ETHOSUXIMIDE ARISTO

Posology Adults, elderly patients and children over 6 years of age:

Treatment is started at a low daily dose of 500 mg (2x 5ml) with increments of 250 mg every five to seven days until the seizures are controlled with 1000-1500 mg daily. Occasionally, 2000 mg in divided doses may be required. Paediatric population aged 0-6 years Begin with a daily dose of 250 mg (5ml) and increase the dose gradually by small increments every few days until control is achieved.

The optimal dose in most children is 20 mg/kg/day. The maximum dose should be 1000 mg. Effective plasma levels of ethosuximide normally lie between 40 and 100 μg/ml but the clinical response should be the criteria for the regulation of the dosage.

The half- life of ethosuximide in plasma is more than 24 hours but the daily dose, if large, is more comfortably divided between morning and evening. Older children and adults will normally take ethosuximide in capsule form. 1. Method of administration Ethosuximide Aristo is for oral use.

The solution can be taken during or after meals. 5 ml steps) and an adapter for the oral syringe. A single dose of the oral solution is drawn into the oral syringe up to the required level and transferred into a glass of water or mixed with milk pudding.

Alternatively, the oral solution can directly be applicated into the mouth. Afterwards, the patient should drink half a glass of water.

Frequencies reported are as follows:

Common (≥ 1/100 to < 1/10); Uncommon (> 1/1,000 to < 1/100); Rare (> 1/10,000 to < 1/1,000); Not known (frequency cannot be estimated from the available data) * AE frequency estimated from post-marketing safety database. 4). Psychiatric or psychological aberrations associated with ethosuximide administration may be noted particularly in patients who have previously exhibited psychological abnormalities.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

General Ethosuximide, when used alone in mixed types of epilepsy, may increase the frequency of generalised tonic clonic (grand mal) seizures in some patients. As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication.

Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) seizures. Psychiatric symptoms Suicidal ideation and behaviour have been reported in patients treated with anti- epileptic agents in several indications.

A meta-analysis of randomised placebo controlled trials of antiepileptic drugs (AEDs) has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for ethosuximide.

Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

All patients treated with AEDs should be routinely evaluated for depression and anxiety. 8, paranoid and hallucinatory symptoms, anxiety, agitation) may occur, therefore special caution is required when treating this group of patients with ethosuximide.

8). It is recommended to check the blood count regularly (initially monthly, after one year every six months) to identify potential bone marrow damage. At a leucocyte count of less than 3500/mm3 or a granulocyte ratio of less than 25%, the dose should be reduced or the therapy discontinued.

The liver enzymes should also be checked regularly. Hepatic/Renal Impairment Ethosuximide should be used with extreme caution in patients with impaired hepatic or renal function. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.

Ethosuximide is capable of producing morphological and functional changes in the animal liver. In humans, abnormal liver and renal function studies have been reported. Autoimmune Disorders Cases of systemic lupus erythematosus have been reported with the use of ethosuximide.

The physician should be alert to this possibility. Additionally, lupus- like reactions have been reported in children given ethosuximide. They vary in severity from systemic immunological disorders, which include the nephrotic syndrome, to the asymptomatic presence of antinuclear antibodies.

The nephrotic syndrome is rare and a complete recovery has usually been reported on drug withdrawal. Severe Cutaneous Adverse Reactions (SCARs) Hypersensitivity Syndrome (HSS) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Hypersensitivity Syndrome (HSS) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking anticonvulsant drugs, including ethosuximide.

Some of these events have been fatal or life threatening. HSS/DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, haematological abnormalities, myocarditis, myositis or pneumonitis.

Initial symptoms may resemble an acute viral infection. Other common manifestations include arthralgias, jaundice, hepatomegaly, leucocytosis, and eosinophilia. The interval between the first drug exposure and symptoms is usually 2 to 4 weeks but has been reported in individuals receiving anticonvulsants for 3 or more months.

If such signs and symptoms occur, the patient should be evaluated immediately. Ethosuximide should be discontinued if an alternative aetiology for the signs and symptoms cannot be established. Patients at higher risk for developing HSS/DRESS include black patients, patients who have experienced this syndrome in the past (with ethosuximide or other anticonvulsant drugs), patients who have a family history of this syndrome and immuno-suppressed patients.

The syndrome is more severe in previously sensitized individuals. Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN) Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN) have been reported with the use of ethosuximide.

4), occurrence of rash and should be monitored closely for skin reactions. Patients should seek medical advice from their physician immediately when observing any indicative signs or symptoms. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.

g. progressive skin rash often with blisters or mucosal lesions) are present, ethosuximide treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug.

Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of ethosuximide, ethosuximide must not be re-started in this patient at any time. If the rash is of a milder type (measles-like or scarlatiniform), therapy may be resumed after the rash has completely disappeared.

If the rash recurs upon reinstitution of therapy, further ethosuximide medication is contraindicated. The risk of serious skin reactions and other hypersensitivity reactions to ethosuximide may be higher in black patients. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of human leukocyte antigen HLA- B*1502, an inherited allelic […]

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