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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HIGHLIGHTS OF PRESCRIBING INFORMATION

No drugs are known to interfere with the conversion of fosphenytoin to phenytoin. Some patients may require more frequent dosing. Decreased serum concentrations of phenytoin the active metabolite of CEREBYX may occur during pregnancy because of altered phenytoin pharmacokinetics [see Clinical Pharmacology Prior to complete conversion, immunoanalytical techniques may significantly overestimate plasma phenytoin concentrations due to cross-reactivity with fosphenytoin.

Continue typing to refine. This registry is collecting information about the safety of antiepileptic drugs inser pregnancy [see Use in Specific Populations 8. Pro-Epanutin should not be used in women of childbearing potential unless other antiepileptic drugs are ineffective or not tolerated and when possible, the woman is made aware of the risk of potential harm to the foetus and the importance of planning pregnancy.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

It is therefore more appropriate to measure plasma unbound phenytoin concentrations rather than plasma total phenytoin concentrations in these patients see section 5. If the rash is of a milder type measles-like or scarlatiniformtherapy may be resumed after the rash has completely disappeared.

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In order to obtain rapid seizure control in patients with continuous seizure activity IV diazepam or lorazepam should be administered prior to administration of Pro-Epanutin. For Dose reduction in the Elderly or patients with Renal or Hepatic impairment, please see guidance towards the end of this section. Following administration of single IV CEREBYX doses of to mg PE, mean maximum total phenytoin concentrations increase in proportion to dose, but do not change appreciably with changes in infusion rate.

Monitoring of Patients Continuous monitoring of electrocardiogram, blood pressure and respiratory function for the duration of the infusion is essential.

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

The severe sensory disturbance lasted from 3 to 50 minutes packkage 6 of these subjects and for 14 hours in the seventh subject. Other signs include tremor, hyperreflexia, lethargy, slurred speech, nausea, vomiting, coma, and hypotension. Attention to these details may prevent some Pro-Epanutin medication errors from occurring.

Fosphenytoin should be discontinued packabe an alternative etiology for the signs and symptoms cannot be established. Haematopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin.

Temporary substitution for oral phenytoin. Reduction in rate of administration or discontinuation of dosing may be needed [see Dosage and Administration 2.

Renal or Hepatic Impairment: Other common manifestations include arthralgias, jaundice, hepatomegaly, leukocytosis, and eosinophilia. The potential of fosphenytoin to induce intra-arterial irritation was not assessed. Similarly, if there is a history of hypersensitivity reactions to these structurally similar drugs in the patient or immediate family members, consider alternatives to CEREBYX.

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Dilution Cerebyx ® -fosphenytoin – GlobalRPH

Date of first authorisation: See Table 3 for infusion times. The lethal dose in pediatrics is not known. After administration of a loading dose, maintenance doses should typically be started at the next identified dosing interval. Women of childbearing potential should use effective contraception during treatment.

Monitoring insedt phenytoin serum levels is recommended when a drug interaction is suspected.

The following drug interactions are the most commonly occurring drug interactions with phenytoin:. Drugs highly bound to albumin could also increase the fosphenytoin unbound fraction with the potential fospphenytoin increase the rate of conversion of fosphenytoin to phenytoin. Concurrent adverse events or clinical laboratory change suggesting an allergic process were not seen [see Warnings and Precautions 5.

This may or may not be associated with extravasation. Fosphenytoin displaces phenytoin from protein binding sites.

Discontinue if an alternative etiology cannot be established. Some patients experienced symptoms for hours. Inform patients that certain over-the-counter medications e.