FOSPHENYTOIN SODIUM injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Amneal Pharmaceuticals LLC

INN (nume internaţional):

FOSPHENYTOIN SODIUM

Compoziție:

PHENYTOIN SODIUM 50 mg in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Fosphenytoin sodium injection, USP is indicated for the control of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin can also be substituted, short-term, for oral phenytoin.  Fosphenytoin should be used only when oral phenytoin administration is not possible.  Fosphenytoin must not be given orally. Fosphenytoin sodium injection, USP is contraindicated in patients who have demonstrated hypersensitivity to fosphenytoin sodium injection, USP or its ingredients, or to phenytoin or other hydantoins. Because of the effect of parenteral phenytoin on ventricular automaticity, fosphenytoin injection is contraindicated in patients with sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome. Coadministration of fosphenytoin is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

Rezumat produs:

Fosphenytoin Sodium Injection, USP is supplied as follows: 10 mL per vial [NDC 65162-999-01] — Each 10 mL vial contains Fosphenytoin Sodium, USP 750 mg equivalent to 500 mg of phenytoin sodium, USP: (Packages of 10 - NDC 65162-999-10). 2 mL per vial [NDC 65162-998-01] — Each 2 mL vial contains Fosphenytoin Sodium, USP 150 mg equivalent to 100 mg of phenytoin sodium, USP:  (Packages of 25 - NDC 65162-998-25). Both sizes of vials contain Tromethamine, USP (TRIS), Hydrochloric Acid, NF, or Sodium Hydroxide, NF, and Water for Injection, USP. Fosphenytoin sodium should always be prescribed in phenytoin sodium equivalents (PE) (see DOSAGE AND ADMINISTRATION ). 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. Brands listed are the trademarks of their respective owners. Made in India Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 10-2015-03

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FOSPHENYTOIN SODIUM- FOSPHENYTOIN SODIUM INJECTION
AMNEAL PHARMACEUTICALS LLC
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FOSPHENYTOIN SODIUM INJECTION, USP
RX ONLY
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
RATES
THE RATE OF INTRAVENOUS FOSPHENYTOIN 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.
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 fosphenytoin sodium, USP
(hereafter referred
to as fosphenytoin) equivalent to 1 mg phenytoin sodium and is
referred to as 1 mg
phenytoin equivalents (PE). The amount and concentration of
fosphenytoin is always
expressed in terms of mg PE.
Fosphenytoin injection is marketed in 2 mL vials containing a total of
100 mg PE and 10
mL vials containing a total of 500 mg PE. The concentration of each
vial is 50 mg PE/mL.
Fosphenytoin is supplied in vials as a ready-mixed solution in Water
for Injection, USP,
and Tromethamine, USP (TRIS), buffer adjusted to pH 8.6 to 9.0 with
either Hydrochloric
Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin injection 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:
The molecular weight of fosphenytoin is 406.24.
IMPORTANT NOTE: THROUGHOUT ALL FOSPHENYTOIN INJECTION PRODUCT
LABELING,
THE AMOUNT AND CONCENTRATION OF FOSPHENYTOIN ARE ALWAYS EXPRESSED IN
TERMS OF PHENYTOIN SODIUM EQUIVALENTS (PE). FOSPHENY