INDICATIONS & USAGE SECTION

Highlight: Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. ( 1)

1 INDICATIONS AND USAGE

Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

DOSAGE & ADMINISTRATION SECTION

Highlight: *NOT FOR ONCE-A-DAY DOSING (2.1)

Adult starting dose in patients who have received no previous treatment is two phenytoin chewable tablets three times a day, with dose adjustments as necessary. For most adults, the satisfactory maintenance dose will be six to eight phenytoin chewable tablets daily; an increase to twelve phenytoin chewable tablets daily may be made, if necessary. ( 2.2)
Pediatric starting dose is 5 mg/kg/day in two to three equally divided doses, with dosage adjustments as necessary, up to a maximum of 300 mg daily. Maintenance dosage is 4 mg/kg/day to 8 mg/kg/day. ( 2.3)
Serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum total concentration is 10 mcg/mL to 20 mcg/mL (unbound phenytoin concentration is 1 mcg/mL to 2 mcg/mL). ( 2.4)

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

NOT FOR ONCE-A-DAY DOSING. Phenytoin chewable tablets can be either chewed thoroughly before being swallowed or swallowed whole.

2.2 Adult Dosage

The recommended starting dosage for adult patients who have received no previous treatment is two 50 mg phenytoin chewable tablets by mouth three times daily. Adjust the dosage to suit individual requirements up to a maximum of twelve phenytoin chewable tablets daily. For most adults, the satisfactory maintenance dosage will be six to eight phenytoin chewable tablets daily.

2.3 Pediatric Dosage

The recommended starting dosage for pediatric patients is 5 mg/kg/day by mouth in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily in divided doses. A recommended daily maintenance dosage is usually 4 mg/kg/day to 8 mg/kg/day in equally divided doses. Children over 6 years and adolescents may require the minimum adult dosage (300 mg/day). If the daily dosage cannot be divided equally, the larger dose should be given before retiring.

2.4 Dosage Adjustments

Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations may be necessary for optimal dosage adjustments. Trough levels provide information about clinically effective serum level range and confirm patient compliance, and are obtained just prior to the patient's next scheduled dose. Peak levels indicate an individual's threshold for emergence of dose-related side effects and are obtained at the time of expected peak concentration. Therapeutic effect without clinical signs of toxicity occurs more often with serum total concentrations between 10 mcg/mL and 20 mcg/mL (unbound phenytoin concentrations of 1 mcg/mL to 2 mcg/mL), although some mild cases of tonic-clonic (grand mal) epilepsy may be controlled with lower serum levels of phenytoin. In patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of unbound phenytoin concentrations may be more relevant [see Dosage and Administration (2.6)] .

With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.

2.5 Switching Between Phenytoin Formulations

The free acid form of phenytoin is used in phenytoin oral suspension and phenytoin chewable tablets. Extended phenytoin sodium capsules and parenteral phenytoin are formulated with the sodium salt of phenytoin. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.

2.6 Dosing in Patients with Renal or Hepatic Impairment or Hypoalbuminemia

Because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients [see Warnings and Precautions (5.11) and Use in Specific Populations (8.6)] .

2.7 Geriatric Dosage

Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required [see Clinical Pharmacology (12.3)] .

2.8 Dosing during Pregnancy

Decreased serum concentrations of phenytoin may occur during pregnancy because of altered phenytoin pharmacokinetics. Periodic measurement of serum phenytoin concentrations should be performed during pregnancy, and the phenytoin chewable tablets dosage should be adjusted as necessary. Postpartum restoration of the original dosage will probably be indicated [see Use in Specific Populations (8.1)] . Because of potential changes in protein binding during pregnancy, the monitoring of phenytoin serum levels should be based on the unbound fraction.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Phenytoin chewable tablets are available as 50 mg scored chewable tablets. (

3 DOSAGE FORMS AND STRENGTHS

Phenytoin chewable tablets are available as 50 mg phenytoin yellow, round, scored chewable tablets.

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

Phenytoin chewable tablets 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 2 antagonists (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, lacosamide, lamotrigine, topiramate, oxcarbazepine
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.

USE IN SPECIFIC POPULATIONS SECTION

Highlight: * Pregnancy: Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. ( 5.13, 8.1)

Renal and/or Hepatic Impairment or Hypoalbuminemia: Monitor unbound phenytoin concentrations in these patients. ( 8.6)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as phenytoin, during pregnancy. Physicians are advised to recommend that pregnant patients taking phenytoin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Risk Summary

In humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. In addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see Data] . There have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy.

Administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see Data] .

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Clinical Considerations

Disease-associated maternal risk

An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see Dosage and Administration (2.4, 2.8)] . However, postpartum restoration of the original dosage will probably be indicated [see Clinical Pharmacology (12.3)] .

Fetal/Neonatal Adverse Reactions

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. This drug-induced condition can be prevented with vitamin K administration to the mother before delivery and to the neonate after birth.

Data

Human Data

Meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. An increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. The fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies.

Animal Data

Administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. Malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100 mg/kg, 75 mg/kg, and 12.5 mg/kg, respectively.

8.2 Lactation

Risk Summary

Phenytoin is secreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phenytoin and any potential adverse effects on the breastfed infant from phenytoin or from the underlying maternal condition.

8.4 Pediatric Use

Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 mg/kg to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see Dosage and Administration (2.3)] .

8.5 Geriatric Use

Phenytoin clearance tends to decrease with increasing age [see Clinical Pharmacology (12.3)] . Lower or less frequent dosing may be required [see Dosage and Administration (2.7)] .

8.6 Renal and/or Hepatic Impairment or Hypoalbuminemia

The liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity.

8.7 Use in Patients with Decreased CYP2C9 Function

Patients who are intermediate or poor metabolizers of CYP2C9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). Thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. If early signs of dose-related central nervous system (CNS) toxicity develop, serum concentrations should be checked immediately [see Clinical Pharmacology (12.5)].

SPL MEDGUIDE SECTION

This Medication Guide has been approved by the U.S. Food and Drug Administration	Revised: June 2022
Dispense with Medication Guide available at: https://www.taro.com/usa- medication-guides
MEDICATION GUIDE Phenytoin (fen´ i toin) chewable tablets
What is the most important information I should know about phenytoin chewable tablets? *Do not stop taking phenytoin chewable tablets without first talking to your healthcare provider. * Stopping phenytoin chewable tablets 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, phenytoin chewable tablets 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. *Phenytoin chewable tablets 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 phenytoin for an extended period of time. These symptoms can be a sign of a serious allergic reaction. *Phenytoin chewable tablets 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 phenytoin chewable tablets? Phenytoin chewable tablets is a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
Do not take phenytoin chewable tablets if you: Are allergic to phenytoin or any of the ingredients in phenytoin chewable tablets. See the end of this leaflet for a complete list of ingredients in phenytoin chewable tablets. Have had an allergic reaction to CEREBYX (fosphenytoin), PEGANONE (ethotoin), or MESANTOIN (mephenytoin). Have had liver problems from taking phenytoin. Take delavirdine.
Before taking phenytoin chewable tablets, 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 phenytoin 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. Phenytoin chewable tablets may harm your unborn baby. If you take phenytoin chewable tablets during pregnancy, your baby is at risk for serious birth defects. If you become pregnant while taking phenytoin chewable tablets, the level of phenytoin in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of phenytoin chewable tablets. If you take phenytoin chewable tablets 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 phenytoin chewable tablets. If you are of childbearing age and are not planning on getting pregnant, you should use effective birth control (contraception) while taking phenytoin chewable tablets. *Pregnancy Registry: If you become pregnant while taking phenytoin chewable tablets, 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 phenytoin chewable tablets 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 phenytoin chewable tablets 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 phenytoin chewable tablets? Take phenytoin chewable tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how much phenytoin chewable tablets to take and when to take it. Your healthcare provider may change your dose if needed. Do not change your dose of phenytoin chewable tablets 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 not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way. Do not stop taking phenytoin chewable tablets without first talking to your healthcare provider. Stopping phenytoin suddenly can cause serious problems.
What should I avoid while taking phenytoin chewable tablets? Do not drink alcohol while you take phenytoin chewable tablets without first talking to your healthcare provider. Drinking alcohol while taking phenytoin chewable tablets 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 chewable tablets affect you. Phenytoin can slow your thinking and motor skills.
What are the possible side effects of phenytoin chewable tablets? See"What is the most important information I should know about phenytoin chewable tablets?" Phenytoin chewable tablets 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 phenytoin chewable tablets include:
Irregular movement of the eye (nystagmus) Problems with movement and balance (ataxia)	Slurred speech Decrease in coordination	Drowsiness (somnolence) Confusion
Phenytoin can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking phenytoin chewable tablets can help prevent this from happening. These are not all of the possible side effects of phenytoin chewable tablets. 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 phenytoin chewable tablets? Store phenytoin chewable tablets at room temperature between 68°F to 77°F (20°C to 25°C). Protect from moisture. Keep phenytoin chewable tablets and all medicines out of the reach of children.
General information about the safe and effective use of phenytoin chewable tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use phenytoin chewable tablets for a condition for which it was not prescribed. Do not give phenytoin chewable tablets 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 phenytoin chewable tablets that is written for health professionals.
What are the ingredients in phenytoin chewable tablets? Active ingredient: 50 mg phenytoin, USP. Inactive ingredients: Artificial banana flavor, compressible sugar, D&C yellow No. 10 aluminum lake, FD&C yellow No. 6 aluminum lake, hypromellose 2208, lactose monohydrate, magnesium stearate, saccharin sodium, and talc.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

Phenytoin Chewable Tablets USP, 50 mg are yellow, uniform to slightly mottled, round normal convex tablets, scored and engraved with "T" above the score and "50" below the score on one side and plain on the other side. The tablets are banana flavored. They are supplied as follows:

NDC: 70518-0841-00

NDC: 70518-0841-01

NDC: 70518-0841-02

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

SPL UNCLASSIFIED SECTION

5200701-0622-10

AI-Powered Research

Premium Access

Phenytoin

FDA Approval Summary

Products1