Lamotrigine 25 tablets are used for the following indications:
Epilepsy: adults and children aged 13 years and over: monotherapy and adjunctive therapy of partial and generalized epileptic seizures, including tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome (this drug is prescribed as adjunctive therapy, but in Lennox-Gastaut syndrome it can be prescribed as an initial antiepileptic drug (AED)); children aged 2 to 12 years: adjunctive therapy of epilepsy, in particular partial and generalized seizures, including tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome; monotherapy of typical minor epileptic seizures; Bipolar disorder in adults (aged 18 years and over): to prevent phases of emotional disturbances in patients with bipolar disorder, mainly by preventing depressive episodes (lamotrigine is not indicated for the emergency treatment of manic or depressive episodes).
Composition
The active substance is lamotrigine (one tablet contains lamotrigine 25 mg).
Excipients: microcrystalline cellulose, colloidal anhydrous silica, povidone, sodium starch glycolate (type A), lactose monohydrate, magnesium stearate.
Contraindication
Hypersensitivity to lamotrigine or other components of the drug.
Method of application
The drug "Lamotrigine 25", tablets, should be swallowed without chewing or breaking. If the calculated dose of lamotrigine (for example, for the treatment of children suffering from epilepsy or patients with impaired liver function) is not a multiple of whole tablets, the dose administered should correspond to the nearest smaller number of whole tablets. If it is impossible to dose this drug for children, it is necessary to use lamotrigine in another dosage form and in the appropriate dosage.
Restarting treatment
When a patient who has discontinued treatment is re-initiated, the need for an increase in the maintenance dose should be clearly established, because there is a risk of rash due to the high initial dose and exceeding the recommended dose escalation schedule for lamotrigine. The longer the interval since the previous dose, the more careful the dose escalation regimen to the maintenance dose level should be. When the interval since discontinuation of lamotrigine has exceeded 5 times the half-life, the lamotrigine dose should be increased to the maintenance dose according to the existing schedule.
It is not recommended to restart lamotrigine if treatment was discontinued due to rash associated with previous treatment with lamotrigine. In such cases, the decision to restart the drug should be based on the expected benefits and potential risks of treatment.
Epilepsy (as monotherapy)
Adults and children over 13 years of age. The initial dose of the drug is 25 mg 1 time per day for 2 weeks, then take 50 mg / day for 2 weeks, then the dose is increased by 50-100 mg every 1-2 weeks until the optimal effect is achieved. The usual maintenance dose is 100-200 mg / day in 1-2 doses. Some patients may require a dose of 500 mg / day.
Children from 2 to 12 years. The initial dose of the drug for the treatment of typical absence seizures is 0.3 mg/kg/body weight/day in 1-2 doses per day for 2 weeks, then take 0.6 mg/kg/body weight/day in 1-2 doses per day for 2 weeks. In the future, the dose should be increased by 0.6 mg/kg every 1-2 weeks until the optimal effect is achieved. The usual maintenance dose is 1-10 mg/kg/day in 1-2 doses. For some patients with typical absence seizures, a large dose may be required. Due to the risk of rashes, the initial dose and the rate of further dose increases should not be exceeded.
Epilepsy (in combination therapy), adults and children aged 13 years and over
For patients taking valproate (alone or with other antiepileptic drugs), the initial dose of this drug is 25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks. After that, the dose should be increased (maximum by 25-50 mg/day) every 1-2 weeks until the optimal therapeutic effect is achieved. The usual maintenance dose is 100-200 mg/day in 1-2 doses. For patients taking other antiepileptic drugs or other drugs that induce lamotrigine glucuronidation in combination with other antiepileptic drugs or without them (except sodium valproate), the initial dose of the drug "Lamotrigine" is 50 mg 1 time per day for 2 weeks, then 100 mg/day in 2 doses for 2 weeks. The dose should then be increased (by a maximum of 100 mg) every 1-2 weeks until the optimal therapeutic effect is achieved. The usual maintenance dose is 200-400 mg/day in 2 divided doses. Some patients may require a dose of 700 mg/day.
For patients taking other drugs that do not significantly induce or inhibit lamotrigine glucuronidation, the initial dose of Lamotrigine is 25 mg once daily for 2 weeks, followed by 50 mg once daily for 2 weeks. After that, the dose should be increased (maximum by 50-100 mg/day) every 1-2 weeks until the optimal therapeutic effect is achieved. The usual maintenance dose is 100-200 mg/day in 1-2 divided doses.
For children receiving sodium valproate in combination with or without other antiepileptic drugs, the initial dose of Lamotrigine is 0.15 mg/kg body weight per day in 1 dose for 2 weeks, then 0.3 mg/kg body weight per day in 1 dose for 2 weeks. Then the dose should be increased (maximum by 0.3 mg/kg body weight) every 1-2 weeks until the optimal therapeutic effect is achieved. The maintenance dose is 1-5 mg/kg body weight in 1-2 doses (maximum - 200 mg/day).
For children taking other antiepileptic drugs or other drugs that induce lamotrigine glucuronidation, with or without other antiepileptic drugs (except sodium valproate), the initial dose of Lamotrigine is 0.6 mg/kg body weight per day in 2 divided doses for 2 weeks, then 1.2 mg/kg body weight per day for 2 weeks. The dose should then be increased (maximum by 1.2 mg/kg body weight) every 1-2 weeks until the optimal therapeutic effect is achieved. The average maintenance dose is 5-15 mg/kg body weight per day in 2 divided doses (maximum - 400 mg/day).
For children taking other drugs that do not significantly induce or inhibit lamotrigine glucuronidation, the initial dose of Lamotrigine is 0.3 mg/kg body weight per day in 1-2 divided doses for 2 weeks, then 0.6 mg/kg body weight per day in 1-2 divided doses for the next 2 weeks. After that, the dose should be increased (maximum by 0.6 mg/kg) every 1-2 weeks until the optimal therapeutic effect is achieved. The usual maintenance dose is 1-10 mg/kg per day in 1-2 divided doses. The maximum dose is 200 mg/day.
Children 2-6 years of age will most likely require a maintenance dose of Lamotrigine at the upper end of the recommended dosage range.
If epileptic control is achieved with adjunctive therapy, concomitant AEDs can be discontinued and lamotrigine monotherapy continued.
To correctly calculate the maintenance dose, it is necessary to monitor the child's body weight.
Bipolar disorder (adults)
Due to the risk of rashes, the initial dose and the rate of subsequent dose increases should not be exceeded.
The drug "Lamotrigine" is recommended for use in patients with bipolar disorders with an increased risk of depressive episodes in the future.
The following transition regimen should be followed. This regimen involves increasing the dose of lamotrigine to a maintenance stabilisation dose over a period of 6 weeks, after which other psychotropic and/or antiepileptic medicinal products may be discontinued if clinically appropriate.
The need for additional therapy to prevent manic episodes should be considered, since the effectiveness of Lamotrigine in manic syndrome has not been clearly established.
The recommended dose escalation schedule for lamotrigine to achieve a maintenance stabilizing daily dose in the treatment of adults with bipolar disorder is:
Adjunctive therapy with inhibitors of lamotrigine glucuronidation, such as valproate. The initial dose for patients taking concomitant therapy with an inhibitor of glucuronidation, such as valproate, is 25 mg every other day for 2 weeks, then 25 mg once daily for the next two weeks. The dose should be increased to 50 mg/day (in 1-2 divided doses) at week 5. The usual dose to achieve optimal response is 100 mg/day (in 1-2 divided doses). However, the dose may be increased to a maximum of 200 mg/day depending on the clinical response. Adjunctive therapy with inducers of lamotrigine glucuronidation in patients not taking inhibitors, such as valproate. This regimen should be used with phenytoin, carbamazepine, phenobarbital, primidone or other inducers of hepatic enzymes. The initial dose for patients taking drugs that induce lamotrigine glucuronidation and not taking valproate is 50 mg once daily for 2 weeks, then 100 mg/day (in 2 divided doses) for the next 2 weeks. The dose should be increased to 200 mg/day (in 2 divided doses) at week 5. The dose may be increased to 300 mg/day at week 6, but the usual dose to achieve optimal response is 400 mg/day (in 2 divided doses), which can be prescribed from week 7. Lamotrigine monotherapy or add-on therapy in patients taking other drugs that do not significantly induce or inhibit lamotrigine glucuronidation. The initial dose for these patients is 25 mg once daily for 2 weeks, then 50 mg/day (in 1-2 divided doses) for the next 2 weeks. The dose should be increased to 100 mg/day at week 5. Typically, 200 mg/day (given in 1-2 divided doses) is required to achieve optimal response. However, doses in the range of 100-400 mg have been used in clinical trials.
Once the required maintenance stabilization dose is reached, the use of other psychotropic drugs can be discontinued.
Application features
Pregnant women
Lamotrigine has been reported to pass into breast milk in variable concentrations. In this case, lamotrigine levels in the infant may reach 50% of the corresponding level in the mother. Therefore, in some infants who were breastfed, serum levels of lamotrigine may reach levels at which a pharmacological effect is possible. In this regard, the benefits of breastfeeding should be compared with the possible risk of adverse reactions in the child.
Drivers
Available data indicate that the effects of lamotrigine on visual coordination, eye movement, body control, and subjective sedation are not different from those of placebo. Neurological adverse reactions, such as dizziness and diplopia, may occur during treatment with lamotrigine. Patients should assess their own response to lamotrigine treatment and consult their physician regarding the possibility of driving a car or operating machinery while taking lamotrigine, since individual responses to anticonvulsant therapy vary.
Overdose
Cases of acute overdose have been reported at doses 10-20 times the maximum therapeutic dose, including fatalities.
Symptoms: dizziness, headache, drowsiness, vomiting, ataxia, nystagmus, impaired consciousness, grand mal seizures, coma, prolongation of the QRS interval on the electrocardiogram (delayed intraventricular conduction).
Treatment: to reduce the absorption of the drug, gastric lavage and the use of enterosorbents are recommended. The patient should be hospitalized in the intensive care unit for appropriate symptomatic and supportive therapy.
Side effects
Epilepsy
Skin and subcutaneous tissue disorders: very common (≥ 1/10) - skin rash.
On the part of the psyche: often (≥ 1/100 to <1/10) - aggressiveness, irritability.
From the nervous system: very often (≥ 1/10) - headache; often (≥ 1/100 to <1/10) - drowsiness, insomnia, dizziness, tremor.
On the part of the gastrointestinal tract: in monotherapy: often (≥ 1/100 to <1/10) - nausea, vomiting and diarrhea; according to other data: very often (≥ 1/10) - nausea, vomiting; often (≥ 1/100 to <1/10) - diarrhea.
Bipolar disorders
Gastrointestinal: often (≥ 1/100 to <1/10) - dry mouth.
Skin and subcutaneous tissue disorders: very common (≥ 1/10) - skin rash.
From the nervous system: very often (≥ 1/10) - headache; often (≥ 1/100 to <1/10) - anxiety, drowsiness, dizziness.
Musculoskeletal and connective tissue disorders: common (≥ 1/100 to <1/10) - arthralgia.
Post-registration use
From the nervous system: very often (≥ 1/10) - drowsiness, ataxia, headache, dizziness; often (≥ 1/100 to <1/10) - nystagmus, tremor, insomnia.
On the part of the organ of vision: very often (≥ 1/10) - diplopia, veil before the eyes.
Gastrointestinal: very often (≥ 1/10) - nausea, vomiting; often (≥ 1/100 to <1/10) - diarrhea.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
