Phytonadione label

Phytonadione

Phytonadione Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

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 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 that the condition being treated is inherently unresponsive to vitamin K.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Phytonadione 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 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.

History

There is currently no drug history available for this drug.

Other Information

Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.71.

Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H4602; and its structural formula is:

Chemical Structure

Phytonadione Injectable Emulsion, USP, is a yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 3.5 to 7.0. It is available for injection by the intravenous, intramuscular, and subcutaneous route.

Each 0.5 mL contains 1 mg phytonadione (Vitamin K1), 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. The air above the liquid in the individual containers has been displaced by flushing with nitrogen during the filling operation.

Phytonadione Manufacturers

  • Phytonadione | Amphastar Pharmaceuticals, Inc.
    No Recall

    Phytonadione | Amphastar Pharmaceuticals, Inc.

    Phytonadione | Amphastar Pharmaceuticals, Inc.

    Whenever possible, phytonadione should be given by the subcutaneous or intramuscular route. 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 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. 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 vial.

    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 phytonadione 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.

    Phytonadione 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 phytonadione 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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.

    Phytonadione Summary of Dosage Guidelines (See insert text for details) Newborns Dosage Hemorrhagic Disease of the Newborn   Prophylaxis 0.5 - 1 mg IM within 1 hour of birth   Treatment 1 mg SC or IM
    (Higher doses may be necessary if the mother has been receiving oral anti-coagulants) Adults Initial Dosage Anticoagulant - induced Prothrombin
    Deficiency
    (caused by coumarin or indanedione derivatives) 2.5 mg - 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 - 25 mg or more
    (rarely up to 50 mg)
  • Phytonadione | General Injectables & Vaccine, Inc
    No Recall

    Phytonadione | General Injectables & Vaccine, Inc

    Phytonadione | General Injectables & Vaccine, Inc

    Whenever possible, phytonadione should be given by the subcutaneous or intramuscular route. 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 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. 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 vial.

    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 phytonadione 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. Phytonadione 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 phytonadione 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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.
    Phytonadione Summary of Dosage Guidelines (See insert text for details)

    Newborns Dosage Hemorrhagic Disease of the Newborn

    Prophylaxis
    0.5 - 1 mg IM within 1 hour of birth
    Treatment
    1 mg SC or IM
    (Higher doses may be necessary if the mother
    has been receiving oral anti-goagulants)
    Adults Initial Dosage Anticoagulant-induced Prothrombin
    Deficiency
    (caused by coumarin or indanedione derivatives)
    2.5 mg - 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 - 25 mg or more
    (rarely up to 50 mg)

  • General Injectables & Vaccines, Inc
    Phytonadione | General Injectables & Vaccines, Inc
    No Recall

    Phytonadione | General Injectables & Vaccines, Inc

    Phytonadione | General Injectables & Vaccines, Inc

    Whenever possible, phytonadione should be given by the subcuteanous route (see Box WARNING). When intravenous or intramuscular 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 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 vial.

    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 phytonadione 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.

    Phytonadione 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 phytonadione 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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.

  • Phytonadione | Amphastar Pharmaceuticals, Inc.
    No Recall

    Phytonadione | Amphastar Pharmaceuticals, Inc.

    Phytonadione | Amphastar Pharmaceuticals, Inc.

    Whenever possible, phytonadione should be given by the subcutaneous route (see Box WARNING). When intravenous or intramuscular 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 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 vial.

    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 phytonadione 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.

    Phytonadione 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 phytonadione 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.

    Phytonadione Summary of Dosage Guidelines (See insert text for details) Newborns Dosage Hemorrhagic Disease of the Newborn
    Prophylaxis
      Treatment 0.5 – 1 mg IM within 1 hour of birth
    1 mg SC or IM
    (Higher doses may be necessary if the mother has been receiving oral anti-coagulants)   Adults Initial Dosage Anticoagulant - Induced Prothrombin Deficiency
    (caused by coumarin or indanedione derivatives) 2.5 mg – 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 – 25 mg or more (rarely up to 50 mg)

    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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.

  • Phytonadione | International Medication Systems, Limited
    No Recall

    Phytonadione | International Medication Systems, Limited

    Phytonadione | International Medication Systems, Limited

    Whenever possible, phytonadione should be given by the subcutaneous route (see Box WARNING). When intravenous or intramuscular 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 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 vial.
    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 phytonadione 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.
    Phytonadione 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 phytonadione should be given concurrently.


    Anticoagulant-lnduced 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
    berepeated.

                                                                  Phytonadione
                                                    Summary of Dosage Guidelines
                                                        (See insert text for details)

    Newborns  Dosage

    Hemorrhagic Disease of the Newborn
    Prophylaxis

    Treatment

     0.5 - 1 mg IM within 1 hour of birth

     1 mg SC or IM

    (Higher doses may be necessary if

    the mother has been receiving

    oral anti-coagulants)

     Adults  Initial Dosage

    Anticoagulant - Induced

    Prothrombin Deficiency

    (caused by coumarin or

    indanedione derivatives)

    2.5 mg - 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 - 25 mg or 

    more (rarely up to 50 mg)

    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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.

  • General Injectables & Vaccines, Inc
    Phytonadione | General Injectables & Vaccines, Inc
    No Recall

    Phytonadione | General Injectables & Vaccines, Inc

    Phytonadione | General Injectables & Vaccines, Inc

    Whenever possible, phytonadione should be given by the subcutaneous route (see Box WARNING). When intravenous or intramuscular 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 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 vial.

    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 phytonadione 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.

    Phytonadione 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 phytonadione should be given concurrently.

    Anticoagulant-Induced Prothrombin Deficiency in Adults

    To correct excessively prolonged prothrombin time caused by oral anticoagulant thearpy - 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.

    Phytonadione Summary of Dosage Guidelines (See insert text for details)

    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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.

  • Phytonadione | Cardinal Health
    No Recall

    Phytonadione | Cardinal Health

    Phytonadione | Cardinal Health

    Whenever possible, phytonadione should be given by the subcutaneous route (see Box WARNING). When intravenous or intramuscular 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 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 vial.

    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 phytonadione 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.

    Phytonadione 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 phytonadione 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.

    Phytonadione Summary of Dosage Guidelines (See insert text for details) Newborns Dosage Hemorrhagic Disease of the Newborn
    Prophylaxis
      Treatment 0.5 – 1 mg IM within 1 hour of birth
    1 mg SC or IM
    (Higher doses may be necessary if the mother has been receiving oral anti-coagulants)   Adults Initial Dosage Anticoagulant - Induced Prothrombin Deficiency
    (caused by coumarin or indanedione derivatives) 2.5 mg – 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 – 25 mg or more (rarely up to 50 mg)

    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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.

  • General Injectables & Vaccines, Inc
    Phytonadione | General Injectables & Vaccines, Inc
    No Recall

    Phytonadione | General Injectables & Vaccines, Inc

    Phytonadione | General Injectables & Vaccines, Inc

    Whenever possible, phytonadione should be given by the subcutaneous route (see Box WARNING). When intravenous or intramuscular 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 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 vial.

    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 phytonadione 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.

    Phytonadione 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 phytonadione 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.

    Phytonadione

    Summary of Dosage Guidelines

    (See insert text for details)

       Newborns Dosage 

    Hemorrhagic Disease of the Newborn

    Prophylaxis

    Treatment 

    0.5 - 1 mg within 1 hour of birth

    1 mg SC or IM

    (Higher doses may be necessary if

    the mother has been receiving

    oral anti-coagulants) 

    Adults  Initial Dosage 

    Anticoagulant - Induced

    Prothrombin Deficiency

    (caused by coumarin or

    indanedione derivatives) 

    2.5 mg - 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 - 25 mg or

    more (rarely up to

    50 mg) 

    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 phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.