Rx Item-Phenytoin 300Mg Cap 30 By Caraco Pharma Gen DIlantin

Clinical Information
Gen. Code and Des.
49444 phenytoin sodium extended ORAL CAPSULE 300 MG
GCN and Des.
15037 phenytoin sodium extended ORAL CAPSULE 300 MG
Strength
300MG ER
Dose Form
CAPSULE
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
1618 phenytoin sodium extended 630933
Inactive Ingredients
10138 blue dye
10141 red dye
2549 gelatin 9000708
3987 lactitol 585864



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,

Phenytoin 300Mg Cap 30 By Cara
Item No.:RX077180 NDC No.62756043283 UPC No.:362756432833 NDC No. 62756-0432-83 UPC/GTIN No. 3-62756-43283-3 MPN 43283

Phenytoin 300Mg Cap 30 By Caraco Pharma
BRAND: PHENYTOIN NDC: 62756-0432-83,62756043283 UPC: 3-62756-43283-3,362756432833

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RX ITEM-Phenytoin 300Mg Cap 30 By Caraco
NDC 62756-0432-83 UPC/GTIN No.3-62756-43283-3 Mfg.Part No.43283