PHENYTOIN- phenytoin suspension 
Pharmaceutical Associates, Inc.

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MEDICATION GUIDE
Phenytoin (fen' i toin) Oral Suspension, USP

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?

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

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

  1. Phenytoin oral suspension 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
  • feeling like your heart is beating slowly or skipping beats
  • tiredness
  • 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:

Before taking phenytoin oral suspension, tell your healthcare provider about all of your medical conditions, including if you:

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 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?

What should I avoid while taking phenytoin oral suspension?

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:

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)
  • Problems with movement and balance (ataxia)
  • Slurred speech
  • Decrease in coordination
  • Drowsiness (somnolence)
  • Confusion

Phenytoin 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?

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: carboxymethylcellulose sodium, citric acid anhydrous, FD&C yellow no. 6, magnesium aluminum silicate, orange flavor spray dry natural and artificial, polysorbate 60, purified water, sodium benzoate, sucrose and vanilla flavored powder artificial.

PACKAGED BY

Pharmaceutical
Associates, Inc.

Greenville, SC 29605
www.paipharma.com

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

Revised: April 2020

Revised: 4/2020
Pharmaceutical Associates, Inc.