PHENYTOIN SODIUM injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Phenytoin Sodium (UNII: 4182431BJH) (Phenytoin - UNII:6158TKW0C5)

Dostopno od:

General Injectables & Vaccines, Inc

INN (mednarodno ime):

Phenytoin Sodium

Sestava:

Phenytoin Sodium 50 mg in 1 mL

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.1, 2.3) and Warnings and Precautions (5.1)] . Phenytoin Sodium Injection is contraindicated in patients with: • A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)] . • Sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome because of the effect of parenteral phenytoin on ventricular automaticity. • A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.6)] . • Coadministration with delavirdine because of the potential for loss of virologic response and pos

Povzetek izdelek:

16.1 How Supplied Phenytoin Sodium Injection, USP – 50 mg/mL      2 mL (100 mg) Single Dose vials packaged in 25s (NDC 0641-0493-25)      5 mL (250 mg) Single Dose vials packaged in 25s (NDC 0641-2555-45) 16.2 Storage and Handling For single-dose only. After opening, any unused product should be discarded. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

PHENYTOIN SODIUM- PHENYTOIN SODIUM INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PHENYTOIN SODIUM 100 MG INJECTION, USP 2 ML VIAL
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYTOIN SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PHENYTOIN SODIUM
INJECTION.
PHENYTOIN SODIUM INJECTION FOR INTRAVENOUS OR INTRAMUSCULAR USE.
INITIAL U.S. APPROVAL: 1953
WARNING: CARIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• THE RATE OF INTRAVENOUS PHENYTOIN SODIUM INJECTION ADMINISTRATION
SHOULD NOT EXCEED
50 MG PER MINUTE IN ADULTS AND 1 TO 3 MG/KG/MIN (OR 50 MG PER MINUTE,
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
PHENYTOIN SODIUM INJECTION.
• REDUCTION IN RATE OF ADMINISTRATION OR DISCONTINUATION OF DOSING
MAY BE NEEDED
_(2.1, 5.1)_
INDICATIONS AND USAGE
Parenteral Phenytoin Sodium Injection is indicated for the treatment
of generalized tonic clonic status
epilepticus and prevention and treatment of seizures occurring during
neurosurgery. Intravenous
phenytoin can also be substituted, as short-term use, for oral
phenytoin. Parenteral phenytoin should be
used only when oral phenytoin administration is not possible. (1) (1)
DOSAGE AND ADMINISTRATION
For Status Epilepticus and Non-emergent Loading Dose:
• Adult loading dose is 10 to 15 mg/kg at a rate not exceeding 50
mg/min. (2.2)
• Pediatric loading dose is 15 to 20 mg/kg at a rate not exceeding 1
to 3 mg/kg/min or 50 mg/min,
whichever is slower. (2.8)
• Continuous monitoring of the electrocardiogram, blood pressure,
and respiratory function is essential.
(2.2) (2)
Maintenance Dosing:
• Initial loading dose should be followed by maintenance doses of
oral or intravenous Phenytoin Sodium
Injection every 6 to 8 hours. (2.2, 2.3) (2)
Intramuscular