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.
Not a healthcare professional? Go to the patient or caregiver website.

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

How Supplied/Storage and Handling

Show Hide

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 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.

16.2 Storage and Handling

Store under refrigeration at 2°C to 8°C (36°F to 46°F). The product should not be stored at room temperature for more than 48 hours. Vials that develop particulate matter should not be used.

Injection vials are single-dose only. After opening, any unused product should be discarded.

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.

*Contact Medical Information. 9AM-5PM ET Monday to Friday; excluding holidays.

*9AM-5PM ET Monday to Friday; excluding holidays.

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch