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DILANTIN INFATABS- phenytoin tablet, chewable


  1. Patient Information
  2. Like Other Antiepileptic Drugs, Dilantin 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:
  3. 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?
  4. Dilantin 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:
  5. Dilantin Can Cause Problems With Your Heart, Including A Slow Heartbeat. Let Your Healthcare Provider Know Right Away If You Have Any Of These Symptoms:
  6. What Is Dilantin?
  7. Do Not Take Dilantin If You:
  8. What Should I Avoid While Taking Dilantin?
  9. What Are The Possible Side Effects Of Dilantin?
  10. Active Ingredient:
  11. Inactive Ingredients:

Patient Information 

Advise patients to read the FDA-approved patient labeling (Medication Guide).

Administration Information

Advise patients taking phenytoin of the importance of adhering strictly to the prescribed dosage regimen, and of informing the physician of any clinical condition in which it is not possible to take the drug orally as prescribed, e.g., surgery, etc.

Withdrawal of Antiepileptic Drugs

Advise patients not to discontinue use of DILANTIN without consulting with their healthcare provider. DILANTIN should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus[

1.
Do not stop taking DILANTIN without first talking to your healthcare provider.
  • Stopping DILANTIN 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).
2.

Like Other Antiepileptic Drugs, Dilantin 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.
3.

Dilantin 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 DILANTIN for an extended period of time. These symptoms can be a sign of a serious allergic reaction.
4.

Dilantin 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 Is Dilantin? 


DILANTIN is a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.

Do Not Take Dilantin If You: 

  • Are allergic to phenytoin or any of the ingredients in DILANTIN.
    • Take DILANTIN exactly as your healthcare provider tells you.
    • Your healthcare provider will tell you how much DILANTIN to take and when to take it.
    • Your healthcare provider may change your dose if needed. Do not change your dose of DILANTIN without talking to your healthcare provider.
    • If your healthcare provider has prescribed DILANTIN oral suspension, ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of DILANTIN.Do notuse a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
    • Do not stop taking DILANTIN without first talking to your healthcare provider. Stopping DILANTIN suddenly can cause serious problems.

What Should I Avoid While Taking Dilantin? 

  • Do not drink alcohol while you take DILANTIN without first talking to your healthcare provider. Drinking alcohol while taking DILANTIN may change your blood levels of DILANTIN which can cause serious problems.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how DILANTIN affects you. DILANTIN can slow your thinking and motor skills.

What Are The Possible Side Effects Of Dilantin? 


  • Store DILANTIN INFATABS at room temperature between 68 F to 77 F (20 C to 25 C).
  • Protect from moisture.
Keep DILANTIN and all medicines out of the reach of children.General information about the safe and effective use of DILANTIN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DILANTIN for a condition for which it was not prescribed. Do not give DILANTIN 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 DILANTIN that is written for health professionals.

Active Ingredient: 

50 mg phenytoin, USP

Inactive Ingredients: 

D & C yellow No. 10, Aluminum Lake, FD&C yellow No. 6, Aluminum Lake, flavor, saccharin sodium, confectioner's sugar, talc, magnesium stearate, and purified water.

Logo

LAB 0776-6.0
For more information about DILANTIN, visit http://www.pfizer.com or call 1 800 438 1985.



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