ישראל - אנגלית - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - phenytoin - suspension - phenytoin 125 mg / 5 ml - phenytoin - phenytoin - for the control of tonic clonic (grand- mal) and psychomotor (temporal lobe seizures).

ארצות הברית - אנגלית - NLM (National Library of Medicine)

a-s medication solutions - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - dilantin is 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. dilantin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . - 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 dilantin, during pregnancy. physicians are advised to recommend that pregnant patients taking dilantin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be d

ארצות הברית - אנגלית - NLM (National Library of Medicine)

carilion materials management - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 30 mg - dilantin is 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. dilantin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . - 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. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as dilantin, during pregnancy. physicians are advised to recommend that pregnant patients taking dilantin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be d

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

upjohn australia pty ltd - phenytoin -

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

viatris limited - phenytoin sodium 100mg; phenytoin sodium 100mg; phenytoin sodium 100mg - capsule - 100 mg - active: phenytoin sodium 100mg excipient: erythrosine gelatin lactose monohydrate magnesium stearate purified talc sucrose sunset yellow fcf titanium dioxide vegetable carbon wheat starch active: phenytoin sodium 100mg excipient: erythrosine gelatin lactose monohydrate magnesium stearate maize starch purified talc sucrose sunset yellow fcf titanium dioxide vegetable carbon active: phenytoin sodium 100mg excipient: confectioner's sugar erythrosine gelatin lactose monohydrate magnesium stearate purified talc sunset yellow fcf titanium dioxide vegetable carbon - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

viatris limited - phenytoin sodium 30.1mg; phenytoin sodium 30mg - capsule - 30 mg - active: phenytoin sodium 30.1mg excipient: gelatin magnesium stearate maize starch purified talc sucrose titanium dioxide vegetable carbon active: phenytoin sodium 30mg excipient: confectioner's sugar gelatin lactose monohydrate magnesium stearate purified talc titanium dioxide vegetable carbon - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

viatris limited - phenytoin 50mg; phenytoin 50mg; phenytoin 50mg - chewable tablet - 50 mg - active: phenytoin 50mg excipient: magnesium stearate purified talc quinoline yellow saccharin sodium spearmint flavour natural 11584 sucrose sunset yellow fcf wheat starch active: phenytoin 50mg excipient: spearmint flavour natural 11584 magnesium stearate maize starch purified talc quinoline yellow saccharin sodium sucrose sunset yellow fcf active: phenytoin 50mg excipient: confectioner's sugar magnesium stearate purified talc quinoline yellow saccharin sodium spearmint flavour natural 11584 sunset yellow fcf - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

viatris specialty llc - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - dilantin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. dilantin is contraindicated in patients with: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as dilantin, during pregnancy. physicians are advised to recommend that pregnant patients taking dilantin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the tollfree 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 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. 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)] . 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. 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, 75, and 12.5 mg/kg, respectively. phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dilantin and any potential adverse effects on the breastfed infant from dilantin 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 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)] .

סינגפור - אנגלית - HSA (Health Sciences Authority)

viatris private limited - phenytoin - suspension - 125.00mg/5ml - phenytoin 125.00mg/5ml

מלזיה - אנגלית - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viatris sdn. bhd. - phenytoin sodium -