Description

Phytomenadione (Vitamin K1) Injection

Healthy Inc is a specialized global supplier and exporter of life-saving hemostatic agents and vitamins. We provide high-purity Phytomenadione Injection (1 mg / 10 mg), manufactured in WHO–GMP certified sterile facilities. This “Hemorrhagic Rescue” specialist is a mandatory export to neonatal intensive care units (NICU), trauma centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive antidote for coumarin anticoagulant toxicity and the essential prophylaxis for Hemorrhagic Disease of the Newborn (HDN).

Product Overview

This formulation contains Phytomenadione (also known as Phytonadione or Vitamin K1), a synthetic lipid-soluble vitamin identical to the naturally occurring vitamin K found in green leafy vegetables.

The “Clotting Factor” Specialist:

• Mechanism (The Hepatic Catalyst): Phytomenadione acts as an essential cofactor for the hepatic microsomal enzyme carboxylase. This enzyme converts precursor proteins into active Coagulation Factors II (Prothrombin), VII, IX, and X via gamma-carboxylation of specific glutamic acid residues. Without Vitamin K, these proteins cannot bind calcium or attach to phospholipid surfaces to form blood clots.
• Warfarin Antidote: Coumarin anticoagulants (like Warfarin) work by inhibiting Vitamin K epoxide reductase, depleting active Vitamin K. Administering Phytomenadione directly bypasses this blockade, restoring the liver’s ability to produce functional clotting factors.
• Neonatal Shield: Newborns are naturally deficient in Vitamin K due to poor placental transfer and a sterile gut. A prophylactic injection at birth is the global standard to prevent fatal intracranial and gastrointestinal bleeding (VKDB).

Product Composition & Strength

We supply this product as a Sterile Aqueous Colloidal Solution or Mixed-Micelle Emulsion in glass ampoules.

*Pack Sizes: Tray of 10 Ampoules or 100 Ampoules.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Micellization Technology: Because Vitamin K1 is highly lipophilic (fat-soluble), it cannot be injected directly into the bloodstream without risking an embolism. Our manufacturing utilizes advanced mixed-micelle technology (Lecithin/Glycocholic acid) to solubilize the vitamin safely, minimizing the risk of anaphylaxis associated with older Polyethoxylated castor oil formulations.
• Photodegradation Control: Phytomenadione degrades rapidly upon exposure to sunlight. Our entire filling and sealing process occurs under specialized low-UV lighting to ensure 100% molecular integrity prior to sealing in amber ampoules.

Therapeutic Indications (Human Use)

Indicated for the correction of severe hypoprothrombinemia:

• Neonatal: Prophylaxis and treatment of Vitamin K Deficiency Bleeding (VKDB) / Hemorrhagic Disease of the Newborn.
• Anticoagulant Toxicity: Reversal of excessively prolonged prothrombin time (PT/INR) induced by Coumarin or Indanedione derivatives.
• Malabsorption Syndromes: Hypoprothrombinemia due to obstructive jaundice, biliary fistula, or celiac disease.
• Drug-Induced: Hypoprothrombinemia caused by long-term broad-spectrum antibiotics, salicylates, or sulfonamides.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Route: Subcutaneous (SC), Intramuscular (IM), or Slow Intravenous (IV).
• Neonatal Prophylaxis: 0.5 mg to 1 mg IM administered within 1 hour of birth.
• Warfarin Overdose (Adult): 2.5 mg to 10 mg (up to 25 mg in severe cases). Dose is titrated based on the target INR.
• IV Administration Warning: If IV route is unavoidable, it must be injected very slowly (not exceeding 1 mg per minute).

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Anaphylaxis): Severe, sometimes fatal, anaphylaxis-like reactions (shock, cardiac arrest) have occurred during and immediately after rapid IV or IM injection, even in patients receiving the drug for the first time. The IV route should be restricted to emergencies.
• Heparin Ineffective: Phytomenadione will NOT counteract the anticoagulant action of Heparin.
• Delayed Effect: It takes 1 to 2 hours for the liver to start synthesizing clotting factors. In life-threatening bleeding, Fresh Frozen Plasma (FFP) or Prothrombin Complex Concentrate (PCC) must be given concurrently.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.