Phytonadione 5 mg/1
Phytonadione · TABLET · Coupler LLC
Phytonadione is a vitamin K supplement taken by mouth that helps your body form blood clots properly. It is used to treat or prevent bleeding problems caused by vitamin K deficiency or certain medications like blood thinners.
Key Facts
- Brand Name
- Phytonadione
- Generic Name
- Phytonadione
- NDC Code (Product)
67046-1581- Manufacturer
- Coupler LLC
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210189
- Drug Class
- Vitamin K [EPC]; Warfarin Reversal Agent [EPC]
- Marketing Start
- 09/08/2025
Recall History
Bausch Health Companies, Inc.
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Walgreens Infusion Services
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
AVKARE Inc.
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Aidapak Services, LLC
Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,
Bausch Health Companies, Inc.
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Sentara Infusion Services
Lack of sterility assurance
Dr. Reddy's Laboratories, Inc.
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Bausch Health Companies, Inc.
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Phytonadione injectable emulsion, USP is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by Vitamin K deficiency or interference with Vitamin K activity. Phytonadione injectable emulsion is indicated in anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis and therapy of hemorrhagic disease of the newborn; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with phytonadione injectable emulsion metabolism, e.g., salicylates.
Dosage & Administration
DOSAGE AND ADMINISTRATION Whenever possible, phytonadione injectable emulsion, should be given by the subcutaneous route. (See Box Warning .) When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute. Protect from light at all times. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Directions for Dilution Phytonadione injectable emulsion may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free (see WARNINGS ). Other diluents should not be used . When dilutions are indicated, administration should be startedimmediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampule. Prophylaxis of Hemorrhagic Diseas e of the Newborn The American Academy of Pediatrics recommends that phytonadione be given to the newborn. A single intr…
Warnings
WARNINGS Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection has been associated with toxicity in newborns. Data are unavailable on the toxicity of other preservatives in this age group. There is no evidence to suggest that the small amount of benzyl alcohol contained in phytonadione injectable emulsion, USP, when used as recommended, is associated with toxicity. An immediate coagulant effect should not be expected after administration of phytonadione. It takes a minimum of 1 to 2 hours for measurable improvement in the prothrombin time. Whole blood or component therapy may also be necessary if bleeding is severe. Phytonadione will not counteract the anticoagulant action of heparin. When Phytonadione is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Phytonadione is not a clotting agent, but overzealous therapy with phytonadione injectable emulsion may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time sh…
Contraindications
CONTRAINDICATIONS Hypersensitivity to any component of this medication.
Drug Interactions
Drug Interactions Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant, or to use one which acts on a different principle, such as heparin sodium.
Adverse Reactions
ADVERSE REACTIONS Deaths have occurred after intravenous and intramuscular administration. (See Box Warning .) Transient “flushing sensations” and “peculiar” sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis. Pain, swelling, and tenderness at the injection site may occur. The possibility of allergic sensitivity including an anaphylactoid reaction, should be kept in mind. Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. In other cases, these lesions have resembled erythema perstans. Hyperbilirubinemia has been observed in the newborn following administration of phytonadione. This has occurred rarely and primarily with doses above those recommended. (See PRECAUTIONS, Pediatric Use .)
Frequently Asked Questions
What is Phytonadione used for?
Phytonadione is a vitamin K supplement taken by mouth that helps your body form blood clots properly. It is used to treat or prevent bleeding problems caused by vitamin K deficiency or certain medications like blood thinners.
Is Phytonadione a controlled substance?
Phytonadione is not classified as a controlled substance by the DEA.
What is the generic name for Phytonadione?
The generic name for Phytonadione is Phytonadione. There are 4 other brand versions of Phytonadione.
What is the NDC code for Phytonadione 5 mg/1?
The NDC (National Drug Code) for Phytonadione 5 mg/1 is 67046-1581, listed by Coupler LLC.