FOSPHENYTOIN- fosphenytoin sodium injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

FOSPHENYTOIN SODIUM (UNII: 7VLR55452Z) (PHENYTOIN - UNII:6158TKW0C5)

Beszerezhető a:

Fresenius Kabi USA, LLC

INN (nemzetközi neve):

FOSPHENYTOIN SODIUM

Összetétel:

PHENYTOIN SODIUM 50 mg in 1 mL

Az alkalmazás módja:

INTRAMUSCULAR

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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 injection on ventricular automaticity. - A history of prior acute hepatotoxicity attributable to fosphenytoin sodium injection or phenytoin

Termék összefoglaló:

Fosphenytoin Sodium Injection, USP is a clear, colorless to pale yellow solution supplied as follows: The container closure is not made with natural rubber latex. Both sizes of vials contain Tromethamine, USP (TRIS), Hydrochloric Acid, NF, or Sodium Hydroxide, NF, and Water for Injection, USP. Fosphenytoin sodium injection, USP 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. 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FOSPHENYTOIN - FOSPHENYTOIN SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOSPHENYTOIN SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FOSPHENYTOIN
SODIUM INJECTION.
FOSPHENYTOIN SODIUM INJECTION, FOR INTRAVENOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1996
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE RATE OF INTRAVENOUS FOSPHENYTOIN SODIUM INJECTION ADMINISTRATION
SHOULD NOT
EXCEED 150 MG PHENYTOIN SODIUM EQUIVALENTS (PE) PER MINUTE IN ADULTS
AND 2 MG
PE/KG/MIN (OR 150 MG PE/MIN, WHICHEVER IS SLOWER) IN PEDIATRIC
PATIENTS BECAUSE OF
THE RISK OF SEVERE HYPOTENSION AND CARDIAC ARRHYTHMIAS.
CAREFUL CARDIAC MONITORING IS NEEDED DURING AND AFTER ADMINISTERING
INTRAVENOUS
FOSPHENYTOIN SODIUM.
REDUCTION IN RATE OF ADMINISTRATION OR DISCONTINUATION OF DOSING MAY
BE NEEDED
(2.3, 2.4, 5.2).
RECENT MAJOR CHANGES
Warnings and Precautions (5.9)
4/2022
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, as short-term use, for oral phenytoin.
Fosphenytoin sodium injection should be
used only when oral phenytoin administration is not possible. (1)
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 di