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EXTENDED PHENYTOIN SODIUM- phenytoin sodium capsule


  1. Patient Information
  2. Dispense With Medication Guide Available At:
  3. What Is The Most Important Information I Should Know About Extendedphenytoin Sodium Capsules?
  4. Extended Phenytoin Sodium Capsules Can Cause Serious Side Effects Including:
  5. Call A Healthcare Provider Right Away If You Have Any Of These Symptoms, Especially If They Are New, Worse, Or Worry You:
  6. How Can I Watch For Early Symptoms Of Suicidal Thoughts And Actions?
  7. Pregnancy Registry:
  8. What Are Extended Phenytoin Sodium Capsules?
  9. Before You Take Extended Phenytoin Sodium Capsules, Tell Your Healthcare Provider If You:
  10. How Should I Take Extended Phenytoin Sodium Capsules?
  11. Extended Phenytoin Sodium Capsules May Cause Other Serious Side Effects Including:
  12. The Most Common Side Effects Of Extended Phenytoin Sodium Capsules Include:
  13. How Should I Store Extended Phenytoin Sodium Capsules?
  14. What Are The Ingredients In Extended Phenytoin Sodium Capsules?
  15. What Is The Most Important Information I Should Know About Extended Phenytoin Sodium Capsules?
  16. 2. Like Other Antiepileptic Drugs, Extended Phenytoin Sodium Capsules 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:
  17. 3. Extended Phenytoin Sodium Capsules 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:
  18. What Are Extended Phenytoin Sodium Capsules?
  19. Do Not Take Extended Phenytoin Sodium Capsules If You:
  20. What Should I Avoid While Taking Extended Phenytoin Sodium Capsules?
  21. What Are The Possible Side Effects Of Extended Phenytoin Sodium Capsules?
  22. Active Ingredient:
  23. 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.

Advise patients not to use capsules which are discolored.

Withdrawal of Antiepileptic Drugs

Advise patients not to discontinue use of extended phenytoin sodium capsules without consulting with their healthcare provider. Extended phenytoin sodium capsules should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus[seeWarnings and Precautions (5.1)].

Suicidal Ideation and Behavior

Counsel patients, their caregivers, and families that AEDs, including extended phenytoin sodium capsules, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers[seeWarnings and Precautions (5.2)].

Potential Signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Other Systemic Reactions

Advise patients of the early toxic signs and symptoms of potential hematologic, dermatologic, hypersensitivity, or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy, facial swelling, and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. Advise the patient that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. In addition, advise the patient that these signs and symptoms should be reported even if mild or when occurring after extended use[seeWarnings and Precautions (5.3,5.4,5.5,5.6,5.7)].

Effects of Alcohol Use and Other Drugs and Over-the-Counter Drug Interactions

Caution patients against the use of other drugs or alcoholic beverages without first seeking their physician's advice[Drug Interactions (7.1,7.2)].

Inform patients that certain over-the-counter medications (e.g., antacids, cimetidine, and omeprazole), vitamins (e.g., folic acid), and herbal supplements (e.g., St. John's wort) can alter their phenytoin levels.

Hyperglycemia

Advise patients that extended phenytoin sodium capsules may cause an increase in blood glucose levels[seeWarnings and Precautions (5.13)].

Gingival Hyperplasia

Advise patients of the importance of good dental hygiene in order to minimize the development of gingival hyperplasia and its complications.

Neurologic Effects

Counsel patients that extended phenytoin sodium capsules may cause dizziness, gait disturbance, decreased coordination and somnolence. Advise patients taking extended phenytoin sodium capsules not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with extended phenytoin sodium capsules.

Use in Pregnancy

Inform pregnant women and women of childbearing potential that use of extended phenytoin sodium capsules during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), cardiac defects, dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using extended phenytoin sodium capsules, keeping in mind that there is a potential for decreased hormonal contraceptive efficacy[seeDrug Interactions (7.2)].

Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breastfeeding or intend to breastfeed during therapy[seeUse in Specific Populations (8.1,8.2)].

Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy[seeUse in Specific Populations (8.1)].

Dispense With Medication Guide Available At: 

www.aurobindousa.com/product-medication-guides

What Is The Most Important Information I Should Know About Extendedphenytoin Sodium Capsules? 

Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider.Stopping extended phenytoin sodium capsules suddenly can cause serious problems.

Extended Phenytoin Sodium Capsules Can Cause Serious Side Effects Including: 

1. Like other antiepileptic drugs, extended phenytoin sodium capsules 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

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 extended phenytoin sodium capsules without first talking to a healthcare provider.

Stopping extended phenytoin sodium capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

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.

2. Extended phenytoin sodium capsules may harm your unborn baby.

If you take extended phenytoin sodium capsules during pregnancy, your baby is at risk for serious birth defects.
Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
If you take extended phenytoin sodium capsules 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 extended phenytoin sodium capsules. If the decision is made to use extended phenytoin sodium capsules, you should use effective birth control (contraception) unless you are planning to become pregnant.
Tell your healthcare provider right away if you become pregnant while taking extended phenytoin sodium capsules. You and your healthcare provider should decide if you will take extended phenytoin sodium capsules while you are pregnant.

Pregnancy Registry: 

If you become pregnant while taking extended phenytoin sodium capsules, 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.

3. Swollen glands (lymph nodes)

4. Allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells.You may or may not have a rash with these types of reactions. Symptoms can include any of the following:

swelling of your face, eyes, lips, or tongue
trouble swallowing or breathing
a skin rash
hives
fever, swollen glands (lymph nodes), or sore throat that do not go away or come and go
painful sores in the mouth or around your eyes
yellowing of your skin or eyes
bruising or bleeding
severe fatigue or weakness
severe muscle pain
frequent infections or an infection that does not go away
loss of appetite (anorexia)
nausea or vomiting

Call your healthcare provider right away if you have any of the symptoms listed above.

What Are Extended Phenytoin Sodium Capsules? 

Extended phenytoin sodium capsules are a prescription medicine used to treat tonic-clonic (grand mal), complex partial (psychomotor or temporal lobe) seizures, and to prevent and treat seizures that happen during or after brain surgery.

Before You Take Extended Phenytoin Sodium Capsules, Tell Your Healthcare Provider If You: 

Have or had liver disease
Have or had porphyria
Have or had diabetes
Have or have had depression, mood problems, or suicidal thoughts or behavior
Are pregnant or plan to become pregnant. If you become pregnant while taking extended phenytoin sodium capsules, the level of extended phenytoin sodium in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of extended phenytoin sodium capsules.
Are breast feeding or plan to breastfeed. Extended phenytoin sodium can pass into breast milk. You and your healthcare provider should decide if you will take extended phenytoin sodium capsules or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take,including prescription and
non-prescription medicines, vitamins, and herbal supplements.
Taking extended phenytoin sodium capsules 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 Extended Phenytoin Sodium Capsules? 

Take extended phenytoin sodium capsules exactly as prescribed. Your healthcare provider will tell you how much extended phenytoin sodium capsules to take.
Your healthcare provider may change your dose. Do not change your dose of extended phenytoin sodium capsules without talking to your healthcare provider.
Extended phenytoin sodium capsules can cause overgrowth of your gums. Brushing and flossing your teeth and
Do not drink alcohol while you take extended phenytoin sodium capsules without first talking to your healthcare provider. Drinking alcohol while taking extended phenytoin sodium capsules may change your blood levels of extended phenytoin sodium capsules which can cause serious problems.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how extended phenytoin sodium capsules affect you. Extended phenytoin sodium capsules can slow your thinking and motor skills.

Extended Phenytoin Sodium Capsules May Cause Other Serious Side Effects Including: 

Softening of your bones (osteopenia, osteoporosis, and osteomalacia). This can cause broken bones.
Call your healthcare provider right away, if you have any of the symptoms listed above.

The Most Common Side Effects Of Extended Phenytoin Sodium Capsules Include: 

problems with walking and coordination
slurred speech
confusion
dizziness
trouble sleeping
nervousness
tremor
headache
nausea
vomiting
constipation
rash

These are not all the possible side effects of extended phenytoin sodium capsules. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 Extended Phenytoin Sodium Capsules? 

Store extended phenytoin sodium capsules at room temperature between 68 F to 77 F (20 C to 25 C) in tight, light-resistant containers. Protect from moisture.

Keep extended phenytoin sodiumcapsules and all medicines out of the reach of children.

General information about extended phenytoin sodium capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use extended phenytoin sodium capsules for a condition for which it was not prescribed. Do not give extended phenytoin sodium capsules to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about extended phenytoin sodium capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about extended phenytoin sodium capsules that was written for healthcare professionals.

For more information about extended phenytoin sodium capsules, visit www.amneal.com or call 1-877-835-5472.

What Are The Ingredients In Extended Phenytoin Sodium Capsules? 

Extended Oral Capsule

Extended phenytoin sodium capsule 100mg: White opaque/lavender opaque, hard gelatin capsules imprinted IP 212 on both cap and body.

Active ingredient: 100 mg phenytoin sodium

Inactive ingredients: D&C Red #28, D&C Red #33, FD&C Blue #1, gelatin, hydroxypropyl cellulose, mannitol, magnesium stearate, talc and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Major information

Rev. 09-2015-02

What Is The Most Important Information I Should Know About Extended Phenytoin Sodium Capsules? 

1. Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider.

  • Stopping extended phenytoin sodium capsules 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, Extended Phenytoin Sodium Capsules 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.

3. Extended Phenytoin Sodium Capsules 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 extended phenytoin sodium capsules for an extended period of time. These symptoms can be a sign of a serious allergic reaction.

What Are Extended Phenytoin Sodium Capsules? 

Extended phenytoin sodium capsules are a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.

Do Not Take Extended Phenytoin Sodium Capsules If You: 

  • Are allergic to phenytoin or any of the ingredients in extended phenytoin sodium capsules.

    • Take extended phenytoin sodium capsules exactly as your healthcare provider tells you.
    • Your healthcare provider will tell you how much extended phenytoin sodium capsules to take and when to take it.
    • Your healthcare provider may change your dose if needed. Do not change your dose of extended phenytoin sodium capsules without talking to your healthcare provider.
    • Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider. Stopping extended phenytoin sodium capsules suddenly can cause serious problems.

What Should I Avoid While Taking Extended Phenytoin Sodium Capsules? 

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

What Are The Possible Side Effects Of Extended Phenytoin Sodium Capsules? 



  • Store extended phenytoin sodium capsules at room temperature between 20 to 25 C (68 to 77 F).
  • Store in tight, light-resistant containers.
  • Protect from moisture.

Keep extended phenytoin sodium capsules and all medicines out of the reach of children.

General information about the safe and effective use of extended phenytoin sodium capsules.


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use extended phenytoin sodium capsules for a condition for which it was not prescribed. Do not give extended phenytoin sodium capsules 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 extended phenytoin sodium capsules that is written for health professionals.

Active Ingredient: 

phenytoin sodium

Inactive Ingredients: 

confectioner s sugar, hypromellose, magnesium oxide, magnesium stearate, microcrystalline cellulose, and talc. In addition, the empty hard gelatin capsule shells also contain gelatin, sodium lauryl sulphate, and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.


For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


This Medication Guide has been approved by the U.S. Food and Drug Administration


The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.


Dispense with Medication Guide available at:www.aurobindousa.com/product-medication-guides


Manufactured for:
AurobindoPharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
AurobindoPharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
AP-509302, INDIA

Revised: 02/2018



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