=====Seizure, During and following neurosurgery=====
* Dosing Information
* 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
* 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
* Dosing Information
Line 66:
Line 55:
:* Dosage
:* 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.
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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)
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.