Fosphenytoin 50 mg/mL
FOSPHENYTOIN SODIUM · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Fosphenytoin is a injection, solution containing fosphenytoin sodium at 50 mg/mL, taken intramuscular. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Fosphenytoin
- Generic Name
- FOSPHENYTOIN SODIUM
- NDC Code (Product)
63323-403- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA078052
- Marketing Start
- 12/14/2009
Recall History
Fresenius Kabi USA, LLC
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Amneal Pharmaceuticals LLC
Presence of Particulate Matter
Fresenius Kabi USA, LLC
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
West-ward Pharmaceutical Corp.
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Amneal Pharmaceuticals
Presence of particulate matter
West-ward Pharmaceutical Corp.
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ] . Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, as short-term use, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The dose, concentration, and infusion rate of fosphenytoin sodium injection should always be expressed as phenytoin sodium equivalents (PE) ( 2.1 ) For Status Epilepticus: Adult loading dose is 15 to 20 mg PE/kg at a rate of 100 to 150 mg PE/min ( 2.3 ) 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: 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 ) 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: Fosphenytoin sodium injection should ordinarily not be given intramuscularly ( 2.3 , 2.4 ) 2.1 Important Administration Instructions to Avoid Dosing Errors Use caution when administering fosphenytoin sodium injection because of the risk of dosing errors [see Warnings and Precautions (5.1) ]. Phenytoin Sodium Equivalents (PE) The d…
Contraindications
4 CONTRAINDICATIONS Fosphenytoin sodium is contraindicated in patients with: A history of hypersensitivity to fosphenytoin sodium injection 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 fosphenytoin sodium on ventricular automaticity. A history of prior acute hepatotoxicity attributable to fosphenytoin sodium 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 fosphenytoin sodium, 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 fosphenytoin sodium 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 fosphenytoin sodium with other drugs that significantly bind to serum albumin. The most significant drug interactions following administration of fosphenytoin sodium 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 fosphenytoin sodium is a potent inducer of hepatic drug-metabolizing enzymes. • Multiple drug interactions because of ext…
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 • Pediatrics: vomiting, nystagmus…
Frequently Asked Questions
What is Fosphenytoin used for?
Fosphenytoin contains FOSPHENYTOIN SODIUM. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Fosphenytoin a controlled substance?
Fosphenytoin is not classified as a controlled substance by the DEA.
What is the generic name for Fosphenytoin?
The generic name for Fosphenytoin is FOSPHENYTOIN SODIUM. There are 11 other brand versions of FOSPHENYTOIN SODIUM.
What is the NDC code for Fosphenytoin 50 mg/mL?
The NDC (National Drug Code) for Fosphenytoin 50 mg/mL is 63323-403, listed by Fresenius Kabi USA, LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)