Lamitor tablets 50 mg, 30 pcs. (lamotrigine)

release form

tablets

Packing

30 pcs

Pharmacological action

Anticonvulsant (antiepileptic) drug. Blocker of voltage-gated sodium channels. It triggers a block of pulsed discharges in a neuronal culture and inhibits the excessive release of glutamate (amino acids that play a key role in generating epileptic seizures) along with inhibition of glutamate-induced effector pulses.

Pharmacokinetics

Absorption

After oral administration, lamotrigine is rapidly and completely absorbed from the gastrointestinal tract. Cmax in plasma is observed 2.5 ± 1.5 hours after oral administration. The time to reach Cmax is somewhat longer if the drug is taken after a meal, but the degree of absorption remains unchanged. Pharmacokinetics is linear in nature up to a dose of 450 mg - the maximum single dose that has been investigated. There are significant individual differences in the Cmax values ​​of the drug, but individual concentrations differ very little.

Distribution of

Plasma protein binding is approximately 55%.

Metabolism

Metabolized in the liver to form predominantly glucuronides.

Excretion of

T1 / 2 in healthy adults is 24-35 hours.

Average clearance in healthy people is 39 ± 14 ml / min.

Lamotrigine is excreted in the urine as glucuronides. Less than 10% is excreted unchanged in urine. Only 2% of metabolic products are excreted in the feces.

Pharmacokinetics in special clinical cases

T1 / 2 lamotrigine is largely dependent on concomitant drug therapy.

T1 / 2 lamotrigine decreases to 14 hours when combined with drugs that induce the activity of isoenzymes of the cytochrome P450 system, such as carbamazepine and phenytoin, and increases on average up to about 70 hours when combined with sodium valproate.

T1 / 2 lamotrigine in children is usually shorter than in adults. T1 / 2 in children is approximately 7 hours when taken with drugs that induce isoenzyme activity, such as carbamazepine, phenytoin, phenobarbital and primidone. T1 / 2 increases to 45-55 hours when combined with sodium valproate.

A study of the pharmacokinetics of lamotrigine in single doses in patients with kidney disease suggests that the pharmacokinetic parameters vary slightly, but the concentration of the main metabolite in the form of glucuronide increases almost 8 times due to a decrease in renal clearance.

Indications

For adults and children over 12 years of age: simple partial convulsive seizures

complex partial seizure seizures

secondary generalized tonic-clonic seizures

primary generalized tonic-clonic seizures srdlpkrd abscesses srdlpkp to other antiepileptic drugs of any type.

For children aged 2 to 12 years - as adjunctive therapy.

Contraindications

severe liver dysfunction

hypersensitivity to lamotrigine and other components of the drug.

Use during pregnancy and lactation

The drug should not be prescribed during pregnancy and lactation, unless the expected benefit of the therapy to the mother outweighs the potential risk to the fetus and the baby.

Composition

1 tab. lamotrigine 50 mg.

Dosage and administration

The initial dose of Lamitor for adults and children over 12 years old who are not taking valproate sodium, but taking other antiepileptic drugs that induce isoenzymes, is 50 mg 1 time / day for the first 2 weeks and 100 mg / day ( in 2 doses) over the next 2 weeks. Then the dose should be increased to 200-400 mg / day (in 2 divided doses).

Lamitor's initial dose for patients taking sodium valproate in combination with other antiepileptic drugs that induce isoenzymes, is 25 mg every other day for the first 2 weeks and then 25 mg 1 time / day for the next 2 weeks. Then the dose should be increased to achieve the optimal therapeutic effect. The maintenance dose is 100-200 mg (in 1 or 2 doses).

The initial dose of Lamitor for children from 2 to 12 years old who do not take sodium valproate, but who take other antiepileptic drugs that induce isoenzymes, is 2 mg / kg / day (in 2 doses) during the first 2 weeks and 5 mg / kg / day (in 2 divided doses) over the next 2 weeks. The maintenance dose is 5-15 mg / kg / day (in 2 divided doses).

The initial dose of Lamitor for children taking sodium valproate in combination with other antiepileptic drugs that induce isoenzymes, is 0.2 mg / kg 1 time / day for the first 2 weeks, then 0.5 mg / kg 1 time / day for the next 2 weeks. Then the dose should be increased to achieve the optimal therapeutic effect. The maintenance dose is 1-5 mg / kg (in 1 or 2 doses).

Side effects of

From the side of the central nervous system: dizziness, headache, drowsiness, sleep disturbance, increased fatigue.

From the digestive system: nausea.

Allergic reactions: maculopapular skin rash (2%), most often occurs in the first 4 weeks after the start of treatment and disappears after discontinuation of the drug. In some cases, Stevens-Johnson syndrome, angioedema, toxic epidermal necrolysis.

Side effects noted when prescribing Lamitor as an additional therapy to standard antiepileptic drugs

From the side of the central nervous system: dizziness, headache, drowsiness, imbalance, increased fatigue, irritability, aggressiveness, tremor, confusion.

From the side of the organ of vision: diplopia, impaired visual acuity.

From the hemopoietic system: neutropenia, leukopenia.

From the digestive system: nausea, vomiting, dyspeptic symptoms.

Drug Interaction

When used concomitantly with antiepileptic drugs that induce isoenzymes of the liver (phenytoin, carbamazepine, phenobarbital, primidone), the metabolism of Lamitor is enhanced, which may require an increase in its dose.

Sodium valproate, competing with lamotrigine for metabolizing liver isoenzymes inhibits its metabolism. There is no evidence that Lamitir is able to induce or inhibit liver isoenzymes metabolizing other drugs. The laminator may induce its own metabolism, but this effect is very minor and does not cause serious clinical manifestations.

Although changes in the concentration of other antiepileptic drugs in plasma have been observed in some patients, controlled studies have not confirmed the effects of Lamitor on the levels of concomitantly administered antiepileptic drugs in blood plasma. In vitro studies indicate that Lamitor does not compete with other antiepileptic drugs for plasma protein binding sites.

Overdose

Symptoms: nystagmus, ataxia, dizziness, drowsiness, headache, nausea, loss of consciousness, coma.

Treatment: gastric lavage, receiving activated carbon. If necessary, conduct symptomatic therapy.

Storage conditions

The drug should be stored in a place protected from light and moisture at a temperature not exceeding 30 ° C.

Expiration

2 years.

Deystvuyuschee substances

Lamotrigine

Dosage form

dosage form

tablets

Torrent, India



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