• June 20, 2019

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 product should not be stored at room temperature for more than 48 hours. Large amounts of phosphate, delivered rapidly, could potentially cause hypocalcemia with paresthesia, muscle spasms, and seizures. The paresthesia and pruritus were transient events that occurred within several minutes of the start of infusion and generally resolved within 10 minutes after packaye of CEREBYX infusion.

CEREBYX should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Warnings and Precautions 5. Packagr and the lymphatic system disorders Not known leukopenia, granulocytopenia, agranulocytosis, pancytopenia with or without bone marrow suppression, thrombocytopenia, aplastic anaemia, lymphadenopathy.

After administration of a loading dose, maintenance doses should typically be started at the next identified dosing interval.

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

Reduction in rate of administration or discontinuation of dosing may be needed. See Table 8 for infusion times. Inset shows time course for the entire hour sampling period. A meta-analysis of randomised, placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.

The highest doses tested in these studies were associated with peak plasma phenytoin levels below human therapeutic concentrations.

Metabolism and Excretion The hydrolysis of fosphenytoin to phenytoin yields 2 metabolites, phosphate and formaldehyde. A small percentage of individuals who have been treated with phenytoin the active metabolite of CEREBYX have been shown to metabolize the drug slowly.


Breast-feeding It is not known whether Pro-Epanutin is excreted in human milk.

Company contact details Pfizer Limited. Drugs that may increase or decrease phenytoin concentrations listed by likely mechanism: Packwge An increase in structural chromosome aberrations were observed in cultured V79 Chinese hamster lung cells exposed to fosphenytoin in the presence of metabolic activation. Risk Summary In humans, prenatal exposure to phenytoin the active metabolite of CEREBYX may increase the risks for congenital malformations and other adverse developmental outcomes.

All adverse events were recorded during the trials by the clinical investigators using terminology of their own choosing.


If administration of Cerebyx does not terminate seizures, the use of other anticonvulsants and other appropriate measures should be considered. Cardiac resuscitative equipment should be available see section 4.

Peak concentrations occur at approximately 30 minutes postdose. Inzert continuing to browse the site you are agreeing to our policy on the use of cookies. The overall incidence and the types of adverse reactions in controlled clinical trials with IV administration of fosphenytoin to paediatric patients with epilepsy or neurosurgical patients were similar among children and adults treated with fosphenytoin.

Not all pack sizes may be marketed. Treatment is non-specific since there is no known antidote to Pro-Epanutin or phenytoin overdosage. Cardiac arrhythmias have included bradycardia, heart block, ventricular tachycardia, and ventricular fibrillation which have resulted in asystole, cardiac arrest, and death. Patients and caregivers of patients should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

The cellular mechanisms of phenytoin thought to be foosphenytoin for its anticonvulsant actions include modulation of voltage-dependent sodium channels of neurones, inhibition of paclage 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.

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Fosphenytoiin phosphate and formaldehyde formate have potentially important biological effects, these effects typically occur at concentrations considerably in excess of those obtained when CEREBYX is administered under conditions of use recommended in this labeling. Temporary substitution of oral phenytoin sodium therapy with Pro-Epanutin. Vials that develop particulate packate should not be used.

Please refer to tables 1 to 10 for examples of dosing, dilution and infusion time calculations. Boxes of 5 vials with 2 mL solution. If the rash is of a milder type measles-like or scarlatiniformtherapy may be resumed after the rash has completely disappeared.

Severe cardiovascular reactions including atrial and ventricular conduction depression, ventricular fibrillation, asystole and fatalities have been reported following phenytoin and fosphenytoin administration.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

See Table 10 for infusion times. Some of these reactions have been fatal see section 4. Pro-Epanutin is therefore, contra-indicated in patients with sinus bradycardia, sino-atrial block, second and third degree A-V block and Adams-Stokes syndrome. In some cases, milder sensory disturbances persisted for as long as 24 hours.

The location of the discomfort varied with the groin mentioned most frequently as a site of involvement. Pro-Epanutin is a prodrug intended for parenteral administration; its active metabolite is phenytoin. Table 10 displays dosing information for the temporary substitution of oral phenytoin sodium in children.

These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression. Some of these reports have been fatal. See Table 3 for infusion times.