Active substance
Phytomenadione
- SFDA 7
- US FDA 28
- US price lines 1
- NHS prices 2
- WHO EML 1
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| AMRI-K 10MG/1ML AMPOULES | 10 mg/ml | Solution for injection · Intramuscular use | 5 Ampoule | SAR 13.45 | Generic · Prescription | ALAMRIAH FOR PHARMACEUTICALS INDUSTRIES | Valid |
| Haemokion | 10 mg | Solution for injection/infusion · Intravenous use | 3 Ampoule | SAR 7.75 | Generic · Prescription | Amoun Pharmaceutical Company | Valid |
| KONAKION MM 10MG-ML AMP I.V. | 10 mg | Solution for injection · Intravenous use | 5 Ampoule | SAR 27.95 | NCE · Prescription | CHEPLAPHARM Arzneimittel GmbH | Valid |
| KONAKION MM PAED 2MG-0.2ML AMP | 2 mg | Solution for injection · Intravenous use | 5 Ampoule | SAR 24.55 | NCE · Prescription | CHEPLAPHARM Arzneimittel GmbH | Valid |
| KONAKION AMP 10MG-ML | 10 mg | Solution for injection · Intravenous use | 25 Ampoule | SAR 65.15 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| KONAKION AMP 1MG-0.5ML | 2 mg/ml | Solution · Intravenous use | 25 Ampoule | SAR 52.50 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| KONAKION DROPS 2% | 2 % | Solution · Intravenous use | 1 Dropper Container | SAR 13.15 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE LIVER FAILURE - COAGULOPATHY; ANESTHESIA-SUPPORTIVE AGENTS/ MANAGEMENT OF BLEEDING; DEFICIENCY OF VITAMIN K; DYSPEPSIA; HEREDITARY TYROSINEMIA TYPE 1 - VITAMIN K DEFICIENCY; MATERNAL AND CHILD HEALTHCARE- PERINATAL,INTRAPARTUM AND POSTPARTUM CARE; PEPTIC ULCER; VENOUS THROMBOEMBOLISM DISEASE (VTE)-LIFE-THREATENING BLEEDING DUE TO ANTICOAGULANTS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | INTL MEDICATION | Prescription | 1 Mar 1976 |
| VITAMIN K1 | 1MG/0.5ML | injectable · injection | HOSPIRA | Prescription | 25 Jul 1983 |
| VITAMIN K1 | 10MG/ML | injectable · injection | HOSPIRA | Prescription | 25 Jul 1983 |
| PHYTONADIONE | 5MG | tablet · oral | AMNEAL PHARMS CO | Prescription | 11 May 2018 |
| PHYTONADIONE | 5MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 20 Feb 2019 |
| PHYTONADIONE | 10MG/ML | injectable · injection | DR REDDYS | Prescription | 22 May 2019 |
| PHYTONADIONE | 1MG/0.5ML; 10MG/ML | injectable · injection | CIPLA | Prescription | 22 Apr 2022 |
| PHYTONADIONE | 5MG | tablet · oral | SCIEGEN PHARMS | Prescription | 28 Jul 2023 |
| PHYTONADIONE | 5MG; EQ 36GM BASE/VIAL;EQ 4.5GMBASE/VIAL | tablet · oral | TP ANDA HOLDINGS | Prescription | 12 Oct 2023 |
| PHYTONADIONE | 10MG/ML | injectable · injection | GLAND | Prescription | 10 Dec 2024 |
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | CIPLA | Prescription | 3 Jan 2025 |
| PHYTONADIONE | 10MG/ML | injectable · injection | CAPLIN | Prescription | 17 Apr 2025 |
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | ALEMBIC | Prescription | 8 Sep 2025 |
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | AMNEAL | Prescription | 4 Nov 2025 |
| PHYTONADIONE | 10MG/ML | injectable · injection | SUNNY | Prescription | 9 Jan 2026 |
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | BAXTER HLTHCARE CORP | Prescription | 26 Feb 2026 |
| PHYTONADIONE | 5MG | tablet · oral | NOVAX | Prescription | 26 Feb 2026 |
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | ORBICULAR | Prescription | 13 Mar 2026 |
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | DR REDDYS | Prescription | 15 May 2026 |
| PHYTONADIONE | 10MG/ML | injectable · injection | AMNEAL | Prescription | 1 Jun 2026 |
| PHYTONADIONE | 1MG/0.5ML | injectable · injection | LUPIN | Prescription | 30 Sep 2026 |
| MEPHYTON | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | BAUSCH | Discontinued | 30 Sep 1955 |
| AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | PAI HOLDINGS PHARM | Discontinued | 28 Jun 1960 |
| VITAMIN K1 | 10MG/ML | injectable · injection | HOSPIRA | Discontinued | 25 Jul 1983 |
| PHYTONADIONE | 1MG/0.5ML; 10MG/ML | injectable · injection | CIPLA | Discontinued | 22 Apr 2022 |
3 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PHYTONADIONE 5 MG TABLET | $8.8257 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Phytomenadione 10mg/1ml solution for injection ampoules | £11.49 | 10 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Phytomenadione 2mg/0.2ml solution for injection ampoules | £11.49 | 5 ampoule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 10.2. Medicines affecting coagulation · core
Haemorrhagic disorder due to circulating anticoagulants or coagulation factors inhibitors; Haemorrhagic or haematological disorders of fetus or newborn
Parenteral > General injections > IV: 10 mg per mL in ampoule; 1 mg per mL in ampoule (EMLc); 2 mg per 0.2 mL in ampoule mixed micelle solution; 10 mg per mL in ampoule mixed micelle solution; 1 mg per 0.5 mL in ampoule (EMLc) | Oral > Solid > tablet: 5 mg tablet | Parenteral > General injections > IV: 10 mg per mL in ampoule (EMLc); 1 mg per mL in ampoule (EMLc); 2 mg per 0.2 mL in ampoule mixed micelle solution (EMLc); 10 mg per mL in ampoule mixed micelle solution (EMLc); 1 mg per 0.5 mL in ampoule (EMLc)
Safety signals and safety-related labeling changes
- US FDA 19 Jul 2021 MEPHYTON — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 7 Mar 2018 AQUAMEPHYTON — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.