PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Phenytoin Sodium

GENERIC: Phenytoin Sodium

DOSAGE: CAPSULE, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-1776-0

NDC: 70518-1776-1

NDC: 70518-1776-2

COLOR: orange

SHAPE: CAPSULE

SCORE: No score

SIZE: 16 mm

IMPRINT: SUN808

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

PHENYTOIN SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

SUCROSE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
BENZYL ALCOHOL
BUTYLPARABEN
D&C YELLOW NO. 10
EDETATE CALCIUM DISODIUM
FD&C RED NO. 3
GELATIN, UNSPECIFIED
METHYLPARABEN
PROPYLPARABEN
SODIUM LAURYL SULFATE
SODIUM PROPIONATE
TITANIUM DIOXIDE

Remedy_Label

mm3

DESCRIPTION SECTION

11 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:

Chemical Structure

Each extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivoperformance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USPwith a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.

Meets USP Dissolution Test 2.

CLINICAL PHARMACOLOGY SECTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.

12.3 Pharmacokinetics

Absorption

For extended phenytoin sodium capsules, peak serum levels occur 4 to 12 hours after administration. Steady-state therapeutic levels are achieved at least 7 to 10 days (5 to 7 half-lives) after initiation of therapy with recommended doses of 300 mg/day. When serum level determinations are necessary, they should be obtained at least 5 to 7 half-lives after treatment initiation, dosage change, or addition or subtraction of another drug to the regimen so that equilibrium or steady-state will have been achieved.

Distribution

Phenytoin is extensively bound to serum plasma proteins.

Elimination

The plasma half-life in man after oral administration of phenytoin averages 22 hours, with a range of 7 to 42 hours.

Metabolism

Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19. Because phenytoin is hydroxylated in the liver by an enzyme system which is saturable at high serum levels, small incremental doses may increase the half-life and produce very substantial increases in serum levels, when these are in the upper range. The steady-state level may be disproportionately increased, with resultant intoxication, from an increase in dosage of 10% or more.

In most patients maintained at a steady dosage, stable phenytoin serum levels are achieved. There may be wide interpatient variability in phenytoin serum levels with equivalent dosages. Patients with unusually low levels may be noncompliant or hypermetabolizers of phenytoin. Unusually high levels result from liver disease, variant CYP2C9 and CYP2C19 alleles, or drug interactions which result in metabolic interference. The patient with large variations in phenytoin serum levels, despite standard doses, presents a difficult clinical problem. Serum level determinations in such patients may be particularly helpful. As phenytoin is highly protein bound, free phenytoin levels may be altered in patients whose protein binding characteristics differ from normal.

Excretion

Most of the drug is excreted in the bile as inactive metabolites which are then reabsorbed from the intestinal tract and excreted in the urine. Urinary excretion of phenytoin and its metabolites occurs partly with glomerular filtration but, more importantly, by tubular secretion.

Specific Populations

Age: Geriatric Population:

Phenytoin clearance tends to decrease with increasing age (20% less in patients over 70 years of age relative to that in patients 20 to 30 years of age). Since phenytoin clearance is decreased slightly in elderly patients, lower or less frequent dosing may be required [see Dosage and Administration (2.6)].

Sex/Race:

Gender and race have no significant impact on phenytoin pharmacokinetics.

Renal or Hepatic Impairment:

Increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia has been reported.

Pregnancy:

It has been reported in the literature that the plasma clearance of phenytoin generally increased during pregnancy, reached a peak in the third trimester and returned to the level of pre-pregnancy after few weeks or months of delivery.

Drug Interaction Studies

Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19.

Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes [see Drug Interactions (7.1, 7.2)] .

12.5 Pharmacogenomics

CYP2C9 activity is decreased in individuals with genetic variants such as the CYP2C92 and CYP2C93 alleles. Carriers of variant alleles, resulting in intermediate (e.g., *1/*3, *2/*2) or poor metabolism (e.g., *2/*3, *3/*3) have decreased clearance of phenytoin. Other decreased or nonfunctional CYP2C9 alleles may also result in decreased clearance of phenytoin (e.g., *5, *6, *8, *11).

The prevalence of the CYP2C9 poor metabolizer phenotype is approximately 2 to 3% in the White population, 0.5 to 4% in the Asian population, and <1% in the African American population. The CYP2C9 intermediate phenotype prevalence is approximately 35% in the White population, 24% in the African American population, and 15 to 36% in the Asian population [see Warnings and Precautions (5.3)and Use in Specific Populations (8.7)] .

INDICATIONS & USAGE SECTION

Highlight: Extended phenytoin sodium capsules are 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. ( 1)

1 INDICATIONS AND USAGE

Extended phenytoin sodium capsules, USP are 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.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Extended phenytoin sodium capsules are available as 100 mg extended phenytoin sodium capsules. ( 3)

3 DOSAGE FORMS AND STRENGTHS

Extended phenytoin sodium capsules, USP are available as:

hard, gelatin capsules No. 3 with an opaque orange cap, opaque orange body with black imprint "SUN808" on both body and cap. Contains white to off-white powder.

CONTRAINDICATIONS SECTION

Highlight: * Hypersensitivity to phenytoin, its ingredients, or other hydantoins ( 4, 5.5)

A history of prior acute hepatotoxicity attributable to phenytoin ( 4, 5.8)
Coadministration with delavirdine ( 4)

4 CONTRAINDICATIONS

Extended phenytoin sodium capsules are contraindicated in patients with:

A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)] . Reactions have included angioedema.
A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.8)].
Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

DRUG INTERACTIONS SECTION

Highlight: Multiple drug interactions because of extensive plasma protein binding, saturable metabolism and potent induction of hepatic enzymes. ( 7.1, 7.2)

7 DRUG INTERACTIONS

Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19, and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Monitoring of phenytoin serum levels is recommended when a drug interaction is suspected.

Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes.

7.1 Drugs that Affect Phenytoin Concentrations

Table 2 includes commonly occurring drug interactions that affect phenytoin concentrations. However, this list is not intended to be inclusive or comprehensive. Individual prescribing information from relevant drugs should be consulted. The addition or withdrawal of these agents in patients on phenytoin therapy may require an adjustment of the phenytoin dose to achieve optimal clinical outcome.

Table 2: Drugs That Affect Phenytoin Concentrations

Interacting Agent	Examples
Antacids may affect absorption of phenytoin. † The induction potency of St. John's wort may vary widely based on preparation. ‡ Valproate sodium and valproic acid are similar medications. The term valproate has been used to represent these medications.
Drugs that may increase phenytoin serum levels
Antiepileptic drugs	Ethosuximide, felbamate, oxcarbazepine, methsuximide, topiramate
Azoles	Fluconazole, ketoconazole, itraconazole, miconazole, voriconazole
Antineoplastic agents	Capecitabine, fluorouracil
Antidepressants	Fluoxetine, fluvoxamine, sertraline
Gastric acid reducing agents	H 2antagonists (cimetidine), omeprazole
Sulfonamides	Sulfamethizole, sulfaphenazole, sulfadiazine, sulfamethoxazole-trimethoprim
Other	Acute alcohol intake, amiodarone, chloramphenicol, chlordiazepoxide, disulfiram, estrogen, fluvastatin, isoniazid, methylphenidate, phenothiazines, salicylates, ticlopidine, tolbutamide, trazodone, warfarin
Drugs that may decrease phenytoin serum levels
Antacids *	Calcium carbonate, aluminum hydroxide, magnesium hydroxide Prevention or Management:Phenytoin and antacids should not be taken at the same time of day
Antineoplastic agents usually in combination	Bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate
Antiviral agents	Fosamprenavir, nelfinavir, ritonavir
Antiepileptic drugs	Carbamazepine, vigabatrin
Other	Chronic alcohol abuse, diazepam, diazoxide, folic acid, reserpine, rifampin, St. John's wort †, sucralfate, theophylline
Drugs that may either increase or decrease phenytoin serum levels
Antiepileptic drugs	Phenobarbital, valproate sodium ‡, valproic acid ‡

7.2 Drugs Affected by Phenytoin

Table 3 includes commonly occurring drug interactions affected by phenytoin. However, this list is not intended to be inclusive or comprehensive. Individual drug package inserts should be consulted. The addition or withdrawal of phenytoin during concomitant therapy with these agents may require adjustment of the dose of these agents to achieve optimal clinical outcome.

Table 3: Drugs Affected by Phenytoin

Interacting Agent	Examples
The effect of phenytoin on phenobarbital, valproic acid and sodium valproate serum levels is unpredictable
Drugs whose efficacy is impaired by phenytoin
Azoles	Fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
Antineoplastic agents	Irinotecan, paclitaxel, teniposide
Delavirdine	Phenytoin can substantially reduce the concentrations of delavirdine. This can lead to loss of virologic response and possible resistance [see Contraindications (4)].
Neuromuscular blocking agents	Cisatracurium, pancuronium, rocuronium and vecuronium: resistance to the neuromuscular blocking action of the nondepolarizing neuromuscular blocking agents has occurred in patients chronically administered phenytoin. Whether or not phenytoin has the same effect on other non-depolarizing agents is unknown. Prevention or Management:Patients should be monitored closely for more rapid recovery from neuromuscular blockade than expected, and infusion rate requirements may be higher.
Warfarin	Increased and decreased PT/INR responses have been reported when phenytoin is coadministered with warfarin
Other	Corticosteroids, doxycycline, estrogens, furosemide, oral contraceptives, paroxetine, quinidine, rifampin, sertraline, theophylline, and vitamin D
Drugs whose level is decreased by phenytoin
Anticoagulants	Apixaban, dabigatran, edoxaban, rivaroxaban
Antiepileptic drugs *	Carbamazepine, felbamate, lamotrigine, topiramate, oxcarbazepine, lacosamide
Antilipidemic agents	Atorvastatin, fluvastatin, simvastatin
Antiplatelets	Ticagrelor
Antiviral agents	Efavirenz, lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir Fosamprenavir: phenytoin when given with fosamprenavir alone may decrease the concentration of amprenavir, the active metabolite. Phenytoin when given with the combination of fosamprenavir and ritonavir may increase the concentration of amprenavir
Calcium channel blockers	Nifedipine, nimodipine, nisoldipine, verapamil
Other	Albendazole (decreases active metabolite), chlorpropamide, clozapine, cyclosporine, digoxin, disopyramide, folic acid, methadone, mexiletine, praziquantel, quetiapine

7.3 Hyperammonemia with Concomitant Use of Valproate

Concomitant administration of phenytoin and valproate has been associated with an increased risk of valproate-associated hyperammonemia. Patients treated concomitantly with these two drugs should be monitored for signs and symptoms of hyperammonemia.

7.4 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 serum 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.

7.5 Drug/Laboratory Test Interactions

Care should be taken when using immunoanalytical methods to measure serum phenytoin concentrations.

ADVERSE REACTIONS SECTION

Highlight: The most common adverse reactions are nervous system reactions, including nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.1)]
Suicidal Behavior and Ideation [see Warnings and Precautions (5.2)]
Serious Dermatologic Reactions [see Warnings and Precautions (5.3)]
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.4)]
Hypersensitivity [see Warnings and Precautions (5.5)]
Cardiac Effects [see Warnings and Precautions (5.6)]
Angioedema [see Warnings and Precautions (5.7)]
Hepatic Injury [see Warnings and Precautions (5.8)]
Hematopoietic Complications [see Warnings and Precautions (5.9)]
Effects on Vitamin D and Bone [see Warnings and Precautions (5.10)]
Exacerbation of Porphyria [see Warnings and Precautions (5.12)]
Teratogenicity and Other Harm to the Newborn [see Warnings and Precautions (5.13)]
Hyperglycemia [see Warnings and Precautions (5.14)]

The following adverse reactions associated with the use of extended phenytoin sodium capsules were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

**Body as a Whole:**Allergic reactions in the form of rash and rarely more serious forms and DRESS have been observed, as has angioedema [see Warnings and Precautions (5.3, 5.4, 5.7)] . Anaphylaxis has also been reported.

There have also been reports of coarsening of facial features, systemic lupus erythematosus, periarteritis nodosa, and immunoglobulin abnormalities.

**Digestive System:**Acute hepatic failure, toxic hepatitis, liver damage, nausea, vomiting, constipation, enlargement of the lips, and gingival hyperplasia.

**Hematologic and Lymphatic System:**Hematopoietic 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. Pure red cell aplasia has also been reported. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's disease have been reported [see Warnings and Precautions (5.9)] .

**Laboratory Test Abnormality:**Phenytoin may decrease serum concentrations of thyroid hormone (T4 and T3), sometimes with an accompanying increase in thyroid-stimulating hormone (TSH), but usually in the absence of clinical hypothyroidism. Phenytoin may also produce lower than normal values for dexamethasone or metyrapone tests. Phenytoin may cause increased serum levels of glucose [see Warnings and Precautions (5.14)] , alkaline phosphatase, and gamma glutamyl transpeptidase (GGT).

**Nervous System:**The most common adverse reactions encountered with phenytoin therapy are nervous system reactions and are usually dose-related. Reactions include nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion. Dizziness, vertigo, insomnia, transient nervousness, motor twitchings, paresthesias, 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. Cerebellar atrophy has been reported, and appears more likely in settings of elevated phenytoin levels and/or long-term phenytoin use [see Warnings and Precautions (5.15)] . A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy.

**Skin and Appendages:**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, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis [see Warnings and Precautions (5.3)] . There have also been reports of hypertrichosis and urticaria.

**Special Senses:**Altered taste sensation including metallic taste.

**Urogenital:**Peyronie's disease

OVERDOSAGE SECTION

10 OVERDOSAGE

The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to be 2 grams to 5 grams. The initial symptoms are nystagmus, ataxia, and dysarthria. Other signs are tremor, hyperreflexia, lethargy, slurred speech, blurred vision, nausea, and vomiting. The patient may become comatose and hypotensive. Bradycardia and cardiac arrest have been reported [see Warnings and Precautions (5.6)] . Death is caused by respiratory and circulatory depression.

There are marked variations among individuals with respect to phenytoin serum levels where toxicity may occur. Nystagmus, on lateral gaze, usually appears at 20 mcg/mL, ataxia at 30 mcg/mL; dysarthria and lethargy appear when the serum concentration is over 40 mcg/mL, but as high a concentration as 50 mcg/mL has been reported without evidence of toxicity. As much as 25 times the therapeutic dose has been taken to result in a serum concentration over 100 mcg/mL with complete recovery. Irreversible cerebellar dysfunction and atrophy have been reported.

**Treatment:**Treatment is nonspecific since there is no known antidote.

The adequacy of the respiratory and circulatory systems should be carefully observed and appropriate supportive measures employed. Hemodialysis can be considered since phenytoin is not completely bound to plasma proteins. Total exchange transfusion has been used in the treatment of severe intoxication in pediatric patients.

In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind.

NONCLINICAL TOXICOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis[see Warnings and Precautions (5.9)]

In carcinogenicity studies, phenytoin was administered in the diet to mice (10 mg/kg/day, 25 mg/kg/day, or 45 mg/kg/day) and rats (25 mg/kg/day, 50 mg/kg/day, or 100 mg/kg/day) for 2 years. The incidences of hepatocellular tumors were increased in male and female mice at the highest dose. No increases in tumor incidence were observed in rats. The highest doses tested in these studies were associated with peak serum phenytoin levels below human therapeutic concentrations.

In carcinogenicity studies reported in the literature, phenytoin was administered in the diet for 2 years at doses up to 600 ppm (approximately 160 mg/kg/day) to mice and up to 2400 ppm (approximately 120 mg/kg/day) to rats. The incidences of hepatocellular tumors were increased in female mice at all but the lowest dose tested. No increases in tumor incidence were observed in rats.

Mutagenesis

Phenytoin was negative in the Ames test and in the in vitroclastogenicity assay in Chinese hamster ovary (CHO) cells.

In studies reported in the literature, phenytoin was negative in the in vitromouse lymphoma assay and the in vivomicronucleus assay in mouse. Phenytoin was clastogenic in the in vitrosister chromatid exchange assay in CHO cells.

Fertility

Phenytoin has not been adequately assessed for effects on male or female fertility.

SPL MEDGUIDE SECTION

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: December 2023 5201244-1223-05
MEDICATION GUIDE Extended Phenytoin (fen´ i toin) Sodium Capsules
What is the most important information I should know about extended phenytoin sodium capsules? *Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider. * Stopping extended phenytoin sodium capsules suddenly can cause serious problems. * Stopping a seizure medicine suddenly can cause you to have seizures more often or seizures that will not stop (status epilepticus). *Like other antiepileptic drugs, extended phenytoin sodium capsules 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:
	Thoughts about suicide or dying Attempts to commit suicide New or worse depression New or worse anxiety Feeling agitated or restless Panic attacks	Trouble sleeping (insomnia) New or worse irritability Acting aggressive, being angry, or violent Acting on dangerous impulses An extreme increase in activity and talking (mania) Other unusual changes in behavior or mood
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. *Extended phenytoin sodium capsules can cause a type of serious allergic reaction that may affect different parts of the body such as your liver, kidneys, blood, heart, skin or other parts of your body. These can be very serious and cause death. Call your healthcare provider right away if you have any or all of these symptoms:
	Fever Rash Swollen lymph glands Swelling of your face, eye, lips, or tongue Trouble swallowing or breathing Sore throat Sores in your mouth	Bruise easily Purple or red spots on your skin Increase infections Not wanting to eat (anorexia) Nausea Vomiting Yellowing of the skin and the white part of your eyes (jaundice)
Call your healthcare provider even if the symptoms are mild or if you have been taking extended phenytoin sodium capsules for an extended period of time. These symptoms can be a sign of a serious allergic reaction.
*Phenytoin can cause problems with your heart, including a slow heartbeat. Let your healthcare provider know right away if you have any of these symptoms: * dizziness * tiredness * feeling like your heart is beating slowly or skipping beats * chest pain
What are extended phenytoin sodium capsules? Extended phenytoin sodium capsules are a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
Do not take extended phenytoin sodium capsules if you: Are allergic to phenytoin or any of the ingredients in extended phenytoin sodium capsules. See the end of this leaflet for a complete list of ingredients in extended phenytoin sodium capsules. Have had an allergic reaction to CEREBYX ®(fosphenytoin), PEGANONE (ethotoin), or MESANTOIN (mephenytoin). Have had liver problems from taking phenytoin. Take delavirdine.
Before taking extended phenytoin sodium capsules, tell your healthcare provider about all of your medical conditions, including if you: Have or have had depression, mood problems, or suicidal thoughts or behavior Have had an allergic reaction to a medicine similar to extended phenytoin sodium capsules called carboxamides, barbiturates, succinimides, and oxazolidinediones Have or had liver or kidney problems Have or had an enzyme problem called porphyria Have or had high blood sugar (hyperglycemia) Drink alcohol Are pregnant or plan to become pregnant. Extended phenytoin sodium capsules may harm your unborn baby. If you take extended phenytoin sodium capsules during pregnancy, your baby is at risk for serious birth defects. If you become pregnant while taking extended phenytoin sodium capsules, the level of phenytoin in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of phenytoin. If you take extended phenytoin sodium capsules during pregnancy, your baby is also at risk for bleeding problems right after birth. Your healthcare provider may give you and your baby medicine to prevent this. All women of child-bearing age should talk to their healthcare provider about using other possible treatments instead of extended phenytoin sodium capsules. If you are of childbearing age and are not planning on getting pregnant, you should use effective birth control (contraception) while taking extended phenytoin sodium capsules. *Pregnancy Registry:If you become pregnant while taking extended phenytoin sodium capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. Are breastfeeding or plan to breastfeed. Phenytoin can pass into breast milk. You and your healthcare provider should decide if you will take extended phenytoin sodium capsules while you are breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These medicines can change the levels of phenytoin in your blood. Taking extended phenytoin sodium capsules with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take extended phenytoin sodium capsules? Take extended phenytoin sodium capsules exactly as your healthcare provider tells you. Your healthcare provider will tell you how much extended phenytoin sodium capsules to take and when to take it. Your healthcare provider may change your dose if needed. Do not change your dose of extended phenytoin sodium capsules without talking to your healthcare provider. If your healthcare provider has prescribed phenytoin oral suspension, ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of phenytoin.Do notuse a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way. Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider. Stopping extended phenytoin sodium capsules suddenly can cause serious problems.
What should I avoid while taking extended phenytoin sodium capsules? Do not drink alcohol while you take phenytoin without first talking to your healthcare provider. Drinking alcohol while taking phenytoin may change your blood levels of phenytoin which can cause serious problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how phenytoin affects you. Phenytoin can slow your thinking and motor skills.
What are the possible side effects of extended phenytoin sodium capsules? See"What is the most important information I should know about extended phenytoin sodium capsules?" Extended phenytoin sodium capsules may cause other serious side effects including: Liver problems. Low blood count which could increase your chance of getting infections, bruising, bleeding and increased fatigue. Softening of your bones (osteopenia, osteoporosis, and osteomalacia) can cause your bones to break (fractures). High blood sugar (hyperglycemia). High levels of phenytoin in your blood that could cause confusion also known as delirium, psychosis or a more serious condition that affects how your brain works (encephalopathy). Call your healthcare provider right away, if you have any of the symptoms listed above. The most common side effects of extended phenytoin sodium capsules include:
Irregular movement of the eye (nystagmus) Problems with movement and balance (ataxia) Slurred speech	Decrease in coordination Drowsiness (somnolence) Confusion
Extended phenytoin sodium capsules can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking extended phenytoin sodium capsules can help prevent this from happening. These are not all of the possible side effects of extended phenytoin sodium capsules. 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? Store extended phenytoin sodium capsules at room temperature between 68° to 77°F (20° to 25°C). Store in tight, light-resistant containers. Protect from moisture. Keep extended phenytoin sodium capsules and all medicines out of the reach of children.
General information about the safe and effective use of extended phenytoin sodium capsules. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use extended phenytoin sodium capsules for a condition for which it was not prescribed. Do not give extended phenytoin sodium capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about extended phenytoin sodium capsules that is written for health professionals.
What are the ingredients in extended phenytoin sodium capsules? Active ingredient:100 mg phenytoin sodium, USP Inactive ingredients:confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. All trademarks are the property of their respective owners.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

Extended Phenytoin Sodium Capsules USP, 100 mg are hard, gelatin capsules No. 3 with an opaque orange cap, opaque orange body with black imprint "SUN808" on both body and cap. Contains white to off-white powder.

They are available in:

NDC: 70518-1776-00

NDC: 70518-1776-01

NDC: 70518-1776-02