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Phenytek (Phenytoin Sodium Extended Release) - Summary



PHENYTEK® (phenytoin sodium) is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring.

PHENYTEK® CAPSULES (extended phenytoin sodium capsules, USP) 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).

See all Phenytek indications & dosage >>


Published Studies Related to Phenytek (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...

more studies >>

Clinical Trials Related to Phenytek (Phenytoin)

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.

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.

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.

Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin« Kapseals« 100 mg [Completed]
The objective of this study was to investigate the steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin« Kapseals«, 100mg (3x100mg), under both fasting and fed conditions.

more trials >>

Reports of Suspected Phenytek (Phenytoin) Side Effects

Loss of Consciousness (5)Convulsion (5)Balance Disorder (4)Dyspnoea (4)Dizziness (3)Drug Level Fluctuating (2)Fatigue (2)Coordination Abnormal (2)Back Pain (2)Pain in Extremity (2)more >>

Page last updated: 2014-11-30

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