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DILANTIN® Infatabs®Index Section (phenytoin)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Adult Dosage

2.3 Pediatric Dosage

2.4 Dosage Adjustments

2.5 Switching Between Phenytoin Formulations

2.6 Dosing in Patients with Renal or Hepatic Impairment or Hypoalbuminemia

2.7 Geriatric Dosage

2.8 Dosing during Pregnancy

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Withdrawal Precipitated Seizure, Status Epilepticus

5.2 Suicidal Behavior and Ideation

5.3 Serious Dermatologic Reactions

5.4 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

5.5 Hypersensitivity

5.6 Cardiac Effects

5.7 Angioedema

5.8 Hepatic Injury

5.9 Hematopoietic Complications

5.10 Effects on Vitamin D and Bone

5.11 Renal or Hepatic Impairment or Hypoalbuminemia

5.12 Exacerbation of Porphyria

5.13 Teratogenicity and Other Harm to the Newborn

5.14 Hyperglycemia

5.15 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 Enteral Feeding/Nutritional Preparations Interaction

7.4 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

8.7 Use in Patients with Decreased CYP2C9 Function

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.5 Pharmacogenomics

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.
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