Parenteral dilantin phenytoin sodium injection, usp fda. Depakene valproic acid is indicated for use as sole and adjunctive therapy in. Warfarin and phenytoin interaction annals of internal. Concomitant use of levothyroxine and simethicone may decrease levothyroxine efficacy by binding to and delaying or preventing levothyroxine absorption, potentially resulting in hypothyroidism. If you experience a rash while taking dilantin or any of the symptoms listed below, contact your doctor immediately. Phenytoin chewable tablets usp can be either chewed thoroughly before being swallowed or swallowed whole. The dosage may be increased by 5 to 10 mgkgweek to achieve optimal clinical response. Refer to the glycophos package insert for full prescribing. Kaletra oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. Trileptal oxcarbazepine filmcoated tablets, for oral use trileptal oxcarbazepine oral suspension initial u. Safety and effectiveness of lamictal have not been established 1 as initial monotherapy.
The use of concomitant strong cyp3a4 inducers should be avoided eg, phenytoin, carbamazepine, rifampin, rifabutin, dexamethasone, and phenobarbital. A serious, lifethreatening disorder called stevensjohnson syndrome and drug reaction with eosinophilia and systemic symptoms dress, which can be fatal. Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide tablets, for oral use. Dilantin is a prescription medicine used to treat certain types of seizures called tonicclonic grand mal and psychomotor temporal lobe seizures. Seroquel quetiapine tablets, for oral use initial u. Dilantin phenytoin sodium injection, usp is a readymixed solution of phenytoin sodium in a vehicle containing 40% propylene glycol and 10% alcohol in water for injection, adjusted to ph 12 with sodium hydroxide. The chemical name is sodium 5,5diphenyl2, 4imidazolidinedione, having the following structural formula. Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus.
The content on this site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Observe the patient for possible diminished effect of steroid and increase the steroid dosage accordingly. The reduction in seizure frequency was somewhat greater at 12 mg than at 8 mg see clinical studies 14. Anabolic steroids particularly c17 alkylated androgens such as oxymetholone, methandrostenolone. Dilantin is an anticonvulsant drug which can be useful in the treatment of epilepsy. Highlights of prescribing information 4 coadministrationof. Phenytoin 100mg filmcoated tablets summary of product. Therapeutic drug monitoring of phenytoin is carried out to ensure effective and safe levels. Phenytoin sodium has also been employed in the treatment of trigeminal neuralgia but it should only be used as second line therapy if carbamazepine is ineffective or patients are intolerant to carbamazepine.
Drugs highly bound to albumin could increase the unbound fraction of. It is important to note that there are some key differences in the formulation and labeling. Appropriate diagnostic procedures should be performed as indicated. Briefly, dilantin can produce mental confusion, however, depression and aggrestion are not listed specifically. It will also address phenytoin dosing, other monitoring parameters, and management of phenytoin adverse effects. Phenytoin dosing guidelines the concentration at steady state can be estimated using the following equation. Each vial contains fosphenytoin sodium 150 mg equivalent to 100 mg phenytoin sodium, tromethamine tris as a buffer, hydrochloric acid or sodium hydroxide to adjust the ph to 8. Highlights of prescribing information these highlights do not. Coadministration of strong inducers of cyp3a4 such as rifampin, carbamazepine, phenytoin,and st. If patients require coadministration of a strong cyp3a4 inducer, consider increasing the afinitor dose from 10 mg daily up to 20 mg daily based on pharmacokinetic data, using 5 mg increments. The addition or withdrawal of phenytoin during concomitant therapy with these agents may require adjustment of the dose of these agents to achieve optimal clinical outcome. Store so that pediatric patients cannot eat these flavored tablets as candy. Because there is approximately an 8% increase in drug content in the free form over that of the sodium salt, dosage adjustments and serum level monitoring may. Dilantin capsules contain phenytoin sodium 30 mg and 100 mg.
Do not use trikafta after the expiration date on the package. Information for the user epanutin 100mg capsules phenytoin sodium read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Jun 17, 2019 drugs highly bound to albumin could increase the unbound fraction of. Phenytoin may also raise the serum glucose level in diabetic patients. It is useful for the prevention of tonicclonic seizures and focal seizures, but not absence seizures. The potential interaction of warfarin and phenytoin was not mentioned and deserves attention, since both of these drugs are commonly prescribed. Phenytoin may produce lower than normal values for the dexamethasone test b.
Coadministration of ubrelvy with moderate or weak cyp3a4 inducers was not evaluated in a clinical study. Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins. Studies using dilantin have shown that phenytoin and its sodium salt are usually completely absorbed from the gi tract. Highlights of prescribing information these highlights do not include all the information needed to use briviact safely and effectively.
A safe and effective dose of kaletra oral solution in this. Keep trikafta and all medicines out of the reach of children. Dilantin may cause serious side effects, including. Cerebyx fosphenytoin sodium pfizer medical information us. These highlights do not include all the information needed to use seroquel safely and effectively. Selection of an alternative concomitant medication with no or minimal enzyme induction potential should be considered. Ordinarily, optimal clinical response is achieved at daily doses below 60 mgkgday. Aug 16, 2019 see package insert for full prescribing information. These reagents are packaged specifically for use on a variety of au clinical chemistry systems. See the end of this leaflet for a complete list of ingredients in dilantin. When cancidas is coadministered to pediatric patients with other inducers of hepatic cyp enzymes, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a cancidas dose of 70mgm2 once daily not to exceed 70mg should be considered see drug interactions 7. Lamotrigine tablets, usp are indicated for conversion to monotherapy in adults aged 16 years and older with partialonset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug aed. If you have any further questions, ask your doctor or pharmacist.
Individual drug package inserts should be consulted. Fosphenytoin sodium injection, usp is indicated for the control of generalized tonicclonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. The package insert 2 does not list phenytoin as a drug that can influence the prothrombin time of a patient maintained on warfarin therapy. The incidences of hepatocellular tumors were increased in male and female mice at the highest dose. The primary site of action appears to be the motor cortex where spread of seizure. General information about the safe and effective use of trikafta. Dilantin phenytoin sodium 100 mg extended oral capsule. Parenteral phenytoin sodium injection, usp warning. Johns wort with coartem tablets can result in decreased concentrations of artemether andor lumefantrine and loss of antimalarial efficacy see warnings and precautions 5.
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Infatabs dilantin phenytoin chewable tablets, for oral use. Avoid the use of concomitant strong cyp3a4 inducers e. Pe phenytoin sodium equivalents for im or iv use rx only 2mlsingle use vials sterile. Pharmacokinetics, phenytoin, therapeutic drug monitoring what is phenytoin. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease. Are allergic to phenytoin or any of the ingredients in dilantin. Following cerebyx administration, it is recommended that phenytoin concentrations not be monitored until conversion to phenytoin is essentially complete. In carcinogenicity studies, phenytoin was administered in the diet to mice 10, 25, or 45 mgkgday and rats 25, 50, or 100 mgkgday for 2 years. You can get a package insert from a pharmacist which list all side effects. Some of the factors complicating phenytoin dosing include a narrow therapeutic window, high degree of protein binding, and nonlinear pharmacokinetics.
Four metabolites have been identified in human urine which together account. Aug 15, 2019 drugs highly bound to albumin could increase the unbound fraction of. Read highlighted changes phenytoin revised july 2010 7a67 345870r14 en phenytoin list number in vitro diagnostic medical device consult instructions af for. Cerebyx medication page for healthcare professionals to search for scientific information on pfizer medications. When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of. Lamictal is indicated for conversion to monotherapy in adults aged 16 years and older with partialonset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug aed. Phenytoin sodium pharmacokinetics absorption bioavailability. Cerebyx or phenytoin doses are usually selected to attain therapeutic serum total phenytoin concentrations of 10 to 20 mcgml unbound phenytoin concentrations of 1 to 2 mcgml. Drugs, which may increase phenytoin serum levels, include. Buffered pfizerpen for injection is an antibacterial agent for intramuscular, continuous intravenous drip, intrapleural or other local infusion, and intrathecal administration. Phenytoin sodium injection, usp is a sterile solution containing in each ml phenytoin sodium 50 mg, propylene glycol 0.
The pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Pharmacode position may change as per suppliers mc. If concurrent use of levothyroxine and simethicone is required, administration. Dilantin extended capsules and parenteral dilantin are formulated with the sodium salt of phenytoin. Low levels of the drug have been det ected in the aqueous and vitr eous humors of the eye. You may have been given phenytoin injection as a single dose to control seizures in an emergency. Phenytoin is an antiepileptic drug which can be used in the treatment of epilepsy. These highlights do not include all the information needed to use phenytoin sodium injection safely and effectively. Fosphenytoin, the longawaited phosphate ester prodrug of phenytoin, was developed to overcome many of the cerebyx package insert. Each dilantinextended phenytoin sodium capsule, uspcontains 30 mg phenytoin sodium, usp. Oct 28, 2019 phenytoin may increase serum alkaline phosphatase concentrations b. Patient information is perforated for dispensing to the. Phenytoin may increase risk of suicidal thoughts or behavior.
Dec 10, 2018 phenytoin sodium injection, usp is a sterile solution containing in each ml phenytoin sodium 50 mg, propylene glycol 0. Highlights of prescribing information these highlights do not include all the information needed to use genvoya safely and effectively. Mylan manufactures fosphenytoin sodium injection in strengths of mg pe in 2ml vial mg pe in 10 ml vial. Fosphenytoin injection, usp 100 mg pe2 ml sodium store. This leaflet is part iii of a threepart product monograph published when. Buffered pfizerpen penicillin g potassium for injection is a sterile, pyrogenfree powder for reconstitution. Phenytoin 100mg filmcoated tablets summary of product characteristics smpc by aurobindo pharma. People on phenytoin should be monitored for any changes in mood, the development or worsening depression, andor any thoughts or behavior of suicide. Some of the factors complicating phenytoin dosing include a narrow therapeutic window, high degree of pr. Phenytoin is not indicated for seizures due to hypoglycemic or other metabolic causes.
Package insert template for simethicone tabletcapsule brand or product name product name tablet. Chronic phenytoin use has been associated with decreased bone density and increased bone fractures. Clinical trials revealed a substantially reduced effect on seizure rates in these patients. Depakene valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Phenytoin pht, sold under the brand name dilantin among others, is an antiseizure medication. The 2 gram dose that your husband took can also produce toxic effects. However, this list is not intended to be inclusive or comprehensive. The intravenous form is used for status epilepticus that does not improve with benzodiazepines. Johns wort, loss of ubrogepant efficacy is expected, and concomitant use should be avoided. Adjusted phenytoin concentration if low serum albumin measured total concentration 0. Indications and clinical use phenytoin sodium injection usp is an anticonvulsant used to control tonicclonic grand mal and psychomotor or partial focal seizures. Package insert template for simethicone tabletcapsule brand. Depending on the location of the brain injury, some areas can produce personality changes.
Phenytoin may cause slight decreases in urinary 17hydroxycorticosteroids and 17ketosteroids while urinary 6. Highlights of prescribing information these highlights do not include all the information needed to use kaletra safely and effectively. This package insert must be read carefully before product use. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. Fosphenytoin should be used only when oral phenytoin administration is not possible. Dose adjustment is recommended with concomitant use of ubrelvy and moderate or weak cyp3a4. Highlights of prescribing information provide adequate. Coadministration of ubrelvy with moderate or weak cyp3a4 inducers was not evaluated in a clinical. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa. Highlights of prescribing information these highlights do not include all the information needed to use trileptal safely and effectively. Coartem tablets are not approved for theprevention of malaria.
May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Treatment with phenytoin sodium injection can be initiated either with a loading dose or an infusion. Contact your local representative or find country specific contact information on. Dilantin125 is available as a 125 mg phenytoin5 ml oral suspension. Depakene may be added to the patients regimen at a dosage of 10 to 15 mgkgday. Seizure treatment dilantin extended phenytoin sodium. Coartem tabletshave been shown to be effective in geographical regions where resistance to chloroquine has been reported.
Fosphenytoin sodium injection, usp amneal pharmaceuticals. No increases in tumor incidence were observed in rats. Information for the user phenytoin sodium milpharm 100 mg filmcoated tablets phenytoin sodium black as. Based on extrapolation from a drug interaction study with. Fosphenytoin can also be substituted, shortterm, for oral phenytoin. Phenytoin moll 0 10 20 40 79 158 1 intended use the emit 2000 phenytoin assay is a homogeneous enzyme immunoassay drugintended for use in the quantitative analysis of phenytoin in human serum or plasma. Drugs that may increase phenytoin serum levels, include. Bioavailability may vary enough among oral phenytoin sodium preparations of different manufacturers to result in toxic serum concentrations or a loss of seizure control. In combination with carbamazepine, phenobarbital, or phenytoin see drug interactions 7. Call your abbott representative this package insert must be read carefully before product use. A loading dose of parenteral phenytoin sodium injection should be injected slowly, not exceeding 50 mg per minute in adults and 1 to 3 mgkgmin or 50 mg per minute, whichever is slower in pediatric patients.