CEREBYX Solution for injection Ref.[10769] Active ingredients:

Source: FDA, National Drug Code (US) Revision Year: 2021

Product 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 phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE.

The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant.

CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE and 10 mL vials containing a total of 500 mg PE, for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution.

The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt.

The molecular structure of fosphenytoin is:

The molecular weight of fosphenytoin is 406.24.

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 containing 500 mg phenytoin sodium equivalents 2 mL single-dose injection vials, each containing 100 mg phenytoin sodium equivalents

How Supplied

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

mg phenytoin sodium equivalents (PE) per vial	Volume per vial (mL)	Package Configuration	NDC
500 mg PE/10 mL vial	10 mL per vial	Package contains 10 vials of NDC 0069-6001-10	NDC 0069-6001-21
100 mg PE/2 mL vial	2 mL per vial	Package contains 25 vials of NDC 0069-6001-02	NDC 0069-6001-25

Both sizes of vials contain Tromethamine, USP (TRIS), Hydrochloric Acid, NF, or Sodium Hydroxide, NF, and Water for Injection, USP.

CEREBYX should always be prescribed in phenytoin sodium equivalents (PE) [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].

1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg PE. The amount and concentration of fosphenytoin is always expressed in terms of mg of phenytoin sodium equivalents (PE). Fosphenytoin’s weight is expressed as phenytoin sodium equivalents to avoid the need to perform molecular weight-based adjustments when substituting fosphenytoin for phenytoin or vice versa.

Drugs

Drug	Countries
CEREBYX	Canada, United States

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