Lamotrigine, tablets 100 mg 30 pcs

An anticonvulsant agent. The mechanism of action is related to the effect on potential-dependent sodium channels of presynaptic membrane. This leads to decrease of mediators release into the synaptic cleft, first of all glutamate – excitatory amino acid, which plays an important role in the formation of epileptic discharges in the brain.

Indications

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

Active ingredient

Composition

1 tablet contains

The active ingredient:

Lamotrigine 100 mg

Auxiliary substances:

Lactose monohydrate (milk sugar) – 167.8 mg

Microcrystalline cellulose – 76 mg

/p>

Povidone K-25 – 19 mg

Sodium carboxymethyl starch – 11.4 mg

Magnesium stearate – 3.8 mg

Colloid silicon dioxide – 2 mg

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 – hepatic metabolism inducers (including phenytoin, carbamazepine, phenobarbital, primidone), lamotrigine metabolism is accelerated. When concomitant use of lamotrigine and carbamazepine or phenytoin decreases 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 the 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If lamotrigine is withdrawn suddenly, epilepsy manifestations may worsen, so treatment should be gradually discontinued, reducing the dose over 2 weeks.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 vehicles and machines.

A slowing of psychomotor reactions is observed during treatment. This must be taken into account by persons engaged in potentially hazardous activities requiring increased attention and quick psychomotor reactions.

Synopsis

The tablets are white or white with a yellowish tint, round, flat-cylindrical, with a groove on one side and bevels on both sides.

Contraindications

– severe hepatic impairment;

– hypersensitivity to lamotrigine.

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.

Pregnancy use

Pregnancy

The clinical data on the safety of lamotrigine in 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. No adverse effects have been noted in a small number of infants whose mothers received lamotrigine.

Similarities