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Dilantin Kapseals (Phenytoin Sodium) - Summary

 
 



SUMMARY

Phenytoin sodium is an antiepileptic drug.

Dilantin is 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).


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NEWS HIGHLIGHTS

Published Studies Related to Dilantin Kapseals (Phenytoin)

Fosphenytoin for seizure prevention in childhood coma in Africa: a randomized clinical trial. [2013]
in children with acute coma... CONCLUSION: A single intramuscular injection of fosphenytoin (20 phenytoin

The effect of topical phenytoin on healing in diabetic foot ulcers: a randomized controlled trial. [2011.10]
AIM: The aim of the study was to evaluate the effect of topical phenytoin on healing in diabetic foot ulcers. A randomized, controlled, double-blind, clinical trial was conducted... CONCLUSIONS: There were no differences in diabetic foot ulcer closure rates or in diabetic foot ulcer area over time between the two groups. This study does not support the use of phenytoin in the treatment of diabetic foot ulcers. (c) 2011 The Authors. Diabetic Medicine (c) 2011 Diabetes UK.

Effects of lamotrigine and phenytoin on the pharmacokinetics of atorvastatin in healthy volunteers. [2011.07]
PURPOSE: Statins and antiepileptic drugs (AEDs) are frequently coprescribed to individuals with hypercholesterolemia and new-onset seizures...

Folic acid supplementation prevents phenytoin-induced gingival overgrowth in children. [2011.04.12]
OBJECTIVE: Gingival overgrowth is an important adverse effect of phenytoin (PHT) therapy, occurring in about half of the patients. This study aimed to evaluate the effect of oral folic acid supplementation (0.5 mg/day) for the prevention of PHT-induced gingival overgrowth (PIGO) in children with epilepsy aged 6-15 years on PHT monotherapy for 6 months... CONCLUSIONS: Oral folic acid was found to decrease the incidence of PIGO in children on PHT monotherapy, in a statistically significant and clinically relevant manner. Classification of evidence: This study provides Class I evidence that folic acid supplementation, 0.5 mg/day, is associated with prevention of gingival overgrowth in children taking PHT monotherapy.

Pregabalin effect on steady-state pharmacokinetics of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, valproate, and tiagabine. [2011.02]
By reducing neuronal excitability through selective binding to the alpha(2)delta subunit of voltage-dependent calcium channels, pregabalin effectively treats epilepsy, chronic pain, and anxiety disorders. To evaluate if pregabalin coadministration affects pharmacokinetics of other antiepileptic drugs, population pharmacokinetic analyses using NONMEM software were performed on data from three epilepsy trials involving seven antiepileptic drugs with pregabalin as add-on therapy...

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Clinical Trials Related to Dilantin Kapseals (Phenytoin)

Phenytoin as a Neuroprotective Agent Against Corticosteroid-Induced Functional Imaging Changes [Recruiting]
The purpose of this research is to determine if patients who receive phenytoin (also commonly known as Dilantin) before taking corticosteroids will show less memory impairment and hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those receiving placebo (an inactive substance). This research also seeks to determine if patients taking phenytoin before corticosteroids show more activity in the area of the brain involved with memory than those receiving placebo.

This research is being done because increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with forgetfulness, and interventions that may prevent or reverse this effect are of great importance.

Bioequivalence Study Of Phenytoin Suspension Versus Epamin« In 34 Healthy Volunteers. [Recruiting]
Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.

The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance [Recruiting]
The primary objective of this two-phase trial is as follows:

- To determine the elimination half-life of NVP in HIV positive pregnant women

receiving it as a single dose in labour in addition to the ZDV and 3TC with or without seven days phenytoin (pilot PK phase)

- To determine NVP resistance in HIV positive pregnant women receiving it as a single

dose in labour in addition to ZDV and 3TC with or without seven days phenytoin (main trial phase)

The secondary objectives of this two-phase trial are as follows:

- To determine the safety of single dose nevirapine with seven days phenytoin as a part

of ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part of ARV prophylaxis for PMTCT

- To determine the HIV status of the infant

- To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin

on the newborn

Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.

Phenytoin and Multidose Activated Charcoal [Recruiting]
Phenytoin is a medicine used to treat seizures. If too much is taken, patients have ill effects including sleepiness, unsteady gait, and eye problems. The amount of drug in their system can be measured in their blood. Charcoal is a medicine that can absorb phenytoin. We want to see if giving multiple doses of charcoal will quicken the removal of phenytoin from the blood. This is theorized to occur as charcoal absorbs phenytoin from across the intestines and then is secreted in the stool. Patients will be selected to receive either charcoal in multiple doses or no charcoal and their serum levels will be drawn repeatedly to follow their level. The different groups will then be compared to see if multidose charcoal does indeed shorten the half-life of phenytoin in the blood.

Evaluating the Transporter Protein Inhibitor Probenecid In Patients With Epilepsy [Recruiting]
The study is being done to understand why some patients with epilepsy (disease of recurrence of seizures) do not respond very well to drug treatment with anticonvulsants.

Despite the availability of many anticonvulsants, about 30% of patients with epilepsy are resistant to them. The cause of the resistance is not clear, but one of the reasons could be an increased amount of proteins in the cells of the body called transporter proteins.

Transporter proteins are a group of proteins that help to defend the body against toxins, including drugs, by pumping them out of the cells. Studies have shown that the number of transporter proteins is higher in the parts of the brain that trigger seizures when compared to other parts of the brain.

Studies in animals have shown that taking an anticonvulsant with an inhibitor (meaning "to stop" or "to reduce") of a transporter protein can increase the concentration of that anticonvulsant inside the brain cells. The main purpose of the study is to determine if taking an anticonvulsant and a transporter protein inhibitor will change the brain concentration of the anticonvulsant.

In this study, a single dose of phenytoin (Dilantin® is a brand name anticonvulsant which has phenytoin as its active ingredient), a commonly used anticonvulsant, will be given once by itself, and then will be given a separate time with a single (i. e. one time only) dose of probenecid. Probenecid, a medicine used commonly to treat gout (a disease of increased uric acid), is known to be an inhibitor of transporter proteins. The study will use electroencephalogram or EEG (recording of brain wave activities) to determine if the EEG pattern when probenecid is given, will be different from the EEG pattern when phenytoin is given alone. This will suggest that probenecid has affected the brain concentration of phenytoin.

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Page last updated: 2014-11-30

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