Dilantin Infatabs

In the U.S.

• Dilantin
• Dilantin-125
• Dilantin Infatabs
• Phenytek

In Canada

• Dilantin-30

Available Dosage Forms:

• Suspension
• Tablet, Chewable
• Capsule, Extended Release
• Capsule

Therapeutic Class: Anticonvulsant

Chemical Class: Hydantoin (class)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of phenytoin in children.

Geriatric

No information is available on the relationship of age to the effects of phenytoin in geriatric patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients taking phenytoin.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Artemether
• Atazanavir
• Boceprevir
• Cobicistat
• Daclatasvir
• Darunavir
• Dasabuvir
• Delamanid
• Delavirdine
• Elbasvir
• Elvitegravir
• Grazoprevir
• Isavuconazonium
• Lurasidone
• Maraviroc
• Ombitasvir
• Paritaprevir
• Piperaquine
• Praziquantel
• Ranolazine
• Rilpivirine
• Ritonavir
• Telaprevir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone
• Afatinib
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Apazone
• Apixaban
• Apremilast
• Aprepitant
• Aripiprazole
• Axitinib
• Beclamide
• Bedaquiline
• Blinatumomab
• Bortezomib
• Bosutinib
• Brexpiprazole
• Brigatinib
• Bupropion
• Cabozantinib
• Calcifediol
• Calcium Carbonate
• Carbamazepine
• Cariprazine
• Ceritinib
• Clarithromycin
• Clozapine
• Cobimetinib
• Crizotinib
• Cyclophosphamide
• Dabigatran Etexilate
• Dasatinib
• Deferasirox
• Deflazacort
• Desogestrel
• Diazepam
• Diazoxide
• Dienogest
• Digoxin
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Dolutegravir
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Eliglustat
• Enzalutamide
• Erlotinib
• Eslicarbazepine Acetate
• Estradiol
• Ethinyl Estradiol
• Ethosuximide
• Ethynodiol
• Etonogestrel
• Etravirine
• Everolimus
• Exemestane
• Ezogabine
• Fentanyl
• Fluvastatin
• Fosaprepitant
• Gefitinib
• Gestodene
• Golimumab
• Guselkumab
• Halothane
• Ibrutinib
• Idelalisib
• Ifosfamide
• Imatinib
• Infliximab
• Irinotecan
• Irinotecan Liposome
• Itraconazole
• Ivabradine
• Ivacaftor
• Ixabepilone
• Ixazomib
• Ketoconazole
• Lapatinib
• Ledipasvir
• Levonorgestrel
• Lidocaine
• Linagliptin
• Lopinavir
• Macitentan
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Manidipine
• Mestranol
• Methadone
• Methotrexate
• Miconazole
• Midostaurin
• Mifepristone
• Naloxegol
• Netupitant
• Nifedipine
• Nilotinib
• Nimodipine
• Nintedanib
• Norethindrone
• Norgestimate
• Norgestrel
• Olaparib
• Orlistat
• Osimertinib
• Oxycodone
• Palbociclib
• Panobinostat
• Pazopanib
• Perampanel
• Pixantrone
• Ponatinib
• Posaconazole
• Quetiapine
• Regorafenib
• Reserpine
• Ribociclib
• Rifampin
• Rivaroxaban
• Rocuronium
• Roflumilast
• Rolapitant
• Romidepsin
• Saquinavir
• Secukinumab
• Sertraline
• Simeprevir
• Sonidegib
• Sorafenib
• St John's Wort
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tasimelteon
• Temsirolimus
• Tenofovir Alafenamide
• Theophylline
• Thiotepa
• Ticagrelor
• Tofacitinib
• Tolvaptan
• Trabectedin
• Ulipristal
• Valbenazine
• Vandetanib
• Velpatasvir
• Vemurafenib
• Venetoclax
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Voriconazole
• Vortioxetine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetaminophen
• Acetazolamide
• Acyclovir
• Amiodarone
• Amitriptyline
• Amprenavir
• Aripiprazole Lauroxil
• Atorvastatin
• Betamethasone
• Bexarotene
• Bleomycin
• Busulfan
• Capecitabine
• Carboplatin
• Caspofungin
• Chloramphenicol
• Cimetidine
• Ciprofloxacin
• Cisplatin
• Clobazam
• Clofazimine
• Clopidogrel
• Colesevelam
• Cortisone
• Cyclosporine
• Dexamethasone
• Dicumarol
• Digitoxin
• Diltiazem
• Disopyramide
• Disulfiram
• Doxepin
• Doxifluridine
• Felbamate
• Fluconazole
• Fludrocortisone
• Fluorouracil
• Fluoxetine
• Fluvoxamine
• Folic Acid
• Fosamprenavir
• Ginkgo
• Imipramine
• Isoniazid
• Levodopa
• Levomethadyl
• Levothyroxine
• Meperidine
• Methoxsalen
• Methsuximide
• Midazolam
• Nafimidone
• Nelfinavir
• Nilutamide
• Nisoldipine
• Ospemifene
• Oxcarbazepine
• Paclitaxel
• Pancuronium
• Paroxetine
• Phenprocoumon
• Piperine
• Prednisolone
• Prednisone
• Progabide
• Quinidine
• Quinine
• Remacemide
• Rifapentine
• Risperidone
• Rufinamide
• Sabeluzole
• Shankhapulshpi
• Simvastatin
• Sirolimus
• Sulfamethizole
• Sulfamethoxazole
• Sulfaphenazole
• Sulthiame
• Tegafur
• Telithromycin
• Tenidap
• Tiagabine
• Ticlopidine
• Ticrynafen
• Tirilazad
• Tizanidine
• Tolbutamide
• Topiramate
• Trazodone
• Triamcinolone
• Trimethoprim
• Tubocurarine
• Valacyclovir
• Valproic Acid
• Vecuronium
• Verapamil
• Vigabatrin
• Viloxazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Enteral Nutrition
• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (eg, osteomalacia, osteoporosis) or
• Depression or mental illness, history of or
• Diabetes or
• Lymphadenopathy (lymph node problems) or
• Porphyria (an enzyme problem) or
• Vitamin D deficiency—Use with caution. May make these conditions worse.

• Hypoalbuminemia (low albumin in the blood) or
• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal from the body.

This section provides information on the proper use of a number of products that contain phenytoin. It may not be specific to Dilantin Infatabs. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine may be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Do not change brands or dosage forms of phenytoin without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.

Swallow the tablet whole or chew it thoroughly before being swallowed together with a glass of water.

Measure the oral suspension with a marked measuring spoon, oral syringe, or medicine cup. Rinse the dosing spoon or cup with water after each use.

If you are receiving tube feeding preparations, it is best to take this medicine before or after a feeding.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For seizures:
  • For oral dosage form (extended-release capsules):
    • Adults—At first, 100 milligrams (mg) three times a day or 300 mg once a day. Your doctor may increase your dose as needed. For patients in the clinic or hospital (except with a history of liver or kidney disease), a loading dose of 1000 mg is divided into three doses (400 mg, 300 mg, 300 mg) and given every 2 hours. Then, normal maintenance dose may be started 24 hours after the loading dose.
    • Teenagers and children older than 6 years of age—300 mg per day. Your doctor may adjust your dose as needed.
    • Children 6 years of age and below—Dose is based on body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) of body weight given in two or three divided doses per day. The doctor may adjust the dose as needed.
  • For oral dosage form (suspension):
    • Adults—At first, 5 milliliters (mL) or one teaspoonful three times a day. Your doctor may adjust your dose as needed.
    • Teenagers and children older than 6 years of age—300 mg per day. Your doctor may adjust your dose as needed.
    • Children 6 years of age and below—Dose is based on age and body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) of body weight given in two or three divided doses per day. Your doctor may adjust your dose as needed.
  • For oral dosage form (tablets):
    • Adults—At first, 100 milligrams (mg) three times a day. Your doctor may adjust your dose as needed.
    • Teenagers and children older than 6 years of age—300 mg per day, given in two or three divided doses per day. Your doctor may adjust your dose as needed.
    • Children 6 years of age and below—Dose is based on age and body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) of body weight given in two or three divided doses per day. The doctor may adjust the dose as needed.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• It is used to help control certain kinds of seizures.
• It may be given to you for other reasons. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in balance.
• Trouble walking.
• Feeling confused.
• Slurred speech.
• Swollen or sore gums.
• Very bad muscle pain.
• Trouble controlling body movements.
• If seizures are worse or not the same after starting this medicine.
• A burning, numbness, or tingling feeling that is not normal.
• Not able to control eye movements.
• Shakiness.
• A very bad and sometimes deadly effect has happened in people taking drugs for seizures like this medicine (Dilantin Infatabs). Call your doctor right away if you have swollen glands; fever; rash; chest pain; unable to pass urine or change in the amount of urine passed; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Rarely, certain blood problems have happened with this medicine. This can lead to bleeding problems or infections. Sometimes, these have been deadly. Tell your doctor right away if you have signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal. Tell your doctor right away if you have any unexplained bruising or bleeding, or if you feel very tired or weak.

Dilantin Infatabs 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.

Dilantin Infatabs are available as 50 mg phenytoin yellow triangular scored chewable tablets.

DILANTIN is contraindicated in patients with:

• A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)].
• A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.6)].
• 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.

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)]
• Hepatic Injury [see Warnings and Precautions (5.6)]
• Hematopoietic Complications [see Warnings and Precautions (5.7)]
• Effects on Vitamin D and Bone [see Warnings and Precautions (5.8)]
• Exacerbation of Porphyria [see Warnings and Precautions (5.10)]
• Teratogenicity and Other Harm to the Newborn [see Warnings and Precautions (5.11)]
• Hyperglycemia [see Warnings and Precautions (5.13)]

The following adverse reactions associated with the use of DILANTIN 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 [see Warnings and Precautions (5.3, 5.4)]. 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. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's disease have been reported [see Warnings and Precautions (5.7)].

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 (5.13)], 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 (5.14)].

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, Stevens-Johnson syndrome, and toxic epidermal necrolysis [see Warnings and Precautions (5.3)]. There have also been reports of hypertrichosis.

Special Senses: Altered taste sensation including metallic taste.

Urogenital: Peyronie's disease

How Supplied

Dilantin Infatabs contain 50 mg phenytoin and are supplied in a yellow triangular scored chewable tablet as follows:

Storage and Handling

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

Protect from moisture.