Tablets: from yellowy-brown till pale yellow color, square shape with the rounded-off corners, on the flat party the text of "GSEC7", "GSEE1" or "GSEE5", on many-sided – a convex square with an engraving "25", "50" or "100" respectively is squeezed out (on 10 pieces in blisters, in a cardboard pack 3 blisters);
Tablets soluble or chewing: white or almost white color with insignificant impregnations, with a blackcurrant smell; on tablets of the extended biconvex form the engraving on one party "GS CL2", is applied on another – "5", on square with the rounded corners – on one party there is a convex square with an engraving "25" or "100", on another – "GS CL5" or "GS CL7" respectively (on 10 pieces in blisters, in a box 3 blisters).

Active ingredient of Lamiktal – ламотриджин:

1 tablet: 25 mg, 50 mg or 100 mg;
1 tablet soluble or chewing: 5 mg, 25 mg or 100 mg.

Auxiliary components:

Tablets: cellulose microcrystallic, lactoses monohydrate, carboxymethylstarch of sodium, magnesium stearate, povidone, ferrous oxide yellow (E172);
Tablets soluble or chewing: the hydroxypropyl cellulose low-replaced calcium a carbonate, aluminum-magnesium silicate, K30 povidone, starch sodium glycollate type A, saccharin of sodium, magnesium stearate, blackcurrant fragrance 500.009/AP 0551.

Indications to use

Lamiktal's use is shown at treatment of epilepsy:

Patients are more senior than 12 years: monotherapy and as a part of the combined treatment of partial and generalized attacks, including toniko-clonic spasms, attacks at Lennox-Gasto's syndrome;
Children of 3-12 years: a combination therapy of partial and generalized attacks, including toniko-clonic spasms, attacks at Lennox-Gasto's syndrome (after achievement of clinical control of epilepsy of the patient it is possible to transfer to monotherapy lamotridzhiny); monotherapy of typical absentias epileptica.

Besides, the patient 18 years with bipolar affective disorders drug are more senior appoint for the prevention of disturbances of mood (a hypomania, a mania, a depression, the mixed episodes).

Contraindications

Treatment of bipolar disorders at patients is younger than 18 years;
Hypersensitivity to drug components.

With care it is necessary to appoint Lamiktal at a renal failure.

Purpose of a lamotridzhin during pregnancy and breastfeeding is possible, only if the expected advantage for mother exceeds potential risk for a fruit and the child. As the physiological changes developing in time of pregnancy can influence action of a lamotridzhin and/or reduce the level of its concentration, it is necessary to provide the therapy tactics corresponding to a condition of the patient.

Route of administration and dosage

Pill is taken inside, swallowing entirely, not breaking and without chewing. At compliance of the doses calculated taking into account body weight, to incomplete tablets it is necessary to take smaller quantity of the whole pill.

Soluble or chewable tablets before reception can be dissolved in the insignificant volume of water (sufficient for a tablet covering), to chew or swallow entirely, having washed down with water.

The mode of dosing and the period of use are appointed by the doctor on the basis of clinical indications.

The recommended dosing for patients is more senior than 12 years:

Monotherapy: an initial dose – on 25 mg of 1 times a day within 2 weeks, then on 50 mg of 1 times a day within 2 weeks. Further, for achievement of optimum clinical effect the dose should be raised on 50-100 mg every 1-2 week, sometimes to 500 mg a day. A maintenance dose – 100-200 mg a day, taken for 1-2 times;
Combination therapy with valproic acid and other antiepileptic means or without them: an initial dose – on 25 mg a day accepted every other day within 2 weeks then – on 25 mg of 1 times a day within 2 weeks. For achievement of optimum clinical effect the dose is increased by 25-50 mg with an interval of 1-2 weeks. A maintenance dose of Lamiktal – 100-200 mg a day for 1 or 2 receptions;
Combination therapy (without valproic acid) with Phenytoinum, carbamazepine, phenobarbital, Primidonum (the antiepileptic means inducing liver enzymes) and other antiepileptic drugs or without them: an initial dose – 50 mg of 1 times a day within 2 weeks, then – on 50 mg 2 times a day within 2 weeks. The dose is raised at an interval of 1-2 weeks no more than on 100 mg to achievement of desirable therapeutic effect, in certain cases to 700 mg a day. A maintenance dose – on 100-200 mg 2 times a day.

The recommended dosing for children from 2 to 12 years:

In combination with Valproatum and other antiepileptic medicines or without them: an initial dose – from calculation for 0,15 mg on 1 kg of weight of the child of 1 times a day within 2 weeks, then – on 0,3 mg on 1 kg of 1 times a day within 2 weeks. Further, the dose is increased by 0,3 mg on 1 kg of weight by each 1-2 weeks before optimum clinical effect. The supporting daily dose of 1-5 mg on 1 kg of weight of the child in 1-2 receptions, but no more than 200 mg a day;
In combination with the antiepileptic means inducing liver enzymes (carbamazepine, Primidonum, Phenytoinum, phenobarbital) in combination with other antiepileptic medicines or without them (except Valproatum): an initial daily dose – 0,6 mg on 1 kg of weight of the child in 2 receptions, duration – 2 weeks, then – on 1,2 mg on 1 kg of weight of the child in 2 receptions, duration – 2 weeks. The dose is increased by 1,2 mg on 1 kg of weight of the child by each 1-2 weeks before achievement of optimum therapeutic effect. The supporting daily dose – 5-15 mg on 1 kg of weight of the child in 2 receptions, but no more than 400 mg a day.

Correction of the mode of dosing should be carried out according to change of weight of the child. The maintenance dose for children of 2-6 years can correspond to the upper bound of the recommended doses.

Side effects

Nervous system: often – fatigue, irritability, a headache, uneasiness, drowsiness, dizziness, sleeplessness, balance disturbance, a nystagmus, an ataxy, a tremor; sometimes – aggression; seldom – hallucinations, tics, confusion of consciousness, excitement, a choreoathetosis, motive and/or extrapyramidal frustration, increase of convulsive attacks;
Dermatological reactions: often – skin rash (usually spotty and papular, passing, appears during the first two months of therapy); seldom – a toxic epidermal necrolysis (Lyell's disease), a multiformny exudative erythema (including Stephens-Johnson's syndrome);
Alimentary system: often – dysfunctions of digestive tract (nausea, vomiting, diarrhea); seldom – functional disorder of a liver, increase in indicators of hepatic tests, a liver failure;
Hemopoietic and lymphatic systems: seldom – anemia, a neutropenia, a pancytopenia, a leukopenia, aplastic anemia, thrombocytopenia, an agranulocytosis;
Skeletal and muscular system: often – back pains, an arthralgia; seldom – a volchanochnopodobny syndrome;
Immune system: seldom – a hypersensitivity syndrome (fever, a face edema, a lymphadenopathy, hematologic disturbances, a trombogemorragichesky syndrome, damage of a liver, multiorgan insufficiency);
Organ of sight: often – a sight illegibility, a diplopia, conjunctivitis;
Others: at sharp cancellation of Lamiktal – increase of attacks against the background of development of a withdrawal; it can be noted (at insufficient clinical effect, including at the epileptic status) – multiorgan dysfunction, рабдомиолиз, the disseminated intravascular blood coagulation up to a lethal outcome.

Special instructions

In case of lack of the obvious reason of emergence of fever and a lymphadenopathy (against the background of absence of skin rash) administration of drug needs to be stopped, the patient needs immediate careful survey.

Skin rash is one of hypersensitivity syndrome symptoms, in rare instances its severity can lead to development of multiorgan insufficiency and a trombogemorragichesky syndrome.

Enanthesis is in most cases expressed slightly, passes independently and is not dozozavisimy effect (except a Lyell's disease and Stephens-Johnson).

Drug withdrawal should be made by a gradual dose decline within two weeks, except the cases demanding the urgent termination of therapy including emergence of skin rash.

Because of risk of development of skin rash, including the serious, demanding hospitalization cases to exceed the recommended mode of dosing or it is impossible to violate the scheme of therapy.

Being weak inhibitor of a digidrofolatreduktaza, at prolonged use Lamiktal can exert impact on metabolism of folates. Nevertheless, at therapy by duration till 1 year of serious changes in the level of maintenance of average volume of uniform elements in blood, hemoglobin, concentration of folates in serum or erythrocytes (with reception duration up to 5 years) does not occur.

Because of risk of accumulation of a glucuronide (a metabolite of a lamotridzhin) by the patient with a renal failure it is necessary to appoint drug with care.

Drug cannot be accepted without consultation of the doctor at simultaneous therapy by other antiepileptic means containing ламотриджин.

At purpose of a daily dose of 1-2 mg, about 2 mg within 2 first weeks are allowed to accept it every other day. Less than 1 mg it is not necessary to accept drug in a dose.

In pediatric practice children with initially established diagnosis as an initial method of treatment should not appoint monotherapy drug. Only after achievement by means of a combination therapy of anticonvulsant effect it is possible to cancel at the same time used antiepileptic drugs and to continue treatment by Lamiktal in the form of monotherapy.

It is necessary to consider a possibility of disturbance of pharmacokinetics of a lamotridzhin at change of the therapy connected with accession or cancellation of the accompanying antiepileptic means.

During Lamiktal's use by the patient it is necessary to abstain from potentially dangerous types of activity which performance demands the high speed of psychomotor reactions and concentration of attention.

Medicinal interaction

Phenytoinum, phenobarbital, carbamazepine, Primidonum (antiepileptic means), paracetamol accelerate metabolism and reduce twice time of disintegration of a half of all atoms _(T1/2) of a lamotridzhin.

Valproatum constrains metabolism of a lamotridzhin and prolongs its _T1/2 till 45-55 o'clock at children and till 70 o'clock at adults as it is competitively metabolized by liver enzymes.

Lamiktal's appointment to therapy by carbamazepine can make sick, dizziness, a diplopia, an ataxy, a sight illegibility (it is recommended to lower a carbamazepine dose for disappearance of undesirable effects).

Accession to reception of an anhydrous gluconate of lithium (on 2 g 2 times a day within 6 days) does not break lithium pharmacokinetics at a dose of a lamotridzhin of 100 mg a day.

After reception of one dose of a bupropion at its repeated use of essential change of pharmacokinetics of a lamotridzhin does not occur, except slight increase of AUC for a lamotridzhin of a glucuronide.