Phytonadione (Vitamin K1) Injection is a medication used to treat or prevent bleeding in people with low levels of vitamin K. Vitamin K is essential for your blood to clot properly.

Uses

• Prevention and treatment of Vitamin K deficiency bleeding (VKDB) in newborns — newborns are often given a single dose shortly after birth to prevent dangerous bleeding.
• Reversal of bleeding or risk of bleeding due to:
  • Warfarin (Coumadin®) or other coumarin anticoagulant overdose/toxicity
  • Malabsorption disorders causing low vitamin K (such as obstructive jaundice, celiac disease, or cystic fibrosis)
  • Severe liver disease impairing vitamin K absorption

What is it?

• Phytonadione is the synthetic form of Vitamin K1.
• When given by injection, it helps the liver produce the blood clotting factors needed to stop bleeding.

Phytonadione (Vitamin K1) Injection 1 mg/0.5 mL Neonatal Concentration by Cipla USA is the gold standard for preventing Vitamin K Deficiency Bleeding (VKDB) in newborns. Recommended by leading pediatricians and the American Academy of Pediatrics (AAP), this neonatal vitamin K injection provides essential, life-saving protection against internal bleeding in the first weeks of life. Each single-use 0.5 mL dose is pre-measured for precise administration right after birth, ensuring safety and efficacy for hospital neonatal units and maternity care providers.

How is it given?

• Routes:
  • Intramuscularly (IM, into a muscle; common for newborns)
  • Subcutaneously (under the skin)
  • Intravenously (IV, into a vein; used in urgent situations but with caution because of rare severe allergic reactions)
• Dose and frequency: Depends on the age, condition, and reason for use.

How does it work?

• It promotes the production of clotting factors in the liver, helping blood to clot and preventing or treating uncontrolled bleeding.

Brand Names

• Common brand names: Mephyton® (oral), AquaMEPHYTON® (injection)

Benefits

• Essential Newborn Bleeding Protection: Prevents hemorrhagic disease of the newborn (HDN) and Vitamin K Deficiency Bleeding (VKDB).
• Clinically Recommended Neonatal Dose: AAP-endorsed 1 mg/0.5 mL single-use injectable ampule for newborns (IM use).
• Safe, Preservative-Free Formulation: Manufactured to the highest U.S. FDA standards, free from preservatives and additives.
• Easy to Use: Each dose is prefilled and ready for injection—no mixing, measuring, or waste.
• Trusted by Hospitals Nationwide: Cipla USA is a leading provider for labor and delivery, NICU, and maternity settings.
• Convenient 10-Pack: Ensures multiple doses on hand for new arrivals or high-volume facilities.

Product Details

• Active Ingredient: Phytonadione (Vitamin K1) 1 mg per 0.5 mL
• Concentration: 1 mg/0.5 mL (Neonatal)
• Dose/Package: 0.5 mL single-dose ampules, box of 10
• Route of Administration: Intramuscular (IM) injection, typically in the vastus lateralis muscle (thigh)
• Manufacturer: Cipla USA Inc.
• NDC: [Insert applicable NDC here]
• Preservative-Free, Latex-Free
• Storage: Store at room temperature, protect from light.

Indications & Clinical Uses

• Routine Newborn Care: Provides mandatory vitamin K prophylaxis at birth.
• VKDB Prevention: Prevents life-threatening bleeding in the brain, intestines, and other organs.
• Standard of Care in Hospitals: Used for all newborns regardless of delivery method.

Administration Instructions

1. Administer within 1 hour of birth, as recommended by neonatal guidelines.
2. Inject 0.5 mL intramuscularly in the newborn's thigh (vastus lateralis).
3. Monitor the injection site for redness or swelling; rare and mild.

Always follow your facility’s protocols and manufacturer instructions. For healthcare professional use only.

Why Choose Cipla USA Phytonadione (Vitamin K) Neonatal Injection?

• Meets All Current Medical & Hospital Standards
• Precise, Premeasured Dosing for Newborn Safety
• Zero Preservatives for Best Neonatal Outcomes
• Trusted Provider to Hospitals, Birth Centers, and Clinics
• Consistent Supply – 10 Doses Per Box

 

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• Prevent hemorrhagic disease of the newborn
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Safety Information

• Minimal Side Effects: Rare, mild reactions may include slight redness or swelling at injection site.
• Allergen-Free: No latex, preservatives, or harmful additives.
• Contraindications: Hypersensitivity to phytonadione is extremely rare but should be monitored.
• Vital for All Newborns: Do not substitute oral vitamin K for IM injection except under direct pediatric guidance.

Precautions

• IV injection should be given slowly and under medical supervision due to rare risk of severe allergic reactions (anaphylaxis).
• Not used for anticoagulant toxicity from heparin or other non-coumarin anticoagulants.
• Only use under the direction of a healthcare provider.

Buy Phytonadione (Vitamin K1) 1 mg/0.5 mL Neonatal Injection by Cipla USA – Hospital-Standard Newborn Bleeding Protection

Protect your baby from life-threatening bleeding in the crucial first days of life. Trusted by pediatricians and maternity hospitals nationwide.