Extended Phenytoin Sodium
FULL PRESCRIBING INFORMATION: CONTENTS*
- EXTENDED PHENYTOIN SODIUM DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- EXTENDED PHENYTOIN SODIUM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- EXTENDED PHENYTOIN SODIUM ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- MEDICATION GUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
EXTENDED PHENYTOIN SODIUM DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
DOSAGE AND ADMINISTRATIONandCLINICAL PHARMACOLOGYsections).
EXTENDED PHENYTOIN SODIUM CONTRAINDICATIONS
WARNINGS
Suicidal Behavior and Ideation
Table 1 Risk by indication for antiepileptic drugs in the pooled analysis
Usage In Pregnancy:
PRECAUTIONS, Laboratory Tests). However, postpartum restoration of the original dosage will probably be indicated.
PRECAUTIONS
General:WARNINGSsection regarding drug discontinuation). 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. (SeeADVERSE REACTIONSsection.) If the rash is of a milder type (measles-like or scarlatiniform), therapy may be resumed after the rash has completely disappeared. If the rash recurs upon reinstitution of therapy, further phenytoin medication is contraindicated.
CONTRAINDICATIONS). Additionally, caution should be exercised if using structurally similar compounds (e.g., barbiturates, succinimides, oxazolidinediones, and other related compounds) in these same patients.
WARNINGS section.)
Information for Patients:
Suicidal Thinking and Behavior- Patients, their caregivers, and families should be counseled that AEDs, including extended phenytoin sodium, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
PRECAUTIONS: Pregnancy section).
Do not use capsules which are discolored.
Laboratory Tests:
Drug Interactions:
Drug Enteral Feeding/Nutritional Preparations Interaction:Literature reports suggest that patients who have received enteral feeding preparations and/or related nutritional supplements have lower than expected phenytoin plasma levels. It is therefore suggested that phenytoin not be administered concomitantly with an enteral feeding preparation. More frequent serum phenytoin level monitoring may be necessary in these patients.
Drug/Laboratory Test Interactions:
Carcinogenesis:
WARNINGSsection for information on carcinogenesis.
Pregnancy:
WARNINGSsection.
Nursing Mothers:
Pediatric Use:SeeDOSAGE AND ADMINISTRATIONsection.
EXTENDED PHENYTOIN SODIUM ADVERSE REACTIONS
Central Nervous System:The most common manifestations encountered with phenytoin therapy are referable to this system and are usually dose-related. These include nystagmus, ataxia, slurred speech, decreased coordination, and mental confusion. Dizziness, insomnia, transient nervousness, motor twitchings, and headaches have also been observed. There have also been rare reports of phenytoin induced dyskinesias, including chorea, dystonia, tremor, and asterixis, similar to those induced by phenothiazine and other neuroleptic drugs.Gastrointestinal System:Nausea, vomiting, constipation, toxic hepatitis, and liver damage.
Integumentary System:Dermatological manifestations sometimes accompanied by fever have included scarlatiniform or morbilliform rashes. A morbilliform rash (measles-like) is the most common;; other types of dermatitis are seen more rarely. Other more serious forms which may be fatal have included bullous, exfoliative or purpuric dermatitis, lupus erythematosus, Stevens-Johnson syndrome, and toxic epidermal necrolysis (seePRECAUTIONS section).
Hemopoietic System:Hemopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin. These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression. While macrocytosis and megaloblastic anemia have occurred, these conditions usually respond to folic acid therapy. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's disease have been reported (seeWARNINGSsection).
Connective Tissue System:Coarsening of the facial features, enlargement of the lips, gingival hyperplasia, hypertrichosis, and Peyronie's disease.
Immunologic:Hypersensitivity syndrome (which may include, but is not limited to, symptoms such as arthralgias, eosinophilia, fever, liver dysfunction, lymphadenopathy, or rash), systemic lupus erythematosus, periarteritis nodosa and immunoglobulin abnormalities.
OVERDOSAGE
Treatment:
DOSAGE & ADMINISTRATION
General:
Adult Dosage:
Divided daily dosage:
Once-a-day dosage:
Loading dose:
Pediatric Dosage:
HOW SUPPLIED
100 mgare supplied as white opaque / light lavender opaque, hard gelatin capsules imprinted with "IP 212" on both cap and body.STORAGE AND HANDLING
Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.MEDICATION GUIDE
Extended Phenytoin Sodium CapsulesWhat is the most important information I should know about extendedphenytoin sodium?
Do not stop taking extended phenytoin sodium without first talking to your healthcare provider.Stopping extended phenytoin sodium suddenly can cause serious problems.
Extended phenytoin sodium can cause serious side effects including:
1. Like other antiepileptic drugs, extended phenytoin sodium may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
How can I watch for early symptoms of suicidal thoughts and actions?
Do not stop taking extended phenytoin sodium without first talking to a healthcare provider.
2. Extended phenytoin sodium may harm your unborn baby.
3. Swollen glands (lymph nodes)
4. Allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Symptoms include:
Call your healthcare provider right away if you have any of the symptoms listed above.
What is extended phenytoin sodium?
Who should not take extended phenytoin sodium?
What should I tell my healthcare provider before taking extended phenytoin sodium?
Tell your healthcare provider about all the medicines you take,including prescription and
How should I take extended phenytoin sodium capsules?
What should I avoid while taking extended phenytoin sodium?
What are the possible side effects of extended phenytoin sodium?
is the most important information I should know about extended phenytoin sodium?
Extended phenytoin sodium may cause other serious side effects including:
Call your healthcare provider right away, if you have any of the symptoms listed above.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store extended phenytoin sodium capsules?
Keep extended phenytoin sodiumand all medicines out of the reach of children.
General information about extended phenytoin sodium
What are the ingredients in extended phenytoin sodium capsules?
Extended Oral Capsule
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Extended Phenytoin SodiumPHENYTOIN SODIUM CAPSULE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
