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CEREBYX® (fosphenytoin sodium)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
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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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Dosing Errors
Phenytoin Sodium Equivalents (PE)
...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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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How Supplied/Storage and Handling
...
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Cardiovascular Risk Associated with Rapid Infusion
Inform patients that rapid intravenous administration...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.