Seizar, tablets 25 mg 30 pcs

The mechanism of action is the effect on the potential-dependent sodium channels of the presynaptic membrane, which leads to a decrease in the release of mediators into the synaptic cleft. One of the main ones is glutamate. It is an excitatory amino acid that plays an important role in the formation of epileptic discharges in the brain.

Pharmacokinetics

Lamotrigine is rapidly and completely absorbed from the GI tract after oral administration. C_max in plasma is reached after approximately 2.5 h.

The binding to plasma proteins is 55%. It is subjected to intensive metabolism with the formation of the main metabolite N-glucuronide.

T_1/2 in adults averages 29 h. It is excreted by kidneys mainly as a metabolite; about 8% of active substance is excreted unchanged.

T_1/2 in children is less than in adults.

Indications

Partial and generalized tonic-clonic seizures (more often in cases of resistance to treatment with other anticonvulsants).

Active ingredient

Composition

* – The generic international name recommended by the WHO is lamotrigine.

15 pcs. – Contour cell packs (2) – packs of cartons.

How to take, the dosage

In oral administration for adults and children over 12 years of age, the initial single dose is 25-50 mg, with maintenance doses of 100-200 mg/day. In rare cases, doses of 500-700 mg/day may be required.

In children aged 2 to 12 years, the starting dose is 0.2-2 mg/kg/day and the maintenance dose is 1-15 mg/kg/day.

The maximum daily dose for children aged 2 to 12 years, depending on the treatment regimen used, is 200-400 mg.

The frequency of dosing and the intervals between doses depend on the treatment regimen used and the patient’s response to the ongoing treatment.

Interaction

In concomitant use with anticonvulsants – inducers of metabolism in the liver (including phenytoin, carbamazepine, phenobarbital, primidone) the metabolism of lamotrigine is accelerated.

The concomitant use of lamotrigine and carbamazepine or phenytoin decreases the T1/2 of lamotrigine. There have been reports of dizziness, ataxia, diplopia, blurred vision and nausea in patients taking carbamazepine after starting treatment with lamotrigine.

Due to inhibition of hepatic microsomal enzymes by sodium valproate, concomitant use slows down lamotrigine metabolism and increases T1/2 of lamotrigine.

Special Instructions

With caution, use in patients with renal insufficiency.

Lamotrigine should not be used in elderly patients.

Lamotrigine should be discontinued if there are significant skin allergic reactions.

If lamotrigine is withdrawn suddenly, epilepsy manifestations may worsen, so treatment should be gradually discontinued, reducing the dose over 2 weeks.

Concomitant use with carbamazepine may cause dizziness, diplopia, ataxia, visual disturbances, and nausea. These phenomena usually disappear with reduction of the carbamazepine dose.

Lamotrigine should not be used in children under 2 years of age.

Impact on the ability to drive and operate machinery

During treatment there is a slowing down of psychomotor reactions. This must be taken into account by those engaged in potentially hazardous activities requiring increased attention and quick psychomotor reactions.

Contraindications

Severe hepatic impairment, hypersensitivity to lamotrigine.

Hypatic impairment use

Contraindicated in severe hepatic impairment.

The use in renal dysfunction

Cautious use in patients with renal insufficiency.

The use in elderly patients

Lamotrigine should not be used in elderly patients.

Side effects

CNS disorders: headache, dizziness, drowsiness, sleep disturbances, fatigue, aggressiveness, confusion.

Digestive system disorders: nausea, liver function disorders.

Hematopoietic system disorders: leukopenia, thrombocytopenia.

Allergic reactions: skin rash (usually maculopapular), angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, lymphadenopathy.

Overdose

Single administration of doses exceeding the maximum therapeutic by 10-20 times has been reported.

Symptoms: nystagmus, ataxia, impaired consciousness to coma.

Treatment: hospitalization and appropriate symptomatic therapy. In case of recent (less than 2 hours) ingestion of the drug, gastric lavage should be performed.

Pregnancy use

Clinical data on the safety of lamotrigine administration during pregnancy and lactation are insufficient.

The expected benefit to the mother and the potential risk to the fetus should be weighed when deciding whether to use in pregnancy.

Preliminary data show that lamotrigine penetrates into breast milk at a concentration of 40-45% of the plasma concentration.

In a small number of breastfed infants whose mothers received lamotrigine, no adverse effects have been noted.

Pediatric use

Lamotrigine should not be used in children less than 2 years of age.

Similarities