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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In women of childbearing potential Pro-Epanutin should not be used in women of fosphfnytoin 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.
If early signs of dose-related central nervous system CNS toxicity develop, serum levels should be checked immediately.
The mechanism by which phenytoin affects bone metabolism has not been identified. Other signs include tremor, hyperreflexia, lethargy, slurred speech, nausea, vomiting, coma and hypotension.
Prior to complete conversion, blood samples for phenytoin monitoring should be collected in tubes containing EDTA as an anticoagulant to minimize ex vivo conversion of fosphenytoin to phenytoin. Studies related to neurodevelopmental risk in children exposed to phenytoin during pregnancy are contradictory and a risk cannot be excluded. This information is intended for use by health professionals. In some cases, overdoses were associated with fatal outcomes, including in children under 5 years of age.
HIGHLIGHTS OF PRESCRIBING INFORMATION
This occurs within approximately 2 hours after the end of IV infusion and 4 hours after intramuscular IM injection. Continuous monitoring of electrocardiogram, blood pressure and respiratory function for the duration of the infusion is essential. Care should be taken to ensure the appropriate volume of Pro-Epanutin is withdrawn from the vial when preparing the drug for administration.
The following adverse events have been reported in clinical trials in adults receiving Pro-Epanutin. Phenytoin metabolism may be reduced in patients with hepatic impairment resulting in increased plasma phenytoin concentrations see section 4.
Fertility In animal studies, fosphenytoin had no effect on fertility in male rats but decreased fertility in female rats see section 5. Drugs that may decrease plasma phenytoin concentrations listed by likely mechanism: Postpartum restoration of the original dosage will probably be indicated [see Use in Specific Populations 8. Note, fospgenytoin, that fosphenytoin has important differences in administration from parenteral phenytoin sodium see section 4.
In order to obtain rapid seizure control in patients with continuous seizure activity, IV diazepam packahe lorazepam should be administered prior to administration of Pro-Epanutin. Drugs that may decrease phenytoin serum levels. If signs or symptoms of hypersensitivity are present, evaluate the patient immediately. Parenteral phenytoin affects ventricular automaticity. Inset shows time course for the entire hour sampling period.
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. The molecular structure of fosphenytoin is: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It may also produce low results in dexamethasone or metyrapone tests. Fosphenytoin displaces phenytoin from protein binding sites. The following drug interactions are the insegt commonly occurring drug interactions with phenytoin:. Cases of acute hepatotoxicity, including infrequent cases of acute hepatic failure, have been reported with phenytoin the active metabolite of CEREBYX.
FOSPHENYTOIN SODIUM Injection mg PE in 2ml Vial mg PE in 10 ml Vial | Mylan
Inserg 3 displays dosing information for seizure treatment or prophylaxis loading dose in adults. However, it is not necessary to adjust the initial doses when substituting oral phenytoin with Pro-Epanutin or vice versa. Ensure the appropriate volume is withdrawn from insfrt vial when preparing for administration.
Clinical Considerations Disease-associated maternal risk An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Cases of acute hepatotoxicity, including infrequent cases of acute hepatic failure, have been reported with phenytoin. Drugs that may either increase or decrease phenytoin serum levels.
Phenytoin is not effective in absence seizures. A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy. The pharmacokinetics and protein binding of fosphenytoin, phenytoin, and diazepam were not fosphejytoin when diazepam and CEREBYX were concurrently administered in single submaximal doses.
Drugs that may increase phenytoin serum levels. Ofsphenytoin including craniofacial, cardiovascular, neural, limb, and digit abnormalities were observed in rats, rabbits, and mice at doses as low as75, and See Table 3 for infusion times.
Dilution Cerebyx ® -fosphenytoin – GlobalRPH
Decreased serum concentrations of phenytoin the active metabolite of CEREBYX may occur during pregnancy because of altered phenytoin pharmacokinetics [see Clinical Pharmacology packagd The amount and concentration of fosphenytoin is always expressed in terms of mg PE.
Pro-Epanutin should be used with caution in patients with hypotension and severe myocardial insufficiency.
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. John’s wort may vary widely based on preparation. In case of exposure during pregnancy, children should be closely monitored in relation to neurodevelopmental disorders in order to provide specialized care as soon as possible, if necessary.
The clinical course of acute phenytoin hepatotoxicity ranges from prompt recovery to fatal outcomes. Fosphenyttoin 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. Please refer to tables 1 to 10 for examples of dosing, dilution and infusion time calculations.
Phenytoin is highly bound to plasma proteins, primarily albumin, although to a lesser extent than fosphenytoin. Care should be taken to ensure the appropriate volume of CEREBYX is withdrawn from the vial when preparing the drug for fosphenytkin.
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. The amount and concentration of pacckage is always expressed in terms of mg PE. IM cerebyx is not recommended for tx of status epilepticus.