Lamictal, 30 pcs., 100 mg, tablets
Inside.
Epilepsy:
adults and children over 12 years of age who have not received sodium valproate,
an initial dose of 25 mg once a day for 2 weeks, then 50 mg once a day for 2 weeks, then the dose is increased by 50-100 mg every 1 week. –2 weeks until the optimal therapeutic effect is achieved. Maintenance dose: 100–200 mg/day in 1 or 2 divided doses (some patients require a dose of 500 mg/day).
Dose escalation schedule for lamotrigine monotherapy in adults and children over 12 years of age
| 1–2 week | 3–4 week | Maintenance dose |
| 25 mg 1 time per day | 50 mg 1 time per day | 100–200 mg/day in 1 or 2 doses. To achieve a therapeutic effect, doses can be increased by 50–100 mg every 1–2 weeks |
For patients receiving sodium valproate,
initial dose: 25 mg every other day for 2 weeks, then 25 mg daily for the next 2 weeks, after which the dose is increased by a maximum of 25–50 mg/day every 1–2 weeks until the optimal therapeutic effect is achieved. Maintenance dose: 100–200 mg/day in 1 or 2 doses.
Patients taking antiepileptic drugs that induce liver enzymes in combination with or without other antiepileptic drugs (except sodium valproate),
initial dose: 50 mg once a day for 2 weeks, then 100 mg/day in 2 doses for 2 weeks. Then the dose is increased by a maximum of 100 mg every 1–2 weeks until the optimal therapeutic effect is achieved. The maintenance dose to achieve the optimal therapeutic effect is 200–400 mg/day in 2 divided doses. Some patients may require a dose of 700 mg/day to achieve the desired effect.
Dose escalation scheme for combination therapy in adults and children over 12 years of age
| Therapy | Dose |
| Lamictal and Valproate, with or without other antiepileptic drugs | |
| 1–2 weeks | 12.5 or 25 mg every other day |
| 3–4 weeks | 25 mg/day |
| Maintenance dose | 100–200 mg in 1 or 2 divided doses (the dose should be increased by 25–50 mg every 1–2 weeks until maintenance is achieved) |
| Lamictal and antiepileptic drugs that induce liver enzymes (phenytoin, carbamazepine, phenobarbital, primidone) in combination with or without other antiepileptic drugs (except valproate): | |
| 1–2 weeks | 50 mg/day |
| 3–4 weeks | 100 mg/day in 2 divided doses |
| Maintenance dose | 200–400 mg/day in 2 divided doses (the dose should be increased by 100 mg every 1–2 weeks until maintenance is achieved) |
Children 2 to 12 years of age receiving sodium valproate with or without other antiepileptic drugs
initial dose - 0.15 mg/kg 1 time per day for 2 weeks; then - 0.3 mg/kg 1 time per day for 2 weeks. Then the dose is increased by 0.3 mg/kg every 1–2 weeks until the optimal therapeutic effect is achieved. Maintenance dose: 1–5 mg/kg/day in 1 or 2 doses. The maximum daily dose is 200 mg.
For patients taking hepatic enzyme-inducing antiepileptic drugs, with or without other antiepileptic drugs (except sodium valproate),
initial dose - 0.6 mg/kg/day in 2 divided doses for 2 weeks, subsequently - 1.2 mg/kg/day in 2 divided doses for 2 weeks. Then the dose is increased by a maximum of 1.2 mg/kg every 1–2 weeks until the optimal therapeutic effect is achieved. The average maintenance dose to achieve the optimal therapeutic effect is 5–15 mg/kg/day in 2 divided doses. The maximum daily dose is 400 mg. To achieve optimal effect in children, it is necessary to systematically monitor body weight in order to adjust doses in accordance with changes in the child's body weight.
Scheme of increasing doses for combination therapy in children from 2 to 12 years
| Therapy | Doses |
| Lamictal and valproate, with or without other antiepileptic drugs | |
| 1–2 weeks | 0.15 mg/kg/day |
| 3–4 weeks | 0.3 mg/kg/day |
| Maintenance dose | The dose is increased by 0.3 mg/kg every 1–2 weeks to a maintenance dose of 1–5 mg/kg (in 1 or 2 doses), but not more than 200 mg/day |
| Lamictal and antiepileptic drugs that induce liver enzymes (phenytoin, carbamazepine, phenobarbital, primidone), with or without other antiepileptic drugs (except valproate) | |
| 1–2 weeks | 0.6 mg/kg in 2 divided doses |
| 3–4 weeks | 1.2 mg/kg in 2 divided doses |
| Maintenance dose | The dose is increased by 1.2 mg/kg every 1–2 weeks to a maintenance dose of 5–15 mg/kg (in 2 divided doses), but not more than 400 mg/day |
Bipolar disorders (to prevent the development of a depressive episode). Orally, chewing, dissolving in a small amount of water or swallowing whole with water.
Dose escalation regimen to achieve a maintenance daily stabilizing dose in adults (over 18 years of age) with bipolar disorder
| Therapy | Doses |
| Lamictal in combination with antiepileptic drugs, liver enzyme inhibitors (valproate, etc.) | |
| 1–2 weeks | 12.5 mg (25 mg every other day) |
| 3–4 weeks | 25 mg/day |
| 5 week | 50 mg/day in 1–2 doses |
| Week 6 (stabilizing dose)* | 100 mg/day in 1–2 doses (maximum dose – 200 mg) |
| Lamictal in combination with antiepileptic drugs that induce liver enzymes | |
| 1–2 weeks | 50 mg/day |
| 3–4 weeks | 100 mg/day in 2 divided doses |
| 5 week | 200 mg/day in 2 divided doses |
| Week 6 (stabilizing dose)* | 300 mg |
| week 7 | if necessary, increase the dose to 400 mg in 2 divided doses |
| Lamictal in combination with antiepileptic drugs, the nature of the interaction of which is unknown. Monotherapy with Lamictal | |
| 1–2 weeks | 25 mg/day |
| 3–4 weeks | 50 mg/day in 1–2 doses |
| 5 week | 100 mg/day in 1–2 doses |
| Week 6 (stabilizing dose)* | 200 mg/day in 1–2 doses |
*Stabilization dose varies depending on clinical response
Adults over 18 years of age taking Lamictal in combination with antiepileptic drugs, liver enzyme inhibitors (including sodium valproate),
25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks, then 50 mg/day in 1 or 2 doses for 1 week; stabilizing dose - 100 mg/day in 1 or 2 doses (varies depending on the clinical effect). The maximum dose is 200 mg/day.
Therapy with Lamictal in combination with antiepileptic drugs that induce liver enzymes (carbamazepine, phenobarbital), without sodium valproate,
initial dose: 50 mg once a day for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks. The dose is increased by 5 weeks to 200 mg/day in 2 doses and to 300 mg/day by 6 weeks. To achieve the optimal therapeutic effect - 400 mg/day in 2 doses, starting from 7 weeks.
Therapy with Lamictal and drugs with an unknown nature of interaction (lithium drugs, bupropion). Monotherapy with Lamictal:
initial dose: 25 mg/day for 2 weeks, then 50 mg/day in 1 or 2 doses for 2 weeks. The dose should be increased to 100 mg/day for 5 weeks. To achieve an optimal therapeutic effect, a dose of 200 mg/day is required in 1 or 2 doses.
Once the daily maintenance stabilizing dose is reached, other psychotropic drugs can be discontinued.
Daily dose of Lamictal required to stabilize mood in bipolar disorders after discontinuation of concomitant psychotropic or antiepileptic drugs
| Therapy | Doses | ||
| After discontinuation of valproate | |||
| 1 Week | Double the stabilizing dose, not exceeding 100 mg/week (in 1 week from 100 mg/day to 200 mg/day) | ||
| 2–3 weeks and beyond | Maintain the dose of 200 mg/day in 2 divided doses (if necessary, increase to 400 mg/day) | ||
| After discontinuation of antiepileptic drugs that induce liver enzymes (carbamazepine), depending on the initial dose | |||
| 1 Week | 400 mg | 300 mg | 200 mg |
| 2 week | 300 mg | 225 mg | 150 mg |
| Week 3 onwards | 200 mg | 150 mg | 100 mg |
| After discontinuation of other psychotropic or antiepileptic drugs, the nature of the interaction of which is unknown | Maintenance dose 200 mg/day in 2 divided doses (from 100 to 400 mg) | ||
| For patients taking antiepileptic drugs with unknown interactions, the same dose escalation schedule as when taking lamotrigine with Valproate is recommended. | |||
Therapy with Lamictal after discontinuation of antiepileptic drugs, liver enzyme inhibitors (including sodium valproate):
after discontinuation of sodium valproate, the stabilizing dose is doubled, not exceeding 100 mg/week. For example, a stabilizing dose of 100 mg/day is increased in the first week to 200 mg/day, in the second, third week and then the dose of 200 mg/day is maintained in 2 doses. If necessary, the dose can be increased to 400 mg/day.
Therapy with Lamictal after discontinuation of antiepileptic drugs that induce liver enzymes (carbamazepine), depending on the initial maintenance dose:
The dose of Lamictal is gradually reduced over 3 weeks.
Therapy with Lamictal after withdrawal of psychotropic drugs or other antiepileptic drugs, the nature of the interaction of which with lamotrigine is unknown (lithium drugs, bupropion):
the same maintenance dose is maintained.
Lamotrigine dosage regimen for bipolar disorders after adding other drugs to therapy
| Therapy | Dose, mg/day | |||
| Stabilizing dose | 1 week | 2 weeks | 3 weeks and beyond | |
| Addition of Valproate | 200 | 100 | Maintain dose 100 mg/day | |
| 300 | 150 | Maintain dose 150 mg/day | ||
| 400 | 200 | Maintain dose 200 mg/day | ||
| Addition of antiepileptic drugs that induce liver enzymes | 200 | 200 | 300 | 400 |
| 150 | 150 | 225 | 300 | |
| 100 | 100 | 150 | 200 | |
| Addition of other psychotropic or antiepileptic drugs, the nature of the interaction of which with lamotrigine is unknown | Maintain maintenance dose of 200 mg/day in 2 divided doses | |||
Addition of antiepileptic drugs, liver enzyme inhibitors (sodium valproate), depending on the initial dose of lamotrigine:
with a stabilizing dose of 200 mg/day, in the first week - reduce it to 100 mg/day, in the second, third week and beyond - maintain 100 mg/day. At a dose of 300 mg/day, in the first week, reduce to 150 mg/day and then keep unchanged; at a dose of 400 mg/day, in the first week, reduce to 200 mg/day and then keep unchanged.
Addition of antiepileptic drugs that induce liver enzymes (carbamazepine) in patients not receiving sodium valproate, depending on the initial dose of lamotrigine:
at a dose of 200 mg/day, in the first week keep it unchanged, in the second - increase to 300 mg/day, in the third and further - increase to 400 mg/day.
At a dose of 150 mg/day in the first week, keep it unchanged, in the second - increase to 225 mg/day, in the third and further - increase to 300 mg/day. At a dose of 100 mg/day, keep it unchanged in the first week, increase to 150 mg/day in the second, increase to 200 mg/day in the third and further.
Addition of other psychotropic or antiepileptic drugs, the nature of the interaction of which with lamotrigine is unknown:
maintain a maintenance dose of 200 mg/day in 2 divided doses (from 100 to 400 mg).
In patients with hepatic impairment, initial, escalating, and maintenance doses should be reduced by ~50% and 75% in patients with moderate (stage B) and severe (stage C) hepatic impairment, respectively. In the future, they should be adjusted depending on the clinical effect. If renal function is impaired, a reduction in the maintenance dose is recommended. Patients over 65 years of age do not require changes to the dosage regimen. There are no dosage recommendations for children under 18 years of age.
Lamictal®
For oral administration.
Lamictal® Chewable/Dissoluble Tablets may be chewed, dissolved in a small volume of water (at least enough to cover the entire tablet), or swallowed whole with a small amount of water.
If the calculated dose of lamotrigine (for example, when used in children for the treatment of epilepsy or in patients with impaired liver function) is not equal to whole tablets, then the patient should be prescribed a dose that corresponds to fewer whole tablets.
Resumption of drug use
If Lamictal is restarted, the physician should evaluate the need to increase the maintenance dose in patients who have stopped taking lamotrigine for any reason, as high initial doses and exceeding the recommended dose are associated with a risk of severe rash. The more time has passed since the last dose of the drug, the more caution you should increase the dose to maintenance. If the time after discontinuation exceeds 5 half-lives, the dose of lamotrigine should be increased to a maintenance dose according to an appropriate dosage regimen.
It is recommended not to restart Lamictal therapy in patients in whom lamotrigine treatment was discontinued due to rash, unless the potential benefit clearly outweighs the risk.
Epilepsy
Dose escalation and maintenance doses recommended for adults and adolescents over 12 years of age (Table 2) and children and adolescents 2 to 12 years of age (Table 3) are listed below. Due to the risk of developing a rash, the initial dose of the drug and the subsequent dose escalation regimen should not be exceeded.
When discontinuing concomitant AEDs or adding AEDs or other drugs while taking lamotrigine, be aware that this may affect the pharmacokinetics of lamotrigine.
Table 2. Recommended dosage regimen for the treatment of epilepsy in adults and adolescents (over 12 years of age)
| Dosage regimen | Weeks 1+2 | Weeks 3+4 | Usual maintenance dose |
| Monotherapy: | 25 mg/day (in 1 dose) | 50 mg/day (in 1 dose) | 100-200 mg/day (in 1 or 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 50-100 mg every 1-2 weeks until an optimal response is achieved. Some patients may require a dose of 500 mg/day to achieve the target therapeutic response. |
| Combination therapy with valproate (lamotrigine glucuronidation inhibitor): | |||
| This dosage regimen should be used with valproate regardless of other concomitant therapy. | 12.5 mg/day (prescribed 25 mg every other day) | 25 mg/day (in 1 dose) | 100-200 mg/day (in 1 or 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 25-50 mg every 1-2 weeks until an optimal response is achieved. |
| Combination therapy without valproate and with lamotrigine glucuronidation inhibitors: | |||
| This dosage regimen should be used without valproate, but with phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir/ritonavir | 50 mg/day (in 1 dose) | 100 mg/day (in 2 doses) | 200-400 mg/day (in 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 100 mg every 1-2 weeks until an optimal response is achieved. Some patients may require a dose of 700 mg/day to achieve the target therapeutic response. |
| Combination therapy without valproate and without lamotrigine glucuronidation inhibitors: | |||
| This dosage regimen should be used with other drugs that do not significantly inhibit or induce lamotrigine glucuronidation. | 25 mg/day (in 1 dose) | 50 mg/day (1 appointment) | 100-200 mg/day (in 1 or 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 50-100 mg every 1-2 weeks until an optimal response is achieved. |
| In patients taking drugs that have a currently unknown pharmacokinetic interaction with lamotrigine, the dosage regimen recommended for the use of lamotrigine in combination with valproate should be used. | |||
Table 3. Recommended dosage regimen for the treatment of epilepsy in children (from 2 to 12 years inclusive)
| Dosage regimen | Weeks 1+2 | Weeks 3+4 | Usual maintenance dose |
| Monotherapy for typical absence seizures: | 0.3 mg/kg/day (in 1 or 2 doses) | 0.6 mg/kg/day (in 1 or 2 doses) | 1-15 mg/kg/day (in 1 or 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 0.6 mg/kg/day every 1-2 weeks until an optimal response is achieved with a maximum maintenance dose of 200 mg/day. |
| Combination therapy with valproate (lamotrigine glucuronidation inhibitor): | |||
| This dosage regimen should be used with valproate regardless of other concomitant therapy. | 0.15 mg/kg/day* (in 1 dose) | 0.3 mg/kg/day (in 1 dose) | 1-5 mg/kg/day (in 1 or 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 0.3 mg/kg/day every 1-2 weeks until an optimal response is achieved with a maximum maintenance dose of 200 mg/day. |
| Combination therapy without valproate and with inducers of lamotrigine glucuronidation: | |||
| This dosage regimen should be used without valproate, but with phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir/ritonavir | 0.6 mg/kg/day (in 2 doses) | 1.2 mg/kg/day (in 2 doses) | 5-15 mg/kg/day (in 1 or 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 1.2 mg/kg/day every 1-2 weeks until an optimal response is achieved with a maximum maintenance dose of 400 mg/day. |
| Combination therapy without valproate and without inducers of lamotrigine glucuronidation: | |||
| This dosage regimen should be used with other drugs that do not significantly inhibit or induce lamotrigine glucuronidation. | 0.3 mg/kg/day (in 1 or 2 doses) | 0.6 mg/kg/day (in 1 or 2 doses) | 1-10 mg/kg/day (in 1 or 2 doses). To achieve a maintenance dose, the amount of the drug can be increased by a maximum of 0.6 mg/kg/day every 1-2 weeks until an optimal response is achieved with a maximum maintenance dose of 200 mg/day. |
| In patients taking drugs that have a currently unknown pharmacokinetic interaction with lamotrigine, the dosage regimen recommended for the use of lamotrigine in combination with valproate should be used. *If the calculated daily dose in patients taking valproate is 1 to 2 mg, then Lamictal®, chewable/soluble tablets, 2 mg every other day for the first 2 weeks can be prescribed. If the calculated daily dose in patients taking valproate is less than 1 mg, lamotrigine should not be prescribed. | |||
To ensure that the therapeutic dose is maintained, it is necessary to monitor the child’s body weight and adjust the dose of the drug if it changes. Patients aged 2 to 6 years are likely to require a maintenance dose at the upper end of the recommended range. After achieving control of epilepsy during combination therapy, concomitant antiepileptic drugs (AEDs) can be discontinued and Lamictal® continued as monotherapy.
Children under 2 years old
Data on the safety and effectiveness of lamotrigine as a combination therapy for partial-onset seizures in children aged 1 month to 2 years are limited. There are no data on use in children under 1 month of age. Therefore, Lamictal® is not recommended for use in children under 2 years of age. However, in case of clinical need, a decision may be made to prescribe the drug.
Bipolar affective disorder
Dose escalation and maintenance doses recommended for adults over 18 years of age are listed in the tables below. The bridge dosing regimen involves increasing the lamotrigine dose over 6 weeks to a maintenance stabilization dose (Table 4), after which other psychotropic medications and/or AEDs may be discontinued as clinically indicated (Table 5). Dose adjustments following the addition of other psychotropic medications and/or AEDs are also listed below (Table 6). Due to the risk of rash, the initial dose of the drug and the subsequent dose escalation regimen should not be exceeded.
Table 4. Recommended dose escalation regimen to achieve a maintenance daily stabilization dose for the treatment of bipolar affective disorder in adults aged 18 years or older
| Dosage regimen | Weeks 1+2 | Weeks 3+4 | Week 5 | Target stabilization dose (week 6)* |
| Lamotrigine monotherapy or combination therapy without valproate and without inducers of lamotrigine glucuronidation: | ||||
| This dosage regimen should be used with other drugs that do not significantly inhibit or induce lamotrigine glucuronidation. | 25 mg/day (in 1 dose) | 50 mg/day (in 1 or 2 doses) | 100 mg/day (in 1 or 2 doses) | 200 mg/day is the usual target dose for optimal response (in 1 or 2 divided doses per day). Doses ranging from 100 mg/day to 400 mg/day have been used in clinical studies. |
| Combination therapy with valproate (lamotrigine glucuronidation inhibitor): | ||||
| This dosage regimen should be used with valproate regardless of other concomitant therapy. | 12.5 mg/day (prescribed 25 mg/day every other day) | 25 mg/day (in 1 dose) | 50 mg/day (in 1 or 2 doses) | 100 mg/day is the usual target dose for optimal response (in 1 or 2 divided doses per day). A maximum daily dose of 200 mg/day may be used depending on clinical response. |
| Combination therapy without valproate and with inducers of lamotrigine glucuronidation: | ||||
| This dosage regimen should be used without valproate, but with phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir/ritonavir | 50 mg/day (in 1 dose) | 100 mg/day (in 2 doses) | 200 mg/day (in 2 doses) | 300 mg/day at week 6 of therapy, if necessary increase the dose to 400 mg/day at week 7 of therapy to achieve an optimal response (in 2 doses). |
| In patients taking drugs that have a currently unknown pharmacokinetic interaction with lamotrigine, the dose escalation regimen recommended for the use of lamotrigine in combination with valproate should be used. | ||||
*Target stabilization dose varies depending on clinical response.
Once the target daily maintenance stabilization dose has been achieved, other psychotropic medications may be discontinued as indicated in the dosing schedule below.
Table 5. Maintenance stabilizing total daily dose in adults 18 years of age or older for the treatment of bipolar disorder after discontinuation of concomitant medications
| Dosage regimen | Current lamotrigine stabilization dose (before discontinuation) | Week 1 (start of withdrawal) | Week 2 | Week 3 onwards* |
| Discontinuation of valproate (lamotrigine glucuronidation inhibitor) depending on the initial dose of lamotrigine: | ||||
| After discontinuation of valproate, the stabilization dose should be doubled, not exceeding an increase of 100 mg per week | 100 mg/day | 200 mg/day | Maintain dose 200 mg/day at 2 doses | |
| 200 mg/day | 300 mg/day | 400 mg/day | Maintain dose 400 mg/day | |
| Withdrawal of inducers of lamotrigine glucuronidation depending on the initial dose of lamotrigine: | ||||
| This dosage regimen should be used after discontinuation of phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir/ritonavir | 400 mg/day | 400 mg/day | 300 mg/day | 200 mg/day |
| 300 mg/day | 300 mg/day | 225 mg/day | 150 mg/day | |
| 200 mg/day | 200 mg/day | 150 mg/day | 100 mg/day | |
| Withdrawal of drugs that do not significantly induce or inhibit lamotrigine glucuronidation: | ||||
| This dosage regimen should be used after discontinuation of other drugs that do not significantly induce or inhibit lamotrigine glucuronidation. | Maintain the target dose achieved during the dose escalation regimen (200 mg/day in 2 divided doses; dose range 100 to 400 mg/day) | |||
| In patients taking drugs that have a currently unknown pharmacokinetic interaction with lamotrigine, it is recommended that the current lamotrigine dose be maintained and lamotrigine dose titration should be based on clinical response. | ||||
* If necessary, the dose can be increased to 400 mg/day.
There is no clinical experience with adjusting daily doses of Lamictal® after adding other drugs. However, based on studies evaluating drug interactions, the following recommendations can be formulated (Table 6).
Table 6. Daily dosage adjustments for the treatment of bipolar affective disorder in adults aged 18 years and older after the addition of other drugs
| Dosage regimen | Current lamotrigine stabilization dose (before addition) | Week 1 (beginning of adding) | Week 2 | Week 3 onwards |
| Addition of valproate (lamotrigine glucuronidation inhibitor) depending on the initial dose of lamotrigine: | ||||
| This dosage regimen should be used when adding valproate regardless of other concomitant therapy. | 200 mg/day | 100 mg/day | Maintain dose 100 mg/day | |
| 300 mg/day | 150 mg/day | Maintain dose 150 mg/day | ||
| 400 mg/day | 200 mg/day | Maintain dose 200 mg/day | ||
| Addition of inducers of lamotrigine glucuronidation in patients not receiving valproate, depending on the initial dose of lamotrigine: | ||||
| This dosage regimen should be used without valproate when adding phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir/ritonavir | 200 mg/day | 200 mg/day | 300 mg/day | 400 mg/day |
| 150 mg/day | 150 mg/day | 225 mg/day | 300 mg/day | |
| 100 mg/day | 100 mg/day | 150 mg/day | 200 mg/day | |
| Addition of other drugs that do not have a significant inducing or inhibitory effect on lamotrigine glucuronidation: | ||||
| This dosage regimen should be used when adding other drugs that do not have a significant inducing or inhibitory effect on lamotrigine glucuronidation | Maintain the target dose achieved during the dose escalation regimen (200 mg/day; dose range 100 to 400 mg/day) | |||
| In patients taking drugs that have a currently unknown pharmacokinetic interaction with lamotrigine, the dosage regimen recommended for the use of lamotrigine in combination with valproate should be used. | ||||
Discontinuation of Lamictal® in patients with bipolar affective disorder
During clinical trials, abrupt discontinuation of lamotrigine did not cause an increase in the frequency, severity, or nature of adverse reactions compared to placebo. Thus, patients can be discontinued from Lamictal without gradually reducing its dose.
Children and teenagers under 18 years of age
Lamictal® is not recommended for the treatment of bipolar affective disorder in children and adolescents under 18 years of age because randomized drug withdrawal trials did not demonstrate significant efficacy and an increase in reports of suicidal behavior was observed.
General recommendations for dosing of Lamictal® in special groups of patients
Women taking hormonal contraceptives
When using the ethinyl estradiol/levonorgestrel combination (30 mcg/150 mcg), the clearance of lamotrigine approximately doubles, resulting in a decrease in lamotrigine levels. After dose titration, higher maintenance doses of lamotrigine (up to a twofold increase) may be required to achieve maximum therapeutic response. During the week without contraceptive use, a twofold increase in lamotrigine levels was observed. Dose-related adverse reactions cannot be ruled out. Therefore, contraception that does not include a contraceptive-free week (eg, permanent hormonal contraceptives or non-hormonal methods) should be considered as first-line therapy.
Initiation of hormonal contraceptives in patients already receiving maintenance doses of lamotrigine and NOT receiving inducers of lamotrigine glucuronidation
In most cases, an increase in the maintenance dose of lamotrigine is required, but not more than 2 times. From the moment the use of hormonal contraceptives is started, it is recommended to increase the dose of lamotrigine by 50-100 mg every week, depending on the individual clinical response. It is not recommended to exceed these doses unless the patient's clinical condition requires a further increase in the dose of Lamictal®.
To ensure that baseline lamotrigine levels are maintained, consider measuring serum lamotrigine levels before and after initiating hormonal contraceptives. If necessary, dose adjustment should be made. For women taking hormonal contraceptives that include one week without the use of the active drug (a "contraceptive-free week"), serum lamotrigine levels should be monitored during week 3 of the active drug, that is, days 15 to 21 of the pill cycle. . Therefore, contraception that does not include a contraceptive-free week (eg, permanent hormonal contraceptives or non-hormonal methods) should be considered as first-line therapy.
Discontinuation of hormonal contraceptives in patients already receiving maintenance doses of lamotrigine and NOT receiving inducers of lamotrigine glucuronidation
In most cases, a reduction in the maintenance dose of lamotrigine is required, but not by more than 50%. It is recommended to gradually reduce the daily dose of lamotrigine by 50-100 mg/day every week (the rate of reduction should not exceed 25% of the daily dose per week) over 3 weeks, unless the patient's clinical condition requires a different approach.
To confirm maintenance of baseline lamotrigine levels, consider measuring serum lamotrigine levels before and after discontinuation of hormonal contraceptives. For women wishing to stop taking hormonal contraceptives that include one week without the use of the active drug (a “contraceptive-free week”), serum lamotrigine levels should be monitored during week 3 of the active drug, that is, days 15 to 21 of the cycle. taking pills. Blood samples to assess lamotrigine levels after permanently stopping a contraceptive should not be collected during the first week after stopping the pills.
Initiating lamotrigine in patients already using hormonal contraceptives
Dose increases should be carried out according to the usual recommendations for use presented in the tables.
Initiation and discontinuation of hormonal contraceptives in patients already taking maintenance doses of lamotrigine and taking inducers of lamotrigine glucuronidation
No adjustment to the recommended maintenance dose of lamotrigine may be necessary.
Use with atazanavir/ritonavir combination
If lamotrigine is added to existing atazanavir/ritonavir therapy, there is no need to adjust the recommended lamotrigine dose escalation regimen. In patients already taking maintenance doses of lamotrigine and not using inducers of glucuronidation, it may be necessary to increase the dose of lamotrigine when adding the atazanavir/ritonavir combination or to reduce the dose of lamotrigine if discontinuing the atazanavir/ritonavir combination. In order to determine the need for lamotrigine dose adjustment, lamotrigine plasma levels should be monitored before and for 2 weeks after starting or stopping the use of the atazanavir/ritonavir combination.
Use together with lopinavir/ritonavir
If lamotrigine is added to existing lopinavir/ritonavir therapy, there is no need to adjust the recommended lamotrigine dose escalation regimen. In patients already taking maintenance doses of lamotrigine and not using glucuronidation inducers, it may be necessary to increase the dose of lamotrigine when adding lopinavir/ritonavir or to reduce the dose of lamotrigine if discontinuing lopinavir/ritonavir. To determine the need for lamotrigine dose adjustment, lamotrigine plasma levels should be monitored before and for 2 weeks after starting or stopping the use of lopinavir/ritonavir.
Elderly patients (over 65 years old)
No adjustment of the dosage regimen is required compared to the recommended regimen. The pharmacokinetics of lamotrigine in this age group are not significantly different from those in older adults.
Patients with impaired renal function
Lamictal® should be administered with caution to patients with renal failure. In patients with end-stage renal failure, initial doses of Lamictal* should be calculated depending on the concomitant medications the patient is taking. In patients with significant renal impairment, reduced maintenance doses may be effective.
Patients with liver dysfunction
Initial, escalating, and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh stage B) and 75% in severe (Child-Pugh stage C) liver dysfunction. Escalating and maintenance doses should be adjusted based on clinical response.
Publications in the media
(Lamoiriginum) INN
Synonyms. Lamictal.
Composition and release form. Tablets of 0.025, 0.05 and 0.1 g of lamotrigine.
Indications. Epilepsy (mono- and auxiliary therapy for partial and generalized seizures).
Pharmachologic effect. Lamotrigine is an anticonvulsant that can block the action of excitatory non-irotransmitter amino acids (glutamate and aspartate). Blockade of voltage-dependent sodium channels, prevention of the release of excitatory amino acids and stabilization of presynaptic neuronal membranes provide its anticonvulsant effect. Lamotrigine exerts its action through NMDA receptors of excitatory amino acids. Pharmacokinetics. When taken orally, the drug is absorbed quickly and completely from the gastrointestinal tract into the blood; the bioavailability of lamotrigine is 98%; food intake does not affect bioavailability. The volume of distribution is 1.2 l/kg. Peak plasma concentrations are observed on average 2.5 hours after administration. Binds to plasma proteins by 55%. The drug is almost completely metabolized in the liver with the formation of the main metabolite - N-glucuronide. T1/2 is 29 hours. It is excreted mainly in the urine in the form of the main metabolite and, partially, unchanged. Side effects . Nausea, vomiting; feeling tired, headache, dizziness, irritability, drowsiness, tremor; blurred vision, diplopia; allergic reactions; lymphadenopathy. Contraindications. Severe diseases of the liver, kidneys; hypersensitivity to the drug.
Adverse reactions when interacting with other drugs. The drug is not recommended to be taken simultaneously with drugs that depress the central nervous system and with alcohol due to the dangerous potentiation of effects. Valproic acid, chloramphenicol, cimetidine inhibit the metabolism of lamotrigine and may increase its side effects. Carbamazepine, when taken simultaneously with lamotrigine, causes dizziness, diplopia, and blurred vision. The clearance of lamotrigine increases when it is taken simultaneously with carbamazepine or phenobarbital, or phenytoin, or primidone, which leads to a decrease in its T1/2. Information for the patient. Lamotrigine is prescribed to adults and children 0.05 g 2 times a day 30-40 minutes before meals or, to avoid irritation of the gastric mucosa, after meals. If necessary, the daily dose can be increased. Alcohol and other CNS depressants should not be used during treatment with lamotrigine. Use caution when driving. Lamotrigine should be avoided during pregnancy. The drug is discontinued gradually to avoid a sharp exacerbation of the disease. Missed dose: Take the missed dose as soon as possible; if there is no time left to take the missed dose, do not take it; do not take double doses.
Lamictal®
Epilepsy
Adults and children over 12 years old
For monotherapy
The initial dose of Lamictal is 25 mg 1 time / day for the first 2 weeks, followed by an increase in dose to 50 mg 1 time / day over the next 2 weeks. The dose should then be increased by 50-100 mg every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose to maintain the optimal therapeutic effect is 100-200 mg/day in 1-2 doses. Some patients require Lamictal at a dose of 500 mg/day to achieve a therapeutic effect.
As part of combination therapy when using Lamictal together with valproic acid drugs in combination with other antiepileptic drugs (AEDs) or without them
The initial dose of Lamictal is 25 mg every other day for the first 2 weeks; subsequently – 25 mg 1 time/day for the next 2 weeks. Then the dose should be increased by a maximum of 25-50 mg/day every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose to maintain the optimal therapeutic effect is 100-200 mg/day in 1-2 doses.
As part of combination therapy with concomitant therapy with AEDs or other drugs that induce glucuronidation of lamotrigine (phenytoin, carbamazepine, phenobarbital and primidone), in combination or without other AEDs (except for valproic acid drugs)
The initial dose of Lamictal is 50 mg 1 time / day for the first 2 weeks, then for the next 2 weeks - 100 mg / day in 2 doses. Then the dose is increased by 100 mg every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose is 200-400 mg/day in 2 divided doses. Some patients may require a dose of 700 mg/day to achieve a therapeutic effect.
As part of combination therapy with oxcarbazepine, with or without any other inducers or inhibitors of lamotrigine glucuronidation
The initial dose of Lamictal is 25 mg 1 time / day for the first 2 weeks, then 50 mg / day in 1 dose for the next 2 weeks. Then the dose is increased by a maximum of 50-100 mg every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose is 100-200 mg per day in 1 or 2 doses.
Due to the risk of developing a rash, the initial dose of the drug and the recommended dose escalation regimen should not be exceeded.
Table 1. Recommended dosage regimen for the treatment of epilepsy in adults and children over 12 years of age.
| Destination mode | Week 1-2 | Week 3-4 | Maintenance dose |
| Monotherapy | |||
| 25 mg 1 time/day | 50 mg 1 time/day | 100-200 mg 1 or 2 times/day; to achieve a therapeutic effect, the dose can be increased by 50-100 mg every 1-2 weeks | |
| Combination therapy with Lamictal and valproic acid preparations, regardless of other concomitant therapy | |||
| 12.5 mg (or 25 mg every other day) | 25 mg 1 time/day | 100-200 mg (in 1 or 2 doses); to achieve a therapeutic effect, the dose can be increased by 25-50 mg every 1-2 weeks | |
| Combination therapy without valproic acid drugs | |||
| with phenytoin, carbamazepine, phenobarbital, primidone or other inducers of lamotrigine glucuronidation | 50 mg 1 time/day | 100 mg (in 2 doses) | 200-400 mg (in 2 doses); to achieve a therapeutic effect, the dose is increased by 100 mg every 1-2 weeks |
| with oxcarbazepine without inducers or inhibitors of lamotrigine glucuronidation | 25 mg 1 time/day | 50 mg 1 time/day | 100-200 mg (in 1 or 2 doses) to achieve a therapeutic effect, the dose can be increased by 50-100 mg every 1-2 weeks |
| In patients taking AEDs whose pharmacokinetic interaction with lamotrigine is currently unknown, the regimen recommended for lamotrigine in combination with valproic acid should be used. | |||
Children aged 2 to 12 years
It should be noted that accurate initial therapy with Lamictal in 5 mg tablets according to the proposed dosage regimen is impossible if the child’s body weight is less than 17 kg. Children ages 2 to 6 years are likely to require the highest maintenance doses.
Initial dose of Lamictal for monotherapy of typical absence seizures
is 0.3 mg/kg body weight/day in 1 or 2 doses during the first 2 weeks, followed by increasing the dose to 0.6 mg/kg/day in 1 or 2 doses over the next 2 weeks. The dose should then be increased by a maximum of 0.6 mg/kg every 1-2 weeks until the optimal therapeutic effect is achieved. The usual maintenance dose for optimal therapeutic effect is 1 to 10 mg/kg/day in 1 or 2 divided doses, although some patients with typical absence seizures require higher doses to achieve therapeutic effect.
As part of combination therapy when using Lamictal with valproic acid drugs in combination with or without other AEDs
The initial dose of Lamictal is 0.15 mg/kg body weight 1 time/day for the first 2 weeks, then 0.3 mg/kg 1 time/day for the next 2 weeks. The dose should then be increased by 0.3 mg/kg every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose is 1-5 mg/kg/day in 1-2 doses. The maximum daily dose is 200 mg.
As part of combination therapy with concomitant therapy with AEDs or other drugs that induce glucuronidation of lamotrigine (phenytoin, carbamazepine, phenobarbital and primidone), in combination with or without other AEDs (except for valproic acid drugs)
The initial dose of Lamictal is 0.6 mg/kg/day in 2 divided doses during the first 2 weeks, then 1.2 mg/kg/day in 2 divided doses over the next 2 weeks. Then the dose should be increased by a maximum of 1.2 mg/kg/day every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose at which the maximum therapeutic effect is achieved is 5-15 mg/kg/day in 2 divided doses. The maximum daily dose is 400 mg.
As part of combination therapy with oxcarbazepine without any other inducers or inhibitors of lamotrigine glucuronidation
The initial dose of Lamictal is 0.3 mg/kg body weight 1 or 2 times/day for the first 2 weeks, then 0.6 mg/kg/day in 1 or 2 doses over the next 2 weeks. Then the dose is increased by a maximum of 0.6 mg/kg every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose is 1-10 mg/kg/day in 1 or 2 divided doses. The maximum dose is 200 mg/day.
To ensure that the therapeutic dose is maintained, it is necessary to monitor the child's body weight and adjust the drug dose as it changes.
Due to the risk of developing a rash, the initial dose of the drug and the recommended dose escalation regimen should not be exceeded.
Table 2. Recommended dosage regimen for the treatment of children with epilepsy aged 2 to 12 years (total daily dose in mg/kg body weight).
| Destination mode | Week 1-2 | Week 3-4 | Maintenance dose |
| Monotherapy for typical absence seizures | |||
| 0.3 mg/kg (in 1 or 2 doses) | 0.6 mg/kg (in 1 or 2 doses) | Increase the dose by 0.6 mg/kg every 1-2 weeks until a maintenance dose of 1-10 mg/kg/day is reached (given in 1 or 2 divided doses) to a maximum dose of 200 mg/day | |
| Combination therapy with Lamictal and valproic acid preparations, regardless of other concomitant therapy | |||
| 0.15 mg/kg 1 time/day | 0.3 mg/kg 1 time/day | Increase the dose by 0.3 mg/kg every 1-2 weeks until a maintenance dose of 1-5 mg/kg/day is reached (given in 1 or 2 divided doses) to a maximum dose of 200 mg/day | |
| Combination therapy without valproic acid drugs | |||
| with phenytoin, carbamazepine, phenobarbital, primidone or other inducers of lamotrigine glucuronidation | 0.6 mg/kg (in 2 doses) | 1.2 mg/kg (in 2 doses) | Increase the dose by 1.2 mg/kg every 1-2 weeks until a maintenance dose of 5-15 mg/kg/day (given in 1 or 2 divided doses) is reached, up to a maximum dose of 400 mg/day |
| with oxcarbazepine without inducers or inhibitors of lamotrigine glucuronidation | 0.3 mg/kg (in 1 or 2 doses) | 0.6 mg/kg (in 1 or 2 doses) | Increase the dose by 0.6 mg/kg every 1-2 weeks until a maintenance dose of 1-10 mg/kg/day is reached (given in 1 or 2 divided doses) to a maximum dose of 200 mg/day |
| In patients taking AEDs whose pharmacokinetic interaction with lamotrigine is currently unknown, the regimen recommended for lamotrigine in combination with valproic acid should be used. | |||
| If the calculated daily dose in patients taking valproic acid drugs is 2.5-5 mg, then Lamictal 5 mg tablets can be taken every other day for the first 2 weeks. If the calculated daily dose in patients taking valproic acid is less than 2.5 mg, Lamictal should not be prescribed | |||
There is insufficient information on the use of Lamictal in children under 2 years of age
.
When discontinuing concomitant antiepileptic drugs to switch to Lamictal monotherapy or when prescribing other drugs or AEDs while taking Lamictal, it is necessary to take into account that this may affect the pharmacokinetics of lamotrigine.
Bipolar disorders
Adult patients over 18 years of age
Due to the risk of developing a rash, the initial dose of the drug and the subsequent dose escalation regimen should not be exceeded.
It is necessary to follow a transitional dosing regimen, which includes increasing the dose of lamotrigine over 6 weeks to a maintenance stabilizing dose (Table 3), after which, if indicated, other psychotropic and/or antiepileptic drugs can be discontinued (Table 4).
Table 3. Recommended dosage escalation schedule to achieve a maintenance daily stabilization dose for adults (over 18 years of age) with bipolar disorders.
| Weeks 1-2 | Weeks 3-4 | Week 5 | Maintenance stabilizing dose (week 6) |
| Combination therapy with inhibitors of lamotrigine glucuronidation (for example, with valproic acid preparations) | |||
| 12.5 mg (25 mg every other day) | 25 mg 1 time/day | 50 mg (in 1 or 2 doses)/day | 100 mg (in 1 or 2 doses)/day, maximum daily dose 200 mg |
| Combination therapy with inducers of lamotrigine glucuronidation in patients not taking inhibitors such as valproic acid. This regimen should be used with phenytoin, carbamazepine, phenobarbital, primidone, or other inducers of lamotrigine glucuronidation | |||
| 50 mg 1 time/day | 100 mg (in 2 doses)/day | 200 mg (in 2 doses)/day | 300 mg at week 6 of therapy, if necessary, increase the dose to 400 mg at week 7 of therapy (in 2 doses) |
| Lamictal monotherapy or adjunctive therapy in patients taking lithium, bupropion, olanzapine, oxcarbazepine or other drugs that do not have a significant inducing or inhibitory effect on lamotrigine glucuronidation | |||
| 25 mg 1 time/day | 50 mg (in 1 or 2 doses)/day | 100 mg (in 1 or 2 doses)/day | 200 mg (from 100 mg to 400 mg) in 1 or 2 doses/day |
| In patients taking AEDs whose pharmacokinetic interaction with lamotrigine has not been studied, it is necessary to use a dose escalation regimen as recommended for lamotrigine in combination with valproic acid drugs. | |||
The maintenance stabilizing dose varies depending on the clinical effect.
As part of combination therapy with the combined use of Lamictal and other AEDs that inhibit liver enzymes (for example, with valproic acid preparations),
During the first 2 weeks, Lamictal is prescribed at a dose of 25 mg every other day, then 25 mg 1 time / day for the next 2 weeks, at week 5 the dose should be increased to 50 mg / day in 1-2 doses. The stabilizing dose at week 6 is 100 mg/day in 1-2 doses; however, it may be increased to a maximum daily dose of 200 mg depending on clinical response.
As part of combination therapy with the combined use of Lamictal and other AEDs that induce liver enzymes (for example, carbamazepine, phenobarbital), in patients not receiving valproic acid drugs,
during the first 2 weeks, Lamictal is prescribed at a dose of 50 mg 1 time / day, at 3-4 weeks - 100 mg / day in 2 doses, at week 5 - 200 mg / day in 2 doses. At week 6, the dose can be increased to 300 mg/day, however, the stabilizing dose to achieve the optimal therapeutic effect is 400 mg/day in 2 doses, and is prescribed starting from week 7.
With monotherapy
Lamictal or as
part of combination therapy when using Lamictal together with lithium drugs, bupropion, olanzapine, oxcarbazepine, without the use of inducers or inhibitors of lamotrigine glucuronidation
during the first 2 weeks Lamictal is prescribed in a dose of 25 mg 1 time / day, at 3-4 weeks - 50 mg/day in 1-2 doses, at week 5 - 100 mg/day in 1-2 doses. The stabilizing dose at week 6 is 200 mg/day in 1-2 doses. However, clinical trials used doses ranging from 100 to 400 mg.
After reaching the daily maintenance stabilizing dose, other psychotropic drugs may be discontinued.
Table 4. Maintenance stabilizing total daily dose for the treatment of bipolar disorders after discontinuation of concomitant psychotropic or antiepileptic drugs.
| Dosage regimen | Week 1 | Week 2 | Week 3 onwards |
| After discontinuation of lamotrigine glucuronidation inhibitors, such as valproic acid | Double the stabilizing dose, not exceeding 100 mg/week, i.e. maintenance stabilizing dose of 100 mg/day increases at 1 week to 200 mg/day | Maintain dose 200 mg/day in 2 divided doses | |
| After discontinuation of inducers of lamotrigine glucuronidation, depending on the initial dose. This regimen should be used when using phenytoin, carbamazepine, phenobarbital, primidone, or other inducers of lamotrigine glucuronidation | 400 mg | 300 mg | 200 mg |
| 300 mg | 225 mg | 150 mg | |
| 200 mg | 150 mg | 100 mg | |
| After discontinuation of other psychotropic or antiepileptic drugs in patients not taking inducers or inhibitors of lamotrigine glucuronidation (including lithium, bupropion, olanzapine, oxcarbazepine) | Maintain the stabilizing dose achieved during the escalation regimen (200 mg/day in 2 divided doses; dose range 100 mg to 400 mg) | ||
| Note: For patients taking AEDs whose pharmacokinetic interactions with lamotrigine are currently unknown, a dosage regimen similar to that for lamotrigine with valproic acid is recommended. | |||
If necessary, the dose can be increased to 400 mg/day.
After discontinuation of additional therapy with inhibitors of lamotrigine glucuronidation (for example, valproic acid preparations)
, the stabilizing initial dose of lamotrigine is doubled and maintained at this level.
After discontinuation of additional therapy with inducers of lamotrigine glucuronidation (including phenytoin, carbamazepine, phenobarbital, primidone)
The dose of lamotrigine is gradually reduced over 3 weeks depending on the initial maintenance dose.
After discontinuation of concomitant psychotropic or antiepileptic drugs that do not have significant pharmacokinetic interactions with lamotrigine (for example, lithium, bupropion, olanzapine, oxcarbazepine)
The stabilizing dose of Lamictal achieved during the escalation regimen should be maintained.
There is no clinical experience with adjustment of daily doses of lamotrigine in patients with bipolar disorders after the addition of other drugs. However, based on drug interaction studies, the following recommendations can be made (Table 5).
Table 5. Adjustment of daily doses of lamotrigine in patients with bipolar disorder after adding other drugs to therapy.
| Dosage regimen | Current stabilizing dose of lamotrigine (mg/day) | Week 1 | Week 2 | Week 3 onwards |
| Addition of inhibitors of lamotrigine glucuronidation (for example, valproic acid preparations), depending on the initial dose of lamotrigine | 200 mg | 100 mg | Maintain dose 100 mg/day | |
| 300 mg | 150 mg | Maintain dose 150 mg/day | ||
| 400 mg | 200 mg | Maintain dose 200 mg/day | ||
| Addition of inducers of lamotrigine glucuronidation (including phenytoin, carbamazepine, phenobarbital, primidone) in patients not receiving valproic acid drugs, depending on the initial dose of lamotrigine | 200 mg | 200 mg | 300 mg | 400 mg |
| 150 mg | 150 mg | 225 mg | 300 mg | |
| 100 mg | 100 mg | 150 mg | 200 mg | |
| Addition of other psychotropic or antiepileptic drugs with insignificant pharmacokinetic interaction with lamotrigine (for example, lithium preparations, bupropion, olanzapine, oxcarbazepine) | Maintain target dose achieved during escalation regimen (200 mg/day; dose range 100 mg to 400 mg) | |||
| Note: For patients taking AEDs whose pharmacokinetic interactions with lamotrigine are currently unknown, a dosage regimen similar to that for lamotrigine with valproic acid is recommended. | ||||
During clinical trials of Lamictal for bipolar disorders, abrupt discontinuation of lamotrigine did not cause an increase in the frequency, severity, or nature of adverse reactions compared to placebo. Thus, Lamictal can be discontinued immediately, without gradually reducing the dose.
Lamotrigine is not indicated for bipolar disorder in children and adolescents under 18 years of age.
. The safety and effectiveness of lamotrigine for bipolar disorder have not been evaluated in patients in this age group.
When prescribing Lamictal to women already taking hormonal contraceptives,
Specific lamotrigine dose escalation regimens have not been developed (despite the fact that hormonal contraceptives increase the clearance of lamotrigine). Dosage escalation regimens should follow recommended guidelines depending on whether lamotrigine is administered with valproic acid (an inhibitor of lamotrigine glucuronidation) or an inducer of lamotrigine glucuronidation; or lamotrigine is prescribed in the absence of valproic acid or inducers of lamotrigine glucuronidation (Table 1 for epilepsy and Table 3 for bipolar disorder).
When prescribing hormonal contraceptives to patients already taking maintenance doses of Lamictal and not taking inducers of lamotrigine glucuronidation, in most cases an increase in the dose of lamotrigine is required, but not more than 2 times. When prescribing hormonal contraceptives, it is recommended to increase the dose of lamotrigine by 50 - 100 mg/day every week, depending on the clinical picture. It is not recommended to exceed these figures unless the patient's clinical condition requires a further increase in the dose of lamotrigine.
When stopping hormonal contraceptives in patients already taking maintenance doses of Lamictal and not taking inducers of lamotrigine glucuronidation, in most cases a lamotrigine dose reduction is required by half. It is recommended to gradually reduce the daily dose of lamotrigia by 50-100 mg every week (reduction of no more than 25% of the daily dose per week) for more than 3 weeks, depending on the clinical picture.
Despite the fact that when atazanavir/ritonavir is co-administered
Plasma concentrations of lamotrigine decreased; the recommended dose increase of lamotrigine is not required when co-administering atazanavir/ritonavir. Lamotrigine dose increases should be based on recommendations based on whether lamotrigine is added to therapy with valproic acid (an inhibitor of lamotrigine glucuronidation) or therapy with a glucuronidation inducer of lamotrigine, or whether lamotrigine is used in the absence of valproic acid or the glucuronidation inducer lamotrigine.
In patients already taking maintenance doses of lamotrigine and not taking inducers of lamotrigine glucuronidation, the lamotrigine dose may need to be increased when atazanavir/ritonavir is prescribed, and the lamotrigine dose may need to be reduced when atazanavir/ritonavir is discontinued.
Dosage regimen adjustments in elderly patients (over 65 years of age)
not required (since the pharmacokinetics in this age group do not differ from those in adults).
For moderate (class B on the Child-Pugh scale) and severe liver dysfunction (class C on the Child-Pugh scale)
initial, escalating and maintenance doses should be reduced by approximately 50% and 75%, respectively. Incremental and maintenance doses should be adjusted based on clinical response.
For end-stage renal failure
The initial dose of lamotrigine is calculated in accordance with the standard antiepileptic drug regimen. For patients with a significant decrease in renal function, a reduction in the maintenance dose may be recommended.
Lamictal chewable/dissolvable tablets can be chewed, dissolved in a small volume of water (enough to cover the entire tablet), or swallowed whole with a small amount of water.
If the calculated dose of lamotrigine (for example, when prescribed to children or patients with impaired liver function) cannot be divided into a whole number of lower-strength tablets, then the patient should be prescribed a dose that corresponds to the nearest whole tablet at a lower dosage.
When restarting lamotrigine, the physician should evaluate the need to increase the maintenance dose in patients who have discontinued the drug for any reason, as high initial doses and higher than recommended doses are associated with a risk of severe rash. The more time has passed since the last dose of the drug, the more caution you should increase the dose to maintenance. If the time after discontinuation exceeds 5 half-lives, the dose of lamotrigine should be increased to a maintenance dose according to an appropriate dosage regimen.
Lamotrigine therapy should not be restarted in patients whose lamotrigine treatment was discontinued because of rash, unless the potential benefit of such therapy clearly outweighs the potential risk.
