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

greenstone llc - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - phenytoin infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)]. - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in

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

genus lifesciences inc. - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 125 mg in 5 ml - phenytoin oral suspension, usp is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration and clinical pharmacology sections). phenytoin oral suspension, usp is contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients or other hydantoins. coadministration of phenytoin oral suspension, usp is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. the free acid form of phenytoin is used in phenytoin oral suspension, usp. because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage

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

mylan institutional inc. - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - phenytoin chewable tablets are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration and clinical pharmacology sections). phenytoin chewable tablets are contraindicated in those patients with a history of hypersensitivity to phenytoin or its inactive ingredients, or other hydantoins. coadministration of phenytoin is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

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

amneal pharmaceuticals llc - fosphenytoin sodium (unii: 7vlr55452z) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see dosage and administration (2.4)  and warnings and precautions (5.2)] . fosphenytoin sodium injection is contraindicated in patients with: - a history of hypersensitivity to fosphenytoin sodium injection or its inactive ingredients or to phenytoin or other hydantoins [see warnings and precautions (5.6)] . reactions have included angioedema. - sinus bradycardia, sino-atrial block, second and third degree a-v block or adams-stokes syndrome because of the effect of parenteral phenytoin or fosphenytoin sodium injection on ventricular automaticity. - a history of prior acute hepatotoxicity attributable to fosphenytoin sodium or phenytoin [see warnings and precautions (5.8)] . - co-administration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fosphenytoin sodium, during pregnancy. physicians are advised to recommend that pregnant patients taking fosphenytoin sodium enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334 and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin (the active metabolite of fosphenytoin sodium) may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. in addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly) and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data] . there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment and behavioral abnormalities) in multiple species at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.  the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.5, 2.9)] . however, postpartum restoration of the original dosage will probably be indicated. fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts and digital hypoplasia has been reported. the fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency and neurodevelopmental deficiencies. administration of phenytoin to pregnant rats, rabbits and mice during organogenesis resulted in embryofetal death, fetal malformations and decreased fetal growth. malformations (including craniofacial, cardiovascular, neural, limb and digit abnormalities) were observed in rats, rabbits and mice at doses as low as 100 mg/kg, 75 mg/kg and 12.5 mg/kg, respectively. risk summary it is not known whether fosphenytoin is secreted in human milk. following administration of phenytoin (the active metabolite of fosphenytoin sodium), phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fosphenytoin sodium and any potential adverse effects on the breastfed infant from fosphenytoin sodium or from the underlying maternal condition. fosphenytoin sodium is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery in all pediatric age groups [see indications and usage (1)  and dosage and administration (2.3, 2.4)] . because rapid intravenous administration of fosphenytoin sodium increases the risk of adverse cardiovascular reactions, the rate of administration should not exceed 2 mg pe/kg/min (or 150 mg pe/min, whichever is slower) in pediatric patients [see dosage and administration (2.3, 2.4)  and warnings and precautions (5.2)] . no systematic studies in geriatric patients have been conducted. phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)] . lower or less frequent dosing may be required [see clinical pharmacology (12.3)  and dosage and administration (2.8)] . the liver is the site of biotransformation. patients with impaired liver function, elderly patients or those who are gravely ill may show early toxicity. because the fraction of unbound phenytoin (the active metabolite of fosphenytoin sodium) is increased in patients with renal or hepatic disease or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. after intravenous administration to patients with renal and/or hepatic disease or in those with hypoalbuminemia, fosphenytoin clearance to phenytoin may be increased without a similar increase in phenytoin clearance. this has the potential to increase the frequency and severity of adverse events. patients who are intermediate or poor metabolizers of cyp2c9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses to maintain similar steady-state concentrations compared to normal metabolizers. in patients who are known to be carriers of the decreased function cyp2c9*2 or *3 alleles (intermediate and poor metabolizers), consider starting at the low end of the dosage range and monitor serum concentrations to maintain total phenytoin concentrations of 10 mcg/ml to 20 mcg/ml. if early signs of dose-related central nervous system (cns) toxicity develop, serum concentrations should be checked immediately [see clinical pharmacology (12.5)] .

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

fresenius kabi usa, llc - fosphenytoin sodium (unii: 7vlr55452z) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see dosage and administration (2.4) and warnings and precautions (5.2)] . fosphenytoin sodium injection is contraindicated in patients with: - a history of hypersensitivity to fosphenytoin sodium injection or its inactive ingredients, or to phenytoin or other hydantoins [see warnings and precautions (5.6)] . reactions have included angioedema. - sinus bradycardia, sino-atrial block, second and third degree a-v block, or adams-stokes syndrome because of the effect of parenteral phenytoin or fosphenytoin sodium injection on ventricular automaticity. - a history of prior acute hepatotoxicity attributable to fosphenytoin sodium injection or phenytoin

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

morton grove pharmaceuticals, inc. - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 125 mg in 5 ml - phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. phenytoin oral suspension is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] .reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin[see warnings and precautions (5.8) - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin oral suspension, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin oral suspension enroll in the north american antiepileptic drug (naa

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

greenstone llc - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 125 mg in 5 ml - phenytoin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. phenytoin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)]. reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)]. - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the tollfree number 1-888-233

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

american health packaging - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin chewable tablets are contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)] . - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. in addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data] . there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.4, 2.8)] . however, postpartum restoration of the original dosage will probably be indicated [see clinical pharmacology (12.3)] . fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. the fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. animal data administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100 mg/kg, 75 mg/kg, and 12.5 mg/kg, respectively. risk summary phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phenytoin and any potential adverse effects on the breastfed infant from phenytoin or from the underlying maternal condition. initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. a recommended daily maintenance dosage is usually 4 mg/kg to 8 mg/kg. children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see dosage and administration (2.3)] . phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)] . lower or less frequent dosing may be required [see dosage and administration (2.7)] . the liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. patients who are intermediate or poor metabolizers of cyp2c9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. if early signs of dose-related central nervous system (cns) toxicity develop, serum concentrations should be checked immediately [see clinical pharmacology (12.5)].

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

taro pharmaceuticals u.s.a., inc. - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 125 mg in 5 ml - phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. phenytoin oral suspension is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)] . - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by call

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

remedyrepack inc. - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin chewable tablets are contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)] . - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. in addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data] . there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.4, 2.8)] . however, postpartum restoration of the original dosage will probably be indicated [see clinical pharmacology (12.3)] . fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. the fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. animal data administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100 mg/kg, 75 mg/kg, and 12.5 mg/kg, respectively. risk summary phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phenytoin and any potential adverse effects on the breastfed infant from phenytoin or from the underlying maternal condition. initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. a recommended daily maintenance dosage is usually 4 mg/kg to 8 mg/kg. children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see dosage and administration (2.3)] . phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)] . lower or less frequent dosing may be required [see dosage and administration (2.7)] . the liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. patients who are intermediate or poor metabolizers of cyp2c9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. if early signs of dose-related central nervous system (cns) toxicity develop, serum concentrations should be checked immediately [see clinical pharmacology (12.5)].