Dilantin® (Extended Phenytoin Sodium Capsules, USP)

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	Indication DILANTIN^® (Extended Phenytoin Sodium Capsules, USP) is indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures, and for the prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments. Subject: DILANTIN^® (extended phenytoin sodium capsules, USP) 30 mg Dear Healthcare Provider: The FDA recently approved Pfizer’s update to its manufacturing process for DILANTIN^® (extended phenytoin sodium capsules, USP) 30 mg. Updates to the manufacturing process include: Formulation change in excipients (inactive ingredients) Change in the appearance of the capsule As a result, Pfizer has discontinued DILANTIN Kapseals^® (extended phenytoin sodium, USP) 30 mg and replaced them with the 30-mg Extended Oral Capsules. Although the discontinued DILANTIN is trademarked “Kapseals” and the new DILANTIN is referred to as “Capsule,” both are in fact gelatin capsules and both contain the same amount of extended phenytoin sodium. The change you and your patients will notice is the appearance of the capsule. The new 30-mg capsule will be half pink (cap) and half white (body). The FDA approved Pfizer’s manufacturing changes for DILANTIN 30-mg Extended Oral Capsules based on studies for bioequivalence. Pfizer recognizes that this change may cause confusion for you and your patients, and would like to assure you and your patients of the therapeutic equivalence between the 2 products. If you have any questions, please contact Pfizer Medical Information at 1-800-438-1985 for more information. Angela Hwang Senior Director, US Established Products Pfizer Inc. 235 East 42^nd St. New York, NY 10017 Guy Cohen Senior Medical Director Pfizer Inc. 235 East 42^nd St. New York, NY 10017 Please see enclosed full prescribing information for DILANTIN^® (extended phenytoin sodium capsules, USP) 30-mg Extended Oral Capsules. Click here to learn about the specific details pertaining to the switch from DILANTIN^® 30 mg Kapseal to DILANTIN^® 30 mg Capsule.

dilantin.htm

DILANTIN Safety Information

Important Safety Information

Phenytoin is contraindicated in patients who are hypersensitive to phenytoin, other hydantoins, or any of the inert ingredients.

Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus.

Antiepileptic drugs, including DILANTIN, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any antiepileptic drug should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

There have been reports suggesting a relationship between phenytoin and the development of lymphadenopathy, including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin’s disease.

Acute alcoholic intake may increase phenytoin serum levels, while chronic alcohol use may decrease serum levels.

Caution should be exercised in using this medication in patients suffering from porphyria.

An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential harm to the fetus.

A potentially life-threatening bleeding disorder related to decreased levels of vitamin K-dependent clotting factors may occur in newborns exposed to phenytoin in utero.

Osteomalacia has been associated with phenytoin therapy and is considered to be due to phenytoin’s interference with vitamin D metabolism.

Patients should be instructed to call their physician if a skin rash appears. Phenytoin should be discontinued if a skin rash appears. If the rash is exfoliative, purpuric, or bullous or if lupus erythematosus, Stevens-Johnson syndrome, or toxic epidermal necrolysis is suspected, use of this drug should not be resumed and alternative therapy should be considered.

The importance of good dental hygiene should be stressed in order to minimize the development of gingival hyperplasia and its complications.

There are many drugs that may increase or decrease phenytoin levels or that phenytoin may affect.

The most common side effects encountered with phenytoin therapy are referable to the central nervous system and include nystagmus, ataxia, slurred speech, decreased coordination, and mental confusion.

Please see full prescribing information.

DILANTIN^® (Extended Phenytoin Sodium Capsules, USP)

dilantin_safety_information.htm

Dilantin^® (Extended Phenytoin Sodium Capsules, USP)

Full Prescribing Information

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