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)

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)

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)

mylan institutional 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 is contraindicated in patients with: 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 websi

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

hikma pharmaceuticals usa inc. - 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)

amneal pharmaceuticals llc - fosphenytoin sodium (unii: 7vlr55452z) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - fosphenytoin sodium injection, usp is indicated for the control of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. fosphenytoin can also be substituted, short-term, for oral phenytoin.  fosphenytoin should be used only when oral phenytoin administration is not possible.  fosphenytoin must not be given orally. fosphenytoin sodium injection, usp is contraindicated in patients who have demonstrated hypersensitivity to fosphenytoin sodium injection, usp or its ingredients, or to phenytoin or other hydantoins. because of the effect of parenteral phenytoin on ventricular automaticity, fosphenytoin injection is contraindicated in patients with sinus bradycardia, sino-atrial block, second and third degree a-v block, and adams-stokes syndrome. coadministration of fosphenytoin 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)

west-ward pharmaceuticals corp - fosphenytoin sodium (unii: 7vlr55452z) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - fosphenytoin sodium injection, usp is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. fosphenytoin sodium injection, usp can also be substituted, short-term, for oral phenytoin. fosphenytoin sodium injection, usp 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)] . - 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 [see warnings and pr

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

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - phenytoin sodium, quantity: 100 mg - injection, solution - excipient ingredients: propylene glycol; sodium hydroxide; ethanol; water for injections - control of status epilepticus, tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occuring during or following neurosurgery. phenytoin will prevent or effectively decrease the incidence and severity of convulvsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, phenytoin frequently improves the mental condition and outlook of epileptic patients. it has also been used in the treatment of certain cardiac arrhythmias, particularly in those patients who do not respond to convential antiarrhythmic agents or to cardioversion. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administation).