FOSPHENYTOIN

Fosphenytoin is a prodrug of phenytoin. Fosphenytoin sodium is indicated as a short-term substitute for oral phenytoin in patients with seizure disorders and should only be used when oral phenytoin administration is not possible (Prod Info CEREBYX(R) intravenous injection, 2014).

FORMS

Fosphenytoin is supplied in vials containing a ready-mixed solution of 75 mg/mL fosphenytoin sodium, which is equivalent to 50 mg/mL phenytoin sodium (Prod Info CEREBYX(R) intravenous injection, 2014).

-CLINICAL EFFECTS

GENERAL CLINICAL EFFECTS

USES: Fosphenytoin is an anticonvulsant prodrug of phenytoin, used for seizure prophylaxis and treatment.

PHARMACOLOGY: Fosphenytoin is an anticonvulsant that is metabolized to phenytoin and regulates voltage-dependent sodium and calcium channels and enhances sodium-potassium ATPase activity. The modulation of voltage-dependent sodium channels is the primary means of anticonvulsant activity.

TOXICOLOGY: Toxicity is an extension of therapeutic effects. Patients may develop CNS depression, ataxia, nausea, vomiting and eventually coma and respiratory depression. Cardiac effects are much less common with IV infusion than with phenytoin because propylene glycol is not used as a diluent for fosphenytoin.

EPIDEMIOLOGY: Poisoning is uncommon and rarely severe.

WITH POISONING/EXPOSURE

MILD TO MODERATE TOXICITY: Nausea, vomiting, lethargy, nystagmus, ataxia, dysarthria, hyperreflexia, and mild sedation.
SEVERE TOXICITY: Hypotension, dysrhythmias, asystole, CNS depression, mental status changes, hallucinations, hypocalcemia, coma, metabolic acidosis, and cardiac arrest may occur.

WITH THERAPEUTIC USE

The most common side effects of fosphenytoin administration are pruritus, hypotension, dysrhythmias, nystagmus, dizziness, somnolence, lightheadedness, ataxia, paresthesias, headache, tremor, agitation, hypesthesia, dysarthria, vertigo, hyperreflexia, intracranial hypertension, and altered mental status. OTHER EFFECTS: Nausea, vomiting, injection site pain and inflammation, hyperglycemia, hypocalcemia, pelvic pain, asthenia, and back pain.

Editor's Note: An ERG guide with information appropriate to this material does not exist.

-FIRST AID

FIRST AID AND PREHOSPITAL TREATMENT

Fosphenytoin is administered parenterally; gastrointestinal decontamination is not useful.

-RANGE OF TOXICITY

MINIMUM LETHAL EXPOSURE

GENERAL/SUMMARY

Massive overdoses of fosphenytoin have resulted from misinterpretation of vial labeling. Practitioners have confused the Phenytoin Equivalent (PE) per mL and the total vial mL content. Fosphenytoin vials, both the 2 mL and the 10 mL vials, have a 50 mg PE/mL concentration. Therefore, the 2 mL vials contain a total of 100 mg PE and the 10 mL vials contain 500 mg PE (Parker F, 2006).
Lateral gaze nystagmus generally appears at phenytoin concentrations greater than 20 mcg/mL (80 mcmol/L), ataxia at concentrations 30 mcg/mL (120 mcmol/L), and dysarthria and lethargy at concentrations greater than 40 mcg/mL (160 mcmol/L) (Prod Info CEREBYX(R) intravenous injection, 2013).

PEDIATRIC

CASE REPORT: A 15-month-old boy with Down's Syndrome suffered a seizure and was taken to the Emergency Department. An order was written for 200 mg of fosphenytoin and the dose was administered. Shortly after receiving the dose the patient expired. It was then determined that 2000 mg of fosphenytoin was inadvertently given. Post mortem serum phenytoin concentration was 110 mcg/mL (Litovitz et al, 2002).
CASE REPORT: A 6-year-old boy was admitted after a fall resulting in a fractured right temporal bone and small subdural hematoma occurred. Seizures developed and a loading dose of fosphenytoin 15 mg PE/kg IV was ordered. At 20 kg, the child's dose was calculated as 300 mg PE. Once administered, the child experienced a cardiac arrest and resuscitation was unsuccessful. It was then discovered that 3000 mg PE of fosphenytoin had been given in error (Institute for Safe Medication Practices, 1999).
CASE REPORT: A 2-year-old boy with a history of seizure disorder was admitted to the ICU in status epilepticus and metabolic acidosis. Lorazepam and fosphenytoin IV were given. A total of three 10 mL vials of fosphenytoin (1500 mg PE) was administered instead of 3 mL of fosphenytoin (150 mg PE). Shortly after fosphenytoin administration, the patient went into ventricular tachycardia followed by ventricular fibrillation and cardiac arrest. Resuscitation was successful and a vasopressor infusion was required to maintain a systolic blood pressure of 70 to 80 mm Hg. Despite multiple vasopressors, the child remained profoundly hypotensive and expired 18 hours later. The phenytoin concentration was greater than 72 mcg/mL, declining to 40 mcg/mL prior to death (Litovitz et al, 1999).
CASE REPORT: An 18-month-old boy weighing 11 kg was inadvertently administered 2000 mg of IV fosphenytoin and developed bradycardia then asystole. Despite 3 hours of aggressive resuscitation, including prolonged CPR, epinephrine, atropine, magnesium, albumin and an exchange transfusion the patient died (Watson et al, 2004).

MAXIMUM TOLERATED EXPOSURE

ADULT

CASE REPORT: A 74-year-old woman (weight, 58 kg) with chronic subdural hematoma developed coma after receiving 10 times the prescribed fosphenytoin (prescribed dose: 375 mg) for postoperative prophylaxis of seizures. The phenytoin blood concentration was 79 mcg/mL (normal 10 to 20 mcg/mL). Following supportive care, including 5 days of mechanical ventilation, she gradually improved. No cardiovascular effects were observed. Her phenytoin serum concentration returned to therapeutic range on day 8. She was discharged after 20 days of hospitalization (Presutti et al, 2000).

PEDIATRIC

CASE REPORT: A 9-month-old developmentally delayed infant developed severe cardiomyopathy after an inadvertent infusion of fosphenytoin 125 mg/kg rather than 15 to 20 mg/kg. She was treated with multiple vasoactive agents and hydrocortisone. She received further treatment with activated charcoal, folate, phenobarbital, and albumin. As her phenytoin level declined, she gradually improved. Serum phenytoin was undetectable 7 days after the exposure. At 7-month follow up, her cardiac assessment was normal (Grageda et al, 2013).
CASE REPORT: Hypotension (systolic blood pressure, 30 torr) was reported in a 13-day-old infant after an inadvertent intravenous fosphenytoin overdose of 300 mg (110 mg/kg) (phenytoin equivalent) as a 15 minute infusion. Bradycardia followed by asystole occurred. The infant recovered following resuscitation and vasopressors (Lieber & Snodgrass, 1998).

Carcinogenicity Ratings for CAS93390-81-9 :

ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
EPA (U.S. Environmental Protection Agency, 2011): Not Listed
IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
MAK (DFG, 2002): Not Listed
NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

TOXICITY AND RISK ASSESSMENT VALUES

EPA IRIS

EPA Risk Assessment Values for CAS93390-81-9 (U.S. Environmental Protection Agency, 2011):

Not Listed

TOXICITY VALUES

PHENYTOIN
- LD50- (INTRAVENOUS)DOG:
- LD50- (INTRAVENOUS)MOUSE:
- LD50- (INTRAVENOUS)RAT:

-STANDARDS AND LABELS

WORKPLACE STANDARDS

ACGIH TLV Values for CAS93390-81-9 (American Conference of Governmental Industrial Hygienists, 2010):

Not Listed

AIHA WEEL Values for CAS93390-81-9 (AIHA, 2006):

Not Listed

NIOSH REL and IDLH Values for CAS93390-81-9 (National Institute for Occupational Safety and Health, 2007):

Not Listed

OSHA PEL Values for CAS93390-81-9 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):

Not Listed

OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS93390-81-9 (U.S. Occupational Safety and Health Administration, 2010):

Not Listed

ENVIRONMENTAL STANDARDS

EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS93390-81-9 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS93390-81-9 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA RCRA Hazardous Waste Number for CAS93390-81-9 (U.S. Environmental Protection Agency, 2010b):

Not Listed
Editor's Note: The D, F, and K series waste numbers and Appendix VIII to Part 261 -- Hazardous Constituents were not included. Please refer to 40 CFR Part 261.

EPA SARA Title III, Extremely Hazardous Substance List for CAS93390-81-9 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA SARA Title III, Community Right-to-Know for CAS93390-81-9 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):

Not Listed

DOT List of Marine Pollutants for CAS93390-81-9 (49 CFR 172.101 - App. B, 2005):

Not Listed

EPA TSCA Inventory for CAS93390-81-9 (EPA, 2005):

Not Listed

LABELS

NFPA

NFPA Hazard Ratings for CAS93390-81-9 (NFPA, 2002):

Not Listed

-PERSONAL PROTECTION

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

PROTECTIVE CLOTHING

CHEMICAL PROTECTIVE CLOTHING. Search results for CAS 93390-81-9.

Specific recommendations and test data for this chemical were not found in the available manufacturers' product literature. A complete list of consulted manufacturers and references is presented below.

-PHYSICAL HAZARDS

FIRE HAZARD

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

FLAMMABILITY CLASSIFICATION

NFPA Flammability Rating for CAS93390-81-9 (NFPA, 2002):

Not Listed

FIRE CONTROL/EXTINGUISHING AGENTS

Editor's Note: An ERG guide with information appropriate to this material does not exist.

NFPA Extinguishing Methods for CAS93390-81-9 (NFPA, 2002):

Not Listed

EVACUATION PROCEDURES

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

AIHA ERPG Values for CAS93390-81-9 (AIHA, 2006):

Not Listed

DOE TEEL Values for CAS93390-81-9 (U.S. Department of Energy, Office of Emergency Management, 2010):

Not Listed

AEGL Values for CAS93390-81-9 (National Research Council, 2010; National Research Council, 2009; National Research Council, 2008; National Research Council, 2007; NRC, 2001; NRC, 2002; NRC, 2003; NRC, 2004; NRC, 2004; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; United States Environmental Protection Agency Office of Pollution Prevention and Toxics, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; 62 FR 58840, 1997; 65 FR 14186, 2000; 65 FR 39264, 2000; 65 FR 77866, 2000; 66 FR 21940, 2001; 67 FR 7164, 2002; 68 FR 42710, 2003; 69 FR 54144, 2004):

Not Listed

NIOSH IDLH Values for CAS93390-81-9 (National Institute for Occupational Safety and Health, 2007):

Not Listed

CONTAINMENT/WASTE TREATMENT OPTIONS

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

SMALL LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

LARGE LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

-PHYSICAL/CHEMICAL PROPERTIES

MOLECULAR WEIGHT

406.24 (Prod Info CEREBYX(R) injection, 2002)

DESCRIPTION/PHYSICAL STATE

Clear, colorless to pale yellow, sterile solution (Prod Info CEREBYX(R) injection, 2002)

8.6 to 9.0 (Prod Info CEREBYX(R) injection, 2002)

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GENERAL BIBLIOGRAPHY

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40 CFR 372.65: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Chemicals and Chemical Categories to which this part applies. National Archives and Records Association (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Apr 3, 2006.

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65 FR 14186: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

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66 FR 21940: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2001.

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Classification | Information to evaluate chemical incidents

Information to evaluate chemical incidents

Information to evaluate chemical incidents

Information to evaluate chemical incidents