Phytomenadione Injection (Vitamin K1) IP 1mg per 0.5ml

A sterile, IP-standard Vitamin K1 injection (1mg/0.5ml) indicated for the prevention of Hemorrhagic Disease of the Newborn and the rapid reversal of anticoagulant-induced prothrombin deficiency. It acts as an essential hepatic cofactor to restore normal blood clotting function via intramuscular, subcutaneous, or emergency slow IV administration.

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Phytomenadione Injection IP (Vitamin K1) — 1mg / 0.5ml

Phytomenadione Injection IP is a sterile, clear solution of synthetic Vitamin K1, formulated strictly in accordance with Indian Pharmacopoeia (IP) standards. Each 0.5ml low-volume ampoule delivers a precise 1mg dose of Phytomenadione, a critical procoagulant factor essential for hepatic synthesis of blood clotting factors.

This high-precision pediatric and adult formulation is primary therapy for the immediate prevention and treatment of various coagulation disorders and vitamin K deficiencies.

Core Therapeutic Indications

Prophylaxis & Treatment of HDN: The gold standard for preventing and treating Hemorrhagic Disease of the Newborn (Vitamin K Deficiency Bleeding or VKDB).
Anticoagulant Reversal: Rapidly counteracts hypoprothrombinemia induced by oral anticoagulants (such as Coumarin or Warfarin derivatives).
Malabsorption-Induced Deficiency: Corrects severe Vitamin K deficiencies caused by obstructive jaundice, sprue, ulcerative colitis, or prolonged antibiotic therapy that disrupts gut microbiota.

Mechanism of Action

Phytomenadione is an essential cofactor in the hepatic enzyme system. It drives the post-translational gamma-carboxylation of clotting factors:

Factor II (Prothrombin)
Factor VII (Proconvertin)
Factor IX (Christmas Factor)
Factor X (Stuart-Prower Factor)

By activating these proteins, it restores normal blood coagulation mechanics and stabilizes prothrombin times ( $PT/INR$ ).

Product Specifications

Attribute	Specification
Active Ingredient	Phytomenadione IP (Vitamin K1)
Strength / Concentration	1 mg per 0.5 ml
Dosage Form	Sterile Injection (Aqueous Colloidal Solution)
Route of Administration	Intramuscular (IM) / Subcutaneous (SC) / Slow Intravenous (IV)
Packaging Variant	Light-resistant glass ampoules (0.5ml single-dose)

Storage & Handling Safety

⚠️ CRITICAL LIGHT SENSITIVITY: Phytomenadione degrades rapidly upon exposure to light. Keep ampoules stored inside the original outer carton box until the exact moment of use. Store below 30°C and do not freeze. Do not use if the solution is turbid or shows phase separation.

Important Safety Warning

🚫 WARNING: For clinical and hospital use only. Intravenous administration should be reserved strictly for emergency situations where hypoprothrombinemia presents an immediate life threat. Severe, acute anaphylactoid reactions have been reported during rapid IV infusion. Always administer slowly and under strict medical supervision.