MEDICATION GUIDE

Phenytoin (fen' i toin) Oral Suspension, USP

125 mg/5 mL

What is the most important information I should know about Phenytoin Oral Suspension?

1. Do not stop taking Phenytoin Oral Suspension without first talking to your healthcare provider.

• Stopping Phenytoin Oral Suspension 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, Phenytoin Oral Suspension 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. Phenytoin Oral Suspension 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 Phenytoin Oral Suspension for an extended period of time. These symptoms can be a sign of a serious allergic reaction.

4. Phenytoin 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 Phenytoin Oral Suspension?

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

Do not take Phenytoin Oral Suspension if you:

• Are allergic to phenytoin or any of the ingredients in Phenytoin Oral Suspension. See the end of this leaflet for a complete list of ingredients in Phenytoin Oral Suspension.
• Have had an allergic reaction to CEREBYX (fosphenytoin), PEGANONE (ethotoin), or MESANTOIN (mephenytoin).
• Have had liver problems from taking phenytoin.
• Take delavirdine.

Before taking Phenytoin Oral Suspension, tell your healthcare provider about all of your medical conditions, including if you:

• Have or have had depression, mood problems, or suicidal thoughts or behavior
• Have had an allergic reaction to a medicine similar to Phenytoin Oral Suspension called carboxamides, barbiturates, succinimides, and oxazolidinediones
• Have or had liver or kidney problems
• Have or had an enzyme problem called porphyria
• Have or had high blood sugar (hyperglycemia)
• Drink alcohol
• Are pregnant or plan to become pregnant. Phenytoin Oral Suspension may harm your unborn baby.
• If you take Phenytoin Oral Suspension during pregnancy, your baby is at risk for serious birth defects.
• If you become pregnant while taking Phenytoin Oral Suspension, the level of Phenytoin Oral Suspension in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of Phenytoin Oral Suspension.
• If you take Phenytoin Oral Suspension 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 Phenytoin Oral Suspension.
• If you are of childbearing age and are not planning on getting pregnant, you should use effective birth control (contraception) while taking Phenytoin Oral Suspension.
• Pregnancy Registry : If you become pregnant while taking Phenytoin Oral Suspension, 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.
• Are breastfeeding or plan to breastfeed. Phenytoin Oral Suspension can pass into breast milk. You and your healthcare provider should decide if you will take Phenytoin Oral Suspension while you are breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These medicines can change the levels of Phenytoin Oral Suspension in your blood.

Taking Phenytoin Oral Suspension 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 Phenytoin Oral Suspension?

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

What should I avoid while taking Phenytoin Oral Suspension?

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

What are the possible side effects of Phenytoin Oral Suspension?

See "What is the most important information I should know about Phenytoin Oral Suspension?" Phenytoin Oral Suspension may cause other serious side effects including:

• Liver problems.
• Low blood count which could increase your chance of getting infections, bruising, bleeding and increased fatigue.
• Softening of your bones (osteopenia, osteoporosis, and osteomalacia) can cause your bones to break (fractures).
• High blood sugar (hyperglycemia).
• High levels of Phenytoin Oral Suspension in your blood that could cause confusion also known as delirium, psychosis or a more serious condition that affects how your brain works (encephalopathy).

Call your healthcare provider right away, if you have any of the symptoms listed above. The most common side effects of Phenytoin Oral Suspension include:

• Irregular movement of the eye (nystagmus)
• Slurred speech
• Drowsiness (somnolence)
• Problems with movement and balance (ataxia)
• Decrease in coordination
• Confusion

Phenytoin Oral Suspension can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking Phenytoin Oral Suspension can help prevent this from happening.

These are not all of the possible side effects of Phenytoin Oral Suspension.

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 Phenytoin Oral Suspension?

• Store Phenytoin Oral Suspension at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect from light.
• Do not freeze.

Keep Phenytoin Oral Suspension and all medicines out of the reach of children.

General information about the safe and effective use of Phenytoin Oral Suspension.

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

What are the ingredients in Phenytoin Oral Suspension?

Active ingredient: phenytoin, USP

Inactive ingredients: alcohol, USP (0.35 percent), carboxymethylcellulose sodium, citric acid, anhydrous, FD&C Yellow No. 6, glycerin, liquid sugar, magnesium aluminum silicate, orange flavor, polysorbate 40, purified water, sodium benzoate, sodium citrate dihydrate and vanillin

For more information about Phenytoin Oral Suspension, visit http://www.wockhardtusa.com or call 1-800-445-4290.

Product No: 8131

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

28131P

Rev. 02-21

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