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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If such signs and symptoms occur, the patient should be evaluated immediately. A potentially life-threatening bleeding disorder related to decreased levels of vitamin K-dependent clotting factors may occur in newborns exposed to phenytoin in utero.

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

For this reason, plasma phenytoin concentrations may increase when IM or IV Pro-Epanutin is substituted for oral phenytoin sodium therapy. Following CEREBYX administration, it is recommended that phenytoin concentrations not be monitored until conversion to phenytoin is essentially complete.

Boxes of 25 vials with 2 mL solution. Show table of contents Hide table of contents 1. However, postpartum restoration of the original dosage will probably be indicated. Pregnancy Risk related to antiepileptic medicinal products in general When possible, medical advice regarding the potential risks to a foetus caused by both seizures and antiepileptic treatment should be given to all women of childbearing potential taking antiepileptic treatment, and especially to women planning pregnancy and women who are pregnant.

Chromatographic assay methods e.

The pharmacokinetics of phenytoin following IV administration of Pro-Epanutin, are complex and when used in an emergency paackage e. Administration pavkage phenytoin to pregnant animals resulted in an insrt incidence of fetal malformations and foslhenytoin manifestations of developmental toxicity including embryofetal death, growth impairment, and behavioral abnormalities in multiple species at clinically relevant doses [see Data ].

Vials that develop particulate matter should not be used. Meta-analyses pacmage data from published observational studies and registries have estimated an approximately 2. There have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy.

An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Alterations in dosing may be necessary in patients with impaired kidney or liver function, elderly patients or those who are gravely ill see section 4.

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Intravenous IV Infusion rate Adults: The effect of continuing infusion unaltered in the presence of these sensations is unknown. Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes.

The fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. Severe cardiovascular reactions including atrial and ventricular conduction depression, ventricular fibrillation, asystole and fatalities have been reported following phenytoin and fosphenytoin administration.

HPLC accurately quantitate phenytoin concentrations in biological fluids in the presence of fosphenytoin. Last updated on eMC: Death is caused by respiratory and circulatory depression.

Cisatracurium, pancuronium, rocuronium and vecuronium: After administration of a loading dose, maintenance doses should typically be started at the next identified dosing interval.

Large amounts of phosphate, delivered rapidly, could potentially cause hypocalcaemia with paraesthesia, muscle spasms and seizures. Blood and the lymphatic system disorders Not known leukopenia, granulocytopenia, agranulocytosis, pancytopenia with or without bone marrow suppression, thrombocytopenia, aplastic packzge, lymphadenopathy.

Cerebyx has important differences in administration from those for parenteral phenytoin sodium see below. The location of the discomfort varied among subjects with the groin mentioned most frequently as an area of discomfort. Diabetes Phenytoin may raise blood glucose in diabetic patients.

There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term pzckage with phenytoin. There are marked variations among individuals with respect to plasma phenytoin concentrations where toxicity occurs. Musculoskeletal and connective tissue disorders. Infusion tolerance was evaluated in clinical studies.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

The effect of age on the pharmacokinetics of fosphenytoin was evaluated in patients 5 to 98 years of age. Mutagenesis An increase in structural chromosome aberrations were observed in cultured V79 Chinese hamster lung cells exposed to fosphenytoin in the presence of metabolic activation.

The adverse events most commonly associated with withdrawal were pruritus 0. Both treatments were administered for 5 days.

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

Equally phenytoin may affect the metabolism of a number of other drugs because of its potent enzyme-inducing potential. The phosphate load provided by Pro-Epanutin is 0.

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Alcohol Use Acute alcohol intake may increase plasma phenytoin concentrations while chronic alcohol use may decrease plasma phenytoin concentrations. Drugs highly bound to albumin could also increase the fosphenytoin unbound fraction with the potential to increase the rate of conversion of fosphenytoin to phenytoin. If the rash recurs upon reinstitution of therapy, further fosphenytoin or phenytoin administration is contraindicated. Conversion could be affected by alterations in the level of phosphatase activity, but given the abundance and wide distribution of phosphatases in the body it is unlikely that drugs would affect this activity enough to affect conversion of fosphenytoin to phenytoin.

Because the fraction of unbound phenytoin the active metabolite of CEREBYX is increased in patients with renal or hepatic fospuenytoin, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. The overall incidence of adverse reactions and the types of adverse reactions seen were similar among children and adults treated with CEREBYX.

Initial symptoms may resemble an acute viral infection. Vials that develop particulate matter should not be used. The amount and concentration of fosphenytoin is always expressed in terms of mg PE.

Coadministration of Pro-Epanutin is contra-indicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors see section 4. Large amounts of phosphate, fosphenytion rapidly, could potentially cause hypocalcemia with paresthesia, muscle spasms, and seizures.

Local irritation following IV or IM dosing or inadvertent fospphenytoin administration was less severe with fosphenytoin than with phenytoin and was generally comparable to that observed with vehicle injections. Prior to complete conversion, immunoanalytical techniques may significantly overestimate plasma phenytoin concentrations due to cross-reactivity with fosphenytoin. The sensations are not consistent with the signs of an allergic reaction and may be avoided or minimised by using a slower rate of IV infusion or by temporarily stopping the infusion.

Attention to these details may prevent some Pro-Epanutin medication errors from occurring.