Peganone

What is Peganone?

Peganone is a prescription medicine thatused to help control certain kinds of seizures.

Description

PEGANONE (ethotoin tablets, USP) is an oral antiepileptic of the hydantoin series and is chemically identified as 3-ethyl-5-phenyl-2,4-imidazolidinedione. It is represented by the following structural formula:

PEGANONE tablets are available in a dosage strength of 250 mg.

Inactive Ingredients: Acacia, lactose, sodium carboxymethylcellulose, stearic acid and talc.

Before taking Peganone, tell your doctor:

• If you are allergic to Peganone; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Blood problems or liver disease.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Peganone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Peganone?

• Tell all of your health care providers that you take Peganone. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Peganone affects you.
• Do not stop taking Peganone all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop Peganone, you will want to slowly stop it as ordered by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Take good care of your teeth. See a dentist often.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Peganone.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Peganone, call your doctor right away.
• A bleeding problem that can be life-threatening may happen in newborns if you took Peganone during pregnancy.

How is Peganone best taken?

Use Peganone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take after eating with a full glass of water.
• Do not change the dose or stop Peganone. This could cause seizures. Talk with your doctor.
• Keep taking Peganone as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Peganone that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Change in balance.
• Swollen or sore gums.
• Chest pain or pressure.
• Not able to control eye movements.
• Seeing double.
• A burning, numbness, or tingling feeling that is not normal.
• Swollen gland.
• If seizures are worse or not the same after starting Peganone.
• The ability of your bone marrow to make blood cells may be lowered. This can lead to very bad bleeding problems or infections. Tell your doctor right away if you have signs of infection like fever, chills, or sore throat; any bruising or bleeding; or if you feel very tired or weak.
• Patients who take Peganone may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Peganone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Dizziness.
• Headache.
• Not able to sleep.
• Upset stomach or throwing up.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Peganone?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

• NDC 55292-601-01
  100 Tablets
  Peganone®
  (ethotoin tablets, USP)
  250 mg
  DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT. GO TO
  WWW.RECORDATIRAREDISEASES.COM
  RECORDATI RARE DISEASES GROUP
  Rx only
• Each tablet contains:
  Ethotoin 250 mg
  See enclosure for prescribing information.
  Store at 20-25ºC (68-77ºF). See USP controlled room temperature.
  Dispense in a USP tight container.
  Do not accept if seal over bottle opening is broken or missing.
  Manufactured by:
  UPM Pharmaceuticals, Inc.
  501 5th Street, Bristol, TN 37620, U.S.A.
  For: Recordati Rare Diseases Inc.
  Lebanon, NJ 08833, U.S.A.
• Exp.
  Lot
  MS-04227

SRC: NLM .