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: Dile Zulutaur
Country: Belgium
Language: English (Spanish)
Genre: Software
Published (Last): 23 November 2015
Pages: 180
PDF File Size: 1.71 Mb
ePub File Size: 3.73 Mb
ISBN: 540-5-70097-958-1
Downloads: 84027
Price: Free* [*Free Regsitration Required]
Uploader: Vit

An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Caution is advised when administering Pro-Epanutin in patients requiring phosphate restriction, such as those with severe renal impairment. Marketing authorisation holder 8. The occurrence and intensity of the discomfort can be lessened by slowing or temporarily stopping the infusion.

Fosphenytoin should be discontinued if an alternative etiology for the signs and symptoms cannot be established. These events were dose and rate related. Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis, and death have been reported in cases of overdosage with CEREBYX. There are marked variations among individuals with respect to plasma phenytoin concentrations where toxicity occurs.

General disorders and administration site conditions. Diabetes Phenytoin may raise blood glucose in diabetic patients. Information on the registry can also be found at the website http: Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

Dilution Cerebyx ® -fosphenytoin – GlobalRPH

The amount and concentration of fosphenytoin is always expressed in terms of mg of phenytoin sodium equivalents PE. The amount and concentration of fosphenytoin is always expressed in terms of mg PE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.


The location of the discomfort varied with the groin mentioned insrrt frequently as a site of involvement. Some of these events have been fatal or life-threatening.

Individual drug labels should be consulted.

Marketing authorisation fowphenytoin s 9. Date of first authorisation: Pro-Epanutin should always be prescribed and dispensed in phenytoin sodium equivalent units PE. In some cases, overdoses were associated with fatal outcomes, including in children under 5 years of age. This product’s label may have been updated. Cerebyx should always be prescribed and dispensed in phenytoin sodium equivalent units PE.

Pro-Epanutin may result in a fosphenytokn of hormonal contraceptives, hence women of childbearing potential should be counselled regarding the use of other effective contraceptive methods see section 4.


However, even with specific assay methods, phenytoin concentrations measured before conversion of fosphenytoin is complete will not reflect phenytoin concentrations ultimately achieved. Unbound concentration of phenytoin may be elevated in patients with hyperbilirubinaemia see section 4.

Although resolution of symptoms may occur without treatment, skin necrosis and limb ischemia have occurred that required surgical interventions and, in rare cases, amputation. The study demonstrated better local tolerance pain and burning at the infusion ineertfewer disruptions of the infusion, and a shorter infusion period for CEREBYX-treated patients Table 5.

Fosphenytoin is metabolized to phenytoin, phosphate, and formate. However, fosphenytoin displaces phenytoin from plasma protein binding sites.

Fosphenytoin had no effect on fertility in male rats. When appropriate, counsel pregnant women pakcage women of childbearing potential about alternative therapeutic options. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. The adverse clinical events most commonly observed with the use of fosphenytoin in clinical trials were nystagmus, dizziness, pruritus, paraesthesia, headachesomnolence, and ataxia.


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

This can be done by calling the packaeg free numberand must be done by patients themselves. Vitamin K has been shown to prevent or correct this defect and has been recommended to be given to the mother during the last gestational month and to the neonate after birth. The risk of serious skin reactions and other hypersensitivity reactions to phenytoin may be higher in black patients. Fosphenytoin conversion to phenytoin is more rapid in patients with renal or hepatic disease than with other patients because of decreased plasma protein binding, secondary to hypoalbuminaemia, occurring in these disease states.

Other common manifestations include jaundice, hepatomegaly, elevated serum transaminase levels, leukocytosis, and eosinophilia. Initial symptoms may resemble an acute viral infection. To view the changes to a medicine you must sign up and log in.

Pro-Epanutin Concentrate for Infusion / Solution for Injection

Plasma concentrations of phenytoin should be monitored during concomitant treatment with nelfinavir. Continuous monitoring of the electrocardiogram, blood pressure, and respiratory function is essential and the patient should be observed throughout the period where maximal serum phenytoin concentrations occur, approximately 10 to 20 minutes after the end of Cerebyx infusions.

Fosphenytoin is extensively bound to human tosphenytoin proteins. Mean total phenytoin half-life values Fosphenytoin displaces phenytoin from protein binding sites.

The clinical course of acute phenytoin hepatotoxicity ranges from prompt recovery to fatal outcomes.