Recommended Topic Related To:

vitamin k1 injection

"A drug candidate developed by researchers at the NIH's National Center for Advancing Translational Sciences (NCATS) and its collaborators to treat sickle cell disease has been acquired by Baxter International's BioScience business. The drug c"...

Vitamin K1

Vitamin K1

INDICATIONS

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:

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

The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of Vitamin K1 Injection 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.

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)

Newborns Dosage Dosage
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)
Adults Initial Dosage
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.

HOW SUPPLIED

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.

A A A

Vitamin K1 - User Reviews

Vitamin K1 User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Vitamin K1 sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations