FOSPHENYTOIN SODIUM injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

FOSPHENYTOIN SODIUM

Skład:

PHENYTOIN SODIUM 50 mg in 1 mL

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Fosphenytoin Sodium Injection, USP 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 NDC 0641-6137-10 100 mg PE/2 mL vial 2 mL per vial Package contains 25 vials NDC 0641-6136-25 Both sizes of vials contain Tromethamine, USP (TRIS), Hydrochloric Acid, NF, or Sodium Hydroxide, NF, and Water for Injection, USP. Fosphenytoin sodium injection 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. Vials are single-dose only. After opening, any unused product should be discarded. Not made with natural rubber latex. Brands listed are the trademarks of their respective owners.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

FOSPHENYTOIN SODIUM- FOSPHENYTOIN SODIUM INJECTION
HIKMA PHARMACEUTICALS USA INC.
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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, USP, 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 INJECTION.
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) 1/2023
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