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Indanedione anticoagulant (vitamin K antagonist) Pregnancy: Contraindicated in pregnancy. Oral anticoagulant therapy is contraindicated in pregnancy because of possible teratogenicity and the risk of foetal haemorrhage near term; heparin, which does not cross the placenta, is suggested for the first trimester and after 37 weeks, though heparin use in pregnancy is not absolutely safe and specialist guidance should be obtained. Women of child-bearing age should be cautioned about possible complications of pregnancy. Breast-feeding: the drug is distributed into breast milk and infants should not be fed with breast milk from treated mothers. Fertility: no data available.

Phenindione

Brand names: Dindevan

Phenindione is an oral anticoagulant of the indanedione class, used to prevent and treat thromboembolism, generally reserved for patients intolerant of warfarin.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initial loading dose 200 mg, followed on the second day by 100 mg. From the third day the dose must be adjusted according to coagulation tests (prothrombin time reported as INR). A maintenance dose of 50-150 mg/day is satisfactory in most patients.
Route: Oral
Frequency: Once daily, adjusted according to INR
A 'resistant' patient may need 200 mg/day or more; a 'sensitive' patient may need less than 50 mg/day. Concomitant heparin therapy affects INR control tests — heparin should be discontinued at least 6 hours before the first INR control test. Control tests must be undertaken at regular intervals and the dose adjusted according to the results. Monitoring (§4.4): when started using a standard dosing regimen, determine the INR daily or on alternate days in the early days of treatment; once stabilised in the target range the INR can be determined at longer intervals; monitor more frequently in patients at increased risk of over-anticoagulation (e.g. severe hypertension, liver or renal disease) and where adherence may be difficult. Thrombophilia: in patients with protein C deficiency, therapy should be introduced WITHOUT a loading dose (risk of skin necrosis) even if heparin is given; patients with protein S deficiency may also be at risk and therapy should be introduced slowly. Factors that exaggerate the effect and require dose reduction: weight loss, elderly patients, acute illnesses, deficient renal function, decreased dietary vitamin K intake, and certain drugs. Factors that reduce the effect and may require dose increase: weight gain, diarrhoea and vomiting, increased intake of vitamin K, fats or oils, and certain drugs. Review the need for therapy regularly and discontinue when no longer required; issue a patient-held anticoagulant card. Rare cases of calciphylaxis have been reported with vitamin K antagonists — consider stopping treatment if diagnosed. Metabolites often colour the urine pink or orange. Paediatric use: the fetched SPC sections contain no paediatric posology — no paediatric dose is given; verify any paediatric use against a children's formulary and specialist haematology advice. Section 4.5 was not captured in the source bundle; the interactions listed here are drawn from the §4.3 and §4.4 text that was retrieved.

Dose adjustments

Renal

Contraindicated in severe renal disease (§4.3). Deficient renal function may exaggerate the effect and require a reduction of dosage (§4.4). Monitor the INR more frequently in patients with renal disease. No numeric renal dose adjustment is stated in the source.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Haemorrhagic stroke
  • Clinically significant bleeding
  • Within 72 hours of major surgery with risk of severe bleeding
  • Within 48 hours postpartum
  • Pregnancy
  • Lactation — infants should not be fed with breast milk from mothers being treated
  • Drugs where interactions may lead to a significantly increased risk of bleeding
  • Severe renal or hepatic disease, bacterial endocarditis, actual or potential haemorrhagic conditions, or uncontrolled hypertension

Side effects

  • Haemorrhage — the most frequently reported adverse effect of all oral anticoagulants (including cerebral haemorrhage, cerebral subdural haematoma, gastrointestinal and rectal haemorrhage, haematemesis, melaena, haemothorax, epistaxis, haematuria)
  • Hypersensitivity reactions — rash, exanthema, purpura, ecchymosis, alopecia, skin necrosis, exfoliative dermatitis, blue toe syndrome
  • Blood disorders — leucopenia, agranulocytosis, pancytopenia, eosinophilia, leukocytosis, lymphadenopathy, leukaemoid syndrome; decreased haematocrit and haemoglobin
  • Hepatobiliary — hepatitis, jaundice
  • Renal — haematuria, renal damage with tubular necrosis, albuminuria
  • Gastrointestinal — pancreatitis, diarrhoea, nausea, vomiting, dysgeusia; fever also reported
  • All frequencies are reported as 'Not known'. If any of these effects occur, therapy should be stopped immediately and blood, liver and renal function fully investigated.

Interactions

  • Drugs where interactions may lead to a significantly increased risk of bleeding are contraindicated (§4.3, cross-referring to §4.5)
  • Administration of certain drugs may exaggerate the effect and require a reduction of dosage (§4.4)
  • Administration of certain drugs may reduce the effect and may require the dosage to be increased (§4.4)
  • Concomitant heparin affects INR control tests — discontinue heparin at least 6 hours before the first INR control test (§4.2)
  • Concomitant NSAID use is listed as a risk factor for serious haemorrhage (§4.4)
  • Full §4.5 interactions text was not captured in the source bundle — check current prescribing references before co-prescribing

Clinical monograph

How it works

Like coumarins it antagonises vitamin K, inhibiting hepatic synthesis of the vitamin K-dependent clotting factors II, VII, IX and X to produce an anticoagulant effect.

Prescribing in practice

  • Haemorrhage is the principal risk, and dosing must be guided by the INR; the effect is potentiated or reduced by numerous drug and dietary interactions.
  • It can cause hypersensitivity reactions and may colour the urine pink or orange, which is harmless but should be distinguished from haematuria.
  • It is generally used only when warfarin is unsuitable, with dosing titrated to INR per current prescribing references.

Monitoring

Monitor the INR regularly to keep anticoagulation within the target range and review for bleeding and hypersensitivity reactions.

Counselling the patient

  • Warn that the medicine can turn urine pink or orange, which is not dangerous.
  • Advise reporting unusual bleeding or bruising, rash, sore throat or fever, and the importance of regular blood tests.

Evidence & guidelines

Phenindione's role as a reserve oral anticoagulant for warfarin-intolerant patients is established in UK practice and the SPC.

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.