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DOSAGE AND ADMINISTRATION
FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE
Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. Dilantin® Kapseals® is formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in Dilantin-125 Suspension and Dilantin Infatabs. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.
Dosage should be individualized to provide maximum benefit. In some cases serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum level is usually 10–20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.
Patients who have received no previous treatment may be started on one teaspoonful (5 mL) of Dilantin-125 Suspension three times daily, and the dose is then adjusted to suit individual requirements. An increase to five teaspoonfuls daily may be made, if necessary.
Dosing in Special Populations
Patients with Renal or Hepatic Disease
Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution. Unbound phenytoin concentrations may be more useful in these patient populations.
Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required.
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 over 6 years and adolescents may require the minimum adult dose (300 mg/day).
N 0071-2214-20—Dilantin-125® Suspension (phenytoin oral suspension, USP), 125 mg phenytoin/5 mL with a maximum alcohol content not greater than 0.6 percent, an orange suspension with an orange-vanilla flavor; available in 8-oz bottles.
Store at controlled room temperature 20°–25°C (68°–77°F). [See USP.] Protect from freezing and light
Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017. Revised February 2013
Last reviewed on RxList: 3/20/2013
This monograph has been modified to include the generic and brand name in many instances.
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