Drug Catalog - Product Detail
PHENYTOIN ORAL SUSPENSION SUSP 125MG/5ML 237ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00472-5002-08 | ACTAVIS MID ATLANTIC | 237 | 125MG/5ML | SUSPENSION |
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Description
DESCRIPTION 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: Each 5 ml of suspension contains 125 mg of phenytoin, USP; anhydrous citric acid, USP; carboxymethylcellulose sodium, USP; FD&C Yellow #6; flavor orange-vanilla; glycerin, USP; magnesium aluminum silicate, NF; polysorbate 80, NF; purified water, USP; sodium benzoate, NF and sucrose, NF. Chemical Structure
How Supplied
HOW SUPPLIED Phenytoin Oral Suspension, USP, 125 mg/5 mL, an opaque orange liquid with orange-vanilla flavor, is available as follows: NDC 0472-5002-08: Bottles of 8 fluid ounces (237 mL). SHAKE WELL BEFORE USING Store at controlled room temperature 20°–25°C (68°–77°F) [See USP Controlled Room Temperature]. Preserve in a tight container. Avoid Freezing. Protect from light. Rx only Manufactured by: VistaPharm, Inc. Largo, FL 33771 Distributed by: Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA VC111073 VP2023R3 02/12
Indications & Usage
INDICATIONS AND USAGE Phenytoin Oral Suspension, USP is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).
Dosage and Administration
DOSAGE AND ADMINISTRATION – FOR ORAL ADMINISTRATION; 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. The free acid form of phenytoin is used in Phenytoin Oral Suspension, USP. 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 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. Adult Dose Patients who have received no previous treatment may be started on one teaspoonful (5 mL) of Phenytoin Oral Suspension, USP 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. Elderly Patients Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required. Pediatric 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).