7 DRUG INTERACTIONS. Fosphenytoin is extensively bound to human plasma proteins. Drugs highly bound to albumin could increase the unbound fraction of. Mylan manufactures FOSPHENYTOIN SODIUM Injection in strengths of mg PE in 2ml Vial mg PE in 10 ml Vial. Category: Human Prescription Drug. Fosphenytoin, the long-awaited phosphate ester pro-drug of phenytoin, was developed to overcome many of the .. Cerebyx package insert. Morris Plains, N.J.

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The mechanism of fosphenytoin conversion has not been determined, but phosphatases probably play a major role. The cellular mechanisms of phenytoin thought to be responsible for its anticonvulsant actions include modulation of voltage-dependent sodium channels of neurones, inhibition of calcium flux across neuronal membranes, modulation of voltage-dependent calcium channels of neurones and enhancement of the sodium-potassium ATPase activity of neurones and glial cells.

Knsert this disorder is variable in its expression, other organ systems not noted here may be involved. Local irritation following IV or IM dosing or inadvertent perivenous administration was less severe with fosphenytoin than with phenytoin and was generally comparable to that observed with vehicle injections.

The hydrolysis of fosphenytoin to phenytoin yields two metabolites, phosphate and formaldehyde.

Binding to plasma proteins is saturable with the result that the fraction unbound increases as total fosphenytoin concentrations increase. Phenytoin is highly bound to plasma proteins, primarily albumin, although to a lesser extent than fosphenytoin.

Mutagenesis An increase in structural chromosome aberrations were observed ijsert cultured V79 Chinese hamster lung cells exposed to fosphenytoin in the presence of metabolic activation. The syndrome may not develop for several days after injection.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

Drugs that may either increase or decrease phenytoin serum levels. 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. Fosphenytoin is not excreted in urine.


After dilution Pro-Epanutin is suitable only for immediate use. In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.

When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options.

FOSPHENYTOIN SODIUM Injection mg PE in 2ml Vial mg PE in 10 ml Vial | Mylan

Irreversible cerebellar dysfunction foshpenytoin atrophy have been reported after overdosage. Sign Up Log In Cancel. The paresthesia and pruritus were transient events that occurred within several minutes of the start of infusion and generally resolved within 10 minutes after completion of CEREBYX infusion.

Phenytoin may cause increased blood glucose or serum concentrations of alkaline phosphatase and gamma glutamyl transpeptidase GGT.

The following adverse events have been reported in clinical trials in adults receiving Pro-Epanutin. No drugs are known to interfere with the conversion of fosphenytoin to phenytoin. With one exception, these reactions are commonly associated with the administration of IV phenytoin. Children aged 5 years and older. Prenatal exposure to phenytoin may increase the inert for congenital malformations and other adverse development outcomes see section 4.

These reactions did not increase fosphenytin severity with repeated administration. Each onsert mL vial contains mg PE. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Hypotension can occur when either drug is administered rapidly by the IV route.

Phenytoin the active metabolite of CEREBYX prenatal exposure may increase risks for congenital malformations and other adverse developmental outcomes 5.

The fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. Cisatracurium, pancuronium, rocuronium and vecuronium: Gastrointestinal disorders Common nausea, dry mouth, vomiting Uncommon hypoaesthesia of the tongue Not known gingival hyperplasia, constipation Hepatobiliary disorders Not known toxic hepatitis, hepatocellular damage Skin and subcutaneous tissue disorders Very Common pruritus Common ecchymosis Uncommon rash.


Fosphenytoin had no effect on fertility in male rats. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.

Fosphenytoin can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome SJSand toxic epidermal necrolysis TENwhich can be fatal. The error is dependent on serum phenytoin and fosphenytoin concentration influenced by CEREBYX dose, route and rate of administration, and time of sampling relative to dosingand analytical method. Discontinue if an alternative etiology cannot be established. The effect of age on the pharmacokinetics of fosphenytoin was evaluated in patients 5 to 98 years of age.

Care should be taken to ensure the appropriate volume of CEREBYX is withdrawn from the vial when preparing the drug for administration.

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Unbound phenytoin concentrations are more appropriate in these patients see sections 4. Eosinophilia is often present. Inset shows time course for the entire hour sampling period.

Some of these events have been fatal or life-threatening. May precipitate status epilepticus. Phenytoin sodium equivalents PE Pro-Epanutin is a prodrug intended for parenteral administration; its active metabolite is phenytoin.

If tonic-clonic seizures are present simultaneously with absence seizures, combined drug therapy is recommended. When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative antiepileptic medication arises, this should be done gradually. In females, altered estrous cycles, delayed mating, prolonged gestation length, and developmental toxicity were observed at all insrrt, which were associated with maternal toxicity.

Hypotension can occur when either drug is administered rapidly by the IV route. Discontinue at the first sign of a rash, unless clearly not drug-related. When possible, patients should be informed of the potential harm to the foetus.