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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Table 9 displays dosing information for seizure treatment or prophylaxis maintenance dose in children. Marketing authorisation number s 9. Caution is advised when administering Pro-Epanutin in patients requiring phosphate restriction, such as those with severe renal impairment.

Intramuscular IM inserf is not recommended for children. These events were dose and rate related. Gender and race have no significant impact on fosphenytoin or phenytoin pharmacokinetics.

Musculoskeletal and connective tissue disorders Uncommon muscular weakness, muscle twitching, muscle spasms Not known systemic lupus erythematosus, polyarthritis, Purple Glove Syndrome see section 4.

Vascular disorders Common vasodilatation, hypotension Respiratory, thoracic and mediastinal disorders Not known pneumonitis, alterations in respiratory function including respiratory arrest.

Fosphenytoin displaces phenytoin from protein binding sites. Phenytoin metabolism is slightly decreased in elderly patients. Intramuscular IM administration of Pro-Epanutin is not recommended in the treatment of status epilepticus.

Phenytoin is highly bound to plasma proteins, primarily albumin, although to a lesser extent than fosphenytoin. Body as a Whole: Cerebyx should always be prescribed and dispensed in phenytoin sodium equivalent units PE.

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

Drug a Mechanism Antineoplastic agents Carbamazepine Chlordiazepoxide Ciprofloxacin Diazepam Phenobarbital Phenothiazines Sodium valproate Valproic acid Certain antacids Unknown a This list is not intended to be inclusive or comprehensive. 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.

Phenytoin metabolism may be reduced in patients with hepatic impairment resulting in increased plasma phenytoin concentrations see section 4. Angioedema 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.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

Appropriate dose, dosing volume, number of vials of Pro-Epanutin, volume of diluent, and minimum infusion time should always be calculated for the patient’s exact body weight pxckage not included in the examples. 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 fsophenytoin site. Postpartum restoration of the gosphenytoin dosage will probably be indicated [see Use in Specific Populations 8.

Pro-Epanutin is intended for short-term parenteral administration, and has not been evaluated for periods of more than 5 days. 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.

Phenytoin is highly bound to plasma proteins, primarily albumin, although to a lesser extent than fosphenytoin. Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required. Pro-Epanutin must be diluted to a concentration ranging from 1.

If based on a careful evaluation of the risks and the benefits, Pro-Epanutin treatment is continued during the pregnancy, it is recommended to use the lowest effective dose and to institute specialized prenatal monitoring, oriented on the possible occurrence of the described malformations. Studies related to neurodevelopmental risk in children exposed to phenytoin during pregnancy are contradictory and a risk cannot be excluded.

Cardiac arrhythmias have included bradycardia, heart block, QT interval prolongation, ventricular tachycardia, and ventricular fibrillation which have resulted in asystole, cardiac arrest, and death. This may or may not be associated with extravasation. The interval between first drug exposure and symptoms is usually weeks of treatment but has also been reported in individuals receiving anticonvulsants for 3 or more months.

Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind. In contrast, switching between IM and oral phenytoin requires dosage adjustments because of slow and erratic phenytoin absorption from muscle. Rapid intravenous administration of CEREBYX increases the risk of adverse fosphenytojn reactions, including severe hypotension and cardiac arrhythmias.

The clinical course of acute phenytoin hepatotoxicity ranges from prompt recovery to fatal outcomes. Phenytoin sodium equivalents PE: Fosphenytoin is completely converted to phenytoin following IV administration, with a half-life of approximately 15 minutes.

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Abrupt withdrawal of antiepileptic drugs may increase seizure frequency and may lead to status epilepticus. Additionally, consider alternatives to structurally similar drugs such as carboxamides e.

Fosphenyotin phenytoin affects ventricular automaticity. Carcinogenesis [see Warnings and Precautions 5. An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics.

Date of first authorisation: These reactions did not increase in severity with repeated administration. Phenytoin may also cause increased serum levels of gamma glutamyl transpeptidase GGT. Pro-Epanutin is a prodrug of phenytoin and accordingly, its anticonvulsant effects are attributable to phenytoin.

The addition or withdrawal of these agents in patients on phenytoin therapy may require an adjustment of the phenytoin dose to achieve optimal clinical outcome. Blood and the lymphatic system disorders Not known leukopenia, granulocytopenia, agranulocytosis, pancytopenia with or without bone marrow suppression, thrombocytopenia, aplastic anaemia, lymphadenopathy.

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. In addition, advise the patient that these signs and symptoms should be reported even if mild or when occurring after extended use [see Warnings and Precautions 5.

This drug-induced condition can be prevented with vitamin K administration to the mother before delivery and to the neonate after birth. 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. Prenatal exposure to phenytoin the active metabolite of CEREBYX may increase the risks for congenital malformations and other adverse developmental outcomes [see Use in Specific Populations 8.

In some cases, overdoses were associated with fatal outcomes, including in children under 5 years of age.

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