25 mg Lamictal 30s chewing tablets
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The instruction for medical use
of Lamiktal® medicine
the Trade name
of Lamiktal®
the International unlicensed
name Lamotrigin Lekarstvennaya a form
chewable tablets of 5 mg, 25 mg, 50 mg, 100 mg
Structure
active agent - lamotrigin 5 mg, 25 mg, 50 mg or 100 mg,
excipients: calcium the carbonate, the hydroxypropyl cellulose low-substituted of magnesium aluminum silicate, sodium of starch glikolit, type A, K30 povidone, saccharin of sodium, magnesium stearate, fragrance of blackcurrant 502.009/AP 0551
the Description
of the Tablet of 5 mg
White or almost white tablets with a smell of the blackcurrant extended a biconvex form with an engraving 5 on one party and GS CL2 - on another. Small impregnations can be noted.
Tablets of 25 mg
White or almost white tablets with a smell of blackcurrant, square shape with the rounded-off corners and an engraving 25 on one party and GSCL5 - on another. Small impregnations can be noted.
Tablets of 50 mg
White or almost white tablets with a smell of blackcurrant, square shape with the rounded-off corners and an engraving 50 on one party and GSCX7 - on another. Small impregnations can be noted.
Tablets of 100 mg
White or almost white tablets with a smell of blackcurrant, square shape with the rounded-off corners and an engraving 100 on one party and GSCL7 - on another. Small impregnations can be noted.
Pharmacotherapeutic group
Antiepileptic drugs. Antiepileptic drugs others. Lamotrigin.
The ATX N03AX09 code
the Pharmacological
Lamotrigin Pharmacokinetics Absorption properties is quickly and completely soaked up from intestines. The maximum concentration in plasma is reached approximately in 2.5 h after administration of drug inside. Time of achievement of the maximum concentration slightly increases after meal, but the level of absorption remains invariable. The pharmacokinetics has linear character at reception in a dose to 450 mg.
Distribution
Extent of linking of a lamotrigin with proteins of plasma - about 55% that proves the small probability of influence on toxicity of drug in connection with substitution of plasma proteins. Distribution volume – 0.92-1.22 l/kg.
Metabolism
takes part In metabolism of a lamotrigin enzyme glucuronosyltransferase. Lamotrigin can strengthen somewhat own metabolism depending on a dose. Nevertheless, it was not revealed influences of a lamotrigin on pharmacokinetics of other antiepileptic drugs, and interaction between lamotridzhiny and other drugs which are metabolized by means of the system of P450 cytochrome it is improbable.
Removal
At adults clearance of a lamotrigin averages 30 ml/min. (39±14 ml/min.). Lamotrigin is metabolized to glucuronides which are removed with urine. Less than 10% of drug are allocated with urine in not changed look, about 2% – with excrements. The clearance and elimination half-life do not depend on a dose. Elimination half-life (T1/2) of a lamotrigin averages 33 hours (from 24 to 35 hours) and depends on the accompanying administration of drugs. So, elimination half-life decreases till 14 o'clock at joint appointment with carbamazepine and Phenytoinum and increases till 70 o'clock at joint appointment with Valproatum.
In a research of patients with Gilbert's syndrome it is established that the average clearance decreased by 32% in comparison with control, but values were within range for population in general.
Children
the Clearance of a lamotrigin calculated on body weight are higher at children, than at adults, it is highest at children up to 5 years. At children the elimination half-life of a lamotrigin is usually shorter, than at adults. So, average rates are about 7 hours at joint appointment about enzyme - the inducing drugs, such as carbamazepine and Phenytoinum, and 45-50 hours – when assigning with Valproatum.
Patients of advanced age
point the Available data to lack of significant differences in clearance of a lamotrigin at patients of advanced age in comparison with young patients.
Patients with a renal failure
and the patients who are on a hemodialysis make Average values of clearance of a lamotrigin for patients with chronic kidney disease 0.42 ml/min. (chronic kidney disease), 0.33 ml/min. (between hemodialysis sessions) and 1.57 ml/min. (during a hemodialysis). Average elimination half-life makes 42.9 hours, 57.4 hours and 13.0 hours respectively in comparison with 26.2 hours at patients with normal function of kidneys. During the 4-hour session of a hemodialysis about 20% (5.6 - 35.1%) of a lamotrigin are brought out of an organism. Thus, in a renal failure the initial dose of a lamotrigin is calculated according to the standard scheme of prescribing of antiepileptic drug.
Patients with an abnormal liver function
Average values of clearance of a lamotrigin at patients with an abnormal liver function of easy, average and heavy degree (stages of A, B and C on a scale of Chayld-Pyyu) make 0.31, 0.24 and 0.10 ml/min. respectively in comparison with 0:34 ml/min. at patients with normal function of a liver.
Generally, doses of a lamotrigin have to be reduced by 50% at patients with average degree of a liver failure and for 75% - at patients with heavy degree of a liver failure. The initial and increasing doses have to be adjusted depending on the clinical response to the carried-out therapy.
The pharmacodynamics
of Lamiktal® is a blocker potential - dependent natrium channels of presynaptic membranes of neurons. Ламиктал® suppresses the steady repeating activization of neurons and inhibits release of a glutamate – the neurotransmitter playing a key role in development of epileptic seizures.
The mechanisms providing therapeutic action of a lamotrigin in bipolar disorders were not installed. Interaction with tension of natrium channels is supposed.
Indications
Epilepsy
Adults and children are more senior than 13 years:
- in monotherapy or as a part of the combined treatment of partial and generalized attacks, including toniko-clonic spasms
- the spasms connected with Lennox-Gasto's syndrome: as a part of auxiliary therapy, or as basic antiepileptic means in case of initial manifestations of a syndrome of Lennox-Gasto.
Children and teenagers from 2 to 12 years:
- as a part of combination therapy of partial and generalized attacks, including the toniko-clonic spasms and spasms connected with Lennox's syndrome – Gasto. After achievement of control of epilepsy by means of combination therapy, other antiepileptic drugs can be cancelled and treatment can continue in the monotherapy mode the drug Lamiktal®
- monotherapy of typical absentias epileptica
Bipolar disorders
- at patients 18 years with mainly depressive phases (prevention of a depression, mania, hypomanias, the mixed pathologies) are more senior.
Ламиктал® it is not shown for treatment of an acute mania, or depressive episodes.
The route of administration and doses
the Lamiktal® Chewable tablets can be chewed, dissolved in the small volume of water (sufficient to cover all tablet) or to swallow entirely, washing down with water.
Monoterapiya's epilepsy at adults and children is more senior than 13 years
the Initial maximum daily dose of Lamiktala® at monotherapy makes 25 mg within 2 weeks once a day, further a dose it is necessary to increase a maximum by 50-100 mg each 1-2 weeks, before achievement of optimum therapeutic effect and an optimum maintenance dose. The standard maintenance dose makes 100-200 mg the day accepted in one or two receptions. To some patients for achievement of therapeutic effect the required dose of Lamiktala® makes 500 mg/days.
Combination therapy at adults and children is more senior than 13 years
Therapy of Lamiktalom® and Valproatum in combination with other antiepileptic drugs (PEP) or without them
For patients who already receive Valproatum in combination with other PEP or without them, the initial dose of Lamiktala® makes 25 mg every other day within 2 weeks, further - on 25 mg within 2 weeks once a day. Then the dose should be increased as much as possible by 25-50 mg/days each 1-2 weeks before achievement of optimum therapeutic effect. The standard maintenance dose makes 100-200 mg the day accepted in one or two receptions.
Therapy of Lamiktalom® in combination with other anti-epileptic drugs (except for Valproatum) and the drugs inducing liver enzymes (for example, Phenytoinum, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir)
the Initial dose of Lamiktala® makes 50 mg within 2 weeks, further once a day – 100 mg/days divided into two receptions within 2 weeks. Then the dose increases at most by 100 mg each 1-2 weeks, before achievement of optimum therapeutic effect. The standard maintenance dose makes 200-400 mg a day, accepted in two steps. The dose of 700 mg/days can be required by some patients for achievement of therapeutic effect.
Therapy of Lamiktalom® in combination with other medications which do not have significant inhibiting effect on liver enzymes
the Initial dose of Lamiktala® makes 25 mg within 2 weeks, further once a day – 50 mg/days within 2 weeks. Then a dose it is necessary to increase a maximum by 50-100 mg each 1-2 weeks, before achievement of optimum therapeutic effect. The dose of drug can be increased at most by 50-100 mg each 1-2 weeks before achievement of an optimum maintenance dose. The standard maintenance dose makes 100-200 mg the day accepted in one or two receptions.
Table 1. The mode of dosing Lamiktala® in treatment of epilepsy at adults and children is more senior than 13 years
Therapeutic
scheme 1+2nd of week
the 3+4th week
the Standard maintenance dose
of Monoterapiya
of 25 mg/days
(once a day)
of 50 mg/days
(once a day)
of 100 - 200 mg/days
(one or twice a day)
the Dose increases by 50-100 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Combination therapy with Valproatum
This mode of dosing is used in a combination by Valproatum, irrespective of intake of other medicines
of 12.5 mg/days
(or on 25 mg every other day)
25 mg/days
(once a day)
of 100 - 200 mg/days
(one or twice a day)
the Dose increases by 25-50 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Combination therapy with other anti-epileptic drugs (except for Valproatum) and the drugs inducing liver enzymes
Combination therapy
(Phenytoinum, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir)
50 mg/days
(once a day)
of 100 mg/days
(twice a day)
of 200 - 400 mg/days
(twice a day)
the Dose increases by 100 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Combination therapy with other drugs which are not influencing liver enzymes
This mode of dosing is used at intake of other medications which do not have significant inhibiting effect on liver enzymes
of 25 mg/days
(once a day)
of 50 mg/days
(once a day)
of 100 - 200 mg/days
(one or twice a day)
the Dose increases by 50-100 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Other drugs
At the patients taking the anticonvulsant drugs which interaction with Lamiktalom® is unknown recommend to apply the same scheme of increase in doses as to the patients accepting Lamiktal® with sodium Valproatum.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
Children from 2 to 12 years
the Dose of Lamiktala® depends on the child's weight.
Monotherapy of Lamiktalom® of typical absentias epileptica
the Initial dose of Lamiktala® makes 0.3 mg/kg/day, accepted in one or two receptions within 2 weeks, further - 0.6 mg/kg/day, also in one or two receptions within the next 2 weeks. The dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose. The standard maintenance dose makes 1-10 mg/kg a day, accepted in one or in two steps.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
Combination therapy of epilepsy at children from 2 to 12 years
Therapy of Lamiktalom® and Valproatum in combination with other anti-epileptic drugs or without them
the Initial dose of Lamiktala® makes 0.15 mg/kg within 2 weeks, further once a day - 0.3 mg/kg a day in one step within 2 weeks. Then the dose has to be increased as much as possible by 0.3 mg/kg each 1-2 weeks, before achievement of optimum therapeutic effect, the standard maintenance dose at the same time makes 1-5 mg/kg a day in one or in two steps. The maximum daily dose - 200 mg/days.
Therapy of Lamiktalom® with other anti-epileptic drugs (except for Valproatum) and the medicines inducing liver enzymes
the Initial dose of Lamiktala® makes 0.6 mg/kg a day, accepted in two steps within 2 weeks, further – 1.2 mg/kg of body weight a day in two steps within 2 weeks. Then it is necessary to increase a dose by 1.2 mg/kg each 1-2 weeks, before achievement of optimum therapeutic effect. The standard maintenance dose makes 5-15 mg/kg a day in two steps. The maximum daily dose - 400 mg/days.
Therapy of Lamiktalom® in combination with other medications which do not have significant inhibiting effect on liver enzymes
the Initial dose of Lamiktala® makes 0.3 mg/kg/day, accepted in one or two receptions within 2 weeks, further - 0.6 mg/kg/day, also in one or two receptions within the next 2 weeks. The dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose. The standard maintenance dose makes 1-10 mg/kg a day, accepted in one or in two steps. The maximum daily dose - 200 mg/days.
For children aged from 2 up to 6 years when assigning a maintenance dose the use of the maximum doses in the recommended dosing limits is recommended.
Table 2. The mode of dosing Lamiktala® in treatment of epilepsy at children from 2 to 12 years
Therapeutic
scheme 1+2nd of week
the 3+4th weeks
the Standard maintenance dose
of Monoterapiya of typical absentias epileptica
of 0.3 mg/kg/days
(one or twice a day)
0.6 mg/kg/days
(one or twice a day)
1-10 mg/kg/days
(one or twice a day)
the Dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose –
200 mg a day
Combination therapy with Valproatum
This mode of dosing is used in a combination by Valproatum, irrespective of intake of other medicines
of 0.15 mg/kg/days *
(once a day)
0.3 mg/kg/days
(once a day)
of 1-5 mg/kg/days
(one or twice a day)
the Dose of drug can be increased at most by 0.3 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose – 200 mg a day
Combination therapy with other anti-epileptic drugs (except for Valproatum) and the drugs inducing liver enzymes
This mode of dosing is used in a combination, for example, with drugs
Phenytoinum, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir
0.6 mg/kg/days
(twice a day)
of 1.2 mg/kg/days
(twice a day)
of 5-15 mg/kg/days
(one or twice a day)
the Dose of drug can be increased at most by 1.2 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose – 400 mg a day
Combination therapy with other drugs which are not influencing liver enzymes
This mode of dosing is used at intake of other medications which do not have significant inhibiting effect on liver enzymes
of 0.3 mg/kg/days
(one or twice a day)
0.6 mg/kg/days
(one or twice a day)
1-10 mg/kg/days
(one or twice a day).
The dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose – 200 mg a day
Other drugs
At the children taking the anticonvulsant drugs which interaction with Lamiktalom® is unknown recommend to apply the same scheme of increase in doses as to the patients accepting Lamiktal® with sodium Valproatum.
* if the calculated daily dose at the patients accepting Valproatum, 1 – 2 mg/day, then is allowed reception of Ламиктала® 2 mg/days every other day within the first two weeks.
If the calculated daily dose at a combination with Valproatum is less than 1 mg in day, then Lamiktal® is not recommended to appoint.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
For providing the supporting therapeutic dose, it is necessary to control the weight of the child and to adjust a dosage at changes of weight.
If epileptic control is reached using additional treatment, the accompanying PEP can be cancelled and patients can continue treatment by means of monotherapy, with use of Lamiktala®.
Children are younger than 2 years
Lamiktal® is not recommended for use at children 2 years in view of lack of recommendations about drug dosing at this to an age group are younger.
There is a limited amount of data on efficiency and safety of a lamotrigin as additional therapy in partial attacks for children aged from 1 month up to 2 years. No data concerning children aged up to 1 month are provided.
Bipolar disorders
of Lamiktal® it is not applied to treatment of bipolar disorders at persons 18 years are younger.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
Table 3. The dosing mode in bipolar disorders at persons 18 years of age or over
Therapeutic
scheme 1-2nd of week
the 3-4th weeks
the 5th week
the Stabilizing dose
(from 6th week) *
Monoterapiya of Lamiktalom® or in a combination with the drugs which are not influencing metabolism of liver enzymes
of 25 mg/days
(once a day)
of 50 mg/days
(one or twice a day)
100 mg/days
(one or twice a day)
200 mg/days
(1 or 2 times a day)
In clinical trials were used by 100 - 400 mg/days
Combination therapy with Valproatum
of 12.5 mg/days
(to appoint on 25 mg every other day)
25 mg/days
(once a day)
50 mg/days
(one or twice a day)
100 mg/days
(1 or 2 times a day).
The maximum daily dose – 200 mg
Combination therapy with the anti-epileptic drugs inducing liver enzymes **
(except for Valproatum)
50 mg/days
(once a day)
100 mg/days
(twice a day)
200 mg/days
(twice a day)
300 mg (in two steps) on the 6th week of therapy.
If necessary - to increase a dose to 400 mg on the 7th week of therapy, accepted in two steps
* the Stabilizing dose changes depending on clinical effect
** for example: Phenytoinum, carbamazepine, phenobarbital, Primidonum and others
At the patients taking the anticonvulsant drugs which interaction with Lamiktalom® is unknown recommend to apply the same scheme of increase in doses as to the patients accepting Lamiktal® with sodium Valproatum.
As soon as the daily supporting stabilizing dose is reached, other psychotropic drugs can be cancelled (see tab. 4).
Table 4. The stabilizing daily dose of Lamiktala® in bipolar disorders after cancellation of the accompanying psychotropic or anti-epileptic drugs
the Therapeutic
schemes Stabilizing Dose Accepted at the Moment Week 1
Week 2 Weeks 3 and further *
After Valproatum cancellation:
to double the stabilizing dose, without exceeding
100 mg/week.
100
mg/days 200 mg/days
to Keep a dose of 200 mg/days in two steps. *
200
mg/days 300 mg/days 400 mg/days
to Support a dose of 400 mg/days
After cancellation of PEP inducing liver enzymes (for example, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir), depending on an initial dose
of 400
mg/days 400 mg/days 300 mg/days 200 mg/days 300 mg/days 300 mg/days 225 mg/days 150 mg/days 200 mg/days 200 mg/days 150 mg/days 100 mg/days
After cancellation of other psychotropic drugs or PEP with the unknown nature of interaction with lamotridzhiny (for example, lithium, bupropion)
the Maintenance dose - 200 mg/days (in two steps)
(from 100 mg to 400 mg)
* if necessary a dose can be increased up to 400 mg/days
to the Patients taking the antiepileptic drugs which nature of interaction with lamotridzhiny is not known the same scheme of increase in doses, as is recommended at reception of Lamiktala® with Valproatum.
At cancellation of accompanying Lamiktalu® of drugs the former maintenance dose has to be kept.
In table 5 recommendations about dosing at bipolar disturbances in case of accession to monotherapy of Lamiktalom® of other drugs are provided.
Table 5. The scheme of dosing in bipolar disorders after accession to Lamiktalu® of other drugs
the Therapeutic
schemes Stabilizing Dose Accepted at the Moment Week 1
Week 2 Weeks 3 and further
Valproatum Accession, depending on an initial dose
of Ламиктала® 200
mg/days 100 mg/days
to Keep a dose
(100 mg/days)
of 300
mg/days 150 mg/days
to Keep a dose
(150 mg/days)
of 400
mg/days 200 mg/days
to Keep a dose
(200 mg/days)
Accession of PEP (except for Valproatum) and the drugs inducing liver enzymes (for example, Phenytoinum, carbamazepine, Phenobarbitonum, Primidonum and others), depending on an initial dose
of Ламиктала® 200
mg/days 200 mg/days 300 mg/days 400 mg/days 150 mg/days 150 mg/days 225 mg/days 300 mg/days 100 mg/days 100 mg/days 150 mg/days 200 mg/days
Accession of other medications which do not have significant inhibiting effect on liver enzymes
the same scheme of increase in doses, as is recommended to Keep a maintenance dose of 200 mg/days in two steps (from 100 mg to 400 mg) to the Patients taking the antiepileptic drugs which nature of interaction with lamotridzhiny is not known at reception of Lamiktala® with Valproatum.
Cancellation of Lamiktala® at bipolar disturbances
Sharp cancellation of Lamiktala® does not cause increase in frequency of occurrence or weight of side reactions in comparison with placebo. Patients can cancel Lamiktal® at once, without gradual decrease in its dose.
The general recommendations about dosing of Lamiktala® at special groups of patients
of the Woman accepting hormonal contraceptives
Use of a combination of ethinylestradiol / levonorgestrel (30 mg / 150 mkg) are increased by clearance of a lamotrigin almost twice that leads to decrease in level of a lamotrigin. After titration, maintenance of higher doses of a lamotrigin (twice higher) can be necessary for achievement of the maximum therapeutic effect. At cancellation of contraceptive tablets within a week, increase in level of a lamotrigin was observed twice. The adverse phenomena connected with a dosage cannot be excluded. Thus, attention has to be paid to use of a method of contraception without existence of week of a break in administration of drug, as the first line of therapy (for example, continuous hormonal contraceptives, or non-hormonal methods).
The beginning of reception of hormonal contraception at the patients who are receiving treatment by maintenance doses of Lamiktala® and not using drugs, inducing liver enzymes
the Maintenance dose of Lamiktala® in most cases it has to be increased twice. From the moment of the beginning of reception of contraceptives it is recommended to increase a dose of a lamotrigin by 50-100 mg/days every week according to the individual clinical answer. Doses should not exceed the recommended limits in case of the adequate clinical response to the carried-out therapy.
Measurement of concentration of a lamotrigin in serum, till the beginning of use of hormonal contraceptives, can be considered confirmation that basic concentration of a lamotrigin is maintained now. If necessary, the dose has to be adapted. At the women accepting hormonal contraceptives which include one week of inactive treatment (week without use of tablets) control of level of a lamotrigin in serum it has to be carried out within the 3rd week of active treatment, i.e. in days from 15 on 21 cycles of reception of tablets. Thus, attention has to be paid to use of contraceptive means without existence of week without reception of tablets, as the first line of therapy (for example, continuous hormonal contraceptives, or non-hormonal methods)
the Termination of reception of hormonal contraceptives at the patients who are receiving treatment by maintenance doses of Lamiktala® and not using the drugs inducing liver enzymes
the Maintenance dose of Lamiktala® in most cases has to be reduced by 50% according to the individual clinical answer. It is recommended to lower a drug dose by 50-100 mg every week for 3 weeks, before achievement of the optimum clinical answer.
Measurement of concentration of a lamotrigin in serum before phase-out of hormonal contraceptives, it is possible to consider confirmation that basic concentration of a lamotrigin is maintained now. At women who wish to stop reception of hormonal contraceptives which include one week of inactive treatment (Week without tablets) the control of level of a lamotrigin in serum has to be carried out within the 3rd week of active treatment, i.e. in days from 15 on 21 cycles of reception of tablets. It is not necessary to collect samples for assessment of levels of a lamotrigin after the constant termination of contraceptive tablets within the first week after a stop in reception of tablets.
The beginning of therapy of Lamiktalom® by the women who are already accepting hormonal contraceptives prior to treatment
Increase in a dose should be supported according to the normal recommended dose described in the above-stated tables.
The beginning and the termination of reception of hormonal contraceptives by patients which already accept maintenance doses of Lamiktala® and also ACCEPT inductors of a glyukuronidation of a lamotrigin
Correction of the recommended maintenance dose of a lamotrigin is not required.
Combined use with atazanavirom/ritonaviry
In spite of the fact that atazanavir/ritonavir reduces plasma concentration of a lamotrigin, is not present need to adjust the recommended dose of Lamiktala® and to change the schemes of treatment shown at monotherapy or combination therapy.
At the patients who are already accepting a maintenance dose of Lamiktala® without glyukuronization inductors when assigning an atazanavira/ritonavir the increase in a dose of a lamotrigin or its reduction in case of cancellation of an atazanavira/ritonavir can be required.
Combined use with lopinaviry / ritonaviry
Is not present need to adjust the recommended dose of a lamotrigin at addition to the existing therapy lopinaviry / ritonaviry.
At the patients who are already accepting maintenance doses of a lamotrigin and not accepting glyukuronidation inductors, the dose of Lamiktala® has to be increased if lopinavir / ритонавир it is added, or is reduced if use of a lopinavira/ritonavir is stopped. Monitoring of a lamotrigin in plasma should be carried out to and within 2 weeks after addition, or cancellation of a lopinavira/ritonavir to reveal, need of correction of a dose of Lamiktala®.
Resuming of administration of drug of Lamiktal®
When resuming therapy by the drug Lamiktal® the attending physician has to estimate carefully need of increase in a maintenance dose at the patients who stopped administration of drug for any reasons in connection with risk of developing skin rashes of heavy degree when assigning high initial doses of drug. It must be kept in mind that than the bigger interval is available between the last and expected administration of drug, especially assessment of the appointed maintenance dose has to be careful. If having rummaged in reception exceeds the indicator equal to five elimination half-life of a lamotrigin (more than 150 hours) it is recommended to begin reception with that maintenance dose which was established before cancellation.
Administration of drug of Lamiktal® should not be resumed if treatment was cancelled because of development of rash if the expected advantage of reception does not exceed possible risks.
Patients of advanced age (65 years are more senior)
Change of the scheme of drug dosing is not required.
The Initial, increasing and supporting doses
to Develop an abnormal liver function
of Lamiktal® medicine
the Trade name
of Lamiktal®
the International unlicensed
name Lamotrigin Lekarstvennaya a form
chewable tablets of 5 mg, 25 mg, 50 mg, 100 mg
Structure
active agent - lamotrigin 5 mg, 25 mg, 50 mg or 100 mg,
excipients: calcium the carbonate, the hydroxypropyl cellulose low-substituted of magnesium aluminum silicate, sodium of starch glikolit, type A, K30 povidone, saccharin of sodium, magnesium stearate, fragrance of blackcurrant 502.009/AP 0551
the Description
of the Tablet of 5 mg
White or almost white tablets with a smell of the blackcurrant extended a biconvex form with an engraving 5 on one party and GS CL2 - on another. Small impregnations can be noted.
Tablets of 25 mg
White or almost white tablets with a smell of blackcurrant, square shape with the rounded-off corners and an engraving 25 on one party and GSCL5 - on another. Small impregnations can be noted.
Tablets of 50 mg
White or almost white tablets with a smell of blackcurrant, square shape with the rounded-off corners and an engraving 50 on one party and GSCX7 - on another. Small impregnations can be noted.
Tablets of 100 mg
White or almost white tablets with a smell of blackcurrant, square shape with the rounded-off corners and an engraving 100 on one party and GSCL7 - on another. Small impregnations can be noted.
Pharmacotherapeutic group
Antiepileptic drugs. Antiepileptic drugs others. Lamotrigin.
The ATX N03AX09 code
the Pharmacological
Lamotrigin Pharmacokinetics Absorption properties is quickly and completely soaked up from intestines. The maximum concentration in plasma is reached approximately in 2.5 h after administration of drug inside. Time of achievement of the maximum concentration slightly increases after meal, but the level of absorption remains invariable. The pharmacokinetics has linear character at reception in a dose to 450 mg.
Distribution
Extent of linking of a lamotrigin with proteins of plasma - about 55% that proves the small probability of influence on toxicity of drug in connection with substitution of plasma proteins. Distribution volume – 0.92-1.22 l/kg.
Metabolism
takes part In metabolism of a lamotrigin enzyme glucuronosyltransferase. Lamotrigin can strengthen somewhat own metabolism depending on a dose. Nevertheless, it was not revealed influences of a lamotrigin on pharmacokinetics of other antiepileptic drugs, and interaction between lamotridzhiny and other drugs which are metabolized by means of the system of P450 cytochrome it is improbable.
Removal
At adults clearance of a lamotrigin averages 30 ml/min. (39±14 ml/min.). Lamotrigin is metabolized to glucuronides which are removed with urine. Less than 10% of drug are allocated with urine in not changed look, about 2% – with excrements. The clearance and elimination half-life do not depend on a dose. Elimination half-life (T1/2) of a lamotrigin averages 33 hours (from 24 to 35 hours) and depends on the accompanying administration of drugs. So, elimination half-life decreases till 14 o'clock at joint appointment with carbamazepine and Phenytoinum and increases till 70 o'clock at joint appointment with Valproatum.
In a research of patients with Gilbert's syndrome it is established that the average clearance decreased by 32% in comparison with control, but values were within range for population in general.
Children
the Clearance of a lamotrigin calculated on body weight are higher at children, than at adults, it is highest at children up to 5 years. At children the elimination half-life of a lamotrigin is usually shorter, than at adults. So, average rates are about 7 hours at joint appointment about enzyme - the inducing drugs, such as carbamazepine and Phenytoinum, and 45-50 hours – when assigning with Valproatum.
Patients of advanced age
point the Available data to lack of significant differences in clearance of a lamotrigin at patients of advanced age in comparison with young patients.
Patients with a renal failure
and the patients who are on a hemodialysis make Average values of clearance of a lamotrigin for patients with chronic kidney disease 0.42 ml/min. (chronic kidney disease), 0.33 ml/min. (between hemodialysis sessions) and 1.57 ml/min. (during a hemodialysis). Average elimination half-life makes 42.9 hours, 57.4 hours and 13.0 hours respectively in comparison with 26.2 hours at patients with normal function of kidneys. During the 4-hour session of a hemodialysis about 20% (5.6 - 35.1%) of a lamotrigin are brought out of an organism. Thus, in a renal failure the initial dose of a lamotrigin is calculated according to the standard scheme of prescribing of antiepileptic drug.
Patients with an abnormal liver function
Average values of clearance of a lamotrigin at patients with an abnormal liver function of easy, average and heavy degree (stages of A, B and C on a scale of Chayld-Pyyu) make 0.31, 0.24 and 0.10 ml/min. respectively in comparison with 0:34 ml/min. at patients with normal function of a liver.
Generally, doses of a lamotrigin have to be reduced by 50% at patients with average degree of a liver failure and for 75% - at patients with heavy degree of a liver failure. The initial and increasing doses have to be adjusted depending on the clinical response to the carried-out therapy.
The pharmacodynamics
of Lamiktal® is a blocker potential - dependent natrium channels of presynaptic membranes of neurons. Ламиктал® suppresses the steady repeating activization of neurons and inhibits release of a glutamate – the neurotransmitter playing a key role in development of epileptic seizures.
The mechanisms providing therapeutic action of a lamotrigin in bipolar disorders were not installed. Interaction with tension of natrium channels is supposed.
Indications
Epilepsy
Adults and children are more senior than 13 years:
- in monotherapy or as a part of the combined treatment of partial and generalized attacks, including toniko-clonic spasms
- the spasms connected with Lennox-Gasto's syndrome: as a part of auxiliary therapy, or as basic antiepileptic means in case of initial manifestations of a syndrome of Lennox-Gasto.
Children and teenagers from 2 to 12 years:
- as a part of combination therapy of partial and generalized attacks, including the toniko-clonic spasms and spasms connected with Lennox's syndrome – Gasto. After achievement of control of epilepsy by means of combination therapy, other antiepileptic drugs can be cancelled and treatment can continue in the monotherapy mode the drug Lamiktal®
- monotherapy of typical absentias epileptica
Bipolar disorders
- at patients 18 years with mainly depressive phases (prevention of a depression, mania, hypomanias, the mixed pathologies) are more senior.
Ламиктал® it is not shown for treatment of an acute mania, or depressive episodes.
The route of administration and doses
the Lamiktal® Chewable tablets can be chewed, dissolved in the small volume of water (sufficient to cover all tablet) or to swallow entirely, washing down with water.
Monoterapiya's epilepsy at adults and children is more senior than 13 years
the Initial maximum daily dose of Lamiktala® at monotherapy makes 25 mg within 2 weeks once a day, further a dose it is necessary to increase a maximum by 50-100 mg each 1-2 weeks, before achievement of optimum therapeutic effect and an optimum maintenance dose. The standard maintenance dose makes 100-200 mg the day accepted in one or two receptions. To some patients for achievement of therapeutic effect the required dose of Lamiktala® makes 500 mg/days.
Combination therapy at adults and children is more senior than 13 years
Therapy of Lamiktalom® and Valproatum in combination with other antiepileptic drugs (PEP) or without them
For patients who already receive Valproatum in combination with other PEP or without them, the initial dose of Lamiktala® makes 25 mg every other day within 2 weeks, further - on 25 mg within 2 weeks once a day. Then the dose should be increased as much as possible by 25-50 mg/days each 1-2 weeks before achievement of optimum therapeutic effect. The standard maintenance dose makes 100-200 mg the day accepted in one or two receptions.
Therapy of Lamiktalom® in combination with other anti-epileptic drugs (except for Valproatum) and the drugs inducing liver enzymes (for example, Phenytoinum, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir)
the Initial dose of Lamiktala® makes 50 mg within 2 weeks, further once a day – 100 mg/days divided into two receptions within 2 weeks. Then the dose increases at most by 100 mg each 1-2 weeks, before achievement of optimum therapeutic effect. The standard maintenance dose makes 200-400 mg a day, accepted in two steps. The dose of 700 mg/days can be required by some patients for achievement of therapeutic effect.
Therapy of Lamiktalom® in combination with other medications which do not have significant inhibiting effect on liver enzymes
the Initial dose of Lamiktala® makes 25 mg within 2 weeks, further once a day – 50 mg/days within 2 weeks. Then a dose it is necessary to increase a maximum by 50-100 mg each 1-2 weeks, before achievement of optimum therapeutic effect. The dose of drug can be increased at most by 50-100 mg each 1-2 weeks before achievement of an optimum maintenance dose. The standard maintenance dose makes 100-200 mg the day accepted in one or two receptions.
Table 1. The mode of dosing Lamiktala® in treatment of epilepsy at adults and children is more senior than 13 years
Therapeutic
scheme 1+2nd of week
the 3+4th week
the Standard maintenance dose
of Monoterapiya
of 25 mg/days
(once a day)
of 50 mg/days
(once a day)
of 100 - 200 mg/days
(one or twice a day)
the Dose increases by 50-100 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Combination therapy with Valproatum
This mode of dosing is used in a combination by Valproatum, irrespective of intake of other medicines
of 12.5 mg/days
(or on 25 mg every other day)
25 mg/days
(once a day)
of 100 - 200 mg/days
(one or twice a day)
the Dose increases by 25-50 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Combination therapy with other anti-epileptic drugs (except for Valproatum) and the drugs inducing liver enzymes
Combination therapy
(Phenytoinum, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir)
50 mg/days
(once a day)
of 100 mg/days
(twice a day)
of 200 - 400 mg/days
(twice a day)
the Dose increases by 100 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Combination therapy with other drugs which are not influencing liver enzymes
This mode of dosing is used at intake of other medications which do not have significant inhibiting effect on liver enzymes
of 25 mg/days
(once a day)
of 50 mg/days
(once a day)
of 100 - 200 mg/days
(one or twice a day)
the Dose increases by 50-100 mg each 1-2 weeks before achievement of an optimum maintenance dose.
Other drugs
At the patients taking the anticonvulsant drugs which interaction with Lamiktalom® is unknown recommend to apply the same scheme of increase in doses as to the patients accepting Lamiktal® with sodium Valproatum.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
Children from 2 to 12 years
the Dose of Lamiktala® depends on the child's weight.
Monotherapy of Lamiktalom® of typical absentias epileptica
the Initial dose of Lamiktala® makes 0.3 mg/kg/day, accepted in one or two receptions within 2 weeks, further - 0.6 mg/kg/day, also in one or two receptions within the next 2 weeks. The dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose. The standard maintenance dose makes 1-10 mg/kg a day, accepted in one or in two steps.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
Combination therapy of epilepsy at children from 2 to 12 years
Therapy of Lamiktalom® and Valproatum in combination with other anti-epileptic drugs or without them
the Initial dose of Lamiktala® makes 0.15 mg/kg within 2 weeks, further once a day - 0.3 mg/kg a day in one step within 2 weeks. Then the dose has to be increased as much as possible by 0.3 mg/kg each 1-2 weeks, before achievement of optimum therapeutic effect, the standard maintenance dose at the same time makes 1-5 mg/kg a day in one or in two steps. The maximum daily dose - 200 mg/days.
Therapy of Lamiktalom® with other anti-epileptic drugs (except for Valproatum) and the medicines inducing liver enzymes
the Initial dose of Lamiktala® makes 0.6 mg/kg a day, accepted in two steps within 2 weeks, further – 1.2 mg/kg of body weight a day in two steps within 2 weeks. Then it is necessary to increase a dose by 1.2 mg/kg each 1-2 weeks, before achievement of optimum therapeutic effect. The standard maintenance dose makes 5-15 mg/kg a day in two steps. The maximum daily dose - 400 mg/days.
Therapy of Lamiktalom® in combination with other medications which do not have significant inhibiting effect on liver enzymes
the Initial dose of Lamiktala® makes 0.3 mg/kg/day, accepted in one or two receptions within 2 weeks, further - 0.6 mg/kg/day, also in one or two receptions within the next 2 weeks. The dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose. The standard maintenance dose makes 1-10 mg/kg a day, accepted in one or in two steps. The maximum daily dose - 200 mg/days.
For children aged from 2 up to 6 years when assigning a maintenance dose the use of the maximum doses in the recommended dosing limits is recommended.
Table 2. The mode of dosing Lamiktala® in treatment of epilepsy at children from 2 to 12 years
Therapeutic
scheme 1+2nd of week
the 3+4th weeks
the Standard maintenance dose
of Monoterapiya of typical absentias epileptica
of 0.3 mg/kg/days
(one or twice a day)
0.6 mg/kg/days
(one or twice a day)
1-10 mg/kg/days
(one or twice a day)
the Dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose –
200 mg a day
Combination therapy with Valproatum
This mode of dosing is used in a combination by Valproatum, irrespective of intake of other medicines
of 0.15 mg/kg/days *
(once a day)
0.3 mg/kg/days
(once a day)
of 1-5 mg/kg/days
(one or twice a day)
the Dose of drug can be increased at most by 0.3 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose – 200 mg a day
Combination therapy with other anti-epileptic drugs (except for Valproatum) and the drugs inducing liver enzymes
This mode of dosing is used in a combination, for example, with drugs
Phenytoinum, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir
0.6 mg/kg/days
(twice a day)
of 1.2 mg/kg/days
(twice a day)
of 5-15 mg/kg/days
(one or twice a day)
the Dose of drug can be increased at most by 1.2 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose – 400 mg a day
Combination therapy with other drugs which are not influencing liver enzymes
This mode of dosing is used at intake of other medications which do not have significant inhibiting effect on liver enzymes
of 0.3 mg/kg/days
(one or twice a day)
0.6 mg/kg/days
(one or twice a day)
1-10 mg/kg/days
(one or twice a day).
The dose of drug can be increased at most by 0.6 mg/kg/day each 1-2 weeks before achievement of an optimum maintenance dose.
The maximum daily dose – 200 mg a day
Other drugs
At the children taking the anticonvulsant drugs which interaction with Lamiktalom® is unknown recommend to apply the same scheme of increase in doses as to the patients accepting Lamiktal® with sodium Valproatum.
* if the calculated daily dose at the patients accepting Valproatum, 1 – 2 mg/day, then is allowed reception of Ламиктала® 2 mg/days every other day within the first two weeks.
If the calculated daily dose at a combination with Valproatum is less than 1 mg in day, then Lamiktal® is not recommended to appoint.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
For providing the supporting therapeutic dose, it is necessary to control the weight of the child and to adjust a dosage at changes of weight.
If epileptic control is reached using additional treatment, the accompanying PEP can be cancelled and patients can continue treatment by means of monotherapy, with use of Lamiktala®.
Children are younger than 2 years
Lamiktal® is not recommended for use at children 2 years in view of lack of recommendations about drug dosing at this to an age group are younger.
There is a limited amount of data on efficiency and safety of a lamotrigin as additional therapy in partial attacks for children aged from 1 month up to 2 years. No data concerning children aged up to 1 month are provided.
Bipolar disorders
of Lamiktal® it is not applied to treatment of bipolar disorders at persons 18 years are younger.
In order to avoid appearance of rash the initial dose and the subsequent doses should not exceed recommended.
Table 3. The dosing mode in bipolar disorders at persons 18 years of age or over
Therapeutic
scheme 1-2nd of week
the 3-4th weeks
the 5th week
the Stabilizing dose
(from 6th week) *
Monoterapiya of Lamiktalom® or in a combination with the drugs which are not influencing metabolism of liver enzymes
of 25 mg/days
(once a day)
of 50 mg/days
(one or twice a day)
100 mg/days
(one or twice a day)
200 mg/days
(1 or 2 times a day)
In clinical trials were used by 100 - 400 mg/days
Combination therapy with Valproatum
of 12.5 mg/days
(to appoint on 25 mg every other day)
25 mg/days
(once a day)
50 mg/days
(one or twice a day)
100 mg/days
(1 or 2 times a day).
The maximum daily dose – 200 mg
Combination therapy with the anti-epileptic drugs inducing liver enzymes **
(except for Valproatum)
50 mg/days
(once a day)
100 mg/days
(twice a day)
200 mg/days
(twice a day)
300 mg (in two steps) on the 6th week of therapy.
If necessary - to increase a dose to 400 mg on the 7th week of therapy, accepted in two steps
* the Stabilizing dose changes depending on clinical effect
** for example: Phenytoinum, carbamazepine, phenobarbital, Primidonum and others
At the patients taking the anticonvulsant drugs which interaction with Lamiktalom® is unknown recommend to apply the same scheme of increase in doses as to the patients accepting Lamiktal® with sodium Valproatum.
As soon as the daily supporting stabilizing dose is reached, other psychotropic drugs can be cancelled (see tab. 4).
Table 4. The stabilizing daily dose of Lamiktala® in bipolar disorders after cancellation of the accompanying psychotropic or anti-epileptic drugs
the Therapeutic
schemes Stabilizing Dose Accepted at the Moment Week 1
Week 2 Weeks 3 and further *
After Valproatum cancellation:
to double the stabilizing dose, without exceeding
100 mg/week.
100
mg/days 200 mg/days
to Keep a dose of 200 mg/days in two steps. *
200
mg/days 300 mg/days 400 mg/days
to Support a dose of 400 mg/days
After cancellation of PEP inducing liver enzymes (for example, carbamazepine, phenobarbital, Primidonum, rifampicin, lopinavir/ritonavir), depending on an initial dose
of 400
mg/days 400 mg/days 300 mg/days 200 mg/days 300 mg/days 300 mg/days 225 mg/days 150 mg/days 200 mg/days 200 mg/days 150 mg/days 100 mg/days
After cancellation of other psychotropic drugs or PEP with the unknown nature of interaction with lamotridzhiny (for example, lithium, bupropion)
the Maintenance dose - 200 mg/days (in two steps)
(from 100 mg to 400 mg)
* if necessary a dose can be increased up to 400 mg/days
to the Patients taking the antiepileptic drugs which nature of interaction with lamotridzhiny is not known the same scheme of increase in doses, as is recommended at reception of Lamiktala® with Valproatum.
At cancellation of accompanying Lamiktalu® of drugs the former maintenance dose has to be kept.
In table 5 recommendations about dosing at bipolar disturbances in case of accession to monotherapy of Lamiktalom® of other drugs are provided.
Table 5. The scheme of dosing in bipolar disorders after accession to Lamiktalu® of other drugs
the Therapeutic
schemes Stabilizing Dose Accepted at the Moment Week 1
Week 2 Weeks 3 and further
Valproatum Accession, depending on an initial dose
of Ламиктала® 200
mg/days 100 mg/days
to Keep a dose
(100 mg/days)
of 300
mg/days 150 mg/days
to Keep a dose
(150 mg/days)
of 400
mg/days 200 mg/days
to Keep a dose
(200 mg/days)
Accession of PEP (except for Valproatum) and the drugs inducing liver enzymes (for example, Phenytoinum, carbamazepine, Phenobarbitonum, Primidonum and others), depending on an initial dose
of Ламиктала® 200
mg/days 200 mg/days 300 mg/days 400 mg/days 150 mg/days 150 mg/days 225 mg/days 300 mg/days 100 mg/days 100 mg/days 150 mg/days 200 mg/days
Accession of other medications which do not have significant inhibiting effect on liver enzymes
the same scheme of increase in doses, as is recommended to Keep a maintenance dose of 200 mg/days in two steps (from 100 mg to 400 mg) to the Patients taking the antiepileptic drugs which nature of interaction with lamotridzhiny is not known at reception of Lamiktala® with Valproatum.
Cancellation of Lamiktala® at bipolar disturbances
Sharp cancellation of Lamiktala® does not cause increase in frequency of occurrence or weight of side reactions in comparison with placebo. Patients can cancel Lamiktal® at once, without gradual decrease in its dose.
The general recommendations about dosing of Lamiktala® at special groups of patients
of the Woman accepting hormonal contraceptives
Use of a combination of ethinylestradiol / levonorgestrel (30 mg / 150 mkg) are increased by clearance of a lamotrigin almost twice that leads to decrease in level of a lamotrigin. After titration, maintenance of higher doses of a lamotrigin (twice higher) can be necessary for achievement of the maximum therapeutic effect. At cancellation of contraceptive tablets within a week, increase in level of a lamotrigin was observed twice. The adverse phenomena connected with a dosage cannot be excluded. Thus, attention has to be paid to use of a method of contraception without existence of week of a break in administration of drug, as the first line of therapy (for example, continuous hormonal contraceptives, or non-hormonal methods).
The beginning of reception of hormonal contraception at the patients who are receiving treatment by maintenance doses of Lamiktala® and not using drugs, inducing liver enzymes
the Maintenance dose of Lamiktala® in most cases it has to be increased twice. From the moment of the beginning of reception of contraceptives it is recommended to increase a dose of a lamotrigin by 50-100 mg/days every week according to the individual clinical answer. Doses should not exceed the recommended limits in case of the adequate clinical response to the carried-out therapy.
Measurement of concentration of a lamotrigin in serum, till the beginning of use of hormonal contraceptives, can be considered confirmation that basic concentration of a lamotrigin is maintained now. If necessary, the dose has to be adapted. At the women accepting hormonal contraceptives which include one week of inactive treatment (week without use of tablets) control of level of a lamotrigin in serum it has to be carried out within the 3rd week of active treatment, i.e. in days from 15 on 21 cycles of reception of tablets. Thus, attention has to be paid to use of contraceptive means without existence of week without reception of tablets, as the first line of therapy (for example, continuous hormonal contraceptives, or non-hormonal methods)
the Termination of reception of hormonal contraceptives at the patients who are receiving treatment by maintenance doses of Lamiktala® and not using the drugs inducing liver enzymes
the Maintenance dose of Lamiktala® in most cases has to be reduced by 50% according to the individual clinical answer. It is recommended to lower a drug dose by 50-100 mg every week for 3 weeks, before achievement of the optimum clinical answer.
Measurement of concentration of a lamotrigin in serum before phase-out of hormonal contraceptives, it is possible to consider confirmation that basic concentration of a lamotrigin is maintained now. At women who wish to stop reception of hormonal contraceptives which include one week of inactive treatment (Week without tablets) the control of level of a lamotrigin in serum has to be carried out within the 3rd week of active treatment, i.e. in days from 15 on 21 cycles of reception of tablets. It is not necessary to collect samples for assessment of levels of a lamotrigin after the constant termination of contraceptive tablets within the first week after a stop in reception of tablets.
The beginning of therapy of Lamiktalom® by the women who are already accepting hormonal contraceptives prior to treatment
Increase in a dose should be supported according to the normal recommended dose described in the above-stated tables.
The beginning and the termination of reception of hormonal contraceptives by patients which already accept maintenance doses of Lamiktala® and also ACCEPT inductors of a glyukuronidation of a lamotrigin
Correction of the recommended maintenance dose of a lamotrigin is not required.
Combined use with atazanavirom/ritonaviry
In spite of the fact that atazanavir/ritonavir reduces plasma concentration of a lamotrigin, is not present need to adjust the recommended dose of Lamiktala® and to change the schemes of treatment shown at monotherapy or combination therapy.
At the patients who are already accepting a maintenance dose of Lamiktala® without glyukuronization inductors when assigning an atazanavira/ritonavir the increase in a dose of a lamotrigin or its reduction in case of cancellation of an atazanavira/ritonavir can be required.
Combined use with lopinaviry / ritonaviry
Is not present need to adjust the recommended dose of a lamotrigin at addition to the existing therapy lopinaviry / ritonaviry.
At the patients who are already accepting maintenance doses of a lamotrigin and not accepting glyukuronidation inductors, the dose of Lamiktala® has to be increased if lopinavir / ритонавир it is added, or is reduced if use of a lopinavira/ritonavir is stopped. Monitoring of a lamotrigin in plasma should be carried out to and within 2 weeks after addition, or cancellation of a lopinavira/ritonavir to reveal, need of correction of a dose of Lamiktala®.
Resuming of administration of drug of Lamiktal®
When resuming therapy by the drug Lamiktal® the attending physician has to estimate carefully need of increase in a maintenance dose at the patients who stopped administration of drug for any reasons in connection with risk of developing skin rashes of heavy degree when assigning high initial doses of drug. It must be kept in mind that than the bigger interval is available between the last and expected administration of drug, especially assessment of the appointed maintenance dose has to be careful. If having rummaged in reception exceeds the indicator equal to five elimination half-life of a lamotrigin (more than 150 hours) it is recommended to begin reception with that maintenance dose which was established before cancellation.
Administration of drug of Lamiktal® should not be resumed if treatment was cancelled because of development of rash if the expected advantage of reception does not exceed possible risks.
Patients of advanced age (65 years are more senior)
Change of the scheme of drug dosing is not required.
The Initial, increasing and supporting doses
to Develop an abnormal liver function
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