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

mylan pharmaceuticals 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: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin chewable tablets, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin chewable tablets 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/. in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is as

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

hikma pharmaceuticals usa inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - parenteral phenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. parenteral phenytoin should be used only when oral phenytoin administration is not possible [see dosage and administration (2.1, 2.3) and warnings and precautions (5.1)] . phenytoin sodium injection is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . - sinus bradycardia, sino-atrial block, second and third degree a-v block, and adams-stokes syndrome because of the effect of parenteral phenytoin on ventricular automaticity. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.6)]. - 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 p regnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin sodium injection, 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 (2.1, 2.7)] . 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 hydantion 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 retardation. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100, 75, 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 sodium injection and any potential adverse effects on the breastfed infant from phenytoin sodium injection or from the underlying maternal condition. a loading dose of 15 to 20 mg/kg of phenytoin sodium injection intravenously will usually produce serum concentrations of phenytoin within the generally accepted serum total concentrations between 10 and 20 mcg/ml (unbound phenytoin concentrations of 1 to 2 mcg/ml). because of the increased risk of adverse cardiovascular reactions associated with rapid administration phenytoin sodium injection should be injected slowly intravenously at a rate not exceeding 1 to 3 mg/kg/min or 50 mg per minute, whichever is slower [see dosage and administration (2.8) and warnings and precautions (5.1)]. 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 (2.6)]. 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 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)

redpharm drug, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - phenytoin is indicated for the control of tonic-clonic (grand mal) and 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 administrationand clinical pharmacologysections). phenytoin is contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. coadministration of phenytoin sodium 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)

x-gen pharmaceuticals, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - parenteral phenytoin sodium injection is indicated for the control of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. parenteral phenytoin should be used only when oral phenytoin administration is not possible. phenytoin is contraindicated in patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. because of its effect on ventricular automaticity, phenytoin is contraindicated in sinus bradycardia, sino-atrial block, second and third degree a-v block, and patients with adams-stokes syndrome. 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)

proficient rx lp - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - phenytoin is indicated for the control of tonic-clonic (grand mal) and 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 administrationand clinical pharmacologysections). phenytoin is contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. coadministration of phenytoin sodium 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)

general injectables & vaccines, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 250 mg in 5 ml - parenteral phenytoing sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. parenteral phenytoind should be used only when oral phenytoin administration is not possible [see dosage and administration and warnings and precautions . phenytoin sodium injection is contraindicated in patients with: • a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)]. • sinus bradycardia, sino-atrial block, second and third degree a-v block, and adams-stokes syndrome because of the effect of parenteral phenytoin on ventricular automaticity. • a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.6)]. • coadministration with delavirdine because of the potential for loss of virologic response and possible resistance

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

sun pharmaceutical industries, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - extended phenytoin sodium capsules, usp are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. extended phenytoin sodium capsules 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 extended phenytoin sodium capsules, during pregnancy. physicians are advised to recommend that pregnant patients taking extended phenytoin sodium capsules 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 (2.3, 2.7)] . 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 extended phenytoin sodium capsules and any potential adverse effects on the breastfed infant from extended phenytoin sodium capsules 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 (2.2)] . 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 (2.6)] . 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)].

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - phenytoin sodium - solution for inj/inf - 250mg/5ml mg/ml - phenytoin

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - phenytoin sodium - oral capsule - 100mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - phenytoin sodium - oral capsule - 100mg