FOSPHENYTOIN PACKAGE INSERT PDF

FOSPHENYTOIN PACKAGE INSERT PDF

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 list also includes adverse effects that have been reported spontaneously following both the acute and chronic use of phenytoin.

Phenytoin may decrease serum concentrations of T 4. Acute alcohol intake, amiodarone, chloramphenicol, chlordiazepoxide, disulfiram, estrogen, fluvastatin, isoniazid, methylphenidate, phenothiazines, salicylates, ticlopidine, tolbutamide, trazodone, warfarin. It may also produce lower than normal values for dexamethasone or metyrapone tests.

CEREBYX should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur. Initial symptoms of Pro-Epanutin toxicity are those associated with indert phenytoin toxicity. Foetal toxicity, developmental toxicity and teratogenicity were observed in offspring of rats given fosphenytoin during pregnancy, similar to those reported with phenytoin see section 5.

Slow metabolism may be caused by limited enzyme availability and lack of induction; it appears to be genetically determined. Patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. One fosphsnytoin of Pro-Epanutin contains 75 mg of fosphenytoin sodium equivalent to 50 mg of phenytoin sodium see section 4.

In some cases, ten-fold overdoses were associated with fatal outcomes. 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. It has been reported in the literature that the plasma clearance of phenytoin the active metabolite of CEREBYX generally increased during pregnancy, reached a peak in the third trimester and returned to the level of pre-pregnancy after few weeks or months of delivery [see Dosage and Administration 2.

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These sensations, generally described as itching, burning, or tingling, were usually not at the infusion site. Blood and the lymphatic system disorders Not known leukopenia, granulocytopenia, agranulocytosis, pancytopenia with or without bone marrow suppression, thrombocytopenia, aplastic anaemia, lymphadenopathy. The effect of age on the pharmacokinetics of fosphenytoin was evaluated in patients 5 to 98 years of age.

If rapid phenytoin loading is a primary goal, IV administration of Pro-Epanutin is preferred because the time to achieve therapeutic plasma phenytoin concentrations following IV administration imsert faster as compared to IM administration.

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

Studies related to neurodevelopmental risk in children exposed to phenytoin during pregnancy are contradictory and a risk cannot be excluded. Continuous monitoring of electrocardiogram, blood pressure and respiratory function for the duration of the infusion is essential. Corticosteroids, doxycycline, estrogens, furosemide, oral contraceptives, paroxetine, quinidine, rifampin, sertraline, theophylline, and vitamin D.

Back to top Pfizer Limited contact details. However, postpartum restoration of the original dosage will probably be indicated. Pro-Epanutin should not be discontinued prior to reassessment of the treatment. This may or may not be associated with extravasation. The molecular structure of fosphenytoin is: Mean total phenytoin half-life values The following adverse reactions have been identified during post-approval use of fosphenytoin.

Discontinue at the first sign of a rash, unless clearly not drug-related. However, the respective role of antiepileptic drugs and other factors in the increased risk is not determined. See Table 8 for infusion times.

HIGHLIGHTS OF PRESCRIBING INFORMATION

Cases of acute inaert, including infrequent cases of acute hepatic failure, have been reported with phenytoin. Antineoplastic agents bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate Chronic alcohol abuse Diazoxide Folic rosphenytoin Fosamprenavir Nelfinavir b Theophylline Vigabatrin Ritonavir St John’s Wort. The overall incidence of adverse reactions and the types of adverse reactions seen were similar among children and adults treated with CEREBYX.

Qualitative and quantitative composition 3. An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. These patients may show early signs of phenytoin toxicity or an increase in the severity of adverse events due to alterations in Pro-Epanutin and phenytoin pharmacokinetics. Boxes of 5 vials with 2 mL solution.

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Prenatal exposure to phenytoin the active metabolite of CEREBYX may increase the risks for congenital malformations and other adverse developmental outcomes [see Use in Specific Populations 8. Lymphadenopathy local or generalised including benign lymph node hyperplasia, pseudolymphoma, lymphoma and Hodgkin’s Disease have been associated with administration of phenytoin, although a cause and effect relationship has not been established.

Unbound phenytoin concentrations may be more useful in these patient populations.

Equally phenytoin may affect the metabolism of a number of other drugs because of its potent enzyme-inducing potential. For Dose reduction in patients with Renal or Hepatic impairment, please see guidance towards the end of this section.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

Whether or not phenytoin has the same effect on other non-depolarizing agents is unknown. 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.

Because of the risks of cardiac and local toxicity associated with intravenous CEREBYX, oral phenytoin should be used whenever possible. An increase in structural chromosome aberrations were observed in cultured V79 Chinese hamster lung cells exposed to fosphenytoin in the presence of metabolic activation.

Patient age had no significant impact on fosphenytoin pharmacokinetics. 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. This occurs within approximately 2 hours after the end of IV infusion and 4 hours after intramuscular IM injection.

Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis, and death have been reported in cases of overdosage with CEREBYX.