PHYTONADIONE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)

Tilgængelig fra:

ScieGen Pharmaceuticals Inc

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Phytonadione is indicated for the treatment of adults with 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. • anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; • hypoprothrombinemia secondary to antibacterial therapy; • hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, 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. Phytonadione is contraindicated in patients with a history of a hypersensitivity reaction to phytonadione or inactive ingredients [see Description (11)] . Risk Summary Published studies with

Produkt oversigt:

Phytonadione tablets, USP 5 mg, are pale yellow colored, round, scored tablets, debossed with ‘ SG 333 ’ on one side and score line on other side. They are supplied as follows: Bottles of 30 tablets: NDC 50228-333-30 Bottles of 100 tablets: NDC 50228-333-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Always protect phytonadione from light. Store in tightly closed original container and carton until contents have been used.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PHYTONADIONE- PHYTONADIONE TABLET
SCIEGEN PHARMACEUTICALS INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHYTONADIONE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PHYTONADIONE
TABLETS.PHYTONADIONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
Phytonadione is a vitamin K replacement indicated for the treatment of
adults with 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:
• Anticoagulant-induced prothrombin deficiency caused by coumarin or
indanedione derivatives; (1)
• Hypoprothrombinemia secondary to antibacterial therapy; (1)
• 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; (1)
• Other drug-induced hypoprothrombinemia where it is definitively
shown that the result is due to
interference with vitamin K metabolism, e.g., salicylates. (1) (1)
DOSAGE AND ADMINISTRATION
• Anticoagulant-Induced Prothrombin Deficiency: 2.5 mg to 10 mg or
up to 25 mg (2.2)
• Hypoprothrombinemia Due to Other Causes: 2.5 mg to 25 mg or more
(2.2)
• Must be given with bile salts when endogenous supply of bile to
gastrointestinal track is deficient. (2.1 (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg (3) (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. (4) (4)
ADVERSE REACTIONS
Most common adverse reactions are transient “flushing sensations”,
“peculiar” sensations of taste and
instances of dizziness, rapid and weak pulse, profuse sweating, brief
hypotension, dyspnea, and cyanosis.
(6.1) (5)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SCIEGEN
PHARMACEUTICALS, INC. AT 1-855-
724-3436 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (5)
DRUG