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:

West-Ward Pharmaceuticals Corp

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, USP is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin Sodium Injection, USP can also be substituted, short-term, for oral phenytoin. Fosphenytoin Sodium Injection, USP 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)] . - 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 [see Warnings and Pr

Termék összefoglaló:

Fosphenytoin Sodium Injection, USP Injection is a clear, colorless to pale yellow sterile 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 of NDC 0143-9782-01 NDC 0143-9782-10 100 mg PE/2 mL vial 2 mL per vial Package contains 25 vials of NDC 0143-9788-01 NDC 0143-9788-25 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 SODIUM- FOSPHENYTOIN SODIUM INJECTION, SOLUTION
WEST-WARD PHARMACEUTICALS CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOSPHENYTOIN SODIUM INJECTION, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FOSPHENYTOIN SODIUM INJECTION, USP.
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
ARRHYTHM IAS.
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
Dosage and Administration (2.3, 2.4) 3/2017
Contraindications (4) 3/2017
Warnings and Precautions (5.2) 3/2017
Warnings and Precautions (5.14) 10/2017
Warnings and Precautions (5.17) 3/2017
INDICATIONS AND USAGE
Fosphenytoin Sodium Injection, USP is indicated for the treatment of
generalized tonic-clonic status epilepticus and
prevention and treatment of seizures occurring during neurosurgery.
Fosphenytoin Sodium Injection, USP can also be
substituted, as short-term use, for oral phenytoin. Fosphenytoin
Sodium Injection, USP 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