Phytonadione

Phytonadione Manufacturers

• 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)

  Close
  No Recall

  More Info
• 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)
  
  

  Close
  No Recall

  More Info
• 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.

  Close
  No Recall

  More Info
• 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.

  Close
  No Recall

  More Info
• 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.

  Close
  No Recall

  More Info
• 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.

  Close
  No Recall

  More Info
• 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.

  Close
  No Recall

  More Info
• 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.

  Close
  No Recall

  More Info