Phytomenadione

Registered South African indications:

• Haemorrhage or threatened haemorrhage associated with vitamin K deficiency
• Haemorrhagic disease of the newborn

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Not to administered IM in adults

Cautions

• Pregnancy
• Breastfeeding
• Severe hepatic impairment
• Elderly
• Mechanical heart valves
• Vitamin K is not an antidote to heparin
• Premature babies weighing less than 2.5kg
• Infants with cholestatic disease
• Large doses >40mg/24hrs

Forms avail. in SA and covered in this monograph: inj

Haemorrhage - severe, life-threatening

• IV: 5-10mg infused slowly; repeat if needed; Max: 40mg/24hrs

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Repeat international normalised ratio (INR) 3hrs after administration to determine if dosage needs to be repeated

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Administer with prothrombin complex concentrate or fresh frozen plasma in cases of severe haemorrhage

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See additional prescribing points

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Asymptomatic (warfarin anticoagulation) with or without minor haemorrhage - INR 5-9

• IV: 0.5-1mg infused slowly
• Oral (inj): Initial: 1-5mg, immediately; After 24hrs: 1-2mg if needed

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For oral dosing: administer contents of vial/syringe directly into patient's mouth; wash down with fluid

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Asymptomatic (warfarin anticoagulation) with or without minor haemorrhage - INR >9

• IV: 1mg infused slowly
• Oral (inj): 2.5-5mg immediately; Max: 10mg/24hrs

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For oral dosing: administer contents of vial/syringe directly into patient's mouth; wash down with fluid

Paed. forms avail. in SA and covered in this monograph: inj

Haemorrhage secondary to severe liver disease or vitamin K deficiency - severe, life-threatening

• IV: 30μg/kg infused slowly; Max: 5mg

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See additional prescribing points

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Administer with prothrombin complex concentrate or fresh frozen plasma in cases of severe haemorrhage

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Antidote therapy to anticoagulation with warfarin - INR >8 (no bleeding or minor bleeding)

• IV/IM/SC/oral (inj): 0.5-2mg

Antidote therapy to anticoagulation with warfarin - major bleeding

• IV/IM/SC: 5mg, repeat 6-8hrly if needed
• Oral (inj): 5mg, repeat 12-48hrly if needed

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Frequent monitoring of vitamin K dependent clotting factors is essential in these patients

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The earliest effect seen with phytomenadione is at 4-6hrs; Therefore, consider replacement with coagulation factor concentrates in severe heamorhage

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For oral administration: give injectable solution orally

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Prophylaxis of haemorrhagic disease of the newborn

• IM/IV: Birthweight less than 1500g: 0.5mg at or soon after birth; Birthweight greater than or equal to 1500g: 1mg at or soon after birth

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Oral dose: Poor compliance therefore oral dosing not recommended for this indication

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Treatment of early and late haemorrhagic disease of the newborn

• IV: 1mg as slow IV injection, immediately; Repeat doses based on coagulation status

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May require more immediately effective treatment such as whole blood or blood clotting factors to compensate for severe blood loss and the delayed response to vitamin K

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See additional prescribing points for administration directions

Pregnancy

• Caution
• There is no specific evidence regarding the safety of phytomenadione during pregnancy but, as with most agents, administration during pregnancy should only occur if the benefits outweigh the risks. Phytomenadione is not recommended for pregnant women as prophylaxis of vitamin K deficiency bleeding in the newborn

Breastfeeding

• Caution
• Phytomenadione is excreted into breast milk.  There is no specific evidence regarding the safety of phytomenadione during breastfeeding but, as with most agents, administration during breastfeeding should only occur if the benefits outweigh the risks

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended 
  Dose at lower end of recommended dosage range

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Immune, Blood and Lymphatic System Disorders

• Anaphylactoid reactions

Others

• Local irritation may occur at the injection site 
• Venous irritation
• Phlebitis
• Inflammation
• Atrophy
• Bleeding at the injection site
• Necrosis

• Coumarin anticoagulants
• Anticonvulsants

International normalised ratio (INR)

Administration Directions

Adult

• IV infusion: Dilute with 55ml of 5% dextrose, infuse slowly; Protect from light

Paediatrics

• IV bolus: Inject dose into lower part of infusion set containing 5% dextrose or 0.9% sodium chlroide; Fluid should be running at > 0.7ml/min; Injection rate NOT to exceed 3mg/m²/min or 1mg/min

Severe haemorrhage indication:

• Given the infectious burden we are faced with in South Africa, sepsis/septicaemia often in the face of malnutrition, bleeding is a relatively frequent occurrence. Part of the management of the sepsis has traditionally included the administration of Vit K (Expert practice). However, Vit K administration is not included in the British society for Haematology guidelines on the management of DIC. 
• Severe haemorrhage could be due to numerous causes: anti-coagulation, liver disease, sepsis - which could all result in low Vit K, in which case it would be reasonable to administer Vit K with plasma. However if the severe bleeding is due to a platelet abnormality or Haemophilia A/Haemophilia B etc, then the Vit K would not be beneficial even though the bleeding is severe.
• In practice, doses have been at the discretion of the physician and have ranged from 1mg to 5mg. In patients with significant liver disease oral Vitamin K 5mg daily is usually prescribed.

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• Phytomenadione (synthetic preparation vitamin K1) is not an antidote to heparin

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Injection 2mg/0.2ml - EML  Primary

Injection 10mg/ml - EML Hospital

Vitamin K is essential for the formation of prothrombin, factor VII, IX and  X; and protein C and S. Lack of vitamin K leads to an increased tendency to haemorrhage. Administration of vitamin K can reverse abnormal coagulation status or haemorrhage due to vitamin K deficiency

Injection (per 0.2ml) 2mg

• Konakion MM Paediatric (Roche) originator

Injection (per ml) 10mg

• Konakion MM (Roche) originator