Phenytoin (oral): Difference between revisions

Phenytoin (oral)
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Revision as of 19:04, 12 September 2014

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

Overview

Phenytoin (oral) is an anticonvulsant that is FDA approved for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. There is a Black Box Warning for this drug as shown here. Common adverse reactions include morbilliform eruption, rash, constipation, gingival enlargement, nausea, vomiting, ataxia, coordination problem, nystagmus, slurred speech, confusion, feeling nervous.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Seizure, Generalized Tonic-Clonic and Complex Partial (psychomotor and temporal lobe) SeizuresView additional information

Dosing Information

oral suspension: 125 mg (5 mL) ORALLY 3 times daily; adjust dose every 7 to 10 days as necessary (MAX dose 625 mg/day)
oral tablets (Infatabs(R)): 100 mg (2 tablets) ORALLY 3 times daily, usual maintenance dose 300 to 400 mg/day (MAX dose 600 mg/day)

Seizure, During and following neurosurgery

Dosing Information

For prophylaxis of seizures during neurosurgical procedures, 100 to 200 milligrams (2 to 4 milliliters) intramuscularly (IM) is indicated at approximately 4-hour intervals during surgery and continued during the postoperative period

Seizure, During neurosurgery; Treatment and Prophylaxis

Nonemergent loading and maintenance dose:

Patients who have not received treatment previously may receive injectable phenytoin sodium solution as a nonemergent loading dose of 10 to 15 mg/kg IV loading dose at a rate not exceeding 50 mg/min, although slower administration rates are recommended to minimize potential cardiovascular reactions. The loading dose should be followed by maintenance doses of oral or IV phenytoin every 6 to 8 hours.

Substitution for oral phenytoin:
When use of oral phenytoin is not possible, IV phenytoin sodium may be substituted at the same total daily dose, administered at a rate not to exceed 50 mg/min. Due to differences in bioavailability, plasma phenytoin concentrations may increase when IV phenytoin is substituted for oral phenytoin therapy

Seizure, During neurosurgery; Treatment and Prophylaxis- oral route:

Patients who have not received treatment previously may be started on the extended-release capsules at a dose of 100 milligrams (mg) orally 3 times daily with adjustments based on individual requirements. Most adults will be satisfactorily maintained on 100 mg 3 to 4 times daily. If necessary, the dose may be increased to 200 mg 3 times daily. For patients established on 100 mg 3 times a day, therapy may be switched to once daily dosing using one 300 mg extended-release capsule [28].
Some authorities recommended use of oral loading doses of phenytoin in patients who require rapid steady-state serum levels but intravenous administration is not desirable. In this case, oral loading doses should be reserved for patients in a clinic or hospital setting where serum levels can be closely monitored. Oral loading regimens should not be administered to patients with a history or renal or liver disease. The recommended loading dose regimen is 1 gram divided into 3 doses (400 milligram (mg), 300 mg, 300 mg) administered every 2 hours. Normal maintenance dose should then begin 24 hours after the loading dose with frequent serum level determinations

Status epilepticus

Dosing Information

For the treatment of status epilepticus, the manufacturer recommends a loading dose of 10 to 15 milligrams/kilogram (mg/kg) administered slowly intravenously at a rate not exceeding 50 mg/minute. The loading dose should be followed by maintenance doses of 100 mg orally or intravenously every 6 to 8 hours. Determination of phenytoin plasma levels is recommended in the subsequent establishment of maintenance dosing].

One author recommends a loading dose of phenytoin for the treatment of status epilepticus of 20 milligrams/kilogram (mg/kg), intravenously at a maximal rate of 50 mg/minute [96]. As much as 30 mg/kg may be required in some patients. Other sources have used an initial loading dose of 18 mg/kg.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Seizure, Generalized Tonic-Clonic and Complex Partial (psychomotor and temporal lobe) Seizures

Dosing Information

Dosage

Seizure, During and following neurosurgery; Treatment and Prophylaxis

Dosing information

Status epilepticus

Dosing information

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Phenytoin (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Phenytoin (oral) in pediatric patients.

Contraindications

Condition1

Warnings

Title

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Phenytoin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Phenytoin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Phenytoin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Phenytoin (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Phenytoin (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Phenytoin (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Phenytoin (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Phenytoin (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Phenytoin (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Phenytoin (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Phenytoin (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Phenytoin (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Phenytoin (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Phenytoin (oral) in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Phenytoin (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Phenytoin (oral) in the drug label.

Pharmacology

There is limited information regarding Phenytoin (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Phenytoin (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Phenytoin (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Phenytoin (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Phenytoin (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Phenytoin (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Phenytoin (oral) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Phenytoin (oral) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Phenytoin (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Phenytoin (oral) in the drug label.

Precautions with Alcohol

Alcohol-Phenytoin (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1] Empty citation (help)

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 16: / Line 16: @@
 <!--FDA-Labeled Indications and Dosage (Adult)-->
-|fdaLIADAdult======Condition1=====
+|fdaLIADAdult======Seizure, Generalized Tonic-Clonic and Complex Partial (psychomotor and temporal lobe) SeizuresView additional information=====
 * Dosing Information
-:* Dosage
+:*oral suspension: 125 mg (5 mL) ORALLY 3 times daily; adjust dose every 7 to 10 days as necessary (MAX dose 625 mg/day)
+:*oral tablets (Infatabs(R)): 100 mg (2 tablets) ORALLY 3 times daily, usual maintenance dose 300 to 400 mg/day (MAX dose 600 mg/day)
-=====Condition2=====
-* Dosing Information
-:* Dosage
-=====Condition3=====
+=====Seizure, During and following neurosurgery=====
 * Dosing Information
-:* Dosage
+:*For prophylaxis of seizures during neurosurgical procedures, 100 to 200 milligrams (2 to 4 milliliters) intramuscularly (IM) is indicated at approximately 4-hour intervals during surgery and continued during the postoperative period
-=====Condition4=====
+:*'''Seizure, During neurosurgery; Treatment and Prophylaxis'''
-* Dosing Information
+:*'''Nonemergent loading and maintenance dose:'''
-:* Dosage
-<!--Off-Label Use and Dosage (Adult)-->
+:*Patients who have not received treatment previously may receive injectable phenytoin sodium solution as a nonemergent loading dose of 10 to 15 mg/kg IV loading dose at a rate not exceeding 50 mg/min, although slower administration rates are recommended to minimize potential cardiovascular reactions. The loading dose should be followed by maintenance doses of oral or IV phenytoin every 6 to 8 hours.
-<!--Guideline-Supported Use (Adult)-->
+:*'''Substitution for oral phenytoin:'''
-|offLabelAdultGuideSupport======Condition1=====
+:*When use of oral phenytoin is not possible, IV phenytoin sodium may be substituted at the same total daily dose, administered at a rate not to exceed 50 mg/min. Due to differences in bioavailability, plasma phenytoin concentrations may increase when IV phenytoin is substituted for oral phenytoin therapy
-* Developed by:
+:*'''Seizure, During neurosurgery; Treatment and Prophylaxis- oral route:'''
-* Class of Recommendation:
+:*Patients who have not received treatment previously may be started on the extended-release capsules at a dose of 100 milligrams (mg) orally 3 times daily with adjustments based on individual requirements. Most adults will be satisfactorily maintained on 100 mg 3 to 4 times daily. If necessary, the dose may be increased to 200 mg 3 times daily. For patients established on 100 mg 3 times a day, therapy may be switched to once daily dosing using one 300 mg extended-release capsule [28].
+:*Some authorities recommended use of oral loading doses of phenytoin in patients who require rapid steady-state serum levels but intravenous administration is not desirable. In this case, oral loading doses should be reserved for patients in a clinic or hospital setting where serum levels can be closely monitored. Oral loading regimens should not be administered to patients with a history or renal or liver disease. The recommended loading dose regimen is 1 gram divided into 3 doses (400 milligram (mg), 300 mg, 300 mg) administered every 2 hours. Normal maintenance dose should then begin 24 hours after the loading dose with frequent serum level determinations
-* Strength of Evidence:
+=====Status epilepticus=====
 * Dosing Information
-:* Dosage
+:*For the treatment of status epilepticus, the manufacturer recommends a loading dose of 10 to 15 milligrams/kilogram (mg/kg) administered slowly intravenously at a rate not exceeding 50 mg/minute. The loading dose should be followed by maintenance doses of 100 mg orally or intravenously every 6 to 8 hours. Determination of phenytoin plasma levels is recommended in the subsequent establishment of maintenance dosing].
+*One author recommends a loading dose of phenytoin for the treatment of status epilepticus of 20 milligrams/kilogram (mg/kg), intravenously at a maximal rate of 50 mg/minute [96]. As much as 30 mg/kg may be required in some patients. Other sources have used an initial loading dose of 18 mg/kg.
-=====Condition2=====
+|fdaLIADPed======Seizure, Generalized Tonic-Clonic and Complex Partial (psychomotor and temporal lobe) Seizures=====
-There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-<!--Non–Guideline-Supported Use (Adult)-->
-|offLabelAdultNoGuideSupport======Condition1=====
 * Dosing Information
@@ Line 66: / Line 55: @@
 :* Dosage
-=====Condition2=====
+=====Seizure, During and following neurosurgery; Treatment and Prophylaxis=====
-There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-<!--Pediatric Indications and Dosage-->
-<!--FDA-Labeled Indications and Dosage (Pediatric)-->
+* Dosing information
-|fdaLIADPed======Condition1=====
-* Dosing Information
-:* Dosage
-=====Condition2=====
+:*
-There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
+====Status epilepticus====
-<!--Off-Label Use and Dosage (Pediatric)-->
+*Dosing information
-<!--Guideline-Supported Use (Pediatric)-->
+:*
 |offLabelPedGuideSupport======Condition1=====