Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

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®Index Section (fosphenytoin sodium)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions to Avoid Dosing Errors

2.2 Preparation

2.3 Status Epilepticus

2.4 Non-emergent Loading and Maintenance Dosing

2.5 Laboratory Tests and Monitoring Levels

2.6 Parenteral Substitution for Oral Phenytoin Therapy

2.7 Dosing in Patients with Renal or Hepatic Impairment or Hypoalbuminemia

2.8 Dosing in Geriatrics

2.9 Dosing during Pregnancy

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Dosing Errors

5.2 Cardiovascular Risk Associated with Rapid Infusion

5.3 Withdrawal Precipitated Seizure, Status Epilepticus

5.4 Serious Dermatologic Reactions

5.5 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

5.6 Hypersensitivity

5.7 Angioedema

5.8 Hepatic Injury

5.9 Hematopoietic Complications

5.10 Sensory Disturbances

5.11 Local Toxicity (Including Purple Glove Syndrome)

5.12 Phosphate Load

5.13 Renal or Hepatic Disease or Hypoalbuminemia

5.14 Exacerbation of Porphyria

5.15 Teratogenicity and Other Harm to the Newborn

5.16 Hyperglycemia

5.17 Serum Phenytoin Levels above Therapeutic Range

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Drugs that Affect Phenytoin or CEREBYX

7.2 Drugs Affected by Phenytoin or CEREBYX

7.3 Drug/Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal and/or Hepatic Impairment, or Hypoalbuminemia

8.7 Use in Patients with Decreased CYP2C9 Function

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.5 Pharmacogenomics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event