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DILANTIN® Infatabs®(phenytoin)

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DILANTIN® Infatabs® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

DILANTIN INFATABS are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

NOT FOR ONCE-A-DAY DOSING. DILANTIN INFATABS can be either chewed thoroughly before being...

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3 DOSAGE FORMS AND STRENGTHS

DILANTIN INFATABS are available as 50 mg phenytoin yellow triangular scored chewable tablets.

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4 CONTRAINDICATIONS

DILANTIN is contraindicated in patients with:

  • A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see ...
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5 WARNINGS AND PRECAUTIONS

5.1 Withdrawal Precipitated Seizure, Status Epilepticus

Abrupt withdrawal of phenytoin in epileptic patients may precipitate status...

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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

  • Withdrawal Precipitated Seizure, Status Epilepticus [see ...
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7 DRUG INTERACTIONS

Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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10 OVERDOSAGE

The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to be 2 to 5 grams. The initial symptoms are nystagmus, ataxia, and dysarthria. Other signs are tremor, hyperreflexia,...

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11 DESCRIPTION

DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:

...
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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

DILANTIN INFATABS contain 50 mg phenytoin and are supplied in a yellow triangular scored chewable tablet as...

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...
This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised: 12/2018    
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