Peganone

DRUG 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® (ethotoin) Structural Formula Illustration

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

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

What are the possible side effects of ethotoin (Peganone)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • vision...

Read All Potential Side Effects and See Pictures of Peganone »

What are the precautions when taking ethotoin (Peganone)?

Before taking ethotoin, tell your doctor or pharmacist if you are allergic to it; or to other hydantoins (e.g., phenytoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood problems (e.g., anemia), liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, lupus, folate or vitamin B12 deficiency (megaloblastic anemia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that...

Read All Potential Precautions of Peganone »


Peganone Consumer (continued)

SIDE EFFECTS: Headache, nausea, vomiting, diarrhea, dizziness, drowsiness, numbness/tingling, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: loss of coordination, swollen glands (lymph nodes), butterfly-shaped rash on the nose/cheeks, vision changes (e.g., blurred vision, double vision), uncontrolled side-to-side eye movements (nystagmus).

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Severe (rarely fatal) blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with ethotoin. Discuss the risks and benefits with your doctor before starting ethotoin.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual bleeding/bruising, symptoms of infection (fever, chills, persistent sore throat), symptoms of anemia (tiredness, pale skin/fingernails, fast heartbeat), liver problems (e.g., severe stomach/abdominal pain, unusual weakness/tiredness, pale stools, dark urine, yellowing eyes/skin).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ethotoin, tell your doctor or pharmacist if you are allergic to it; or to other hydantoins (e.g., phenytoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood problems (e.g., anemia), liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, lupus, folate or vitamin B12 deficiency (megaloblastic anemia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

The use of anti-seizure drugs during pregnancy may increase the risk of bleeding in the newborn baby. Your doctor may order vitamin K injections for you/your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Peganone Patient Information Including Side Effects

Brand Names: Peganone

Generic Name: ethotoin (Pronunciation: ETH oh toyn)

  • What is ethotoin (Peganone)?
  • What are the possible side effects of ethotoin (Peganone)?
  • What is the most important information I should know about ethotoin (Peganone)?
  • What should I discuss with my healthcare provider before taking ethotoin (Peganone)?
  • How should I take ethotoin (Peganone)?
  • What happens if I miss a dose (Peganone)?
  • What happens if I overdose (Peganone)?
  • What should I avoid while taking ethotoin (Peganone)?
  • What other drugs will affect ethotoin (Peganone)?
  • Where can I get more information?

What is ethotoin (Peganone)?

Ethotoin is an anti-epileptic medication, also called an anticonvulsant.

Ethotoin is used alone or in combination with other medications to treat seizures in adults and children.

Ethotoin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ethotoin (Peganone)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • vision problems;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, unusual weakness;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain;
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • worsening of seizures.

Less serious side effects may include:

  • dizziness, headache, tired feeling;
  • vomiting, diarrhea;
  • swelling in your gums;
  • sleep problems (insomnia); or
  • lack of balance or coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ethotoin (Peganone)?

You should not use this medication if you are allergic to ethotoin or if you have liver disease or a blood cell disorder (such as anemia, hemophilia, and others).

Ethotoin can cause a decrease in many types of blood cells (white cells, red cells, platelets). Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, even if these symptoms first occur after you have been using the medication for several months.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Contact your doctor if your seizures get worse or you have them more often while taking ethotoin.

Carry an ID card or wear a medical alert bracelet stating that you are taking ethotoin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

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