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Peganone
Overview
What is Peganone?
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:
What does Peganone look like?
What are the available doses of Peganone?
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What should I talk to my health care provider before I take Peganone?
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How should I use Peganone?
PEGANONE (ethotoin tablets, USP) is indicated for the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures.
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.
What interacts with Peganone?
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What are the warnings of Peganone?
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What are the precautions of Peganone?
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What are the side effects of Peganone?
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What should I look out for while using Peganone?
PEGANONE (ethotoin tablets, USP) is contraindicated in patients with hepatic abnormalities or hematologic disorders.
Suicidal Behavior and Ideation:
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. shows absolute and relative risk by indication for all evaluated AEDs.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy 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:
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 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/.
What might happen if I take too much Peganone?
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.
How should I store and handle Peganone?
Store at PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01).Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc.Revised: July 2016MS-04228 R3.0PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01).Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc.Revised: July 2016MS-04228 R3.0PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01).Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc.Revised: July 2016MS-04228 R3.0PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01).Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc.Revised: July 2016MS-04228 R3.0PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01).Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc.Revised: July 2016MS-04228 R3.0PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01).Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc.Revised: July 2016MS-04228 R3.0PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01).Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap.Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc.Revised: July 2016MS-04228 R3.0
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 nonlinear kinetics. 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.
Non-Clinical Toxicology
PEGANONE (ethotoin tablets, USP) is contraindicated in patients with hepatic abnormalities or hematologic disorders.Suicidal Behavior and Ideation:
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. shows absolute and relative risk by indication for all evaluated AEDs.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy 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:
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 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/.
Metabolism of a number of medications, including antipsychotics, antidepressants, ß-blockers, and antiarrhythmics, occurs through the cytochrome P450 2D6 isoenzyme (debrisoquine hydroxylase). Approximately 10% of the Caucasian population has reduced activity of this enzyme, so-called “poor” metabolizers. Among other populations the prevalence is not known. Poor metabolizers demonstrate higher plasma concentrations of antipsychotic drugs at usual doses, which may correlate with emergence of side effects. In one study of 45 elderly patients suffering from dementia treated with perphenazine, the 5 patients who were prospectively identified as poor P450 2D6 metabolizers had reported significantly greater side effects during the first 10 days of treatment than the 40 extensive metabolizers, following which the groups tended to converge. Prospective phenotyping of elderly patients prior to antipsychotic treatment may identify those at risk for adverse events.
The concomitant administration of other drugs that inhibit the activity of P450 2D6 may acutely increase plasma concentrations of antipsychotics. Among these are tricyclic antidepressants and selective serotonin reuptake inhibitors, e.g., fluoxetine, sertraline and paroxetine. When prescribing these drugs to patients already receiving antipsychotic therapy, close monitoring is essential and dose reduction may become necessary to avoid toxicity. Lower doses than usually prescribed for either the antipsychotic or the other drug may be required.
General:
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, 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 ).
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:
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.
Drug Interactions:
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Pregnancy:
Nonteratogenic Effects:
Nursing Mothers:
Pediatric Use:
Geriatric Use:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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