vitamin k1 injection
"The U.S. Food and Drug Administration today approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting pr"...
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.
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
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.
Vitamin K1 Injection (Phytonadione Injectable
Emulsion, USP) Summary of Dosage Guidelines (See circular text for details)
|Hemorrhagic Disease of the Newborn|
|Prophylaxis||0.5 to 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 anticoagulants)|
|Anticoagulant-Induced Prothrombin Deficiency (caused by coumarin or indanedione derivatives)||2.5 mg to 10 mg or up to 25 mg indanedione derivatives)|
|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)|
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.
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is supplied in a package of 25 as follows:
|Amount of Vitamin K1|
|List No.||Container||Inj. In Container||Volume||Concentration|
|9157||1 mL Ampul||1 mg||0.5 mL||2 mg/mL|
|9158||1 mL Ampul||10 mg||1 mL||10 mg/mL|
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Protect from light. Keep ampuls in tray until time of use.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA. FDA Rev date: 7/19/1999
Last reviewed on RxList: 11/7/2008
This monograph has been modified to include the generic and brand name in many instances.
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