Description

Vitamin K1 (Phytomenadione) Injection

Healthy Inc is a specialized global supplier and exporter of essential life-saving antidotes and neonatal therapies. We provide high-purity Vitamin K1 Injection (10 mg/ml & 1 mg/0.5 ml), manufactured in WHO–GMP certified sterile complex-formulation facilities. This “Hepatic Coagulation Cofactor” is a mandatory export to maternity wards, emergency departments, toxicology centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive intervention for Warfarin toxicity and the universal prophylaxis against Hemorrhagic Disease of the Newborn.

Product Overview

This formulation contains Phytomenadione (also known as Phylloquinone or Vitamin K1), a naturally occurring, fat-soluble vitamin essential for blood clotting.

The “Clotting Factor Synthesizer” Specialist:

• Mechanism (Gamma-Carboxylation): Vitamin K1 acts as an essential cofactor for a hepatic enzyme called gamma-glutamyl carboxylase. This enzyme adds a carboxyl group to specific glutamic acid residues on the inactive precursors of Coagulation Factors II (Prothrombin), VII, IX, and X, as well as the anticoagulant Proteins C and S. This carboxylation allows these factors to bind calcium and attach to phospholipid membranes, initiating the blood clotting cascade.
• The Warfarin Antidote: Coumarin-derivative anticoagulants (like Warfarin) work by blocking the recycling of Vitamin K in the liver, leading to a dangerous depletion of active clotting factors. High-dose exogenous Vitamin K1 bypasses this blockade, restoring the liver’s ability to synthesize new clotting factors and reversing severe, life-threatening hemorrhages.
• Neonatal Prophylaxis: Newborns are born with a sterile gut (unable to produce endogenous Vitamin K) and poor placental transfer of the vitamin. A micro-dose injection immediately after birth prevents Vitamin K Deficiency Bleeding (VKDB), a rare but potentially fatal condition causing intracranial hemorrhage.

Product Composition & Strength

We supply this product as a Sterile, Clear, Yellow to Amber Aqueous Dispersion in glass ampoules.

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

• Micellar Solubilization: Phytomenadione is highly viscous and insoluble in water. Our advanced manufacturing utilizes precise solubilizers (such as Cremophor EL or a lecithin/glycocholic acid mixed-micelle system) to create a stable, injectable colloidal dispersion that allows for rapid absorption without precipitation in the bloodstream.
• Photosensitivity Control: Filling and sealing operations are conducted under strict UV-filtered lighting. The amber ampoule acts as a primary barrier, ensuring 100% therapeutic potency against Warfarin toxicity over a 24 to 36-month shelf life.

Therapeutic Indications (Human Use)

Indicated for coagulation disorders caused by Vitamin K deficiency or interference:

• Anticoagulant Toxicity: Overdose of coumarin-type anticoagulants (Warfarin) causing severe bleeding or dangerously prolonged Prothrombin Time (PT/INR).
• Prophylaxis of VKDB: Universal prevention of Hemorrhagic Disease of the Newborn immediately following delivery.
• Hypoprothrombinemia: Due to prolonged broad-spectrum antibiotic therapy, obstructive jaundice, biliary fistulas, or severe malabsorption syndromes (e.g., Celiac disease).

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Route: Subcutaneous (SC), Intramuscular (IM), or Slow Intravenous (IV). (Subcutaneous is highly preferred for adults to avoid anaphylaxis).
• Neonatal Prophylaxis: 0.5 mg to 1 mg IM administered within 1 hour of birth.
• Warfarin Overdose (Severe Bleeding): 5 mg to 10 mg (rarely up to 25 mg) administered via extremely slow IV infusion (not exceeding 1 mg/minute). Often co-administered with Fresh Frozen Plasma (FFP) or Prothrombin Complex Concentrate (PCC) for immediate clotting factor replacement, as Vitamin K takes 6-12 hours to synthesize new factors.
• Mild Elevated INR (No Bleeding): Oral administration is preferred over injection.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Anaphylaxis with IV/IM Use): Severe, potentially fatal hypersensitivity reactions (anaphylaxis, shock, cardiac arrest) have occurred during and immediately after Intravenous and Intramuscular administration, even with proper dilution and slow infusion rates. The IV route should be restricted strictly to life-threatening emergencies where SC administration is not feasible.
• Re-establishment of Anticoagulation: Massive doses of Vitamin K1 will render the patient highly resistant to Warfarin for several days or weeks. If anticoagulation is still required after the bleeding resolves, Heparin must be used.
• Kernicterus Risk: While primarily a risk with synthetic Vitamin K3 (Menadione), extreme overdosage of Vitamin K1 in premature neonates can theoretically increase the risk of hyperbilirubinemia and kernicterus.

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 Critical Care and Neonatal 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.