Phenytek

Name: Phenytek

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to phenytoin.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking phenytoin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Phenytek Drug Class

Phenytek is part of the drug class:

  • Hydantoin derivatives

Phenytek Usage

  • Take phenytoin exactly as prescribed. Your healthcare provider will tell you how much phenytoin to take.
  • Your healthcare provider may change your dose. Do not change your dose of phenytoin without talking to your healthcare provider.
  • Phenytoin can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking phenytoin can help prevent this.
  • If you take too much phenytoin, call your healthcare provider or local Poison Control Center right away.
  • Do not stop taking phenytoin without first talking to your healthcare provider. Stopping phenytoin suddenly can cause serious problems.

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 happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What other drugs will affect Phenytek (phenytoin)?

Sometimes it is not safe to use certain medications at the same time. Some drugs can raise or lower your blood levels of phenytoin, which may cause side effects or make phenytoin less effective. Phenytoin can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

Taking phenytoin with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking phenytoin with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with phenytoin. Not all possible interactions are listed here. TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE, and any you start or stop using during treatment with phenytoin. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Uses For Phenytek

Phenytoin is used to control seizures (convulsions) in the treatment of epilepsy. It is also used to prevent and treat seizures that occur during brain surgery. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

This medicine is available only with your doctor's prescription.

How is this medicine (Phenytek) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Take Phenytek (phenytoin extended-release capsules) at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not stop taking Phenytek all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Do not take antacids at the same time as this medicine. Ask your doctor if you have a question about how to take antacids with Phenytek.
  • If this medicine is given through a feeding tube, stop tube feeding for 2 hours before giving Phenytek. Restart tube feeding 2 hours after giving.
  • Swallow whole. Do not chew, break, or crush.
  • Do not take if product changes color.
  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine interacts with many other drugs. The chance of Phenytek's side effects may be raised or how well this medicine works may be lowered. The chance of the other drugs' side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take Phenytek with all of your other drugs (prescription or OTC, natural products, vitamins).
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • Wear disease medical alert ID (identification).
  • Follow laws about driving with a seizure problem.
  • Do not switch brands or types of Phenytek (like tablets, liquid) unless you talk with the doctor. They may not work the same.
  • Take good care of your teeth. See a dentist often.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out Phenytek?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Phenytek is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Phenytek or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Phenytek. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

PRINCIPAL DISPLAY PANEL - 300 mg

NDC 0378-3750-93

Phenytek®
(extended phenytoin
sodium capsules, USP)

300 mg

PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

Rx only 30 Capsules

Each capsule contains:
Phenytoin sodium, USP 300 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Protect from light and moisture.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

U.S. Patent No. 6,274,168

RBK3750H5

Phenytek 
extended phenytoin sodium capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-2670
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYTOIN SODIUM (PHENYTOIN) PHENYTOIN SODIUM 200 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
SILICON DIOXIDE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GELATIN  
MAGNESIUM OXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POVIDONES  
PROPYLENE GLYCOL  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)  
SHELLAC  
Product Characteristics
Color BLUE (dark blue opaque) , BLUE (blue opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code BERTEK;670
Contains     
Packaging
# Item Code Package Description
1 NDC:0378-2670-93 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:0378-2670-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040298 12/10/2001
Phenytek 
phenytoin sodium capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0378-3750
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYTOIN SODIUM (PHENYTOIN) PHENYTOIN SODIUM 300 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
SILICON DIOXIDE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GELATIN  
MAGNESIUM OXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POVIDONES  
PROPYLENE GLYCOL  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)  
SHELLAC  
Product Characteristics
Color BLUE (blue opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code BERTEK;750
Contains     
Packaging
# Item Code Package Description
1 NDC:0378-3750-93 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:0378-3750-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040298 12/10/2001
Labeler - Mylan Pharmaceuticals Inc. (059295980)
Revised: 08/2015   Mylan Pharmaceuticals Inc.
(web3)