PHYTONADIONE (Page 2 of 2)

ADVERSE REACTIONS

Deaths have occurred after intravenous and intramuscular administration. (See Box Warning.) Transient “flushing sensations” and “peculiar” sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.

Pain, swelling, and tenderness at the injection site may occur.

The possibility of allergic sensitivity including an anaphylactoid reaction, should be kept in mind.

Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. In other cases, these lesions have resembled erythema perstans.

Hyperbilirubinemia has been observed in the newborn following administration of phytonadione. This has occurred rarely and primarily with doses above those recommended. (See PRECAUTIONS, Pediatric Use.)

OVERDOSAGE

The intravenous LD50 of phytonadione injectable emulsion in the mouse is 41.5 and 52 mL/kg for the 0.2% and 1% concentrations, respectively.

DOSAGE AND ADMINISTRATION

Whenever possible, phytonadione injectable emulsion, 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

Phytonadione injectable emulsion 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 startedimmediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampule.

Prophylaxis of Hemorrhagic Disease of the Newborn

The American Academy of Pediatrics recommends that phytonadione be given to the newborn. A single intramuscular dose of phytonadione injectable emulsion 0.5 to 1 mg within one hour of birth is recommended.

Treatment of Hemorrhagic Disease of the Newborn

Empiric administration of phytonadione 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 phytonadione is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder.

Phytonadione injectable emulsion 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 injectable emulsion 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.

//medlibrary.org/lib/images-rx/phytonadione-5/image1-300x184.jpg
(click image for full-size original)

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

HOW SUPPLIED

Phytonadione injectable emulsion, USP is supplied as follows:

//medlibrary.org/lib/images-rx/phytonadione-5/image2-300x173.jpg
(click image for full-size original)

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from light. Keep ampules in carton until time of use.

Rx Only

Distributor: Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Issued: 0519

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1- 888-375-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Sample Package Label

//medlibrary.org/lib/images-rx/phytonadione-5/label1-300x300.jpg
(click image for full-size original)

PHYTONADIONE
phytonadione injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-405(NDC:43598-405)
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL 70 mg in 1 mL
DEXTROSE MONOHYDRATE 37.5 mg in 1 mL
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-405-11 1 AMPULE in 1 BAG contains a AMPULE
1 1 mL in 1 AMPULE This package is contained within the BAG (52584-405-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207719 08/20/2019
Labeler — General Injectables & Vaccines, Inc. (108250663)

Revised: 11/2021 General Injectables & Vaccines, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.