CEREBYX 50 mg/mL

Fosphenytoin Sodium · INJECTION, SOLUTION · Pfizer Laboratories Div Pfizer Inc

No Recall History

Plain English

CEREBYX is a injection, solution containing fosphenytoin sodium at 50 mg/mL, taken intramuscular. Manufactured by Pfizer Laboratories Div Pfizer Inc.

Key Facts

Brand Name: CEREBYX
Generic Name: Fosphenytoin Sodium
NDC Code (Product): 0069-5474
Manufacturer: Pfizer Laboratories Div Pfizer Inc
Strength: 50 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #: NDA020450
Marketing Start: 10/28/2013

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective123 reports

off label use71 reports

cardiac arrest48 reports

hypotension48 reports

status epilepticus48 reports

convulsion41 reports

pyrexia41 reports

seizure41 reports

stevens-johnson syndrome34 reports

blood pressure decreased29 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ] . 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, as short-term use, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • The dose, concentration, and infusion rate of CEREBYX should always be expressed as phenytoin sodium equivalents (PE) ( 2.1 ) • For Status Epilepticus: o Adult loading dose is 15 to 20 mg PE/kg at a rate of 100 to 150 mg PE/min ( 2.3 ) o Pediatric loading dose is 15 to 20 mg PE/kg at a rate of 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) ( 2.3 ) • For Non-emergent Loading and Maintenance Dosing: o Adult loading dose is 10 to 20 mg PE/kg given IV or IM; initial maintenance dose is 4 to 6 mg PE/kg/day in divided doses ( 2.4 ) o Pediatric loading dose is 10 to 15 mg PE/kg at a rate of 1 to 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower); initial maintenance dose is 2 to 4 mg PE/kg every 12 hours at a rate of 1 to 2 mg PE/kg/min (or 100 mg PE/min, whichever is slower) ( 2.4 ) • Intramuscular Administration: o CEREBYX should ordinarily not be given intramuscularly ( 2.3 , 2.4 ) 2.1 Important Administration Instructions to Avoid Dosing Errors Use caution when administering CEREBYX because of the risk of dosing errors [see Warnings and Precautions (5.1) ]. Phenytoin Sodium Equivalents (PE) The dose, concentration, and infusion rate of CEREBYX…

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 Warnings and Precautions (5.6) ] . Reactions have included angioedema. • Sinus bradycardia, sino-atrial block, second and third degree A-V block, or Adams-Stokes syndrome because of the effect of parenteral phenytoin or CEREBYX on ventricular automaticity. • A history of prior acute hepatotoxicity attributable to CEREBYX or phenytoin [see Warnings and Precautions (5.8) ] . • 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. • Hypersensitivity to CEREBYX, its ingredients, phenytoin, hydantoins ( 4 ) • Sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome ( 4 ) • A history of prior acute hepatotoxicity attributable to CEREBYX or phenytoin ( 4 , 5.8 ) • Coadministration with delavirdine ( 4 )

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 clinically significant effects, caution is advised when administering CEREBYX with other drugs that significantly bind to serum albumin. The most significant drug interactions following administration of CEREBYX are expected to occur with drugs that interact with phenytoin. Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19 and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Monitoring of phenytoin serum levels is recommended when a drug interaction is suspected. Phenytoin or CEREBYX is a potent inducer of hepatic drug-metabolizing enzymes. • Multiple drug interactions because of extensive plasma protein binding, satur…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Cardiovascular Risk Associated with Rapid Infusion [see Warnings and Precautions (5.2) ] • Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.3) ] • Serious Dermatologic Reactions [see Warnings and Precautions (5.4) ] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.5) ] • Hypersensitivity [see Warnings and Precautions (5.6) ] • Angioedema [see Warnings and Precautions (5.7) ] • Hepatic Injury [see Warnings and Precautions (5.8) ] • Hematopoietic Complications [see Warnings and Precautions (5.9) ] • Sensory Disturbances [see Warnings and Precautions (5.10) ] • Local Toxicity (Including Purple Glove Syndrome) [see Warnings and Precautions (5.11) ] • Exacerbation of Porphyria [see Warnings and Precautions (5.14) ] • Teratogenicity and Other Harm to the Newborn [see Warnings and Precautions (5.15) ] • Hyperglycemia [see Warnings and Precautions (5.16) ] Most common adverse reactions (incidence ≥10%) are: • Adults: pruritus, nystagmus, dizziness, somnolence, and ataxia • Pedia…

Frequently Asked Questions

What is CEREBYX used for?

CEREBYX contains Fosphenytoin Sodium. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.

Is CEREBYX a controlled substance?

CEREBYX is not classified as a controlled substance by the DEA.

What is the generic name for CEREBYX?

The generic name for CEREBYX is Fosphenytoin Sodium. There are 10 other brand versions of Fosphenytoin Sodium.

What is the NDC code for CEREBYX 50 mg/mL?

The NDC (National Drug Code) for CEREBYX 50 mg/mL is 0069-5474, listed by Pfizer Laboratories Div Pfizer Inc.

Product NDC

0069-5474

Package NDC

0069-5474-02

Other CEREBYX Dosages

Other Fosphenytoin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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