Data from FDA - Curated by Marshall Pearce - Last updated 05 December 2017

Indication(s)

Indications and 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.

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Advisory information

contraindications
Contraindications Hypersensitivity to any component of this medication.
Special warnings and precautions
Precautions 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. Laboratory Tests Prothrombin time should be checked regularly as clinical conditions indicate. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity, mutagenesis or impairment of fertility have not been conducted with Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP). Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with Vitamin K1 Injection. It is also not known whether Vitamin K1 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vitamin K1 Injection should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Vitamin K1 Injection is administered to a nursing woman. Pediatric Use Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of Vitamin K1 Injection. Therefore, the recommended dose should not be exceeded (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
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.)

Usage information

Dosing and administration
Dosage and 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 single intramuscular dose of Vitamin K1 Injection 0.5 to 1 mg within one hour of birth is recommended. Treatment of Hemorrhagic Disease of the Newborn Empiric administration of vitamin K1 should not replace proper laboratory evaluation of the coagulation mechanism. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of vitamin K1 is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder. Vitamin K1 Injection 1 mg should be given either subcutaneously or intramuscularly. Higher doses may be necessary if the mother has been receiving oral anticoagulants. Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however, does not correct the underlying disorder and Vitamin K1 Injection should be given concurrently. Anticoagulant-Induced Prothrombin Deficiency in Adults To correct excessively prolonged prothrombin time caused by oral anticoagulant therapy—2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition (see WARNINGS). If in 6 to 8 hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated. In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated. Hypoprothrombinemia Due to Other Causes in Adults A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained. If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates; antibiotics) is suggested as an alternative to administering concurrent Vitamin K1 Injection. The severity of the coagulation disorder should determine whether the immediate administration of Vitamin K1 Injection is required in addition to discontinuation or reduction of interfering drugs. Image1.jpg

More information

Category Value
Authorisation number ANDA087955
Agency product number A034SE7857
Orphan designation No
Product NDC 52584-158
Date Last Revised 21-09-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1670192
Marketing authorisation holder General Injectables & Vaccines, Inc
Warnings Boxed Warning WARNING — INTRAVENOUS AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.