United States - English - NLM (National Library of Medicine)

teligent pharma, inc. - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione 2 mg in 1 ml - phytonadione is indicated for the treatment of 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 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; - 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 indicated for prophylaxis and treatment of vitamin k-deficiency bleeding in neonates. hypersensitivity to phytonadione or any other component of this medication. [see warnings and precautions (5.1)]. risk summary   phytonadione c

United States - English - NLM (National Library of Medicine)

american health packaging - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione tablets are 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 tablets are 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 k1 to 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 k1 orally, 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.

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - 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 absorption 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 tablets are 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 dur

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione tablets are 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 tablets are 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 phyto

United States - English - NLM (National Library of Medicine)

oceanside pharmaceuticals - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione tablets are 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 tablets are 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 defect

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione tablets are 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 tablets are 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

United States - English - NLM (National Library of Medicine)

general injectables & vaccines, inc. - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - 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 limiting absorpt

United States - English - NLM (National Library of Medicine)

northstar rx llc. - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - 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 absorption 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 tablets are 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 dur

United States - English - NLM (National Library of Medicine)

avpak - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione tablets are 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 tablets are indicated in: - anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; - hypoprothrombinemia secondary to antibacterial therapy; - hypoprothrombinemia secondary to administration of salicylates; - hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin k will not be absorbed. hypersensitivity to any component of this medication.

United States - English - NLM (National Library of Medicine)

american health packaging - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione tablets, usp are 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 tablets, usp are indicated in: - anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; - hypoprothrombinemia secondary to antibacterial therapy; - hypoprothrombinemia secondary to administration of salicylates; - hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin k will not be absorbed. hypersensitivity to any component of this medication.