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CEREBYX®(fosphenytoin sodium)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

CEREBYX® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES

The rate of intravenous CEREBYX administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg...

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1 INDICATIONS AND USAGE

CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions to Avoid Dosing Errors

Use caution when administering CEREBYX because of the risk of dosing...

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3 DOSAGE FORMS AND STRENGTHS

CEREBYX Injection is a clear, colorless to pale yellow solution available as 50 mg phenytoin sodium equivalents (PE) per mL in:

  • 10 mL single-dose injection vials, each...
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4 CONTRAINDICATIONS

CEREBYX is contraindicated in patients with:

  • A history of hypersensitivity to CEREBYX or its inactive ingredients, or to phenytoin or other hydantoins [see...
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5 WARNINGS AND PRECAUTIONS

5.1 Dosing Errors

Phenytoin Sodium Equivalents (PE)

...

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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

  • Cardiovascular Risk Associated with Rapid Infusion [see

    6.1 Clinical...

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7 DRUG INTERACTIONS

Fosphenytoin is extensively bound to human plasma proteins. Drugs highly bound to albumin could increase the unbound fraction of fosphenytoin. Although, it is unknown whether this could result in...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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10 OVERDOSAGE

Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis, and death have been reported in cases of overdosage with CEREBYX.

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11 DESCRIPTION

CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Fosphenytoin is a prodrug of phenytoin and accordingly, its anticonvulsant effects are attributable to phenytoin....

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

Infusion tolerance was evaluated in clinical studies. One double-blind study assessed infusion-site tolerance of equivalent loading doses (15 to 20 mg PE/kg) of CEREBYX infused at 150 mg PE/min or...

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

CEREBYX Injection is a clear, colorless to pale yellow solution supplied as follows:

...
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17 PATIENT COUNSELING INFORMATION

Cardiovascular Risk Associated with Rapid Infusion

Inform patients that rapid intravenous administration...

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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