Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
FOSPHENYTOIN SODIUM (UNII: 7VLR55452Z) (PHENYTOIN - UNII:6158TKW0C5)
Mylan Institutional LLC
FOSPHENYTOIN SODIUM
PHENYTOIN SODIUM 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
FOSPHENYTOIN SODIUM- FOSPHENYTOIN SODIUM INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- 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._ • • • 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 • • • DOSAGE FORMS AND STRENGTHS Injection: 50 mg phenytoin sodium equivalents (PE)/mL available as: • • 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) Citiți documentul complet