FOSPHENYTOIN PACKAGE INSERT PDF

FOSPHENYTOIN PACKAGE INSERT PDF

May 7, 2020 Environment by admin

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.

Author: Kigashakar Zolomuro
Country: Denmark
Language: English (Spanish)
Genre: Music
Published (Last): 28 May 2005
Pages: 207
PDF File Size: 15.81 Mb
ePub File Size: 17.46 Mb
ISBN: 222-2-83640-735-9
Downloads: 72962
Price: Free* [*Free Regsitration Required]
Uploader: Yorn

Although the risk of cardiovascular toxicity increases with infusion rates above the recommended infusion rate, these events have also been reported at or below the recommended infusion rate.

For example, if the intended dose frequency is every 12 hours then the first maintenance dose of Pro-Epanutin should be administered 12 hours after the loading dose.

Dose reductions or discontinuation should be done gradually. Because the fraction of unbound phenytoin the active metabolite of CEREBYX is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction fosphrnytoin those patients.

Advise patients of the early signs and symptoms of severe cutaneous adverse reactions and to report any occurrence immediately to a physician [ see Warnings and Precautions 5. Pro-Epanutin is a prodrug of phenytoin and accordingly, its anticonvulsant effects are attributable to phenytoin.

HIGHLIGHTS OF PRESCRIBING INFORMATION

Phenytoin crosses the placenta in humans. For current full prescribing information, please visit www. Plasma concentrations of phenytoin should be monitored during concomitant treatment with nelfinavir. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for fosphenytoin.

The rate of conversion of IV Pro-Epanutin to phenytoin may be increased in these patients. Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see Dosage and Administration 2.

  MALAYALAM AKSHARAMALA PDF

Renal and urinary disorders Not known interstitial nephritis General disorders and administration site conditions Common injection-site reaction, injection-site pain, asthenia, chills Not known feeling of warmth or tingling in the groin. Table 3 displays dosing information for seizure treatment or prophylaxis loading dose in adults. Discontinue at the first sign of a rash, unless clearly not drug-related.

In women of childbearing potential 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.

To help minimize confusion, the prescribed dose of Pro-Epanutin should always be expressed in milligrams of phenytoin equivalents mg PE see section 4.

Breast-feeding It is not known whether Pro-Epanutin is excreted in human milk. In controlled trials, IM Cerebyx was administered as a single daily dose utilizing either 1 or 2 injection sites. Whether or pakcage phenytoin has the same effect on other non-depolarizing agents is unknown.

Drugs that may decrease plasma phenytoin concentrations listed by likely mechanism: IM Cerebyx should not be used in the treatment of status epilepticus because therapeutic phenytoin concentrations may not be reached as quickly as with IV administration.

This has the potential to increase the frequency and severity of adverse events. Fosphenytoin had no effect on fertility in male rats. Metabolism and nutrition disorders. The product should not be stored at room temperature for more than 48 hours. The clinical course of acute phenytoin hepatotoxicity ranges fosphenytokn prompt recovery to fatal outcomes.

Alterations in dosing may pacjage necessary in patients with impaired kidney or liver function, elderly patients or those who are gravely ill see section 4. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of packabe toxicity. Advise patients to discontinue CEREBYX and seek immediate medical care if they develop signs or symptoms of angioedema such as facial, perioral, or upper airway swelling [ see Warnings and Precautions 5.

  APOSTILA DE TRAADOS DE CALDEIRARIA EM PDF

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

The adequacy of the respiratory and circulatory systems should be carefully observed and appropriate supportive measures employed. Phenytoin is highly bound to plasma proteins, primarily albumin, although to a lesser extent than fosphenytoin.

If early signs of dose-related central nervous system CNS toxicity develop, serum levels should be checked immediately. Drugs that may increase phenytoin serum levels. Cardiac adverse events have also been reported in adults and children without underlying cardiac disease or comorbidities and at recommended doses and infusion rates. Prior to complete conversion, immunoanalytical techniques may significantly overestimate plasma phenytoin concentrations due to cross-reactivity with fosphenytoin.

Attention to these details may prevent some Pro-Epanutin medication errors from occurring. Fosphenytoin is metabolized to phenytoin, phosphate, and formate.

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

The molecular structure of fosphenytoin is: Alcohol Use Acute alcohol intake may increase plasma phenytoin concentrations while chronic alcohol use may decrease plasma phenytoin concentrations. In humans, prenatal exposure to phenytoin the active metabolite of CEREBYX may increase the risks for congenital malformations and other adverse developmental outcomes. It may also produce lower than normal values for dexamethasone or metyrapone tests.

If administration of Pro-Epanutin does not terminate seizures, the use of alternative anticonvulsants should be considered. Advise the patient that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. The most significant drug interactions following administration of CEREBYX are expected to occur with drugs that interact with phenytoin.

Since fosphenytoin is a prodrug of phenytoin, the carcinogenicity results with phenytoin can be extrapolated.