Ethotoin - Uses, Indications, and Precautions

Overview

Ethotoin drug is approved by the FDA (Food and Drug Administration) for treating epilepsy (repeated seizures) and is available in tablets of 250 milligrams (mg) dose. It is available as tablets, which are to be taken after the food. The drug should be used cautiously as it can show significant side effects. The drug is excreted through urine and feces and also can be transported through breast milk. A serious side effect that can occur due to this drug is coma. Hence, one has to take the drug only under a proper prescription of the physician.

How Does the Drug Ethotoin Work?

It is a nonspecific sodium channel blocker and acts on almost all the subtypes of sodium channels. The result of inhibition of a mechanism called a positive feedback mechanism is the propagation of neuronal signals of high action potentials, which helps Ethotoin to work on tremors caused due to the imbalance of sodium ions.

Available Doses and Dosage Forms:

The drug Ethotoin is available in the form of tablets of 250 mg in white color and is supplied in bottles of hundred each.

The tablet is grooved with the letters OV on one side and 61 numbers on the other side.

Directions:

The tablet is taken with food in divided doses. The doses cannot be the same for every individual. The gap between each dose should be even.

Warnings:

Patients should use the drug cautiously under the conditions listed below.

• Suicidal Behavior: As there is a high tendency for the occurrence of suicidal behavior within a week of administration of the drug, the patient, along with their family, should be informed about it.

• Pregnancy: Transport of the drug from mother to fetus also occurs, leading to major birth defects.

• Breastfeeding: The drug can be transported through breast milk, and hence, the physician can advise either to stop the drug or stop breastfeeding or both as per the clinical condition of the mother.

• Liver Problems: Problems with the liver can be detected by symptoms such as jaundice (certain parts of the skin and eye turning yellowish due to disturbance in the production of liver enzymes) and right-side aches in the abdomen. Patients, when diagnosed with liver problems, are not indicated to use the drug Ethotoin.

For Patients:

What Is a Complex Partial Epileptic Seizure?

Seizures occur due to a surge of impulses to the brain. Depending on the electrical activity that occurs leading to an impulse, the effect can be seen. Complex partial epileptic seizures occur most commonly and last for up to two minutes; unlike seizures where the patient tends to show rapid shivering or rapid movements, complex partial epileptic seizures present as the patient blankly staring or daydreaming, unaware of the surroundings.

Symptoms of complex partial epileptic seizures:

• Eyelid flutters.

• Chewing.

• Screaming.

• Lip-smacking.

Treatment of complex partial epileptic seizure:

• Medication forms the basis for the treatment of epilepsy. Side effects are monitored to determine the best treatment.

• Anti-epileptic medication is given for the treatment. When the patient responds to the treatment, the dosage of the drug is tapered under the guidance of the physician.

• In children with no response to medication, a high ketone diet or low carbohydrate diet can also be helpful.

Learn More About Ethotoin

When Should the Drug Ethotoin Be Taken?

• The drug is to be taken according to the prescription given by the physician. The dose of the drug is decided by the physician, and hence, changes in the dose should not be done without the notice of the health care physician.

• Stopping or irregular usage of the drug should also be stopped as it can cause serious problems.

• The drug Ethotoin should be taken after eating.

What Are the Things to Inform the Doctor Before Taking the Drug Ethotoin?

Inform the healthcare provider if one is having the following symptoms.

• Faced with problems of depression, unusual behavior, or suicidal thoughts.

• Presence of any other medical conditions.

• Pregnancy or pregnancy planning should also be told to the healthcare provider as the drug can harm the unborn baby and also can cause major birth defects. Hence, right away, tell the healthcare provider if there is a positive pregnancy while taking the drug.

• Healthcare providers should be informed about the patient's breastfeeding the child. As a drug can pass into the breast milk, the healthcare provider decides if the drug can be continued or stopped until breastfeeding is done.

• All the medications, including vitamins and herbal supplements, prescribed or non-prescribed medicines, should be informed.

• As the drug can cause adverse effects when interacting with other medicines and how they work, medication should not be started or stopped without talking to the physician.

What Are the Side Effects of Ethotoin?

The side effects of the drug are as follows:

• Thoughts to commit suicide.

• Worsening depression.

• Feeling restless.

• Panic attacks.

• Sleeping trouble.

• Being aggressive.

• Abrupt changes in mood or behavior.

Serious side effects include

• Blood Problems: Symptoms like not feeling well, fever, easy bruising, sore throat, and purple or red spots on the body denote blood problems.

• Liver Problems: Yellowing of the skin or whites of the eyes causing jaundice, nausea or vomiting, dark urine, lack of appetite, and right side stomach ache indicate problems in the liver.

• Swollen Glands: Lymph nodes can become enlarged.

• Serious Rashes: Sore throat, mouth sores, skin rashes, and swelling of the face, lips, and eyes can occur due to the drug's side effects.

What Can Be Done Upon Missing a Dose?

The drug is taken based on divided doses, and the duration between each dose is divided evenly. Do not consider taking the missed dose when it is time for the next dose, as it can double the dose of the drug and affect the body.

What Should Be Done to Treat Overdose?

• Drowsiness, nausea, visual disturbance, and panic attacks are common symptoms of acute dosage, and at very high dosages, coma can also occur.

• Treatment begins by using emesis (vomiting). Alternatively, gastric lavage (suctioning of gastric contents) can also be considered. Necessary supportive measures and evaluation of blood-forming organs are carefully done, followed by recovery.

How to Store the Drug Ethotoin?

The drug is stored at 20 to 25 degrees centigrades (68 to 77 degrees Fahrenheit). They are dispensed in a light-resistant, airtight container with a child-resistant cap.

Avoid Self-Medication:

The drug Ethotoin should not be taken upon the advice of another individual using the drug. As the dosage can be different for every individual, it can turn out harmful to any individual.

For Doctors

Indication

The drug Ethotoin is indicated in treating seizures of two types:

• Tonic-clonic seizures (grand mal epilepsy).

• Complex partial seizures (psychomotor epilepsy).

Dosing:

• Tablets are administered in four to six divided doses every day. The medication is taken after food, and the frequency or duration between each dose is spaced evenly.

• The initial dose is one gram or less, gradually increasing the dosage over several days. An adult maintenance dose is estimated to be around two to three grams daily. Less than two grams of the dose is considered unreactive.

• The weight and age of pediatric patients determine the dosage of the medication. The initial dose in children should not extend beyond 750 milligrams daily, and the maintenance dose ranges from 500 mg to one gram, although in certain rare cases, two or three grams can be necessary.

• The use of the drug Ethotoin with Phenytoin is beneficial in the case of tonic-clonic seizures.

What Are the Pharmacological Aspects?

The antiepileptic effect can be exerted by the drug Ethotonin without inducing any depression of the central nervous system.

Mechanism of Action:

The drug Ethotoin works similarly to the drug Phenytoin. Rather than increasing the threshold of normal seizure and preventing the seizure activity spread, abolishing the focus of seizure discharges, it stabilizes.

Pharmacodynamics:

Ethotoin is an anticonvulsant exerting an antiepileptic effect without any depression of the central nervous system.

• Absorption:

The drug is absorbed rapidly, and the extent of absorption orally is not yet known.

• Distribution:

The drug is distributed in breast milk, which can be passed on to the child.

• Excretion:

Ethotoin is excreted in the feces, urine, and also in trace amounts through saliva.

Saturable metabolism is exhibited by the drug, leading to the formation of N- diethyl, and p-hydroxyl-ethotoin, which are the major metabolites. When there are limited levels of plasma concentrations, the elimination half-life of Ethotoin is up to three to nine hours. Nonlinear kinetics are exhibited by the drug. Multiple dosing increases the degree of nonlinearity that can be seen after a single dose when the plasma half-life is six to nine hours with a dosage interval of four to six hours. Therapeutic plasma concentrations can fall up to a range of 15 to 50 micrograms per milliliter, and this is not reported in any other anti-epileptic drugs.

What Are the Warnings and Precautions?

Suicidal Behavior and Ideation:

• The drugs used for treating epilepsy, including Ethotoin, show an increased risk of thoughts related to suicide and such behavior in patients under this medication. Patients under treatment with any anti-epileptic drug have to be regularly followed up for the occurrence or presence of symptoms such as depression, unusual changes in moods, or behavior like suicidal behavior.

• Patients randomized to a placebo and patients under treatment with one of the antiepileptic drugs (AED), when compared, show that patients under treatment with AED showed symptoms of depression and suicidal thinking. There is an increase in the number of patients having suicidal thoughts or behavior.

• This symptom can be observed as early as one week after starting the treatment with an antiepileptic drug such as Ethotoin.

• The risk of suicidal behavior could not be assessed beyond eight months of treatment.

• This risk was considered consistent among the drugs in the data analysis. With the increased risk of such behavior in drugs with various mechanisms of action or indications, one can apply this to all anti-epileptic drugs.

• The relative risk of suicidal behavior is higher for epilepsy than compared with psychiatric or other conditions. Absolute risk between them was not to a greater extent.

• Any patient under treatment with Ethotoin should balance the risks of untreated illness or suicidal thoughts. Morbidity and mortality, along with suicidal behavior, are associated with epilepsy and other illnesses for which anti-anxiety drugs are prescribed.

• Such risk must be considered to know if the emergence of such symptoms is related to the illness or not.

• Caregivers of the patients and families are informed about the increase in the risk of such behavior and advised to be alerted for the occurrence or listening of such symptoms as depression, mood changes, behavioral changes, or thoughts of self-harm. Such concerning behaviors have to be reported immediately to the healthcare providers.

Use in Pregnancy:

• The drug Ethotoin when used in pregnant women, can cause harm to the fetus. Various side effects have been reported in many cases upon using antiepileptic drugs. One has to be careful upon administration of AED to a pregnant woman. Only when the management of seizures can be done are epileptic drugs administered.

• Increased risk of hypoxia (decreased levels of oxygen) and status epilepticus (seizures) for both mother and newborn child when the drugs to prevent major seizures are stopped abruptly are noticeable. When the frequency, severity, and nature of the seizures are not a threatening risk to the patient, discontinuation of the drug can be done before pregnancy or during the pregnancy under perfect monitoring.

• Neonatal coagulation defect, which leads to bleeding during the early hours of birth, usually within 24 hours, can occur in a pregnant woman. As there is a high chance of occurrence of this defect due to the use of Ethotoin, the administration should be done carefully. This defect is determined by the prolongation of prothrombin time along with the decrease in the levels of clotting factors dependent on vitamin K.

General Precautions:

Blood dyscrasias (blood disorders) have been seen in patients taking the Ethotoin drug, although the cause has not been particularly reported. Healthcare providers alert the patients for the occurrence of symptoms such as sore throat, malaise (feeling discomfort), and symptoms that indicate blood dyscrasias. Certain compounds can be involved in folic acid metabolism, leading to megaloblastic anemia (anemia characterized by the presence of megaloblasts - the large blood cells in the bone marrow). Folic acid therapy should be started when this occurs during pregnancy.

Contraindications:

Ethotoin is not indicated in patients with liver (hepatic) abnormalities or blood (hematologic) disorders.

What Are the Drug Interactions?

• When the drug Ethotoin is used in combination with other drugs, it affect the hematopoietic system and hence should be avoided whenever possible.

• Hydantoin anti-epileptics, Phenytoin, and anti-coagulants of coumarin have suggested two-way interaction between them. Phenytoin can act as a coumarin metabolism stimulator. It has also increased the concentrations of prothrombin and proconvertin. There is an increase in the serum levels and prolongation of the half-life of Phenytoin. There is no report for such interaction, but chances of such interaction between the drug Ethotoin and coumarin anticoagulants can occur. And hence, patients receiving coumarin anticoagulants, when advised with this drug, have to be cautious.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

No reports have been made on the potential for carcinogenicity in the long run in animals or humans.

Non-teratogenic Effects:

Barbiturates can be associated with coagulation defects in neonates. As there is a higher chance of the same occurring with the use of Ethotoin, the drug should be cautiously administered.

Other Specifications:

• Nursing Mothers:

The drug Ethotoin is excreted in breast milk. As the potential for adverse reaction is higher in nursing infants, discontinuation of nursing or discontinuation of the drug has to be decided considering the the need for the drug to the mother.

• Pediatric Use:

Effectiveness and safety in children are also being studied

• Geriatric Use: Selection of the drug for elderly patients must be done very cautiously and started at the dosing range of low-end and then increasing it depending on the frequency of decreased renal hepatic and cardiac function and other drug therapy.