PHYTONADIONE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Exelan 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. 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 the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see Data] . There are maternal and fetal risks associated with vitamin K deficiency during pregnancy [see Clinical Considerations] . Animal reproduction studies have not been conducted with phytonadione. The estimated background risk for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with vitamin K deficiency hypoprothrombinemia may be at increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. Subclinical vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Data Human Data Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma. Administration of vitamin K 1to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. Animal Data In pregnant rats receiving vitamin K 1orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer. Risk Summary Phytonadione is present in breastmilk. There are no data on the effects of phytonadione on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the clinical need for phytonadione and any potential adverse effects on the breastfed child from phytonadione or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established with phytonadione. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin K. Clinical studies of phytonadione did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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 76282-740-30 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
EXELAN 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)
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. (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)
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._
DRUG INTERACTIONS
Anticoag