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Phenytoin (Phenytoin Sodium) - Summary



This drug must be administered slowly. In adults, do not exceed 50 mg per minute intravenously. In neonates, the drug should be administered at a rate not exceeding 1 mg/kg/min to 3 mg/kg/min.




Phenytoin Sodium Injection, USP is a sterile, nonpyrogenic solution of phenytoin sodium and water for injection. Each milliliter (mL) contains phenytoin sodium 50 mg, propylene glycol 40% and alcohol 10%. Headspace nitrogen gassed. Also contains sodium hydroxide for pH adjustment; pH is 11.9 (10.0 to 12.3). The solution contains no bacteriostat, antimicrobial agent or added buffer. Single-dose, discard unused portion. NOTE: Do not use Injection if it is hazy or contains a precipitate.

Phenytoin Sodium Injection is indicated for the control of status epilepticus of the grand mal type, and prevention and treatment of seizures occurring during neurosurgery.

See all Phenytoin indications & dosage >>


Published Studies Related to 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...

Should phenytoin or barbiturates be used as second-line anticonvulsant therapy for toxicological seizures? [2010.10]
CONCLUSION: Despite the lack of high-quality clinical trial data, pharmacological knowledge and animal studies suggest that phenobarbital or thiopentone should be second-line agents for controlling toxicological seizures. The role of newer agents such as propofol and levetiracetam in toxicological seizures is currently unclear because of a lack of clinical or animal studies.

more studies >>

Clinical Trials Related to Phenytoin

Bioequivalence Study Of Phenytoin Suspension Versus EpaminŽ 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.

Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old. [Recruiting]
To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.

Neuroprotection With Phenytoin in Optic Neuritis [Not yet recruiting]
Optic neuritis is caused by inflammation of the optic nerve and causes loss of vision in the affected eye. It is often associated with multiple sclerosis. Loss of vision after an attack of optic neuritis is caused by damage to the nerve fibres in the optic nerve. There are a number of factors that contribute to nerve fibre damage including increased levels of sodium within them, so blocking sodium entry could help to protect them against damage.

The purpose of this study is determine whether phenytoin (which blocks sodium entry into cells) can protect against loss of nerve fibres and prevent loss of vision after optic neuritis.

more trials >>

Reports of Suspected Phenytoin Side Effects

Convulsion (90)Toxicity TO Various Agents (53)Drug Ineffective (48)Drug Rash With Eosinophilia and Systemic Symptoms (43)Drug Interaction (40)Fall (25)Maternal Exposure During Pregnancy (23)Dizziness (22)Ataxia (22)Rash (22)more >>

Page last updated: 2011-12-09

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