DILANTIN-125 Oral suspension (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Parke-Davis Div of Pfizer Inc

Λέξεις κλειδιά

0071-2214

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1. Indications and Usage

DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.

2. Dosage and Administration

2.1 Important Administration Instructions FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household ...

3. Dosage Forms and Strengths

DILANTIN-125 is available as a 125 mg phenytoin/5 mL oral suspension of orange color with an orange-vanilla flavor.

4. Contraindications

DILANTIN is contraindicated in patients with: A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)]. Reactions have included ...

5. Warnings and Precautions

5.1 Withdrawal Precipitated Seizure, Status Epilepticus Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus. When in the judgment of the clinician the need for dosage ...

6. Adverse Reactions

The following serious adverse reactions are described elsewhere in the labeling: Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.1)] Suicidal Behavior and ...

7. Drug Interactions

Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19 and is particularly susceptible ...

8. Use in Specific Populations

8.6 Renal and/or Hepatic Impairment or Hypoalbuminemia The liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as DILANTIN, during pregnancy. Physicians are advised ...

8.2. Lactation

Risk Summary Phenytoin is secreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for DILANTIN and any potential adverse ...

8.4. Pediatric Use

Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children ...

8.5. Geriatric Use

Phenytoin clearance tends to decrease with increasing age [see Clinical Pharmacology (12.3)]. Lower or less frequent dosing may be required [see Dosage and Administration (2.7)].

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, ...

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: ...

12.1. Mechanism of Action

The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction ...

12.3. Pharmacokinetics

Absorption For DILANTIN-125 Suspension, peak levels occur 1½ to 3 hours after administration. Steady-state therapeutic levels are achieved at least 7 to 10 days (5 to 7 half-lives) after initiation of ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis [see Warnings and Precautions (5.9)] In carcinogenicity studies, phenytoin was administered in the diet to mice (10, 25, or 45 mg/kg/day) and rats (25, 50, or 100 mg/kg/day) for ...

16.1. How Supplied

DILANTIN-125 Oral Suspension is supplied as follows: Package Configuration Strength NDC 8 oz glass bottles 125 mg phenytoin/5 mL 0071-2214-20 8 oz amber polyethylene terephthalate (PET) bottles ...

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); see USP controlled room temperature. Protect from light. Do not freeze.

17. Patient Counseling Information

Advise patients to read the FDA-approved patient labeling (Medication Guide). Administration Information Advise patients taking phenytoin of the importance of adhering strictly to the prescribed dosage ...