Drugs Details

Drugs Info of Peganone
Drugs Details
  • Drugs Type  : FDA
  • Date : 16th Feb 2015 04:38 am
  • Brand Name : Peganone
  • Generic Name : ethotoin (Pronunciation: ETH oh toyn)
Descriptions

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® 250 mg (ethotoin tablets, USP)  Structural Formula Illustration

 

PEGANONE 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 problems;
  • signs of infection such as fever,...

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 »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

PEGANONE (ethotoin tablets, USP) is indicated for the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures.

Dosage Administration

PEGANONE (ethotoin tablets, USP) is administered orally in 4 to 6 divided doses daily. The drug should be taken after food, and doses should be spaced as evenly as practicable. Initial dosage should be conservative. For adults, the initial daily dose should be 1 g or less, with subsequent gradual dosage increases over a period of several days. The optimum dosage must be determined on the basis of individual response. The usual adult maintenance dose is 2 to 3 g daily. Less than 2 g daily has been found ineffective in most adults.

Pediatric dosage depends upon the age and weight of the patient. The initial dose should not exceed 750 mg daily. The usual maintenance dose in children ranges from 500 mg to 1 g daily, although occasionally 2 or (rarely) 3 g daily may be necessary.

If a patient is receiving another antiepileptic drug, it should not be discontinued when PEGANONE therapy is begun. The dosage of the other drug should be reduced gradually as that of PEGANONE is increased. PEGANONE may eventually replace the other drug or the optimal dosage of both antiepileptics may be established.

In tonic-clonic (grand mal) seizures, use of the drug with phenobarbital may be beneficial.

How Supplied

PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letters OV on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-601-01).

Recommended storage: Store 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.

Manufactured by: AbbVie Inc. North Chicago, IL 60064, U.S.A. For: Recordati Rare Diseases Inc. Lebanon, NJ 08833, U.S.A. Revised: February 2013.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Adverse reactions associated with PEGANONE, in decreasing order of severity, are:

Isolated cases of lymphadenopathy and systemic lupus erythematosus have been reported in patients taking hydantoin compounds, and lymphadenopathy has occurred with PEGANONE. Withdrawal of therapy has resulted in remission of the clinical and pathological findings. Therefore, if a lymphoma-like syndrome develops, the drug should be withdrawn and the patient should be closely observed for regression of signs and symptoms before treatment is resumed.

Ataxia and gum hypertrophy have occurred only rarely—usually only in patients receiving an additional hydantoin derivative. It is of interest to note that ataxia and gum hypertrophy have subsided in patients receiving other hydantoins when PEGANONE (ethotoin tablets, USP) was given as a substitute antiepileptic.

Occasionally, vomiting or nausea after ingestion of PEGANONE has been reported, but if the drug is administered after meals, the incidence of gastric distress is reduced. Other side effects have included chest pain, nystagmus,diplopia, fever, dizziness, diarrhea, headache, insomnia, fatigue, numbness, skin rash, and Stevens-Johnson syndrome.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare

Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the Peganone (ethotoin) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

PEGANONE used in combination with other drugs known to adversely affect thehematopoietic system should be avoided if possible.

A two-way interaction between the hydantoin antiepileptic, phenytoin, and the coumarin anticoagulants has been suggested. Presumably, phenytoin acts as a stimulator of coumarin metabolism and has been reported to cause decreased serum levels of the coumarin anticoagulants and increased prothrombin-proconvertin concentrations. Conversely, the coumarin anticoagulants have been reported to increase the serum levels and prolong the serum half-life of phenytoin by inhibiting its metabolism. Although there is no documentation of such, a similar interaction between ethotoin and the coumarin anticoagulants may occur. Caution is therefore advised when administering PEGANONE to patients receiving coumarin anticoagulants.

Read the Peganone Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

 
 

Warnings

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs); including PEGANONE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table1: Risk by indication for antiepileptic drugs in the pooled analysis

INDICATION PLACEBO PATIENTS WITH EVENTS PER 1000 PATIENTS DRUG PATIENTS WITH EVENTS PER 1000 PATIENTS RELATIVE RISK: INCIDENCE OF EVENTS IN DRUG PATIENTS/INCIDENCE IN PLACEBO PATIENTS RISK DIFFERENCE: ADDITIONAL DRUG PATIENTS WITH EVENTS PER 1000 PATIENTS
Epilepsy 1 3.4 3.5 2.4
Psychiatric 5.7 8.5 1.5 2.9
Other 1 1.8 1.9 0.9
Total 2.4 4.3 1.8 1.9

 

The relative risk for suicidal thoughts or behavior was higher in clinical trials forepilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing PEGANONE or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and 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.

Use in Pregnancy

Peganone (ethotoin tablets, USP) can cause fetal harm when administered to a pregnant woman. There are multiple reports in the clinical literature which indicate that the use of antiepileptic drugs during pregnancy results in an increased incidence of birth defects in the offspring. Although data are more extensive with respect to phenytoin and phenobarbital, reports indicate a possible similar association with the use of other antiepileptic drugs. Therefore, antiepileptic drugs should be administered to women of child-bearing potential only if they are clearly shown to be essential in the management of their seizures.

Antiepileptic drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and risk to both mother and the unborn child. Consideration should, however, be given to discontinuation of antiepileptics prior to and during pregnancy when the nature, frequency and severity of the seizures do not pose a serious threat to the patient. It is not, however, known whether even minor seizures constitute some risk to the developing embryo or fetus.

Reports have suggested that the maternal ingestion of antiepileptic drugs, particularly barbiturates, is associated with a neonatal coagulation defect that may cause bleeding during the early (usually within 24 hours of birth) neonatal period. The possibility of the occurrence of this defect with the use of PEGANONE should be kept in mind. The defect is characterized by decreased levels of vitamin k-dependent clotting factors, and prolongation of either the prothrombin time or the partial thromboplastin time, or both. It has been suggested that vitamin k be given prophylactically to the mother one month prior to and during delivery, and the infant, intravenously, immediately after birth.

If PEGANONE is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

To provide information regarding the effects of in utero exposure to PEGANONE, physicians are advised to recommend that pregnant patients taking PEGANONE enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll- free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

 
 

Precautions

General

Blood dyscrasias have been reported in patients receiving PEGANONE. Although the etiologic role of PEGANONE has not been definitely established, physicians should be alert for general malaise, sore throat and other symptoms indicative of possible blood dyscrasia.

There is some evidence suggesting that hydantoin-like compounds may interfere with folic acid metabolism, precipitating a megaloblastic anemia. If this should occur during gestation, folic acid therapy should be considered.

Information for Patients

Patients should be advised to report immediately such signs and symptoms as sore throat, fever, malaise, easy bruising, petechiae, epistaxis, skin rash or others that may be indicative of an infection or bleeding tendency.

Patients, their caregivers, and families should be counseled that AEDs, including PEGANONE, may increase the risk of suicidal thoughts and behavior and should be advised 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 of self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 (see WARNINGS, Use In Pregnancy).

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with ethotoin and should counsel them in its appropriate use. A patient Medication Guide is available for PEGANONE. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is available at www.recordatirarediseases.com.

Laboratory Tests

Liver function tests should be performed if clinical evidence suggests the possibility of hepatic dysfunction. Signs of liver damage are an indication for withdrawal of the drug.

It is recommended that blood counts and urinalyses be performed when therapy is begun and at monthly intervals for several months thereafter. As in patients receiving other hydantoin compounds and other antiepileptic drugs, blood dyscrasias have been reported in patients receiving PEGANONE (ethotoin tablets, USP). Marked depression of the blood count is indication for withdrawal of the drug.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on long-term potential for carcinogenicity in animals or humans.

Pregnancy

Pregnancy Category D (see WARNINGS).

Nonteratogenic Effects

Reports have suggested that the maternal ingestion of antiepileptic drugs, particularly barbiturates, is associated with a neonatal coagulation defect that may cause bleeding during the early (usually within 24 hours of birth) neonatal period. The possibility of the occurrence of this defect with the use of PEGANONE should be kept in mind (see WARNINGS).

Nursing Mothers

Ethotoin is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from ethotoin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population were established on the basis of open-label, uncontrolled experience in patients down to the age of one with various types of seizures.

Geriatric Use

Clinical studies of PEGANONE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Symptoms of acute overdosage include drowsiness, visual disturbance, nausea and ataxia. Coma is possible at very high dosage.

Treatment should be begun by inducing emesis; gastric lavage may be considered as an alternative. General supportive measures will be necessary. A careful evaluation of blood-forming organs should be made following recovery.

ContrainDications

PEGANONE (ethotoin tablets, USP) is contraindicated in patients with hepaticabnormalities or hematologic disorders.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

PEGANONE (ethotoin tablets, USP) exerts an antiepileptic effect without causing general central nervous system depression. The mechanism of action is probably very similar to that of phenytoin. The latter drug appears to stabilize rather than to raise the normal seizure threshold, and to prevent the spread of seizure activity rather than to abolish the primary focus of seizure discharges.

Ethotoin is fairly rapidly absorbed; the extent of oral absorption is not known. The drug exhibits saturable metabolism with respect to the formation of N-deethyl and p-hydroxyl-ethotoin, the major metabolites. Where plasma concentrations are below about 8 μg/mL, the elimination half-life of ethotoin is in the range of 3 to 9 hours. A study comparing single doses of 500 mg, 1000 mg, and 1500 mg of PEGANONE (ethotoin tablets, USP) demonstrated that ethotoin, and to a lesser extent 5-phenylhydantoin, a major metabolite, exhibits substantial nonlinearkinetics. The degree of nonlinearity with multiple dosing may be increased over that seen after a single dose, given the likelihood of plasma accumulation based on a reported elimination half-life of 6 to 9 hours and a dosing interval of 4 to 6 hours. Experience suggests that therapeutic plasma concentrations fall in the range of 15 to 50 μg/mL; however, this range is not as extensively documented as those quoted for other antiepileptics.

In laboratory animals, the drug was found effective against electroshock convulsions, and to a lesser extent, against complex partial (psychomotor) and pentylenetetrazol-induced seizures. In mice, the duration of antiepileptic activity was prolonged by hepatic injury but not by bilateral nephrectomy; the drug is apparently biotransformed by the liver.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

PEGANONE® 250 mg Tablets 
(PEG-ah-noan)
(ethotoin) Tablets, USP

Read this Medication Guide before you start taking PEGANONE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about PEGANONE?

Do not stop taking PEGANONE without first talking to your healthcare provider.

Stopping PEGANONE suddenly can cause serious problems.

PEGANONE can cause serious side effects, including:

Like other antiepileptic drugs, PEGANONE 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 PEGANONE without first talking to a healthcare provider.

  • Stopping PEGANONE suddenly can cause serious problems. Stopping aseizure 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.

What is PEGANONE?

PEGANONE is a prescription medicine used to treat tonic-clonic (grand mal) and complex partial (psychomotor) seizures.

It is not known if PEGANONE is safe or effective in children younger than 1 year old.

Who should not take PEGANONE?

Do not take PEGANONE if you have:

  • liver problems
  • blood problems

What should I tell my healthcare provider before taking PEGANONE?

Before you take PEGANONE, tell your healthcare provider if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have any other medical conditions
  • are pregnant or plan to become pregnant. PEGANONE may harm your unborn baby and cause 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. Tell your healthcare provider right away if you become pregnant while taking PEGANONE. You and your healthcare provider should decide if you will take PEGANONE while you are pregnant.
    • If you become pregnant while taking PEGANONE, 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. PEGANONE can pass into breast milk. You and your healthcare provider should decide if you will take PEGANONE or breastfeed. You should not do both. Talk to your healthcare provider about the best way to feed your baby if you take PEGANONE.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking PEGANONE 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.

Especially tell your healthcare provider if you take medicines that affect blood clotting.

How should I take PEGANONE?

  • Take PEGANONE exactly as your healthcare provider tells you. Your healthcare provider will tell you how much PEGANONE to take.
  • Your healthcare provider may change your dose. Do not change your dose of PEGANONE without talking to your healthcare provider.
  • Do not stop taking PEGANONE without first talking to your healthcare provider. Stopping PEGANONE suddenly can cause serious problems.
  • Take PEGANONE after eating, and space doses out evenly.
  • If you take too much PEGANONE, call your healthcare provider or local Poison Control Center right away.

What are the possible side effects of PEGANONE?

See “What is the most important information I should know about PEGANONE?”.

PEGANONE may cause other rare, but serious side effects. These include:

  • Blood problems – symptoms may include: not feeling well, soar throat, fever, bruising easily, red or purple spots on your body, nose bleed
  • Liver problems – symptoms may include: yellowing of your skin or the whites of your eyes (jaundice), dark urine, nausea or vomiting, loss of appetite, pain on the right side of your stomach, bruising easily.
  • Swollen glands (enlarged lymph nodes)
  • Lupus – symptoms may include: a rash on your cheeks or other parts of your body, sensitivity to the sun, new joint or muscle pains, chest pain or shortness of breath, swelling of your feet, ankles or legs.
  • Serious rash – symptoms may include: skin rash, hives, sore throat, sores in your mouth, your skin blisters and peels, swelling of your face, eyes, lips, tongue, or throat.

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

The most common side effects of PEGANONE include:

  • nausea or vomiting
  • tiredness
  • rash
  • dizziness
  • jerky eye movements
  • problems with walking and balance
  • double vision
  • overgrowth of gum tissue

These are not all the possible side effects of PEGANONE. 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 PEGANONE?

  • Store at 20-25°C (68-77°F).
  • Keep PEGANONE in a tightly closed container, and keep PEGANONE out of the light.

Keep PEGANONE and all medicines out of the reach of children.

General Information about PEGANONE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEGANONE for a condition for which it was not prescribed. Do not give PEGANONE 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 PEGANONE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PEGANONE that is written for health professionals.

For more information, go to www.recordatirarediseases.com or call 1-888-575-8344.

What are the ingredients in PEGANONE?

Active ingredient: ethotoin

Inactive ingredients: acacia, lactose, sodium carboxymethylcellulose, stearic acid and talc.

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

Manufactured by: AbbVie Inc. North Chicago, IL 60064, U.S.A. For: Recordati Rare Diseases Inc. Lebanon, NJ 08833, U.S.A. Revised: February 2013

This monograph has been modified to include the generic and brand name in many instances.

 

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ETHOTOIN - ORAL

 

(ETH-oh-toyn)

 

COMMON BRAND NAME(S): Peganone

 

USES: Ethotoin is used to prevent and control seizures. It is known as an anticonvulsant/antiepileptic drug. It works by reducing the abnormal electrical activity in the brain that causes seizures. It belongs to a class of drugs known as hydantoins.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ethotoin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication with food, usually 4-6 times a day or as directed by your doctor. Taking it with food or milk may help prevent an upset stomach.

The dosage is based on your medical condition and response to therapy. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects such as upset stomach and drowsiness. Your doctor will adjust your dose to find the best dose for you. Follow your doctor's directions carefully.

Space your doses evenly throughout the day. It is important to take all doses on time to keep a steady level of medication in your blood. To help you remember, take it at the same times each day. Do not skip doses.

If you are already taking another anti-seizure drug, follow your doctor's directions carefully for stopping or continuing the old drug and starting ethotoin.

Do not stop taking this medication or any anti-seizure medication without consulting your doctor. Your seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition persists or worsens.

Consumer Overview Side Effect

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, fainting, 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.

 

Read the Peganone (ethotoin) Side Effects Center for a complete guide to possible side effects

Learn More »
 

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.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, loss of coordination, or fainting. These side effects can increase the risk of falling.

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.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because a very serious interaction may occur: nisoldipine.

If you are currently using this medication, tell your doctor or pharmacist before starting ethotoin.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: blood thinners (e.g., warfarin), drugs that can cause low blood counts (e.g., cancer chemotherapy), other anti-seizure medications (e.g., phenytoin, valproate).

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Ethotoin is very similar to phenytoin. Many medications interact with phenytoin. It is not known whether the same drugs interact with ethotoin. However, it is very important to tell all your doctors and pharmacists of all the medications you use, including ethotoin.

Also report the use of drugs which might increase seizure risk such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., imipramine), among others. Consult your doctor or pharmacist for details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unusual eye movements, unsteadiness, loss of consciousness.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, kidney/liver tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature below 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

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.

Read the Peganone (ethotoin) Side Effects Center for a complete guide to possible side effects

Learn More »
 

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.

Side Effects Centers
  • Peganone

Patient Detailed How Take

What should I discuss with my healthcare provider before taking 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).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take ethotoin:

  • lupus;
  • liver disease; or
  • folic acid (or folate) deficiency.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category D. Seizure medication may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Do not start taking ethotoin during pregnancy without telling your doctor you are pregnant.

If you become pregnant while taking ethotoin for seizures, do not stop taking it without your doctor's advice. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by taking ethotoin.

If you have taken ethotoin during pregnancy, be sure to tell the doctor who delivers your baby about your ethotoin use. Both you and the baby may need to receive medications to prevent excessive bleeding during delivery and just after birth.

Your name may need to be listed on a pregnancy registry if you take ethotoin during pregnancy. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether the medication had any effect on the baby.

Ethotoin passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ethotoin (Peganone)?

 

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you are switching to ethotoin from another anticonvulsant medication, carefully follow your doctor's instructions about timing and dosage when switching from one drug to another. Your doctor may occasionally change your dose over several weeks or months to make sure you get the best results from this medication.

Take ethotoin after eating to prevent upset stomach.

Ethotoin can cause a decrease in many types of blood cells (white cells, red cells, platelets). This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, including flu-like symptoms. These symptoms may first develop even after you have been using the medication for several months.

To be sure your blood cells do not get too low, your blood may need to be tested on a regular basis while taking ethotoin. Your liver function may also need to be tested. Do not miss any scheduled appointments.

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.

It is important to use ethotoin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store ethotoin at room temperature away from moisture, heat, and light.

Side Effects Centers
  • Peganone

Patient Detailed Avoid Taking

What happens if I miss a dose (Peganone)?

 

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Peganone)?

 

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include vision changes, nausea, vomiting, extreme drowsiness, and trouble standing or walking.

What should I avoid while taking ethotoin (Peganone)?

 

Ethotoin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect ethotoin (Peganone)?

 

Before taking ethotoin, tell your doctor about all other medications you use, especially:

  • medicine to prevent blood clots, such as ticlopidine (Ticlid) or warfarin (Coumadin);
  • an antibiotic such as dapsone, penicillamine (Cuprimine, Depen), pentamidine (Nebupent), rifapentine (Priftin);
  • an antidepressant such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), maprotiline (Ludiomil), mirtazapine (Remeron), nortriptyline (Pamelor), and others;
  • heart rhythm medication such as flecainide (Tambocor), procainamide (Procan, Pronestyl), or propafenone (Rythmol);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), loxapine (Loxitane), perphenazine (Trilafon), pimozide (Orap), prochlorperazine (Compazine), thiothixene (Navane), and others;
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), and others;
  • other seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), felbamate (Felbatol), primidone (Mysoline), phenytoin (Dilantin), or valproic acid (Depakene);
  • a sulfa drug such as Bactrim, Septra, Cotrim, SMX-TMP;
  • thyroid replacement medication such as levothyroxine (Levothroid, Synthroid); or
  • type 2 diabetes medications such as chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol), tolazamide (Tolnase), tolbutamide (Orinase).

This list is not complete and there may be other drugs that can interact with ethotoin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about ethotoin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.02. Revision date: 12/15/2010.

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