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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Fertility In animal studies, fosphenytoin had no effect on fertility in male rats but decreased fertility in female rats see section 5.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies.
Some of these reactions have been fatal see section 4. Do not confuse the amount of drug to be given in PE with the concentration of the drug in the vial. Some of these events have been fatal or life threatening.
Accordingly, at the first sign of acute toxicity, serum levels should be paxkage checked. No developmental effects were observed in offspring of pregnant rabbits given fosphenytoin; malformations have been reported in offspring of pregnant rabbits given phenytoin.
In contrast, mean maximum unbound phenytoin concentrations increase with both dose and rate. The potential of fosphenytoin to induce intra-arterial irritation was not assessed. Haematopoietic System Haematopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin.
Rapid intravenous administration of CEREBYX increases the risk of adverse cardiovascular reactions, including severe hypotension and cardiac arrhythmias. Find out more here.
However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary.
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.
Pro-Epanutin Concentrate for Infusion / Solution for Injection
Paraesthesia and pruritus, however, were seen much more often following fosphenytoin administration and occurred more often with IV fosphenytoin administration than IM fosphenytoin administration. CEREBYX should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Warnings and Precautions 5. It may packag produce lower than normal values for dexamethasone or metyrapone tests.
Total exchange transfusion has been knsert in the treatment of severe intoxication in children. There are marked variations among individuals with respect to serum phenytoin concentrations where toxicity occurs.
Administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations inseert other manifestations of developmental toxicity including embryofetal death, growth impairment, and behavioral abnormalities in multiple species at clinically relevant doses [see Data ]. Death is caused by respiratory and circulatory depression.
Dilution Cerebyx ® -fosphenytoin – GlobalRPH
Reduction in rate of administration or discontinuation of dosing may be needed [see Dosage and Administration 2. Phenytoin may decrease serum concentrations of T 4. Hypotension can occur when either drug is administered rapidly by the IV route.
Table 5 displays dosing information for the temporary substitution of oral phenytoin sodium in adults. Hepatic Injury The liver is the rosphenytoin site of biotransformation of phenytoin. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for fosphenytoin.
For single use only. See Table 9 for infusion times. Therefore, careful cardiac including respiratory monitoring is needed when administering IV loading doses of fosphenytoin. Initial symptoms of Pro-Epanutin toxicity are those associated with acute phenytoin toxicity.
FOSPHENYTOIN SODIUM Injection mg PE in 2ml Vial mg PE in 10 ml Vial | Mylan
The amount and concentration of fosphenytoin is always expressed in terms of mg of phenytoin sodium equivalents mg PE. 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. Inert precipitate status epilepticus.
IM Cerebyx should not be used in the insegt of status epilepticus because therapeutic phenytoin concentrations may not be reached as quickly as with IV administration. Parenteral phenytoin affects ventricular automaticity. To view the changes to a medicine you must sign up and log in. Musculoskeletal and connective tissue disorders Uncommon pacjage weakness, muscle twitching, muscle spasms Not known systemic lupus erythematosus, polyarthritis, Purple Glove Syndrome see section 4.
Show table of contents Hide table of contents 1. The incidences of hepatocellular tumors were increased in female mice at all but the lowest dose tested.
One mL of Pro-Epanutin contains 75 mg of fosphenytoin sodium equivalent to 50 mg of phenytoin sodium see section 4. When possible, patients should inserh informed of the potential harm to the foetus. Plasma fosphenytoin concentrations following IM administration are lower but more sustained than those following IV administration due to the time required for absorption of fosphenytoin from the injection site. Suicidal Ideation and Behaviour Suicidal ideation and behaviour fos;henytoin been reported in patients treated with anti-epileptic agents in several indications.
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