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Dilantin Infatabs

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Dilantin Infatabs

Indications
Dosage
How Supplied

INDICATIONS

Dilantin Infatabs (Phenytoin Tablets, USP) are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).

DOSAGE AND ADMINISTRATION

When given in equal doses, Dilantin Infatabs (phenytoin tablets) yield higher plasma levels than Dilantin Kapseals®. For this reason 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 Suspensions and Dilantin Infatabs (phenytoin tablets) . 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.

General

Not for once-a-day dosing.

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.

Dilantin Infatabs (phenytoin tablets) can be either chewed thoroughly before being swallowed or swallowed whole.

Adult Dosage

Patients who have received no previous treatment may be started on two Infatabs three times daily, and the dose is then adjusted to suit individual requirements. For most adults, the satisfactory maintenance dosage will be six to eight Infatabs daily; an increase to twelve Infatabs daily may be made, if necessary.

Pediatric Dosage

Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years old and adolescents may require the minimum adult dose (300 mg/day). If the daily dosage cannot be divided equally, the larger dose should be given before retiring.

HOW SUPPLIED

Dilantin Infatabs (phenytoin tablets) are supplied as:

N 0071-0007-24 - Bottle of 100.

Store at a room temperature below 30°C (86°F).

N 0071-0007-40 - Unit dose (10/10's).

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from moisture.

Each tablet contains 50 mg phenytoin in a yellow triangular scored chewable tablet.

Distributed by: Parke-Davis Division Pfizer Inc, NY, NY 10017. Revised September 2006

Last reviewed on RxList: 5/18/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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