FOSPHENYTOIN SODIUM injection, solution

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Mylan Institutional LLC

INN (International Name):

FOSPHENYTOIN SODIUM

রচনা:

PHENYTOIN SODIUM 50 mg in 1 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 is contraindicated in patients with: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as fosphenytoin sodium, during pregnancy. Physicians are advised to recommend that pregnant patients taking fosphenytoin sodium enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the websi

পণ্য সারাংশ:

Fosphenytoin sodium injection USP is a clear, colorless solution supplied as follows: 500 mg PE/10 mL - Each 10 mL vial contains fosphenytoin sodium, USP 750 mg equivalent to 500 mg of phenytoin sodium, USP. NDC - 67457-517-01 (Packages of 10) NDC - 67457-517-10 (Packages of 5) 100 mg PE/2 mL - Each 2 mL vial contains fosphenytoin sodium, USP 150 mg equivalent to 100 mg of phenytoin sodium, USP. NDC - 67457-516-25 (Packages of 25) NDC - 67457-516-22 (Packages of 5) 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° to 8°C (36° 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

FOSPHENYTOIN SODIUM- FOSPHENYTOIN SODIUM INJECTION, SOLUTION
MYLAN INSTITUTIONAL 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._
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•
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RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 4/2022
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
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DOSAGE FORMS AND STRENGTHS
Injection: 50 mg phenytoin sodium equivalents (PE)/mL available as:
•
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THE RATE OF INTRAVENOUS FOSPHENYTOIN SODIUM 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.
REDUCTION IN RATE OF ADMINISTRATION OR DISCONTINUATION OF DOSING MAY
BE NEEDED
(2.3, 2.4, 5.2).
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
o
•
o
o
o
Adult loading dose is 15 mg PE/kg to 20 mg PE/kg at a rate of 100 mg
PE/min to 150 mg PE/min
(2.3)
Pediatric loading dose is 15 mg PE/kg to 20 mg PE/kg at a rate of 2 mg
PE/kg/min (or 150 mg
PE/min, whichever is slower)