Composition, form of production and packaging
Tablets of light yellow-brown color, square, with rounded corners, with an embossed inscription "GSEC7" on one side and a convex square with a squeezed out figure "25" - on the other.
1 tab.
lamotrigine 25 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate, iron oxide yellow (E172).
10 pieces. - blisters (3) - packs of cardboard.
Tablets are light yellow-brown in color, square, with rounded corners, with an embossed inscription "GSEE1" on one side and a convex square with a squashed "50" on the other.
1 tab.
lamotrigine 50 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate, iron oxide yellow (E172).
10 pieces. - blisters (3) - packs of cardboard.
Tablets of light yellow-brown color, square, with rounded corners, with an embossed inscription "GSE5" on one side and a convex square with a squashed "100" - on the other.
1 tab.
lamotrigine 100 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate, iron oxide yellow (E172).
10 pieces. - blisters (3) - packs of cardboard.
Tablets are chewable / soluble white or almost white, with a smell of black currant, square, with rounded corners, with a convex square and a number 100 on one side and with an embossed "GS CL7" on the other; there may be small inclusions.
1 tab.
lamotrigine * 100 mg
Excipients: calcium carbonate, low-substituted hydroxypropylcellulose, aluminum-magnesium silicate, sodium starch glycolate (type A), povidone K30, sodium saccharin, blackcurrant flavor 502.009 / AP 0551, magnesium stearate.
10 pieces. - blisters (3) - packs of cardboard.
* Nonproprietary international name recommended by WHO - lamotrigine.
Tablets are chewable / soluble white or almost white, with a smell of black currant, square, with rounded corners, with a convex square and number 25 on one side and with an embossed "GS CL5" on the other; there may be small inclusions.
1 tab.
lamotrigine * 25 mg
Excipients: calcium carbonate, low-substituted hydroxypropylcellulose, aluminum-magnesium silicate, sodium starch glycolate (type A), povidone K30, sodium saccharin, blackcurrant flavor 502.009 / AP 0551, magnesium stearate.
10 pieces. - blisters (3) - packs of cardboard.
* Nonproprietary international name recommended by WHO - lamotrigine.
The tablets are chewable / soluble white or almost white, with the smell of black currant, elongated, biconcave, with an embossed "GS CL2" on one side and number 5 on the other; there may be small inclusions.
1 tab.
lamotrigine * 5 mg
Excipients: calcium carbonate, low-substituted hydroxypropylcellulose, aluminum-magnesium silicate, sodium starch glycolate (type A), povidone K30, sodium saccharin, blackcurrant flavor 502.009 / AP 0551, magnesium stearate.
10 pieces. - blisters (3) - packs of cardboard.
* Nonproprietary international name recommended by WHO - lamotrigine.
Tablets of light yellow-brown color, square, with rounded corners, with an embossed inscription "GSE5" on one side and a convex square with a squashed "100" - on the other.
1 tab.
lamotrigine 100 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate, iron oxide yellow (E172).
10 pieces. - blisters (3) - packs of cardboard.
Tablets of light yellow-brown color, square, with rounded corners, with an embossed inscription "GSEC7" on one side and a convex square with a squeezed out figure "25" - on the other.
1 tab.
lamotrigine 25 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate, iron oxide yellow (E172).
10 pieces. - blisters (3) - packs of cardboard.
Tablets are light yellow-brown in color, square, with rounded corners, with an embossed inscription "GSEE1" on one side and a convex square with a squashed "50" on the other.
1 tab.
lamotrigine 50 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate, iron oxide yellow (E172).
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Antiepileptic drug. Lamotrigine is a blocker of potential-dependent sodium channels. In the culture of neurons, it causes a potential-dependent blockade of continuously recurring impulses and suppresses the pathological release of glutamic acid (an amino acid that plays a key role in the development of epileptic seizures), and also inhibits depolarization caused by glutamate.
The efficacy of lamichtal in preventing mood disorders in patients with bipolar disorders has been demonstrated in two fundamental clinical studies. A combined analysis of the results showed that the duration of remission, defined as the time before the onset of the first episode of depression and before the first episode of mania / hypomania / mixed after stabilization, lasted longer in the lamotrigine group compared with placebo. The duration of remission is more pronounced for depression.
PHARMACOKINETICS
Suction
After ingestion lamotrigine is rapidly and completely absorbed from the digestive tract, practically without undergoing the first systemic pre-systemic metabolism. Cmax in plasma is achieved approximately 2.5 hours after taking the drug. The time to reach C max slightly increases after ingestion, but the degree of absorption remains unchanged. The pharmacokinetics of lamotrigine is linear in the administration of a single dose up to 450 mg (the highest dose studied). Significant interindividual fluctuations of the maximum concentration in the equilibrium state are observed, however, with rare fluctuations in each individual.
Distribution
Lamotrigine binds to plasma proteins by approximately 55%. It is unlikely that the release of the drug from the bond with the protein could lead to the development of a toxic effect. V d is 0.92-1.22 l / kg.
Metabolism
In the metabolism of lamotrigine, the enzyme uridine-diphosphate-glucuronyltransferase (UDP-glucuronyltransferase) participates. Lamotrigine in a small degree increases its own metabolism depending on the dose.
Excretion
In healthy adults, lamotrigine clearance in the state of equilibrium concentrations averages 39 ± 14 ml / min. Lamotrigine is metabolized to glucuronides, which are excreted by the kidneys. Less than 10% of the drug is excreted by the kidneys unchanged, about 2% - through the intestine. Clearance and T 1/2 are dose independent. T1/2 in healthy adults is an average of 24 hours to 35 hours. In patients with Gilbert's syndrome, the clearance of the drug was reduced by 32% compared to the control group, which, however, did not exceed the limits of normal values ​​for the general population. T 1/2 of lamotrigine is greatly influenced by co-administered medications. The mean T 1/2 is reduced to approximately 14 hours with concomitant administration with glucuronizing stimulants such as carbamazepine and phenytoin, and rises to an average of 70 hours with co-administration with valproate.
Pharmacokinetics in special clinical cases
In children the clearance of lamotrigine is higher for body weight than for adults; it is highest in children under 5 years old. In children, T 1/2 lamotrigine is usually less than in adults. Its mean value is approximately equal to 7 hours with simultaneous administration with drugs stimulating glucuronization, such as carbamazepine and phenytoin, and rises to an average of 45-50 hours with co-administration with valproate.
Clinically significant differences in the clearance of lamotrigine in elderly patients in comparison with young patients were not detected.
If the kidney function is disturbed, the initial dose of lamotrigine is calculated according to the standard antiepileptic drug prescription schedule. Dose reduction may be required only with a significant decrease in kidney function.
The initial, increasing and maintenance doses should be reduced by approximately 50% in patients with moderate degree of hepatic insufficiency (class B on the Child-Pugh scale) and 75% in patients with severe hepatic impairment (Child-Pugh class C) . The dose increase and the maintenance dose should be adjusted depending on the clinical effect.
INDICATIONS
Epilepsy
for adults and children over 12 years
- epilepsy (partial and generalized seizures, including tonic-clonic seizures, as well as seizures in the Lennox-Gastaut syndrome) as part of combination therapy or monotherapy.
for children from 2 to 12 years
- Epilepsy (partial and generalized seizures, including tonic-clonic seizures, as well as seizures in the Lennox-Gasto syndrome) as part of combination therapy (after achieving epilepsy control against combined therapy, concomitant antiepileptic drugs can be withdrawn and lamotrigine continued in monotherapy) ;
- monotherapy of typical absences.
Bipolar disorders
for adults (18 years and over)
- to prevent mood disorders (depression, mania, hypomania, mixed episodes).
DOSING MODE
Epilepsy
Adults and children over 12 years of age
For monotherapy, the initial dose of Lamictal is 25 mg 1 time / day for the first 2 weeks, followed by a dose increase of 50 mg 1 time / day for the next 2 weeks. Then the dose should be increased by 50-100 mg every 1-2 weeks until the optimal therapeutic effect is achieved. The standard maintenance dose for maintaining the optimal therapeutic effect is 100-200 mg / day in 1-2 doses. Some patients require the appointment of Lamictal in a dose of 500 mg / day to achieve a therapeutic effect.
In the combination therapy with the combined use of Lamycal with valproic acid preparations in combination with other antiepileptic drugs (PEP) or without them, the initial dose of Lamycal is 25 mg every other day for the first 2 weeks; in the future - 25 mg 1 time / day for the next 2 weeks. Then the dose should be increased as much as 25-50 mg / day every 1-2 weeks, until the optimal therapeutic effect is achieved. The standard maintenance dose for maintaining the optimal therapeutic effect is 100-200 mg / day in 1-2 doses.
In the combination therapy with concomitant therapy of PEP or other drugs inducing glucuronization of lamotrigine (phenytoin, carbamazepine, phenobarbital and primidon), in combination or without other PEP (with the exception of valproic acid preparations), 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 divided doses. The dose is then 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 need a dose of 700 mg / day to achieve a therapeutic effect.
As part of combination therapy with oxcarbazepine in combination with any other inducers or inhibitors of glucuronization of lamotrigine or without them, the initial dose of Lamycal is 25 mg 1 time / day for the first 2 weeks, then 50 mg / day in 1 dose during the following 2 weeks. Then the dose increases by max. 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.
Because of the risk of developing the rash, the initial dose of the drug and the recommended regime for increasing doses should not be exceeded.
Table 1. Recommended dosing 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 Lamycal and preparations of valproic acid, regardless of other concomitant therapy
12.5 mg (or 25 mg every other day) 25 mg once a day 100-200 mg (in 1 or in 2 divided doses); to achieve a therapeutic effect, the dose can be increased by 25-50 mg every 1-2 weeks
Combination therapy without valproic acid preparations
with phenytoin, carbamazepine, phenobarbital, primidon or other inducers of glucuronization of lamotrigine 50 mg 1 time / day 100 mg (in 2 divided doses) 200-400 mg (in 2 divided doses); to achieve a therapeutic effect, the dose is increased by 100 mg every 1-2 weeks
with oxcarbazepine without inducers or inhibitors of glucuronization of lamotrigine 25 mg 1 time / day 50 mg 1 time / day 100-200 mg (in 1 or 2 doses) in order to achieve a therapeutic effect, the dose can be increased by 50-100 mg every 1-2 weeks
In patients taking PEP, pharmacokinetic interaction of which with lamotrigine is currently unknown, the regimen recommended for the appointment of lamotrigine in combination with valproic acid preparations
Children from 2 to 12 years old
It should be noted that the exact carrying out of initial Lamictal therapy in tablets of 5 mg according to the proposed dosing regimen is impossible if the child's body weight is less than 17 kg. Most likely, children between the ages of 2 and 6 years will need the largest maintenance doses.
The initial dose of Lamectal with monotherapy of typical absences is 0.3 mg / kg body weight / day in 1 or 2 doses during the first 2 weeks, followed by a dose increase of 0.6 mg / kg / day in 1 or 2 doses for the next 2 weeks. Then the dose should 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 achieving the optimal therapeutic effect is 1 to 10 mg / kg / day in 1 or 2 doses, although some patients with typical absences require higher doses to achieve a therapeutic effect.
In the combination therapy with Lamycal and valproic acid preparations in combination with other PEP or without them, the initial dose of Lamictal is 0.15 mg / kg of 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.
In the combination therapy with concomitant therapy with PEP or other drugs inducing glucuronization of lamotrigine (phenytoin, carbamazepine, phenobarbital and primidone), in combination with other PEPs or without them (with the exception of valproic acid preparations), the initial dose of Lamictal is 0.6 mg / kg / day in 2 divided doses for the first 2 weeks, then 1.2 mg / kg / day in 2 divided doses for the next 2 weeks. Then the dose should be increased to the 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.
In combination therapy with oxcarbazepine without any other inducers or inhibitors of lamotrigine glucuronin, the initial dose of Lamycal 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 admission for 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 doses. The maximum dose is 200 mg / day.
To be sure that a therapeutic dose is maintained, it is necessary to monitor the weight of the child's body and adjust the dose of the drug as it changes.
Because of the risk of developing the rash, the initial dose of the drug and the recommended regime for increasing doses should not be exceeded.
Table 2. Recommended dosage regimen in 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 with typical absences
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 (prescribed in 1 or 2 doses) to a maximum dose of 200 mg / day
Combination therapy with Lamycal and preparations of valproic acid, regardless of other concomitant therapy
0.15 mg / kg 1 time / day 0.3 mg / kg 1 time / day Increasing the dose by 0.3 mg / kg every 1-2 weeks until a maintenance dose of 1-5 mg / kg / day (prescribed in 1 or 2 doses) to the maximum doses of 200 mg / day
Combination therapy without valproic acid preparations
with phenytoin, carbamazepine, phenobarbital, primidon, or other inducers of lamotrigine glucuronin 0.6 mg / kg (in 2 divided doses) 1.2 mg / kg (in 2 divided doses) Increasing the dose by 1.2 mg / kg every 1-2 weeks until a maintenance dose of 5-15 mg / kg / day (prescribed in 1 or 2 doses) 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 divided doses) 0.6 mg / kg (in 1 or 2 divided doses) Increasing the dose to 0.6 mg / kg every 1-2 weeks until reaching a maintenance dose of 1-10 mg / kg / day (assignable to 1 or 2 divided doses) to a maximum dose of 200 mg / day
in patients taking AEDs pharmacokinetic interaction with lamotrigine is currently unknown, to be used mode recommended for assignment of lamotrigine in combination with a preparation of valproic acid
If the calculated daily dose in patients taking drugs valproic acid is 2.5-5 mg Lamictal tablets 5 mg may be administered every other day for the first 2 weeks. If the calculated daily dose in patients taking valproic acid medications, less 2.5 mg, Lamictal should not be given
the insufficient information on the use of Lamictal in children under 2 years .
If you cancel the related antiepileptic drugs to go to Lamiktalom monotherapy or in the appointment of patients receiving Lamictal other drugs or AEDs should take into account the fact that it may have an effect on the pharmacokinetics of lamotrigine.
Bipolar disorders
Adult patients older than 18 years
Because of the risk of rash should not exceed the initial dose and subsequent doses increase mode.
Should follow transition dosage regimen, which includes increasing for 6 weeks to a maintenance dose of lamotrigine stabilizing dose (Table. 3) and then, if indicated, it is possible to cancel other psychotropic and / or antiepileptic drugs (Table 4).
Table 3. Guided increasing doses to achieve the stabilizing supports daily adult dose (over age 18) in bipolar disorders.
Week 1-2 Week 3-4 Week 5 Supportive anti dose (Week 6)
Combination therapy with lamotrigine glucuronidation inhibitors (e.g., drug valproic acid)
12.5 mg (25 mg every other day) 25 mg 1 time / day to 50 mg (in 1 or 2 divided doses) / d (100 mg, in 1 or 2 divided doses) / day with a maximum daily dose of 200 mg
Combination therapy with inductors glucuronidation lamotrigine patients not taking inhibitors such as valproic acid formulations. This mode should be used with phenytoin, carbamazepine, phenobarbital, primidone or other inducers glucuronidation Lamotrigine
50 mg 1 time / day 100 mg (2 doses) / day to 200 mg (in 2 hours) / day to 300 mg for 6 weeks of therapy, if desired increase the dose up to 400 mg of a 7 week therapy (2 doses)
Monotherapy Lamiktalom or adjunctive therapy in patients taking drugs lithium, bupropion, olanzapine, oxcarbazepine or other preparations which have no significant inducing or inhibitory effect on glucuronidation Lamotrigine
25 mg 1 time / day to 50 mg (in 1 or 2 divided doses) / Day 100 mg (in 1 or 2 divided doses) / day to 200 mg (from 100 mg to 400 mg) in 1 or 2 doses / day
in patients taking AEDs pharmacokinetic interaction with lamotrigine has not been studied, it is necessary to use the mode of increasing doses as recommended for lamotridzh on in combination with valproate preparations
Supportive anti dose varies depending on the clinical effect.
ATa combination therapy with the combined application lamiktal and other PETs, inhibiting hepatic enzymes (e.g., drug valproic acid) for the first 2 weeks Lamictal administered in a dose of 25 mg a day, then - 25 mg 1 time / day for the following 2 weeks , 5 week dose should be increased to 50 mg / day in 1-2 doses. Stabilizing dose at week 6 is 100 mg / day in 1-2 reception; however, it can be increased to a maximum of 200 mg daily depending on the clinical effect.
In a combination therapy with the concomitant use of other probes and lamiktal inducing liver enzymes (e.g., carbamazepine, phenobarbital), in patients who do not receive medication valproic acid,for the first 2 weeks Lamictal administered in a dose of 50 mg 1 time / day for 3-4 weeks - 100 mg / day in 2 divided doses on week 5 - 200 mg / day in 2 divided doses. At week 6 the dose may be increased to 300 mg / day, but the dose for stabilizing the optimal therapeutic effect is 400 mg / day in 2 divided doses, and is assigned starting at 7 weeks.
In monotherapy Lamiktalom or in combination therapy when used in conjunction with lithium lamiktal drugs, bupropion, olanzapine, oxcarbazepine, without inducers or inhibitors of lamotrigine glucuronidationfor the first 2 weeks Lamictal administered in a dose of 25 mg 1 time / day, at 3-4 week - 50 mg / day in 1-2 reception at week 5 - 100 mg / day in 1-2 doses. Stabilizing dose at 6 weeks 200 mg / day in 1-2 doses. However, when clinical trials were used in a dose range of from 100 to 400 mg.
After reaching a daily maintenance dose of stabilizing other psychotropic medications may be canceled.
Table 4. The supporting roll total daily dose for the treatment of bipolar disorders after cancellation concomitant psychotropic or antiepileptics.
Dosage regimen Week 1 Week 2 Week 3 and further
After the cancellation of lamotrigine glucuronidation inhibitors, e.g., valproic acid preparations Double the stabilizing dose not exceeding 100 mg / week, i.e. supporting roll dose 100 mg / day for 1 week, increased to 200 mg / day Save dose 200 mg / day in 2 divided doses
After canceling inductors glucuronidation of lamotrigine according to the initial dose. This mode should be used when applying phenytoin, carbamazepine, phenobarbital, primidone or other inducers glucuronidation Lamotrigine 400 mg 300 mg 200 mg
300 mg 225 mg 150 mg
200 mg 150 mg 100 mg
After the cancellation of other psychotropic or antiepileptic drugs in patients not taking inducers or inhibitors of glucuronidation of lamotrigine (including drugs lithium, bupropion, olanzapine, oxcarbazepine) Maintain stabilizing dose achieved during mode increasing (200 mg / day in 2 divided doses, a dose range of from 100 mg to 400 mg)
Note: patients taking AEDs character pharmacokinetic interaction with lamotrigine which is currently not known, it is recommended dosing regimen, when receiving lamotridzh ina valproic acid formulations
dose may be increased to 400 mg / day, if necessary.
After the cancellation of adjunctive therapy lamotrigine glucuronidation inhibitors (e.g., drug valproic acid)Stabilizing the initial dose of lamotrigine is doubled and maintained at this level.
After the cancellation of the additional inductors glucuronidation lamotrigine therapy (including phenytoin, carbamazepine, phenobarbital, primidone) dose of lamotrigine decreases gradually within 3 weeks, depending on the initial maintenance dose.
After the cancellation of concomitant psychotropic or antiepileptic drugs, without significant pharmacokinetic interactions with lamotrigine (e.g., drugs lithium, bupropion, olanzapine, oxcarbazepine) should be retained anti lamiktal dose achieved during the raising mode.
There is no clinical experience on correction of daily doses of lamotrigine in patients with bipolar disorder after the addition of other drugs. However, the following guidelines (Table. 5) can be given on the basis of studies on the interaction of drugs.
Table 5. Correction of daily doses of lamotrigine in patients with bipolar disorder after joining the therapy of other drugs.
Dosage regimen Current anti dose of lamotrigine (mg / day) Week 1 Week 2 Week 3 and further
fitting inhibitors glucuronidation lamotrigine (e.g., valproic acid formulations) depending on the initial dose of lamotrigine 200mg 100mg Save dose of 100 mg / day
300 mg 150 Save mg dose of 150 mg / day
400 mg 200 mg 200 mg dose Save / day
Accession lamotrigine glucuronidation inducers (including phenytoin, carbamazepine, phenobarbital, primidone) in patients not treated with valproic acid formulations, 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
Accession other psychotropic or antiepileptic drugs with insignificant lamotrigine pharmacokinetic interaction with (e.g., drugs lithium, bupropion, olanzapine, oxcarbazepine) Maintain target dose d ostignutuyu in raising mode (200 mg / day range of doses from 100 mg to 400 mg)
Note: patients taking AEDs character pharmacokinetic interaction with lamotrigine is currently not known, the recommended dosing regimen as when taking lamotrigine with valproic acid formulations
in clinical trials of lamiktal in bipolar disorders abrupt withdrawal of lamotrigine did not cause any increase in frequency, severity or changing the nature of adverse reactions compared to placebo. Thus, Lamictal can be canceled immediately without tapering.
Lamotrigine is not indicated for bipolar disorders for children and adolescents under 18 years . The safety and efficacy of lamotrigine in bipolar disorder in patients in this age group have not been assessed.
In the appointment of Lamictalwomen already taking hormonal contraceptives, special modes of increasing doses of lamotrigine were not developed (despite the fact that hormonal contraceptives increase the clearance of lamotrigine). Increasing doses mode must conform to the recommended instructions depending on whether lamotrigine, valproic acid is assigned (glyukuronirovaniya inhibitor lamotrigine) or inducer glyukuronirovaniya lamotrigine; or lamotrigine administered in the absence of valproic acid or inducers
glyukuronirovaniya lamotrigine (Table. 1 and Table epilepsy. 3 for bipolar disorder).
In the appointment of hormonal contraceptives to patients already taking maintenance doses of Lamictal and not taking inducers of lamotrigine glucuronidation, in most cases, necessary to increase the dose of lamotrigine, but not more than 2 times. In the appointment of hormonal contraceptives 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, if the clinical condition of the patient does not require further dose escalation of lamotrigine.
Upon termination of hormonal contraceptives by patients already receiving maintenance doses lamiktal and receiving inductors glyukuronirovaniya lamotrigine in most cases requires a reduced dose of lamotrigine 2 times. Recommended daily lamotridzhiia gradual reduction in the dose of 50-100 mg every week (not decrease more than 25% of the daily dose per week) for 3 weeks, depending on the clinical picture.
Despite the fact that the combined use of atazanavir / ritonavirlamotrigine plasma concentration decreased, it does not require the recommended dose escalation of lamotrigine while receiving atazanavir / ritonavir. Increasing doses of lamotrigine should be conducted on the basis of the recommendations based on whether lamotrigine to therapy with valproic acid is added (glyukuronirovaniya inhibitor lamotrigine) or therapy inductor glyukuronirovaniya lamotrigine or lamotrigine applied in the absence of valproic acid or inductor glyukuronirovaniya lamotrigine.
In patients already taking maintenance doses of lamotrigine and not taking inducers of lamotrigine glyukuronirovaniya, the appointment of atazanavir / ritonavir dose of lamotrigine may need to be increased and cases of atazanavir / ritonavir dose of lamotrigine may need to be reduced.
A correction mode in elderly patients (over 65 years) is not required (since the pharmacokinetics in this age group does not differ from that of adults).
In human liver average (class B Child-Pugh) and severe (grade C in Child-Pugh) start, and increasing maintenance dose should be reduced by approximately 50% and 75% respectively. Increasing and maintenance doses should be adjusted depending on clinical response.
When ESRDinitial dose of lamotrigine calculated in accordance with the standard assignment scheme antiepileptic drug. For patients with a significant reduction in renal function it can be recommended maintenance dose reduction.
Chewing / soluble Lamictal Tablets may be chewed, dissolved in a small volume of water (enough to cover the whole tablet) or swallowed whole with a little water.
If the calculated dose of lamotrigine (e.g., for administration to children or to patients with impaired liver function) can not be divided by an integer number of tablets lower dosage, the patient the dose is to be assigned, which corresponds to the nearest whole value of the tablet in a lower dosage.
In the case of reintroduction of lamotrigine physician must evaluate the need to improve the maintenance dose in patients who had stopped taking the drug for any reason, since high initial doses and exceeding the recommended doses are associated with a risk of severe rash. The more time has passed after the last dose, the dose should be increased to support more cautious. If the time after stopping is greater than 5 half-lives, the lamotrigine dosage should be increased to support according to the corresponding scheme.
Lamotrigine therapy should not be reopened for patients, discontinuation of treatment with lamotrigine which was associated with the appearance of rash, unless the potential benefits of this therapy clearly exceeds the potential risk.
SIDE EFFECT
Adverse events reported below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is defined as follows: very common (1/10?), Common (1/100, <1/10?), Infrequently, rarely (1/10 000, <(1/1000, <1/100?)? 1/1000), very rare (<1/10 000, including isolated cases). Frequency categories were formed on the basis of clinical trials of the drug and post-marketing surveillance.
In patients with epilepsy
With the side of the skin and subcutaneous fat: very often - skin rash; rarely - Stevens-Johnson syndrome, very rare - toxic epidermal necrolysis.
In double-blind, clinical studies in adults where lamotrigine used as a combination therapy, the incidence of skin eruptions in patients received
