Lamitor tablets 50mg, No. 50

• simple partial seizures;

• complex partial seizures;

• secondary generalized tonic-clonic seizures;

• primary generalized tonic-clonic seizures;

• absences are typical;

• absences are atypical;

• myoclonic seizures;

• seizures resistant to other antiepileptic drugs of any type.

Lamitor is also used as an adjunct therapy for children aged 2 to 12 years.

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

The initial dose of Lamitor for patients taking sodium valproate in combination with other isoenzyme-inducing antiepileptic drugs is 25 mg every other day for the first 2 weeks and then 25 mg once a day for the next 2 weeks. Then the dose should be increased until the optimal therapeutic effect is achieved. 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 are not taking sodium valproate, but who are taking other antiepileptic drugs that induce isozymes, is 2 mg / kg / day (in 2 divided doses) for 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 isozymes 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 until the optimal therapeutic effect is achieved. The maintenance dose is 1-5 mg / kg (in 1 or 2 doses).

lamotrigine

• severe liver dysfunction;

• hypersensitivity to lamotrigine and other components of the drug.

Clinical and pharmacological group: Anticonvulsant drug

Pharmaco-therapeutic group: Anticonvulsant

pharmachologic effect

Anticonvulsant (antiepileptic) drug. Blocker of voltage-gated sodium channels. It induces a block of pulsed discharges in cultured neurons and inhibits the excessive release of glutamate (amino acids that play a key role in the generation of epileptic seizures) along with inhibition of glutamate-induced effector impulses.

Pharmacokinetics

Suction

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

Distribution

Plasma protein binding is approximately 55%.

Metabolism

It is metabolized in the liver with the formation of predominantly glucuronides.

Withdrawal

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

Average clearance values ??in healthy people are 39 ± 14 ml / min.

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

Pharmacokinetics in special clinical situations

The T1 / 2 of lamotrigine is highly dependent on concomitant drug therapy.

T1 / 2 of 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 to an average of about 70 hours in the case of combined use with sodium valproate.

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

The study of the pharmacokinetics of lamotrigine in single doses in patients with kidney disease indicates that the pharmacokinetic parameters change insignificantly, however, the concentration of the main metabolite in the form of glucuronide increases almost 8 times due to a decrease in renal clearance.

Indications of the drug

Lamitor is recommended as monotherapy and adjunctive therapy for adults and children over 12 years of age:

• simple partial seizures;

• complex partial seizures;

• secondary generalized tonic-clonic seizures;

• primary generalized tonic-clonic seizures;

• absences are typical;

• absences are atypical;

• myoclonic seizures;

• seizures resistant to other antiepileptic drugs of any type.

Lamitor is also used as an adjunct therapy for children aged 2 to 12 years.

Dosage regimen

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

The initial dose of Lamitor for patients taking sodium valproate in combination with other isoenzyme-inducing antiepileptic drugs is 25 mg every other day for the first 2 weeks and then 25 mg once a day for the next 2 weeks. Then the dose should be increased until the optimal therapeutic effect is achieved. 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 are not taking sodium valproate, but who are taking other antiepileptic drugs that induce isozymes, is 2 mg / kg / day (in 2 divided doses) for 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 isozymes 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 until the optimal therapeutic effect is achieved. The maintenance dose is 1-5 mg / kg (in 1 or 2 doses).

Side effect

Side effects observed when Lamitor is prescribed as monotherapy

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 observed 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 observed when Lamitor is prescribed as an adjunct 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 hematopoietic system: neutropenia, leukopenia.

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

Contraindications for use

• severe liver dysfunction;

• hypersensitivity to lamotrigine and other components of the drug.

Application during pregnancy and lactation

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

Application for violations of liver function

Contraindicated in severe liver dysfunction.

Application for impaired renal function

In patients with impaired renal function in the terminal stage of the disease, accumulation of the metabolite in the form of glucuronide should be expected. Therefore, if necessary, the appointment of such patients should be used with caution.

Application in children

The initial dose of Lamitor for children from 2 to 12 years old who are not taking sodium valproate, but who are taking other antiepileptic drugs that induce isozymes, is 2 mg / kg / day (in 2 divided doses) for 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 isozymes 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 until the optimal therapeutic effect is achieved. The maintenance dose is 1-5 mg / kg (in 1 or 2 doses).

special instructions

Information on the use of Lamitor in elderly patients is limited. Therefore, the drug should be prescribed with caution in this category of patients.

If the Lamitor dose is exceeded, a skin rash may develop (in this situation, the drug should be canceled).

In some cases, when prescribing the drug, it is possible to develop a pronounced skin rash (including Stevens-Johnson syndrome). Such reactions are more common in children. The lamitor should be canceled at the first sign of a rash. The risk of developing such complications increases with the appointment of Lamitor simultaneously with sodium valproate and if the dose of Lamitor used exceeds the recommended initial and maximum daily dose.

With the development of a skin rash, the use of the drug should be discontinued immediately.

When using Lamitor, it is possible to develop such symptoms of hypersensitivity (in some cases up to the development of a fatal outcome), such as fever, malaise, cold symptoms, drowsiness, lymphadenopathy, facial edema and, in very rare cases, abnormal liver function, hematopoiesis disorders (leukopenia and thrombocytopenia) ... In most patients, these symptoms disappear after Lamitor is discontinued.

If a rash, chills, cold symptoms, drowsiness, worsening control of seizures (especially during the first month) occur during the use of the drug, liver function tests, renal function indicators, blood clotting should be monitored.

With a sharp cancellation of Lamitor, an increase in seizures is possible. The dose of Lamitor should be reduced gradually over 2 weeks.

In patients with impaired renal function in the terminal stage of the disease, accumulation of the metabolite in the form of glucuronide should be expected. Therefore, if necessary, the appointment of such patients should be used with caution.

Influence on the ability to drive vehicles and use mechanisms

The question of the ability to drive vehicles and work with moving mechanisms while taking Lamitor is decided individually, taking into account the clinical situation.

Overdose

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

Treatment: gastric lavage, intake of activated charcoal. If necessary, symptomatic therapy is performed.

Drug interactions

With simultaneous use with antiepileptic drugs that induce liver isoenzymes (phenytoin, carbamazepine, phenobarbital, primidone), Lamitor's metabolism increases, which may require an increase in its dose.

Sodium valproate, which competes with lamotrigine for metabolizing liver isoenzymes, inhibits its metabolism. There is no evidence that Lamitor is able to induce or inhibit liver isoenzymes that metabolize other drugs. Lamitor can induce its own metabolism, but this effect is very minor and does not cause serious clinical manifestations.

Although some patients show changes in plasma concentrations of other antiepileptic drugs, controlled studies have not confirmed the effect of Lamitor on the levels of concomitantly taken antiepileptic drugs in blood plasma. In vitro data indicate that Lamitor does not compete with other antiepileptic drugs for plasma protein binding sites.

Storage conditions

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

Shelf life

Shelf life is 2 years.

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

TORRENT PHARMACIES LTD. (India)