FOSPHENYTOIN SODIUM- fosphenytoin sodium injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Wockhardt USA LLC.

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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)] . 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 fosph

Tuoteyhteenveto:

Fosphenytoin sodium injection, USP is a clear, colorless sterile solution supplied as follows: Both sizes of vials contain Tromethamine (TRIS), Hydrochloric Acid or Sodium Hydroxide and Water for Injection. 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

FOSPHENYTOIN SODIUM - FOSPHENYTOIN SODIUM INJECTION
WOCKHARDT USA LLC.
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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, 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
Dosage and Administration ( 2.3, 2.4) 1/2020
Warnings and Precautions ( 5.4) 7/2019
Warnings and Precautions ( 5.7) 7/2019
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:
o Adult loading dose is 15 to 20 mg PE/kg at a rate of 100 to 150 mg
PE/min ( 2.3)
o 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 DOS