age	3–6	5–10	3–4	5–6.7
4 to 6 years of age	7	11.7	5	8.3
7 to 10 years of age	7	11.7	6–8	10–13

Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Strength(s) usually available
U.S.—


26.6 Units per mL (OTC) [Liqui-E (d-alpha tocopheryl polyethylene glycol 1000 succinate)]


50 Units per mL (OTC) [Aquasol E (dl-alpha tocopheryl acetate)]

Canada—


50 Units per mL (OTC) [Aquasol E (dl-alpha tocopheryl acetate)]


77 Units per mL (OTC) [Webber Vitamin E (d-alpha tocopheryl polyethylene glycol 1000 succinate)]

Note: d-Alpha tocopheryl polyethylene glycol 1000 succinate is a water-miscible form of vitamin E.
Some strengths of these vitamin E preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light. Protect from freezing.


VITAMIN E TABLETS

Usual adult and adolescent dose
See Vitamin E Capsules USP.

Usual pediatric dose
See Vitamin E Oral Solution.

Strength(s) usually available
U.S.—


100 Units (OTC)[Generic]


200 Units (OTC)[Generic]


400 Units (OTC) [Pheryl E (d-alpha tocopheryl acid succinate)][Generic]


500 Units (OTC)[Generic]


800 Units (OTC)[Generic]

Canada—
Not commercially available.

Note: Some strengths of these vitamin E preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light.


VITAMIN E CHEWABLE TABLETS

Usual adult and adolescent dose
See Vitamin E Capsules USP .

Usual pediatric dose
See Vitamin E Oral Solution.

Strength(s) usually available
U.S.—


400 Units (OTC)[Generic]

Canada—
Not commercially available.

Note: The strength of this vitamin E preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light.

Revised: 05/26/1995

References

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2. National Research Council. Recommended Dietary Allowances. 10th ed. Washington DC: National Academy Press, 1989: 99-107.
   

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4. Colestid package insert (Upjohn—US), Rev 9/88, Rec 3/89.
   

5. Paige D, editor. Manual of clinical nutrition. Pleasantville, NJ: Nutrition Publications Inc, 1985: 7.17-7.18.
   

6. AMA-DE. 7th ed. Chicago, IL: American Medical Association, 1990: 2286.
   

7. Wyngaarden J, Smith L, editors. Cecil's textbook of medicine. 18th ed. Philadelphia: W.B. Saunders, 1988: 1238-40.
   

8. Meyer E, Sommers D, Reitz C, Mentis H. Vitamin E and benign breast disease. Surgery 1990; 107(5): 549-51.
   

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13. Sitrin M, Lieberman F, Jensen W, et al. Vitamin E deficiency and neurologic disease in adults with cystic fibrosis. Ann Intern Med 1987; 107: 51-4.
    

14. Traber M, Sokol R, Ringel S, et al. Lack of tocopherol in peripheral nerves of vitamin E-deficient patients with peripheral neuropathy. N Eng J Med 1987; 317(5): 262-5.
    

15. Jeffry G, Muller D, Burroughs A, et al. Vitamin E deficiency and its clinical significance in adults with primary biliary cirrhosis and other forms of chronic liver disease. J Hepatol 1987; 4(3): 307-17.
    

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19. Bieri J, McKenna M. Expressing dietary values for fat-soluble vitamins: changes in concepts and terminology. Am J Clin Nutr 1981; 34: 289-95.
    

20. Committee on Nutritional Status during Pregnancy and Lactation. National Academy of Sciences. Washington, DC: National Academy Press, 1990: 1-23.
    

21. Aquasol E package insert (Rhone-Poulenc Rorer—Canada), 1992 CPS.
    

22. Gross S, Gabriel E. Vitamin E status in preterm infants fed human milk or infant formula. J Pediatr 1985; 106: 635-9.
    

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24. Brin M, Pedley T, Lovelace R, et al. Electrophysiologic features of abetalipoproteinemia: functional consequences of vitamin E deficiency. Neurology 1986: 669-73.
    

25. Sokol R, Guggenheim M, Iannacione S, et al. Improved neurologic function after long-term correction of vitamin E deficiency in children with chronic cholestasis. N Eng J Med 1985; 313: 1580-6.
    

26. Windle M, Miwa L. Vitamin E in children with chronic cholestasis. DICP 1988; 22: 491-2.
    

27. Tazawa Y, Nakagawa M, Yamada M, et al. Serum vitamin E levels in children with corrected biliary atresia. Am J Clin Nutr 1984; 40: 246-50.
    

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30. Food and Drug Administration. Focus on food labeling. FDA Consumer. May, 1993.
    

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33. Corrigan J, Ulfers L. Effect of vitamin E on prothrombin levels in warfarin-induced vitamin K deficiency. Am J Clin Nutr 1981; 34: 1701-5.
    

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35. Roberts H. Perspective on vitamin E as therapy. JAMA 1981; 246(2): 129-31.
    

36. Tsai A, Kelley J, Peng B, Cook N. Study of the effect of megavitamin E supplementation in man. Am J Clin Nutr 1978; 31: 831-7.
    

37. Roberts H. Vitamin E and thrombophlebitis. Lancet 1978; 311: 49.
    

38. London R, Sundaram G, Murphy L, Manimekolai S, Reynolds M, Goldstein P. The effect of vitamin E on mammary dysplasia: a double-blind study. Obstet Gynecol 1985; 65(1): 104-6.
    

39. American Pharmaceutical Association. Handbook of nonprescription drugs. 9th ed. Washington, D.C.: The Association, 1990: 465, 543.
    

40. Panelists' comments, 1993.
    

41. Panel consensus, 1993.
    

42. Panelist comment, 1993.
    

43. Sokol R, Heubi J, Butler-Simon N, McClung H, Lilly J, Silverman A. Treatment of vitamin E deficiency during chronic childhood cholestasis with oral d-tocopheryl polyethylene glycol-1000 succinate. Gastroenterology 1987; 93: 975-85.
    

44. Liqui-E product label (Twinlab—US), Rec 3/93.
    

45. Webber Vitamin E package insert (Ciba-Geigy—Canada), Rev 9/92, Rec 3/93.
    

46. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, July 1991: 5a.
    

47. Red book 1993. Montvale, NJ: Medical Economics Data, 1993: 596.
    

48. Nutrition and Electrolytes Advisory Panel meeting, 1/95.
    

49. Health and Welfare Canada. Nutrition recommendations, the report of the scientific committee. Ottawa Canada: Canadian Government Publishing Centre, 1990: 11-2; 204.
    

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