Phytomenadione


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Over-anticoagulation 2.5-25 mg. IV Over-anticoagulation INR between 5-9: 0.5-1.0 mg. INR >9: 1.0 mg. Prior to surgery: 5 mg. SC/IV Severe over-anticoagulation 5-10 mg with PCC or FFP. Max: 40 mg/24 hours.
Dosage Details
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.

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.

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).

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.
Administration
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).
IM/IV/Parenteral/SC: C
MonitoringParameters
Regularly monitor PT, INR and vitamin K dependent clotting factors; hypersensitivity reactions.
Drug Interactions
Antagonises the effect of coumarin anticoagulants.
Action
Description: 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

Chemical Structure Image
Phytomenadione

Source: National Center for Biotechnology Information. PubChem Database. Vitamin K1, CID=5284607, https://pubchem.ncbi.nlm.nih.gov/compound/Vitamin-K1 (accessed on Jan. 22, 2020)

Storage
Store between 20-25°C. Protect from light.
MIMS Class
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.

Disclaimer: This information is independently developed by MIMS based on Phytomenadione from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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