Expiration date: 01/2025

Pharmacological action

Anticonvulsant drug. Its mechanism of action is associated with inhibition of synaptic transmission in the motor areas of the cerebral cortex that increases the threshold of the occurrence of epileptic seizures.

The drug has analgesic effect in trigeminal neuralgia, yielding efficiency carbamazepine.

Pharmacokinetics

Absorption and distribution

Effective concentration etosximida blood plasma is 40-100 mcg/ml.

Css achieved after 8-10 days after the start of the application.

Metabolism and excretion

Biotransformiroetsa in the liver.

T1/2 in adults is 56-60, children 30-36 h. Ethosuximide is excreted in the urine, 20% unchanged.

Dosage

The mode set individually depending on the clinical picture of the disease, efficacy and tolerability.

The drug is taken during or after meals. Capsules should be swallowed whole, squeezed enough liquid (e.g. glass of water).

The initial daily dose Suxilep for adults and children is 5-10 mg/kg of body weight. Every 4-7 days the daily dose increased by 5 mg/kg.

Maintaining daily dose for adults is 15 mg/kg of body weight, for children 20 mg/kg of body weight.

The maximum daily dose Suxilep is 30 mg/kg for adults and 40 mg/kg for children.

Daily dose take 2 or 3 doses. With good tolerability daily dose can be administered in 1 reception.

Suxilep dose for adults and children over 12 years, with a maintenance dose of 15 mg/kg of body weight given in the table:

Body weight (kg)	Number of capsules	Daily dose (mg)
50	3	750
67	4	1000
83	5	1250

Suxilep dose for children aged 6 to 12 years, with a maintenance dose of 20 mg/kg of body weight given in the table:

Body weight (kg)	Number of capsules	Daily dose (mg)
13	1	250
25	2	500
38	3	750
50	4	1000

Children under the age of 6 years the drug in this dosage form is not prescribed. For accurate dosing in children under 6 years are encouraged to apply ethosuximide in the form of liquid dosage forms.

The duration of treatment is determined individually.

Overdose

Symptoms: fatigue, decreased physical activity, loss of interest in surroundings, depressed mood, anxiety, irritability.

Treatment: gastric lavage, reception activated carbon, if necessary, symptomatic therapy in a hospital environment.

Drug interactions

While the use of carbamazepine may accelerate removal etosximida of the plasma.

Concurrent use of valproic acid can cause both increase and decrease in the concentration of ethosuximide in the plasma due to metabolic changes.

The simultaneous use of drugs, oppressive Central nervous system, leading to increased inhibitory action on the Central nervous system Suxilep.

While admission Suxilep with haloperidol decreases the concentration of the latter in the blood plasma.

Suxilep usually does not affect the levels of other anticonvulsants (such as primidon, phenobarbital, diphenylhydantoin) in the blood plasma. However, in some cases, the level of diphenylhydantoin in blood plasma increases.

Application of pregnancy and breastfeeding

It is not recommended to take Suxilep during pregnancy. In the case of pregnancy, please inform your doctor.

Ethosuximide is excreted in breast milk, so if you need Suxilep the appointment during lactation breastfeeding should be discontinued.

Side effects

Dose-dependent adverse events

CNS: ataxia, dyskinesia, dizziness, drowsiness, headache, irritability, unusual tiredness, weakness, loss of concentration, aggressiveness, depression, increased tonic-clonic seizures, hallucinatory-paranoid disorder.

Digestive system: nausea, vomiting, loss of appetite, diarrhea or constipation,weight loss.

Adverse events, independent of the number of drugs

Allergic reactions: sometimes - skin rash, Stevens-Johnson syndrome; rarely – a syndrome according to the type of SLE of varying severity.

With the hematopoietic system: rarely – leukopenia, eosinophilia, thrombocytopenia, agranulocytosis, and in some cases – aplastic anemia, pancytopenia.

Other: photosensitivity, hiccups, albuminuria, parkinsonism.

Terms and conditions storage

The drug should be stored out of reach of children at temperature not exceeding 25°C.

Testimony

Small epileptic seizures:

• microleptinae absence seizures, and complex or atypical seizures;
  
• myoclonic-astatic small seizures (petit mal);
  
• youth myoclonic seizures (small seizures impulsive).
  

Contraindications

• violations of the liver;
  
• violation of the kidney;
  
• diseases of the blood;
  
• porphyria;
  
• hypersensitivity to the drug.
  

Special instructions

The patient should be warned that if you have symptoms of possible myelotoxic action Suxilep (fever, tonsillitis, increased bleeding) should be reported to the attending physician.

Caution must be exercised in applying the drug in patients with mental disorders in history.

Long-term use of the drug may develop generalized seizures.

Ethosuximide may be excreted from the blood during hemodialysis. Therefore, patients undergoing hemodialysis, it is necessary to increase the dose Suxilep or change the scheme of its reception. During the four-hour session of kidney from the body displayed 39-52% of the dose.

Should comply with the dosage regimen of the drug. In case of non compliance relapse of epileptic seizures.

If the patient missed another drug or by mistake took double dose should continue taking the drug in the usual way, i.e. not to compensate for missed time taking additional doses or not to skip the next appointment.

The occurrence of dose-dependent side effects often possible to prevent starting the treatment with small doses and slowly increasing them as well as taking the drug during meals or after it.

When adverse phenomena that do not depend on the dose of the drug should stop taking Suxilep.

During the reception Suxilep should not drink alcoholic beverages.

Effects on ability to drive vehicles and management mechanisms

The speed of mental reactions after taking Suxilep may be reduced. Therefore, during treatment, patients should avoid driving vehicles and other activities, require high concentration and speed of psychomotor reactions. The simultaneous use of alcohol will lead to an even greater decrease in the speed of mental reactions.

Use in impaired renal function

Contraindicated in impaired renal function

Application in the dysfunction of the liver

Contraindicated in violation of liver function