Dosage/Direction for Use
Oral Vitamin K deficiency bleeding in neonates Child: As prophylaxis: 1-2 mg at birth, followed by 2 mg at 4-7 days of age, and a further 2 mg after 1 month of birth. Oral Over-anticoagulation Adult: 2.5-25 mg. Frequency and amount of subsequent doses are given according to prothrombin time (PT) response or clinical condition. Elderly: Initiate at the lower end of dosing range. Parenteral Over-anticoagulation Adult: For severe cases: 5-10 mg as SC or slow IV inj over at least 30 seconds with PCC or FFP. Max: 40 mg in 24 hours. For patients with INR between 5-9: 0.5-1.0 mg IV. For patients with INR >9: 1.0 mg IV. For purposes of reversal prior to surgery: 5 mg IV. Child: For partial reversal: >13 kg: 0.03 mg/kg via IV inj. For complete reversal: >1.6 kg: 0.25-0.30 mg/kg via IV inj. Elderly: Initiate at the lower end of the dosing range. Incompatibility: Precipitation may occur with Na chloride solution. Parenteral Vitamin K deficiency bleeding in neonates Child: As prophylaxis: For healthy neonates: 1 mg via IM inj at birth. For preterm neonates: <2.5 kg: 0.4 mg/kg via IM or IV inj; ≥2.5 kg: 1 mg via IM or IV inj. Dose is given soon after birth. The amount and frequency of further doses are based on coagulation status. As treatment: Initially, 1 mg via SC/IM/IV with or without prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). Incompatibility: Precipitation may occur with Na chloride solution. |
Administration
May be taken with or without food.
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Contraindications
Hypersensitivity.
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Special Precautions
Patient with mechanical heart valves. Hepatic impairment. Elderly. Children. Pregnancy and lactation. Monitoring Parameters Regularly monitor PT, INR and vitamin K dependent clotting factors; hypersensitivity reactions.
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Adverse Reactions
Cardiac disorders: Dyspnoea.
Gastrointestinal disorders: Taste disturbance.
Injury, poisoning and procedural complications: Irritation, phlebitis, schleroderma-like lesions; erythematous, indurated, and pruritic plaques (repeated inj).
Investigations: Rapid or weak pulse.
Nervous system disorders: Dizziness.
Skin and subcutaneous tissue disorders: Sweating.
Vascular disorders: Hypotension, cyanosis, flushing.
Potentially Fatal: Rarely, anaphylactoid reactions (IM/IV). |
Drug Interactions
Antagonises the effect of coumarin anticoagulants.
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Action
Phytomenadione (vitamin K1), a naturally occurring compound, promotes hepatic synthesis of clotting factors (II, VII, IX, X) and of coagulation inhibitors (protein C and S). It is used to prevent and treat haemorrhages related to vitamin K deficiency.
Absorption: Absorbed from the gastrointestinal tract in the presence of bile salts. Readily absorbed via IM inj. Distribution: Accumulates in the liver and stored in the body for short periods of time. Plasma protein binding: Up to 90%, to lipoproteins. Metabolism: Rapidly metabolised in the liver into polar metabolites (e.g. phytomenadione-2,3-epoxide). Excretion: Via urine and faeces (as glucuronide and sulfate conjugates). Plasma elimination half-life: 2-3 hours. |
Storage
Oral: Store between 20-25°C. Protect from light. Parenteral: Store between 20-25°C. Protect from light.
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CIMS Class
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ATC Classification
B02BA01 - phytomenadione ; Belongs to the class of vitamin K. Used in the treatment of hemorrhage.
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