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Vitamin E (Ester Form, Fat-Soluble Vitamin) Pregnancy: Section 4.6: 'There is no evidence of the safety of high doses of vitamin E in pregnancy nor is there evidence from animal work that it is free from hazard, therefore do not use in pregnancy especially in the first trimester. No information is available on excretion in breast milk, therefore it is advisable not to use during lactation.'

Alpha Tocopheryl Acetate

Brand names: Ephynal (acetate form), various supplement preparations

Alpha-tocopheryl acetate is a stable ester form of vitamin E used to prevent and treat vitamin E deficiency and as a vitamin E source in supplements and topical preparations.

Adult dose

Dose: Correction of vitamin E deficiency occurring in malabsorption disorders, adults including the elderly: cystic fibrosis 100-200 mg/day; abetalipoproteinaemia 50-100 mg/kg/day.
Route: Oral (suspension)
Frequency: Daily (the SPC states the doses as mg/day and mg/kg/day and does not specify how the daily amount is divided)
Strength: Vitamin E Suspension 100 mg/ml; each 5 ml contains 500 mg DL-alpha-tocopheryl acetate (SPC section 2). The SPC does not say whether the mg figures in section 4.2 refer to the acetate; they are printed for this suspension. SCOPE: the only licensed indication (section 4.1) is 'the correction of Vitamin E deficiency occurring in malabsorption disorders ie. cystic fibrosis, chronic cholestasis and abetalipoproteinaemia' - this SPC gives no dose for general vitamin E supplementation or any other use, and none is written here. The SPC gives no adult dose for chronic cholestasis. The dose in cystic fibrosis should be adjusted to maintain serum alpha-tocopherol:cholesterol ratio above 5.4 mg/g; serum levels should be monitored at least annually and 3-6 months after a dosage change. Vitamin E blood levels should be measured at regular intervals and doses adjusted accordingly. See section 6.6 of the SPC for dilution instructions before administration (not retrieved in the bundle).

Paediatric dose

Dose: Cystic fibrosis: 50 mg/day for children less than 1 year; 100 mg/day for children 1 year and over. Abetalipoproteinaemia: the adult dosage (50-100 mg/kg/day). Infants with vitamin E deficiency secondary to chronic cholestasis: 150-200 mg/kg/day.
Route: Oral (suspension)
Frequency: Daily
As printed in SPC section 4.2 'Children'. The SPC gives no neonate-specific regimen and no age band for 'infants'. Dose adjustment target and monitoring as for adults (serum alpha-tocopherol:cholesterol ratio above 5.4 mg/g in cystic fibrosis; blood levels at regular intervals in cholestasis). Section 4.4 cautions: a higher incidence of necrotising enterocolitis has been noted in lower-weight premature infants (less than 1.5 kg) treated with vitamin E; the product contains benzoic acid, which may increase jaundice in newborn babies, and propylene glycol; vitamin E above 4.5 mg/kg daily may delay the response to iron therapy in children with iron-deficiency anaemia.

Dose adjustments

Renal

The SPC (section 4.2) states no renal dose adjustment.

Hepatic

The SPC (section 4.2) states no hepatic dose adjustment; chronic cholestasis is a listed indication, with dosing guided by vitamin E blood levels.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known hypersensitivity to Vitamin E (section 4.3)
  • Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (the suspension contains sucrose) (section 4.3)

Side effects

  • Diarrhoea and abdominal pain may occur with doses greater than 1 g daily (section 4.8)
  • Excipient effects (section 4.4): polyoxyl castor oil may cause stomach upsets and diarrhoea; sucrose may be harmful to the teeth; benzoic acid may increase jaundice in newborn babies
  • Increased bleeding tendency reported in vitamin-K deficient patients or those on anticoagulants; increased risk of thrombosis reported in predisposed patients including those taking oestrogens (not confirmed) (section 4.4)
  • Higher incidence of necrotising enterocolitis in lower-weight premature infants (less than 1.5 kg) treated with vitamin E (section 4.4)

Interactions

  • Anticoagulants - vitamin E may increase the risk of haemorrhage; monitor prothrombin time and INR and adjust the anticoagulant dose if necessary (sections 4.4, 4.5)
  • Oestrogens - vitamin E may increase the risk of thrombosis, particularly women taking oestrogen-containing oral contraceptives (sections 4.4, 4.5)
  • Colestyramine - may reduce absorption of vitamin E; monitor serum vitamin E in cholestatic patients and adjust the dose (sections 4.4, 4.5)
  • Iron - excessive doses of vitamin E (>4.5 mg/kg/day) can delay the red blood cell response to iron supplements in severely anaemic infants; high doses should be avoided in infants (sections 4.4, 4.5)

Monitoring

  • Serum alpha-tocopherol:cholesterol ratio above 5.4 mg/g in cystic fibrosis; serum levels at least annually and 3-6 months after a dosage change (section 4.2)
  • Vitamin E blood levels at regular intervals with dose adjustment (section 4.2)
  • Prothrombin time and INR in vitamin-K deficient patients or those on anticoagulants (section 4.4)
  • Serum vitamin E in cholestatic patients on concurrent colestyramine (section 4.4)
  • Iron concentrations closely in children given vitamin E above 4.5 mg/kg daily (section 4.4)

Clinical monograph

How it works

After hydrolysis to free alpha-tocopherol it acts as a lipid-soluble antioxidant, protecting cell membranes from free-radical-mediated oxidative damage.

Prescribing in practice

  • High doses may increase bleeding tendency and can enhance the effect of anticoagulants, so use cautiously alongside antithrombotic therapy.
  • It is the esterified, more stable form intended to deliver vitamin E activity; reserve supplementation for genuine deficiency or malabsorption.
  • Adequate dietary fat and bile are needed for absorption, which is relevant in cholestatic and malabsorptive conditions.

Monitoring

Monitoring is largely clinical according to the deficiency state, with serum vitamin E measurement reserved for suspected significant deficiency or malabsorption.

Counselling the patient

  • Take with food for better absorption.
  • Inform your clinician if you are on blood-thinning treatment.
  • Avoid high-dose self-supplementation without advice.

Evidence & guidelines

Vitamin E preparations are well established for correcting deficiency, with no robust evidence supporting routine high-dose use for disease prevention.

Reference: NICE CKS Vitamin deficiency; NHS Vitamins and minerals guidance; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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