Phytomenadione


Full Generic Medicine Info
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.
Contraindications
Hypersensitivity.
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.
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.
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.
CIMS Class
Haemostatics
ATC Classification
B02BA01 - phytomenadione ; Belongs to the class of vitamin K. Used in the treatment of hemorrhage.
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