Label: PHYTONADIONE tablet


Drug Label Information

Updated July 3, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.


    Phytonadione is a vitamin which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.

    Phytonadione is 2-methyl-3-phytyl-1,4-naphthoquinone. Its empirical formula is C 31H 46O 2 and its structural formula is:


    Phytonadione tablets, USP containing 5 mg of phytonadione, USP, is light yellow to yellow colored, round tablets.

    Inactive Ingredients
    Phytonadione tablets USP, 5 mg contains: acacia, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch and talc.


    Phytonadione possess the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). The prothrombin test is sensitive to the levels of three of these four factors – II, VII, and X. Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post-translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gamma-carboxyglutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood.

    Oral phytonadione is adequately absorbed from the gastrointestinal tract only if bile salts are present. After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.

    In normal animals and humans, phytonadione is virtually devoid of pharmacodynamic activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function; that is, to promote the hepatic biosynthesis of vitamin K-dependent clotting factors.

    Phytonadione tablets generally exert their effect within 6 to 10 hours.


    Phytonadione tablets are 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 tablets are indicated in:

    • anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
    • hypoprothrombinemia secondary to antibacterial therapy;
    • hypoprothrombinemia secondary to administration of salicylates;
    • hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed.

    Hypersensitivity to any component of this medication.


    An immediate coagulant effect should not be expected after administration of phytonadione.

    Phytonadione will not counteract the anticoagulant action of heparin.

    When vitamin K 1 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 K 1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.

    Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.



    Vitamin K 1 is fairly rapidly degraded by light; therefore, always protect phytonadione from light. Store phytonadione in closed original carton until contents have been used (see also HOW SUPPLIED, Storage).

    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 or impairment of fertility have not been performed with phytonadione. Phytonadione at concentrations up to 2,000 mcg/plate with or without metabolic activation, was negative in the Ames microbial mutagen test.


    Pregnancy Category C: Animal reproduction studies have not been conducted with phytonadione. It is also not known whether phytonadione can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phytonadione should be given to a pregnant woman only if clearly needed.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established with phytonadione. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin K.

    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 phytonadione is administered to a nursing woman.

    Geriatric Use

    Clinical studies of phytonadione did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


    Severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported following parenteral administration. The majority of these reported events occurred following intravenous administration.

    Transient “flushing sensations” and “peculiar” sensations of taste have been observed with parenteral phytonadione, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.

    Hyperbilirubinemia has been observed in the newborn following administration of parenteral phytonadione. This has occurred rarely and primarily with doses above those recommended.

    To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or


    The intravenous and oral LD 50s in the mouse are approximately 1.17 g/kg and greater than 24.18 g/kg, respectively.


    Phytonadione Tablets
    Summary of Dosage Guidelines
    (See circular text for details)


    Initial Dosage

    Anticoagulant-Induced Prothrombin Deficiency
    (caused by coumarin or indanedione derivatives)

    2.5 mg to 10 mg or up to 25 mg (rarely 50 mg)

    Hypoprothrombinemia due to other causes
    (Antibiotics; Salicylates or other drugs;
    Factors limiting absorption or synthesis)

    2.5 mg to 25 mg or more (rarely up to 50 mg)

    Anticoagulant-Induced Prothrombin Deficiency in Adults
    To correct excessively prolonged prothrombin times 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 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.

    Hypoprothrombinemia Due to Other Causes in Adults
    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 phytonadione tablets. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione tablets is required in addition to discontinuation or reduction of interfering drugs.

    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.

    The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.


    Phytonadione tablets USP, 5 mg are supplied as light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side.
    They are available as follows:
    Unit dose packages of 20 (2 x 10) NDC 60687-381-94

    Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    Always protect phytonadione tablets, USP from light. (see PRECAUTIONS, General).


    American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows:
    (5 mg / 20 UD) NDC 60687-381-94 packaged from NDC 69238-1051

    Distributed by:
    American Health Packaging
    Columbus, OH 43217


  • Package/Label Display Panel – Carton – 5 mg

    5 mg Phytonadione Tablet Carton

    NDC 60687- 381-94

    Tablets, USP

    5 mg

    20 Tablets (2 x 10)                Rx Only

    Each Tablet Contains:
    Phytonadione, USP................................................... 5 mg

    Usual Adult Dosage: See package insert for full
    prescribing information.

    Store at 20° to 25°C (68° to 77°F); excursions permitted
    between 15° to 30°C (59° to 86°F) [see USP Controlled
    Room Temperature].

    Protect from light.

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn
    or broken.

    The drug product contained in this package is from
    NDC # 69238-1051, Amneal Pharmaceuticals LLC.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, Ohio 43217


  • Package/Label Display Panel – Blister – 5 mg

    5 mg Phytonadione Tablet Blister

    Tablet, USP

    5 mg

    phytonadione tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60687-381(NDC:69238-1051)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Coloryellow (Light yellow to yellow) Score2 pieces
    FlavorImprint Code AA;05
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-381-9420 in 1 BOX, UNIT-DOSE06/21/2018
    1NDC:60687-381-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - American Health Packaging (929561009)
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(60687-381)