Phytomenadione: Indication, Dosage, Side Effect, Precaution - MIMS
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| Indications and Dosage OralOver-anticoagulationAdult: 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.OralVitamin K deficiency bleeding in neonatesChild: 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.ParenteralVitamin K deficiency bleeding in neonatesChild: 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).ParenteralOver-anticoagulationAdult: 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.Elderly: Initiate at the lower end of the dosing range.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. |
What are the brands available for Phytomenadione in Malaysia?
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| Administration Phytomenadione May be taken with or without food. |
| Incompatibility IV: Precipitation may occur with Na chloride solution. |
| Contraindications Hypersensitivity. |
| Special Precautions Patient with mechanical heart valves. Hepatic impairment. Elderly. Children. Pregnancy and lactation. |
| 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). |
| Pregnancy Category (US FDA) IM/IV/Parenteral/SC: C |
| Monitoring Parameters Regularly monitor PT, INR and vitamin K dependent clotting factors; hypersensitivity reactions. |
| Drug Interactions Antagonises the effect of coumarin anticoagulants. |
| Action Description: Mechanism of 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.Pharmacokinetics: 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. |
Chemical Structure ![]() |
| Storage Store between 20-25°C. Protect from light. |
| MIMS Class Haemostatics |
| ATC Classification B02BA01 - phytomenadione ; Belongs to the class of vitamin K. Used in the treatment of hemorrhage. |
| References Anon. Phytonadione. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/11/2017. Aquamephyton Injection, Emulsion (Teligent Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/11/2017. Buckingham R (ed). Vitamin K Substances. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/11/2017. Joint Formulary Committee. Phytomenadione. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/11/2017. McEvoy GK, Snow EK, Miller J et al (eds). Phytonadione. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 07/11/2017. Mephyton Tablet (Carilion Materials Management). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/11/2017. |
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