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PHYTONE INJECTION (Each 0.5ml contains Phytomenadore 1mg

Phytomenadore

FDA/SD.265-020102 Phytomenadore 1mg

What it does

Phytomenadione is a form of vitamin K used to treat and prevent bleeding problems.

Commonly used for: bleeding disorders, anticoagulant-related bleeding, certain liver diseases

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.265-020102
Registration date
2026-02-06
Expiry date
2030-06-01
Status
Valid
Active ingredient
Phytomenadore
Dosage form
Phytomenadore
Strength
1mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Fressese Pharmaceuticals
Applicant / LTR
SAMOSPHARMA LTD
Country of origin
INDIA
Manufacturer location
827/6 C.P. Industrial Estate, Rakanpur-Santej Rd, Ta, Kalol, Santej, Gujarat 382722, India

Source: Food and Drugs Authority · fetched 2026-05-08 08:00:19 · updated 2026-10-20 04:00:05

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Phytomenadione is a form of vitamin K used to treat and prevent bleeding problems.

What it treats

  • bleeding disorders
  • anticoagulant-related bleeding
  • certain liver diseases

How it works

Phytomenadione helps your blood to clot properly by providing the vitamin K that is necessary for the clotting process.

Who it's for

It is for individuals who have conditions that affect blood clotting or who are taking medications that prevent blood clots.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: phytomenadore

Phytomenadione, also known as vitamin K1, is a fat-soluble vitamin that plays a crucial role in the synthesis of certain proteins required for blood coagulation and bone metabolism. It is essential for the synthesis of clotting factors II (prothrombin), VII, IX, and X in the liver, which are vital for normal blood coagulation. Phytomenadione is commonly used to treat and prevent vitamin K deficiency and to reverse the effects of anticoagulants such as warfarin.

Indications

  • Vitamin K deficiency
  • Reversal of anticoagulation effects of vitamin K antagonists (e.g., warfarin)
  • Management of coagulopathy in patients with malabsorption syndromes
  • Support in cases of hemorrhagic disease of the newborn

Dosage

Adults: Dosage varies based on indication and severity of deficiency. Refer to clinical guidelines for specific dosing regimens.

Mechanism of action

Phytomenadione acts by facilitating the conversion of vitamin K into its active form, which is necessary for the carboxylation of specific glutamic acid residues on clotting factors. This carboxylation is essential for the proper functioning of these factors in the coagulation cascade. Additionally, it helps in the regulation of calcium binding in proteins associated with blood coagulation and bone metabolism.

Pharmacodynamics

Phytomenadione is involved in the regulation of coagulation by maintaining the levels of clotting factors in the blood. Its action is dose-dependent, with higher doses leading to a more pronounced effect on coagulation. The onset of action for phytomenadione can be observed within a few hours when administered intravenously, while oral administration may take longer, depending on the individual's absorption capabilities and vitamin K levels.

Pharmacokinetics

Phytomenadione is well-absorbed from the gastrointestinal tract when taken orally, with peak plasma concentrations occurring approximately 1 to 2 hours post-dose. It is transported in the bloodstream predominantly bound to lipoproteins. The half-life of phytomenadione is approximately 1.5 to 3 hours, but this can vary based on the individual's metabolic state. The drug is primarily metabolized in the liver and excreted in bile and urine, with biliary excretion being the main route of elimination.

Contra-indications

  • Hypersensitivity to phytomenadione or any of its components
  • Severe liver disease
  • Uncontrolled anticoagulation

Adverse effects

  • Allergic reactions such as rash, itching, or swelling
  • Flushing
  • Dizziness
  • Hypotension
  • Gastrointestinal disturbances like nausea or diarrhea

Interactions

  • Increased effect of anticoagulants (e.g., warfarin) when taken concurrently
  • Antibiotics may alter vitamin K metabolism
  • Cholestyramine and other bile acid sequestrants can reduce vitamin K absorption
  • Antiepileptic drugs may lower vitamin K levels

Precautions

  • Monitor INR levels closely in patients on anticoagulants
  • Assess liver function before administration
  • Caution in patients with a history of hypersensitivity reactions

Pregnancy

Phytomenadione is generally considered safe during pregnancy, but should be used under medical supervision especially in high doses.

Breast-feeding

Phytomenadione is excreted in breast milk, but the amounts are considered insufficient to affect the infant. Use caution and consult a healthcare provider.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Injection solution
  • Oral tablets
  • Oral liquid

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.