Sazar, pills 25mg, 30pcs

Composition

* is a nonproprietary international name recommended by WHO-lamotrigine.

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

Pharmacological action

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

After oral use, lamotrigine is rapidly and completely absorbed from the gastrointestinal tract. _cmax in plasma is reached in about 2.5 hours.

Binding to plasma proteins is 55%. It undergoes intensive metabolism with the formation of the main metabolite N-glucuronide.

T_1/2 in adults averages 29 hours. It is mainly excreted by the kidneys as a metabolite; about 8% of the Active ingredient is excreted unchanged.

T_1/2 is less in children than in adults.

Indications

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

Use during pregnancy and lactation

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

When deciding whether to use it during pregnancy, the expected benefit of therapy for the mother and the potential risk to the fetus should be compared.

Preliminary data indicate that lamotrigine passes into breast milk at concentrations of 40-45% of the plasma concentration.

In a small number of children whose mothers received lamotrigine, no side effects were observed.

Use in children

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

Contraindications

Severe hepatic impairment, hypersensitivity to lamotrigine.

Use in patients with liver function disorders

Contraindicated in severe hepatic impairment.

Use in patients with impaired renal function

Use with caution in patients with renal insufficiency.

Use in elderly patients

Lamotrigine should not be used in elderly patients.

Side effects

From the central nervous system:  headache, dizziness, drowsiness, sleep disorders, fatigue, aggressiveness, confusion.

From the digestive system:  nausea, impaired liver function.

From the hematopoietic system:  leukopenia, thrombocytopenia.

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

Interaction

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

With simultaneous use of lamotrigine and carbamazepine or phenytoin, a decrease in T_1/2 of lamotrigine occurs. Dizziness, ataxia, diplopia, blurred vision, and nausea have been reported in patients taking carbamazepine after starting lamotrigine treatment.

Due to the inhibition of microsomal liver enzymes under the influence of sodium valproate, when used simultaneously, lamotrigine metabolism slows down, and lamotrigine T_{1/2 increases}.

How to take, course of use and dosage

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

For children aged 2 to 12 years, the initial dose is 0.2-2 mg/kg/day, 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 use, the intervals between doses when increasing the dose depend on the treatment regimen used, the patient’s reaction to the treatment.

Overdose

A single dose of 10-20 times the maximum therapeutic dose has been reported.

Symptoms:  nystagmus, ataxia, loss of consciousness before coma.

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

Special instructions

Use with caution in patients with renal insufficiency.

Lamotrigine should not be used in elderly patients.

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

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

When used concomitantly with carbamazepine, dizziness, diplopia, ataxia, visual disturbances, nausea are possible. These symptoms usually disappear with a decrease in the dose of carbamazepine.

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

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, the rate of psychomotor reactions slows down. This should be taken into account by people who engage in potentially dangerous activities that require increased attention and rapid psychomotor reactions.

Form of production

Tablets

Storage conditions

In a dark place, at a temperature of 15-25 °C

Shelf life

3 years

Active ingredient

Lamotrigine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets