Section 4.2 – inclusion of optimal dose details for children. Change to effective plasma level information.
Section 4.4 - cautions re: hepatic and renal impairment moved from 4.3 to 4.4 and advice to monitor liver/renal function. Additional information that Emeside should always be withdrawn slowly.
Section 4.7 - caution that ethosuximide may cause drowsiness and if this occurs patients should avoid driving or operating machinery.
Section 4.8 - Replaced with the following:
Blood dyscrasias (leucopenia, agranulocytosis, aplastic anaemia and pancytopenia) have been reported, some with fatal outcome. In most cases of leucopenia the blood picture has returned to normal on reduction of dose or discontinuation. In some instances, patients who become leucopenic on other anticonvulsant therapy have been satisfactorily treated with ethosuximide alone. Elevated neutrophil, monocyte and eosinophil counts have also been noted. Patients should be advised to seek immediate medical attention, for full blood count tests, if symptoms such as fever, sore throat, mouth ulcers, bruising or bleeding develop.
Ethosuximide when used alone in mixed types of epilepsy may increase the frequency of generalised tonic-clonic (grand mal) seizures in some patients.
Other adverse reactions reported include: weight loss, diarrhoea, abdominal pain, gum hypertrophy, swelling of the tongue, hiccoughs, irritability, hyperactivity, sleep disturbances, night terrors, inability to concentrate, aggressiveness, paranoid psychosis, increased libido, myopia and vaginal bleeding.
Mild side effects, common at first but generally transient, include apathy, euphoria, fatigue, drowsiness, dizziness, headache, ataxia, dyskinesia, photophobia, depression and nausea, vomiting, anorexia and gastric upset.
Psychotic states thought to be induced or exacerbated by anticonvulsant therapy have been reported.
Rarely cases of skin rash and isolated cases of erythema nodosum have been reported.
Lupus-like reactions have occasionally been reported in children given ethosuximide, varying from severe systemic immunological disorders e.g. the nephrotic syndrome generally with complete recovery on drug withdrawal, to the detection of antinuclear antibodies without clinical features. Stevens Johnson syndrome has also been reported.
Section 5.1 - Addition regarding relative specificity for pure petit mal
Section 5.2 - Replaced with the following:
Ethosuximide is readily absorbed from the gastro-intestinal tract and extensively metabolised in the liver. It is excreted in the urine mainly in the form of its metabolites. It is widely distributed throughout the body but is not significantly bound to plasma proteins so saliva concentrations may be used for monitoring. Peak serum levels occur 1 to 7 hours after single oral dose. Therapeutic levels are between 40 and 100mcg/ml. It has a long elimination half life: adults: 40-60 hours; children: 30 hours.
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