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Water-soluble vitamin K analogue Pregnancy: SPC section 4.6: There is evidence of hazard if menadiol sodium diphosphate is used in human pregnancy. It is known to be associated with a small risk of haemolytic anaemia, hyperbilirubinaemia and kernicterus in the infant if administered to the mother in late pregnancy or during labour. Menadiol sodium diphosphate is therefore contra-indicated during late pregnancy.

Menadiol sodium phosphate

Menadiol sodium phosphate is a water-soluble synthetic analogue of vitamin K used to prevent or treat vitamin K deficiency, particularly where fat malabsorption impairs absorption of the natural fat-soluble vitamin.

Adult dose

Dose: Haemorrhage or threatened haemorrhage associated with a low blood level of prothrombin or factor VII (main indication: obstructive jaundice, before and after surgery): usual therapeutic dose 10-40 mg daily (adults)
Route: Oral (tablets)
Frequency: Daily - the SPC prints a daily dose range only; no split schedule, dosing interval or duration is printed
PRODUCT (SPC section 2): MENADIOL DIPHOSPHATE 10MG TABLETS (PL168530110, Alliance Pharmaceuticals Ltd) - 'Each tablet contains 10mg of Menadiol Diphosphate (as Menadiol Sodium Diphosphate)'; also contains lactose monohydrate 180.26 mg per tablet. NAME NOTE: the page is titled 'Menadiol sodium phosphate'; the SPC names the substance menadiol sodium diphosphate - judged to be the same water-soluble vitamin K analogue under two names (identity judgement, not stated in the SPC). VERBATIM section 4.1 (indications): 'For the treatment of haemorrhage or threatened haemorrhage associated with a low blood level of prothrombin or factor vii. The main indication is obstructive jaundice (before and after surgery).' VERBATIM posology section (headed '4.1 Posology and method of administration' in the PDF text): 'Menadiol Diphosphate 10mg Tablets are for oral administration. Adults Usual therapeutic dose: 10-40mg daily'. The elderly: 'Recommendations for use in the elderly do not differ from those for other adults.' No maximum dose is printed. CHILDREN: the SPC prints only 'If, on the recommendation of a physician, a children's dosage is required, it is suggested that 5-20mg daily be given' with no age band, while section 4.3 contraindicates administration to neonates and infants - no paediatric block is written; use a children's formulary / specialist advice for anyone under 18. Section 4.4: none. Contraindicated in late pregnancy (section 4.6).

Dose adjustments

Renal

No renal dose adjustment is printed in the retrieved SPC sections.

Hepatic

No hepatic dose adjustment is printed in the retrieved SPC sections (obstructive jaundice is the main indication, section 4.1).

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

  • Administration to neonates, infants or to mothers in the pre- and post-natal periods (section 4.3)
  • Late pregnancy - associated with a small risk of haemolytic anaemia, hyperbilirubinaemia and kernicterus in the infant if administered to the mother in late pregnancy or during labour (section 4.6)
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (lactose in the tablet) (section 4.3)

Side effects

  • Haemolysis (especially in the newborn infant) in the presence of erythrocyte glucose-6-phosphate dehydrogenase deficiency or low concentrations of alpha-tocopherol in the blood (section 4.8)
  • Haemolytic anaemia, hyperbilirubinaemia and kernicterus in the infant if given to the mother in late pregnancy or during labour (section 4.6)

Interactions

  • Anticoagulants - large doses of menadiol sodium diphosphate may decrease patient sensitivity to anticoagulants (section 4.5)

Monitoring

  • Haemolysis may occur in glucose-6-phosphate dehydrogenase deficiency or low blood alpha-tocopherol concentrations (section 4.8)
  • Large doses may decrease sensitivity to anticoagulants (section 4.5)

Clinical monograph

How it works

After conversion in the body it supports hepatic gamma-carboxylation of vitamin K-dependent clotting factors (II, VII, IX and X), thereby restoring their coagulant activity.

Prescribing in practice

  • It should be avoided in neonates and infants and in glucose-6-phosphate dehydrogenase deficiency because it can provoke haemolytic anaemia and, in newborns, kernicterus.
  • It is not the agent of choice for reversing the effect of oral vitamin K antagonists such as warfarin.
  • It is particularly suited to vitamin K deficiency arising from fat malabsorption states because of its water solubility.

Monitoring

Monitor the coagulation profile, such as prothrombin time or INR, to assess the response to treatment.

Counselling the patient

  • This medicine replaces vitamin K when your body cannot absorb it properly.
  • Tell your clinician if you have a known red blood cell enzyme deficiency.

Evidence & guidelines

Its use is based on the well-established role of vitamin K in synthesis of clotting factors; prescribe according to current prescribing references.

Reference: 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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