FOSPHENYTOIN sodium injection solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Fresenius Kabi USA, LLC

INN (Tarptautinis Pavadinimas):

FOSPHENYTOIN SODIUM

Sudėtis:

PHENYTOIN SODIUM 50 mg in 1 mL

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FOSPHENYTOIN- FOSPHENYTOIN SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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FOSPHENYTOIN SODIUM INJECTION USP
Rx only
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
RATES
THE RATE OF INTRAVENOUS FOSPHENYTOIN SODIUM INJECTION ADMINISTRATION
SHOULD NOT EXCEED
150 MG PHENYTOIN SODIUM EQUIVALENTS (PE) PER MINUTE BECAUSE OF THE
RISK OF SEVERE
HYPOTENSION AND CARDIAC ARRHYTHMIAS. CAREFUL CARDIAC MONITORING IS
NEEDED DURING AND
AFTER ADMINISTERING INTRAVENOUS FOSPHENYTOIN SODIUM. ALTHOUGH THE RISK
OF CARDIOVASCULAR
TOXICITY INCREASES WITH INFUSION RATES ABOVE THE RECOMMENDED INFUSION
RATE, THESE EVENTS
HAVE ALSO BEEN REPORTED AT OR BELOW THE RECOMMENDED INFUSION RATE.
REDUCTION IN RATE OF
ADMINISTRATION OR DISCONTINUATION OF DOSING MAY BE NEEDED (SEE
WARNINGS AND DOSAGE
AND ADMINISTRATION).
DESCRIPTION
Fosphenytoin Sodium Injection, USP is a prodrug intended for
parenteral administration; its active
metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent
to 1 mg phenytoin sodium, and is
referred to as 1 mg phenytoin sodium equivalents (PE). The amount and
concentration of fosphenytoin
is always expressed in terms of mg PE.
Fosphenytoin Sodium Injection, USP is marketed in 2 mL vials
containing a total of 100 mg PE. The
concentration of each vial is 50 mg PE/mL. Fosphenytoin Sodium
Injection, USP, is supplied in vials as
a ready-mixed solution in water for injection, and tromethamine
(TRIS), buffer adjusted to pH 8.6 to 9.0
with either hydrochloric acid, or sodium hydroxide. Fosphenytoin
Sodium Injection, USP, is a clear,
colorless to pale yellow, sterile solution.
The chemical name of fosphenytoin is
5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4- imidazolidinedione
disodium salt. The molecular structure of fosphenytoin is:
M.W. 406.24
IMPORTANT NOTE: THROUGHOUT ALL FOSPHENYTOIN SODIUM INJECTION PRODUCT
LABELING, THE
AMOUNT AND CONCENTRATION OF FOSPHENYTOIN ARE ALWAYS EXPRESSED IN TERMS
OF PHENYTOIN SODIUM
EQUIVALENTS (PE). FOSPHENYTOIN’S WEIGHT IS EXPRESSED AS PHENYTOIN
SODIUM EQUIVA