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).

Pharmacological effect

The mechanism of action is the effect on voltage-gated 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

After oral administration, lamotrigine is quickly and completely absorbed from the gastrointestinal tract. Cmax in plasma is reached after approximately 2.5 hours.

Plasma protein binding is 55%. It is subjected to intensive metabolism with the formation of the main metabolite N-glucuronide.

T1/2 in adults averages 29 hours. It is excreted by the kidneys mainly in the form of a metabolite; about 8% of the active substance is excreted unchanged.

T1/2 in children is less than in adults.

Special instructions

Use with caution in patients with renal failure.

Lamotrigine should not be used in elderly patients.

If severe allergic skin reactions occur, use of lamotrigine should be discontinued.

If lamotrigine is suddenly discontinued, the manifestations of epilepsy may increase, so it is necessary to gradually stop treatment, reducing the dose over 2 weeks.

When used simultaneously with carbamazepine, dizziness, diplopia, ataxia, visual impairment, and nausea are possible. These phenomena usually disappear when the dose of carbamazepine is reduced.

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

Impact on the ability to drive vehicles and operate machinery

During the treatment period, a slowdown in the speed of psychomotor reactions is observed. This must be taken into account by persons engaged in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Active ingredient

Lamotrigine

Composition

Pills
1 tab.
lamotrigine
25 mg

* – non-proprietary international name recommended by WHO – lamotrigine.

15 pcs. – contour cell packaging (2) – cardboard packs.

Pregnancy

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

When deciding whether to use it during pregnancy, the expected benefits of therapy for the mother should be weighed against the potential risk to the fetus.

Preliminary data indicate that lamotrigine is excreted in breast milk at concentrations that are 40-45% of plasma concentrations.

A small number of infants whose mothers received lamotrigine did not experience any side effects.

Use in children

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

Contraindications

Severe liver dysfunction, hypersensitivity to lamotrigine.

Use for liver dysfunction

Contraindicated in severe liver dysfunction.

Use for renal impairment

Use with caution in patients with renal failure.

Use in elderly patients

Lamotrigine should not be used in elderly patients.

Side Effects

From the side of the central nervous system: headache, dizziness, drowsiness, sleep disturbances, feeling tired, aggressiveness, confusion.

From the digestive system: nausea, liver dysfunction.

From the hematopoietic system: leukopenia, thrombocytopenia.

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

Interaction

When used simultaneously with anticonvulsants – inducers of metabolism in the liver (including phenytoin, carbamazepine, phenobarbital, primidone), the metabolism of lamotrigine is accelerated.

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

Due to the inhibition of microsomal liver enzymes under the influence of sodium valproate, with simultaneous use the metabolism of lamotrigine slows down and T1/2 of lamotrigine increases.

Overdose

Single administration doses exceeding the maximum therapeutic dose by 10–20 times have been reported.

Symptoms: nystagmus, ataxia, disturbances of consciousness to the point of coma.

Treatment: hospitalization and appropriate symptomatic therapy. In case of recent (less than 2 hours) use of the drug, gastric lavage is necessary.

Storage conditions

In a place protected from light, at a temperature of 15–25 °C

Shelf life

3 years

Manufacturer

Alkaloid AD Skopje, Republic of North Macedonia