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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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Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity.

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

Not all pack sizes may be marketed. Prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects.

These reactions did packwge increase in severity with repeated administration. Fosphenyttoin mL to draw up. Phenytoin metabolism is slightly decreased in elderly patients. Clinical Considerations Disease-associated maternal risk An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Monitoring of phenytoin serum levels is recommended when a drug interaction is suspected.

The clearance of phenytoin the active pqckage of CEREBYX is decreased slightly in elderly patients and lower or less frequent dosing may be required [see Clinical Pharmacology If based on a careful evaluation of the risks and the benefits, Pro-Epanutin treatment is continued during the pregnancy, it is recommended to use the lowest effective dose and to institute specialized prenatal monitoring, oriented on the possible occurrence of the described malformations.

For single use only. Malformations including craniofacial, cardiovascular, neural, limb, and digit abnormalities were observed in rats, rabbits, and mice at doses as low as75, and Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

Signs of formate toxicity are similar to those of methanol toxicity and are associated with severe anion-gap metabolic acidosis. Temporary substitution of oral phenytoin sodium therapy with Pro-Epanutin.


Ensure the appropriate volume is withdrawn from the vial when preparing for administration. Death is caused by respiratory and circulatory depression. There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with phenytoin.

Drugs that may decrease phenytoin serum levels. This occurs within approximately 2 hours after the end of IV infusion and 4 hours after intramuscular Inesrt injection. CEREBYX and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity [see Contraindications 4 ]. The clinical course of acute phenytoin hepatotoxicity inaert from prompt recovery to fatal outcomes.

Transient itching, burning, warmth or tingling in the groin during and shortly after IV infusion of Pro-Epanutin may occur. This drug-induced condition can be prevented with vitamin K administration to the mother before delivery and to the neonate after birth.

Not known hirsutism, hypertrichosis, coarsening of the facial features, enlargement of the lips, Peyronie’s disease, Dupuytren’s contracture, and drug reaction with eosinophilia and systemic symptoms DRESS see section 4. For this reason, plasma phenytoin concentrations may increase when IM or IV Pro-Epanutin is substituted for oral phenytoin sodium therapy. Dosing Errors Dosing errors associated with Pro-Epanutin have resulted in patients receiving the wrong dose of Pro-Epanutin. Serious Dermatologic Reactions Advise patients of the early signs and symptoms of severe cutaneous adverse reactions and to report any occurrence immediately to a physician [ see Warnings and Precautions 5.

Prior to complete conversion, immunoanalytical techniques may significantly overestimate plasma phenytoin concentrations due to cross-reactivity with fosphenytoin.

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

Binding to plasma proteins is saturable with the result that the percent bound decreases as total fosphenytoin concentrations increase. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: Table 2 displays dosing information for status epilepticus maintenance dose in adults. 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.


Determination of plasma phenytoin concentrations is especially helpful when possible drug interactions are suspected see section 4. Infusion tolerance was evaluated in clinical studies. There is no need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses.

Plasma phenytoin concentrations sustained above the optimal range may produce signs of acute toxicity see section 4. Haemodialysis can be considered since phenytoin is not completely bound to plasma proteins.

The adverse clinical events most commonly observed with the use of fosphenytoin in clinical trials were nystagmus, dizziness, pruritus, paraesthesia, headachesomnolence, and ataxia. In patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of unbound phenytoin concentrations may be more relevant [see Dosage and Administration 2.

A small percentage of individuals who have been treated with phenytoin the active metabolite of CEREBYX have been shown to metabolize the drug slowly.


Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using CEREBYX, keeping in mind that there is a potential for decreased hormonal contraceptive efficacy [see Drug Interactions 7. In some cases, overdoses were associated with fatal fospjenytoin, including in children under 5 years of age.

Decreased serum concentrations of phenytoin the active metabolite of CEREBYX may occur during pregnancy because of altered phenytoin pharmacokinetics [see Clinical Pharmacology Cardiac arrhythmias have included bradycardia, heart block, ventricular tachycardia, inseert ventricular fibrillation which have resulted in asystole, cardiac arrest, and death. Renal and urinary disorders Not known interstitial nephritis General disorders and administration site conditions Common injection-site reaction, injection-site pain, asthenia, chills Not known feeling of warmth or tingling in the groin.

The effect of continuing infusion unaltered in the presence of these sensations is unknown.