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DILANTIN- phenytoin sodium capsule, extended release


  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. Do Not Take Dilantin If You:
  6. What Should I Avoid While Taking Dilantin?
  7. What Are The Possible Side Effects Of Dilantin?
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. Dilantin May Cause Rare But Serious, Even Life-threatening, Allergic Reactions.contact Your Healthcare Provider Right Away If You Have Any Of These Symptoms After Taking Dilantin:
  11. Call A Healthcare Provider Right Away If You Have Any Of These Symptoms, Especially If They Are New, Worse, Or Worry You:
  12. How Can I Watch For Early Symptoms Of Suicidal Thoughts And Actions?
  13. What Else Do I Need To Know About Dilantin?
  14. What Is Dilantin?
  15. Who Should Not Take Dilantin?
  16. Before Starting Dilantin, Tell Your Healthcare Provider About All Medications You Take (including Prescription And Nonprescription Medications, Vitamins, And Herbal Medicines) And Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  17. How Should I Take Dilantin?
  18. Dilantin 100mg:
  19. Dilantin 30mg:

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.

Advise patients not to use capsules which are discolored.

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.

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 Capsules at room temperature between 68 F to 77 F (20 C to 25 C).
  • Store in tight, light-resistant containers.
  • 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: 

100 mg phenytoin sodium, USP

Inactive Ingredients: 

lactose monohydrate, confectioner's sugar, talc, and magnesium stearate. The capsule body contains titanium dioxide and gelatin. The capsule cap contains FD&C red No. 28, FD&C yellow No. 6, and gelatin.

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

LAB-0586-10.0
February 2017

Dilantin May Cause Rare But Serious, Even Life-threatening, Allergic Reactions.contact Your Healthcare Provider Right Away If You Have Any Of These Symptoms After Taking Dilantin: 

  • Skin rash and blisters, hives (raised bumps), fever or itching
  • Swelling of your face, mouth, lips, gums, tongue or neck
  • Trouble breathing

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 activity and talking (mania)
  • other unusual changes in behavior or mood

If you have suicidal thoughts or actions, do not stop DILANTIN without first talking to your healthcare provider.

  • Stopping DILANTIN suddenly can increase the possibility of side effects including increased seizure frequency.
  • 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.

Do not stop taking DILANTIN without first talking to your healthcare provider.Stopping DILANTIN suddenly can increase the possibility of side effects including increased seizure frequency.

Use of DILANTIN during pregnancy may increase the risks of birth defects (deformed babies) or may increase seizure frequency in the mother.You should not take DILANTIN if you are pregnant or plan to become pregnant unless instructed to do so by your healthcare provider.

What Else Do I Need To Know About Dilantin? 

Many drugs (including alcohol) can either increase or decrease your DILANTIN level, which can interfere with your optimum dosage. It is recommended that you avoid drinking alcoholic beverages while taking DILANTIN. It is very important to discuss all of your medications with your healthcare provider .DILANTIN may alter the results of some laboratory tests. If you require laboratory tests, you should remind your healthcare provider that you are taking DILANTIN.

It is important to practice good dental hygiene while taking DILANTIN to minimize the development of gingival hyperplasia (excessive formation of the gums over the teeth) and its complications.

Your blood may need to be tested regularly to make sure that you are taking the correct dose of DILANTIN.

What Is Dilantin? 

DILANTIN is a prescription medicineused alone or with other medications to treat different types of seizures in people. DILANTIN may also be used for the prevention and treatment of seizures occurring during or following brain surgery. DILANTIN belongs to a class of prescription medicines called anticonvulsants or anti-seizure medications and affects abnormal chemical activity in the brain that may be involved in causing seizures.

DILANTIN is not effective for the treatment of seizures due to hypoglycemic or other metabolic causes. It is also not effective for absence (petit mal) seizures.

Who Should Not Take Dilantin? 

Do not take DILANTIN if you are allergic or hypersensitive to any of its ingredients. The active ingredient is phenytoin.

Before Starting Dilantin, Tell Your Healthcare Provider About All Medications You Take (including Prescription And Nonprescription Medications, Vitamins, And Herbal Medicines) And Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • Have or had liver disease
  • Have or had porphyria (a blood disorder)
  • Have or had diabetes
  • Are pregnant or plan to become pregnant. Because of the potential harm to your developing baby, DILANTIN should not be taken during pregnancy unless you are told otherwise by your healthcare provider. If you discover you are pregnant, do not suddenly stop taking DILANTIN because this may lead to serious consequences for you and your baby. If you become pregnant, you should talk to your healthcare provider immediately. You should also consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This registry is collecting information about the safety of the use of all antiepileptic drugs during pregnancy. To enroll, call the toll free number 1-888-233-2334.
  • Are breast feeding. Taking DILANTIN while breast feeding it is not recommended.
  • Consume alcohol. Alcohol drinking can increase or decrease the DILANTIN level in your blood.
  • Have or had Vitamin D deficiency or any other condition that causes thinning of the bones.
  • Receive nutrition through a feeding tube. Patients who are receiving nutrition through a feeding tube may have lower-than-expected blood levels of DILANTIN. Do not administer DILANTIN at the same time as the feeding preparation.

How Should I Take Dilantin? 

  • Take DILANTIN exactly as prescribed.Your healthcare provider may need to change (adjust) the dose of DILANTIN until it is right for you. Your blood may need to be tested on a regular basis to make sure that you are taking the correct dose for proper control of your seizures. You may also need a blood test if you are switching from one form of DILANTIN to another.
  • Try to take DILANTIN at the same times each day to avoid missing any doses. If you miss a dose of DILANTIN, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of DILANTIN at the same time.
  • Tell your healthcare provider of any clinical condition (such as surgery) during which it is not possible to take DILANTIN orally as prescribed.
  • In adults whose seizures are well controlled with divided doses of three 100-mg capsules daily, once-a-day dosing may be considered. You should discuss this possibility with your healthcare provider.
  • Do not take capsules that are discolored.
  • Do not stop taking DILANTIN unless your healthcare provider tells you to do so.If your treatment is stopped, it should be done gradually. If you stop taking DILANTIN suddenly or before your healthcare provider tells you, there is an increased risk of seizures.

OVERDOSE

An overdose of DILANTIN can be fatal. If you suspect an overdose,

You should avoid consuming alcoholic beverages while taking DILANTIN without first talking to your healthcare provider."

DILANTIN can cause rare but serious skin allergic reactions which can be fatal. Tell your healthcare provider and

General information about DILANTIN

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 condition. It may harm them.

This Medication Guide summarizes the most important information about DILANTIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about DILANTIN that was written for healthcare professionals. For more information about DILANTIN, visit http://www.pfizer.com

Dilantin 100mg: 

Each capsule contains a white powder. The medium orange cap has "PD" imprinted in black ink and the white, opaque body has "DILANTIN" over "100 mg" printed in black ink.

Dilantin 30mg: 

Each capsule contains a white powder. The small pale pink opaque cap has "PD" imprinted in black ink and the white, opaque body has "Dilantin 30 mg" printed in black ink.


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