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Phytonadione (Phytonadione) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 Injectable Emulsion, USP 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 AND ADMINISTRATION

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)
NewbornsDosage
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)

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.

HOW SUPPLIED

In unit use packages containing one single dose vial and a SAF-T-Jet™ vial injector, 27 G. × 1/2" needle.

Phytonadione Injection USP, 1 mg in 0.5 mL

        Stock No. 1240         NDC 0548-1240-00

Twenty-five unit use packages per carton.

See User Guide

USE ASEPTIC TECHNIQUE

Do not remove from carton or assemble until ready to use.

*CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.

Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP].

Protect from light.

INTERNATIONAL MEDICATION SYSTEMS, LIMITED
SO. EL MONTE, CA 91733, U.S.A.
An Amphastar Pharmaceuticals Company

6912400F

Rev. 2-05

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