PHYTONADIONE PHYTONADIONE- phytonadione injection, emulsion

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Phytonadione (UNII: A034SE7857) (Phytonadione - UNII:A034SE7857)

Verfügbar ab:

Dr.Reddy's Laboratories Inc

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.  Phytonadione injectable emulsion is indicated in­­  - anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; - ­­ prophylaxis and therapy of hemorrhagic disease of the newborn; ­­ prophylaxis and therapy of hemorrhagic disease of the newborn; - ­­ hypoprothrombinemia due to antibacterial therapy; ­­ 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; hypoprothrombinemia secondary to factors limit

Produktbesonderheiten:

Phytonadione injectable emulsion, USP is supplied as follows: For Carton: For Ampule: 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.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PHYTONADIONE PHYTONADIONE- PHYTONADIONE INJECTION, EMULSION
DR.REDDY'S LABORATORIES INC
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PHYTONADIONE INJECTABLE EMULSION, USP
AQUEOUS DISPERSION OF PHYTONADIONE INJECTABLE EMULSION AMPULE
RX ONLY
PROTECT FROM LIGHT. KEEP AMPULES IN CARTON UNTIL TIME OF USE.
BOXED WARNING
WARNING — INTRAVENOUS AND INTRAMUSCULAR USE
SEVERE REACTIONS, INCLUDING FATALITIES, HAVE OCCURRED DURING AND
IMMEDIATELY AFTER
INTRAVENOUS INJECTION OF PHYTONADIONE, EVEN WHEN PRECAUTIONS HAVE BEEN
TAKEN TO
DILUTE THE PHYTONADIONE AND TO AVOID RAPID INFUSION. SEVERE REACTIONS,
INCLUDING FATALITIES,
HAVE ALSO BEEN REPORTED FOLLOWING INTRAMUSCULAR ADMINISTRATION.
TYPICALLY THESE
SEVERE REACTIONS HAVE RESEMBLED HYPERSENSITIVITY OR ANAPHYLAXIS,
INCLUDING SHOCK AND
CARDIAC AND/OR RESPIRATORY ARREST. SOME PATIENTS HAVE EXHIBITED THESE
SEVERE REACTIONS ON
RECEIVING PHYTONADIONE FOR THE FIRST TIME.THEREFORE THE INTRAVENOUS
AND
INTRAMUSCULAR ROUTES SHOULD BE RESTRICTED TO THOSE SITUATIONS WHERE
THE
SUBCUTANEOUS ROUTE IS NOT FEASIBLE AND THE SERIOUS RISK INVOLVED IS
CONSIDERED JUSTIFIED.
DESCRIPTION
Phytonadione is a vitamin, which is a clear, yellow to amber, viscous,
odorless or nearly
odorlessliquid.
It is insoluble in water, soluble in chloroform and slightly soluble
in ethanol. It has a molecular weight
of 450.70.Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its
empirical formula is C
H O
and its structural formula is:
Phytonadione injectable emulsion, USP is a yellow, sterile,
nonpyrogenic aqueous dispersion available
for injection by the intravenous, intramuscular and subcutaneous
routes.
Each milliliter contains phytonadione 10 mg, polyoxyethylated fatty
acid derivative 70 mg, dextrose,
hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as
preservative. May contain
hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0).
Phytonadione is oxygen sensitive.
CLINICAL PHARMACOLOGY
Phytonadione injectable emulsion, is indicated in the following
coagulation disorders which are due to
31
46
2
faulty formation of fac