Rx Item-Phenytoin 50Mg Chewable 100 By Core Pharma Generic Dilantin

Clinical Information
Gen. Code and Des.
4531 phenytoin ORAL TAB CHEW 50 MG
GCN and Des.
17250 phenytoin ORAL TAB CHEW 50 MG
Strength
50MG
Dose Form
TABLET,CHEWABLE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28121200 HYDANTOINS
24040408 CLASS IB ANTIARRHYTHMICS
Active Ingredients
1617 phenytoin 57410
Inactive Ingredients
10143 yellow dye
2432 lactose 64044515
2598 sucrose 57501
2600 saccharin 81072



DILANTIN- phenytoin sodium capsule, extended release
Parke-Davis Div of Pfizer Inc

1 INDICATIONS AND USAGE

DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

2 DOSAGE AND ADMINISTRATION

2.1 Adult Dosage
Divided daily dosage:

The recommended starting dose for adult patients who have received no previous treatment is one 100-mg DILANTIN (extended phenytoin sodium capsule, USP) by mouth three times daily. Adjust the dosage to suit individual requirements up to a maximum of two capsules three times a day. For most adults, the satisfactory maintenance dosage will be one capsule three to four times a day.



Once-a-day dosage:

In adults, if seizure control is established with divided doses of three 100-mg DILANTIN (extended phenytoin sodium capsules, USP) daily, once-a-day dosage with 300 mg of DILANTIN (extended phenytoin sodium capsules, USP) may be considered. Studies comparing divided doses of 300 mg with a single daily dose of this quantity indicated absorption, peak serum levels, biologic half-life, difference between peak and minimum values, and urinary recovery were equivalent. Once-a-day dosage offers a convenience to the individual patient or to nursing personnel for institutionalized patients and is intended to be used only for patients requiring this amount of drug daily. A major problem in motivating noncompliant patients may also be lessened when the patient can take this drug once a day. However, patients should be cautioned not to miss a dose, inadvertently.

Only DILANTIN (extended phenytoin sodium capsules, USP) are recommended for once-a-day dosing. Inherent differences in dissolution characteristics and resultant absorption rates of phenytoin due to different manufacturing procedures and/or dosage forms preclude such recommendation for other phenytoin products. When a change in the dosage form or brand is prescribed, careful monitoring of phenytoin serum levels should be carried out.
DESCRIPTION

DILANTIN (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,

RX ITEM-Phenytoin 50Mg Chewable 100 By
NDC 51672-4146-01 UPC/GTIN No.3-51672-41461-0 Mfg.Part No.414601

Phenytoin 50Mg Chewable 100 By Core Pha
BRAND: PHENYTOIN NDC: 51672-4146-01,51672414601 UPC: 3-51672-41461-0,351672414610

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