PHENYTOIN SODIUM

PHENYTOIN SODIUM- phenytoin sodium injection
HF Acquisition Co LLC, DBA HealthFirst

HIGHLIGHTS OF PRESCRIBING INFORMATION

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 f o r intravenous or intramuscular use Initial U.S. Approval: 1953

HIGHLIGHT WARNING BOX
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RECENT MAJOR CHANGES

Warnings and Precautions ( 5 SECT 5.11) 11/2017

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)

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 SECT 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 SECT 2.8)
Continuous monitoring of the electrocardiogram, blood pressure, and respiratory function is essential. ( 2 SECT 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 SECT 2.2, 2.3)

Intramuscular Administration:

Because of erratic absorption and local toxicity, Phenytoin Sodium Injection should ordinarily not be given intramuscularly. ( 2 SECT 2.2, 2.3)

DOSAGE FORMS AND STRENGTHS

Injection: 50 mg phenytoin sodium per milliliter in:

2 mL and 5 mL single dose vials ( 3)

CONTRAINDICATIONS

Hypersensitivity to phenytoin, its ingredients, or other hydantoins ( 4)

Sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome ( 4)
A history of prior acute hepatotoxicity attributable to phenytoin ( 4, 5 SECT 5.6)
Coadministration with delavirdine ( 4)

WARNINGS AND PRECAUTIONS

Withdrawal Precipitated Seizure: May precipitate status epilepticus. Dose reductions or discontinuation should be done gradually. ( 5 SECT 5.2)
Serious Dermatologic Reactions: Discontinue phenytoin at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. ( 5 SECT 5.3)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity: If signs or symptoms of hypersensitivity are present, evaluate the patient immediately. Discontinue if an alternative etiology cannot be established. ( 5 SECT 5.4)
Hematopoietic Complications: If occurs, follow-up observation is indicated and an alternative antiepileptic treatment should be used. ( 5 SECT 5.7)

ADVERSE REACTIONS

The most common adverse reactions are nervous system reactions, including nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Multiple drug interactions because of extensive plasma protein binding, saturable metabolism and potent induction of hepatic enzymes. ( 7 SECT 7.1, 7.2)

USE IN SPECIFIC POPULATIONS

Pregnancy: Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. ( 5 SECT 5.11, 8 SECT 8.1)
Renal and/or Hepatic Impairment or Hypoalbuminemia: Monitor unbound phenytoin concentrations in these patients. ( 8 SECT 8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Status Epilepticus
2.3 Non-emergent Loading and Maintenance Dosing
2.4 Parenteral Substitution for Oral Phenytoin Therapy
2.5 Dosing in Patients with Renal or Hepatic Impairment or Hypoalbuminemia
2.6 Dosing in Geriatrics
2.7 Dosing During Pregnancy
2.8 Dosing in Pediatrics
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Risk Associated with Rapid Infusion
5.2 Withdrawal Precipitated Seizure, Status Epilepticus
5.3 Serious Dermatologic Reactions
5.4 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
5.5 Hypersensitivity
5.6 Hepatic Injury
5.7 Hematopoietic Complications
5.8 Local Toxicity (Including Purple Glove Syndrome)
5.9 Renal or Hepatic Impairment or Hypoalbuminemia
5.10 Exacerbation of Porphyria
5.11 Teratogenicity and Other Harm to the Newborn
5.12 Slow Metabolizers of Phenytoin
5.13 Hyperglycemia
5.14 Serum Phenytoin Levels Above Therapeutic Range
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Drugs That Affect Phenytoin Concentrations
7.2 Drugs Affected by Phenytoin
7.3 Drug/Laboratory Test Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal and/or Hepatic Impairment or Hypoalbuminemia
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & 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 [see Dosage and Administration- 2 (2.1, 2.3) and Warnings and Precautions- 5 (5.1)].

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