VITAMIN K1 PHYTONADIONE 2 mg/mL
VITAMIN K1, PHYTONADIONE · INJECTION, EMULSION · HF Acquisition Co LLC, DBA HealthFirst
VITAMIN K1 PHYTONADIONE is a injection, emulsion containing vitamin k1, phytonadione at 2 mg/mL, taken intramuscular. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- VITAMIN K1 PHYTONADIONE
- Generic Name
- VITAMIN K1, PHYTONADIONE
- NDC Code (Product)
51662-1537- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA087954
- Drug Class
- Vitamin K [EPC]; Warfarin Reversal Agent [EPC]
- Marketing Start
- 11/01/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS & USAGE Vitamin K1 Injection (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. Vitamin K1 Injection 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 vitamin K metabolism, e.g., salicylates.
Dosage & Administration
DOSAGE & ADMINISTRATION Whenever possible, Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) 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 Vitamin K1 Injection 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 started immediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampul. Prophylaxis of Hemorrhagic Disease of the Newborn The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A sin…
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 Vitamin K1 Injection (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 vitamin K1 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 vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time sho…
Contraindications
CONTRAINDICATIONS Hypersensitivity to any component of this medication.
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 VITAMIN K1 PHYTONADIONE used for?
VITAMIN K1 PHYTONADIONE contains VITAMIN K1, PHYTONADIONE. It is a injection, emulsion taken intramuscular. Consult your doctor for specific uses.
Is VITAMIN K1 PHYTONADIONE a controlled substance?
VITAMIN K1 PHYTONADIONE is not classified as a controlled substance by the DEA.
What is the generic name for VITAMIN K1 PHYTONADIONE?
The generic name for VITAMIN K1 PHYTONADIONE is VITAMIN K1, PHYTONADIONE. There are no other listed brand versions of VITAMIN K1, PHYTONADIONE.
What is the NDC code for VITAMIN K1 PHYTONADIONE 2 mg/mL?
The NDC (National Drug Code) for VITAMIN K1 PHYTONADIONE 2 mg/mL is 51662-1537, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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