Finished product reference
Vitamin K1 (Phytomenadione)
Injection · Parenteral · 10 mg/1mL · 1 mL
- List code
- 1003
- Pharmacologic class
- Fat-soluble vitamin (vitamin K1, phytomenadione); antidote to vitamin K antagonists
What it is and how it works
Phytomenadione is a cofactor for gamma-carboxylation of clotting factors II, VII, IX and X and proteins C and S in the liver, restoring their activity in vitamin K deficiency or after vitamin K antagonist (warfarin-type) therapy.
Indications
Prevention and treatment of vitamin K deficiency bleeding in newborns; reversal of anticoagulation with vitamin K antagonists (such as warfarin) in over-anticoagulation or bleeding; hypoprothrombinaemia due to vitamin K deficiency (malabsorption, obstructive jaundice, prolonged antibiotics).
Dosage and administration (summary)
Newborns: a single prophylactic dose (commonly 1 mg intramuscularly, or an oral regimen) according to national guidance. Warfarin reversal: dose and route (oral or slow intravenous) depend on the INR and the presence of bleeding, according to protocol. Intramuscular injection is avoided in patients being anticoagulated.
Contraindications
Hypersensitivity to phytomenadione or to any excipient.
Warnings and precautions
Severe hypersensitivity or anaphylactoid reactions, sometimes fatal, have occurred with intravenous administration; inject intravenously very slowly. Vitamin K does not counteract heparin. Excessive reversal may cause resistance to subsequent oral anticoagulation.
Pregnancy
Used when clearly indicated; it does not readily cross the placenta.
Storage and supply
Store below 25 °C, protected from light; do not freeze.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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