Description

Phytomenadione (Vitamin K1) Tablets BP/USP (10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced hematological, critical-care, and cardiovascular-rescue therapeutics. We provide ultra-high-purity, kinetically stabilized Phytomenadione (Vitamin K1) Sugar-Coated / Film-Coated Tablets (10 mg), manufactured in WHO–GMP certified, strictly UV-shielded oral solid dosage facilities. This “Coagulation Factor Synthesizer & Warfarin Antidote” is a massive-volume, highly lucrative export to hematology centers, cardiology clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for the rapid reversal of coumarin-induced anticoagulation and severe Vitamin K deficiency.

Product Overview

This highly advanced formulation contains Phytomenadione (Vitamin K1), a fat-soluble vitamin that serves as the absolute metabolic key for the liver to synthesize the proteins necessary for blood clotting, acting as the ultimate biological “off-switch” for anticoagulant toxicity.

The “Coagulation Catalyst & INR Reversal” Specialist:

• Mechanism 1 (The Coagulation Factor Factory): For blood to clot, the liver must produce specific proteins known as Factors II (Prothrombin), VII, IX, and X. However, these proteins are inactive until they undergo a chemical change called gamma-carboxylation. Phytomenadione is the mandatory co-factor for this enzyme. By flooding the liver with Vitamin K1, the body rapidly converts these inactive precursors into active clotting factors, quickly restoring normal hemostasis and stopping internal bleeding.
• Mechanism 2 (The Warfarin Rescue Antidote): Drugs like Warfarin (coumarins) work by forcefully depleting the body’s supply of active Vitamin K. If a patient takes too much Warfarin, their blood becomes dangerously thin (evidenced by a massive spike in their INR blood test). Administering Phytomenadione physically overcomes this competitive blockade. The oral tablet is the global gold standard for non-emergency INR reversal, gently bringing the blood’s thickness back to a safe level over 24 hours without the extreme risks associated with IV injections.
• The Oral Safety Advantage: Intravenous (IV) Phytomenadione carries a severe Black Box Warning for sudden, fatal anaphylaxis (severe allergic shock). The oral tablet completely bypasses this risk, making it the preferred, highly safe protocol for outpatients and clinics managing elevated INRs without active, life-threatening hemorrhage.

Product Composition & Strength

We supply this product as a Precision-Blended, Opaque Coated Tablet, packed exclusively in highly secure, moisture-resistant, and entirely light-blocking Alu-Alu or Opaque PVC/PVDC blister strips to ensure the absolute chemical stability of the photosensitive vitamin.

*Pack Sizes: 10×10 Blisters or Bottles of 100 (Optimized specifically for high-turnover pharmacy dispensing and cardiology ward stockpiles).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Hematology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

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

• Zero-UV Manufacturing Engineering (CRITICAL COMPLIANCE): Because Vitamin K1 is violently destroyed by standard light, manufacturing cannot occur under normal factory conditions. Our facilities utilize strictly controlled, amber-lit or UV-filtered environmental suites during the granulation, compression, and coating phases. The tablets are then heavily coated with Titanium Dioxide (an opaque “sunscreen”) to lock in the potency until the patient swallows the pill, guaranteeing flawless clinical reversal of anticoagulants.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe coagulation disorders and bleeding risks:

• Anticoagulant-Induced Prothrombin Deficiency: Reversal of excessively elevated INR and prevention/treatment of bleeding caused by coumarin derivatives (e.g., Warfarin, Acenocoumarol).
• Hypoprothrombinemia Secondary to Other Causes: Treatment of Vitamin K deficiency caused by prolonged broad-spectrum antibiotic therapy (which kills Vitamin K-producing gut bacteria), salicylates, or severe malabsorption syndromes (e.g., Celiac disease, cystic fibrosis, obstructive jaundice).
• CRITICAL NOTE: Phytomenadione is entirely ineffective against Heparin or Direct Oral Anticoagulants (DOACs like Rivaroxaban/Apixaban) toxicity. It only reverses Vitamin K antagonists.

Dosage & Administration

Recommended Dosage (Strictly as per Hematologist/Cardiologist Guidelines):

• Warfarin Overdose (Elevated INR without major bleeding): Typically, 2.5 mg to 10 mg is administered orally. The dose is highly dependent on the current INR and the target INR. The INR must be re-checked 24 to 48 hours after oral administration.
• Administration (THE DIETARY FAT RULE): Vitamin K1 is a fat-soluble vitamin. For optimal absorption from the gastrointestinal tract, the tablet MUST be taken with a meal containing some fat. Bile salts are strictly required for its absorption.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Warfarin Resistance (The “Overshoot” Risk): The most common clinical complication of giving too much oral Vitamin K1 is “overshooting” the reversal. If a massive dose (e.g., 20mg+) is given, the patient’s liver becomes saturated, and they may become totally refractory (resistant) to their Warfarin therapy for up to two weeks, putting them at massive risk of developing fatal blood clots (stroke/DVT). Dosing must be conservative and precise.
• Hepatic Impairment: If the patient’s liver is severely diseased or failing (e.g., advanced cirrhosis), supplying Vitamin K1 will not work, because the liver simply lacks the cellular machinery to build the clotting factors regardless of how much vitamin is present. In these cases, fresh frozen plasma (FFP) or prothrombin complex concentrate (PCC) is required.

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 Hospital Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Hematological and Critical-Care Formulations. Whether you are looking for a reliable Government Tender Supplier for cardiology wards in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of WHO-GMP certified products.