Lamotriks - instructions for use, dose, side effects, contraindications

Active substance: Lamotrigine	25 mg	50 mg	100 mg	200 mg
Excipients: Lactose Monohydrate	24.7 mg	49.4 mg	98.8 mg	197.6 mg
Microcrystalline cellulose	24.7 mg	49.4 mg	98.8 mg	197.6 mg
Sodium carboxymethyl starch	2.5 mg	5.0 mg	10.0 mg	20.0 mg
Pigment iron oxide yellow E 172	200 μg	400 μg	800 μg	1.6 mg
Povidone	2.5 mg	5.0 mg	10.0 mg	20.0 mg
Magnesium stearate	400 μg	800 μg	1.6 mg	3.2 mg

Description:Tablets 25 mg - round, flat pills of pale yellow color with a facet, engraving "MS" on one side.
Tablets 50 mg, 100 mg and 200 mg - round, flat pills of a pale yellow color with a facet and a risk.

Pharmacotherapeutic group:Antiepileptic agent.

ATX: & nbsp

N.03.A.X Other antiepileptic drugs

N.03.A.X.09 Lamotrigine

Pharmacodynamics:It blocks potential-dependent sodium channels of presynaptic neuronal membranes, suppressing the excess release of glutamic acid, a neurotransmitter,
which plays an important role in the development of epileptic seizures, and the spread of effector impulses associated with the latter.

Pharmacokinetics:Quickly and completely absorbed from the gastrointestinal tract (GIT). The maximum concentration (TC_max) in the plasma is achieved approximately 2-3 hours after taking the drug. An increase in the dose to 450 mg causes a directly proportional increase in its concentration in the plasma. The linearity of pharmacokinetics explains the absence of the need to control its concentration during the treatment. The time to reach the maximum concentration increases somewhat after eating, but the degree of absorption remains unchanged. Bioavailability - 98%, connection with plasma proteins - 55%. The volume of distribution is 0.92-1.22 l / kg.
Metabolized in the liver by glucuronidation (65% of metabolites - N-glucuronides).Does not change the enzymatic activity of the liver (does not significantly affect the metabolism of other drugs clinically); to some extent can strengthen its own metabolism (depending on the dose).
In adults, lamotrigine clearance is 25-53 ml / min, half-life (T_1/2) is 24-35 hours. It is excreted mainly by kidneys in the form of metabolite, in unchanged form - less than 10%, with feces - 2%. Lamotrigine clearance, calculated by body weight, in children (highest in children under 5 years) is higher than in adults. T_1/2 children are usually shorter than adults. Its mean value is 7 h with concurrent administration with glucuronin-inducing drugs (carbamazepine and phenytoin) and increases to an average of 45-55 hours with a co-administration with valproic acid.
In patients with moderate to severe degree of renal failure, doses should be adjusted.
It is excreted in breast milk in concentrations of 40-60% of that in plasma. In some infants who are breastfed, plasma concentrations have reached therapeutic levels.

Indications:- As a monotherapy or complementary therapy for the treatment of epilepsy in adults and children over 12 years of age (partial and generalized seizures,including clonic convulsions, as well as seizures associated with Lennox-Gastaut syndrome).
- As an additional therapy in the treatment of epilepsy in children from 3 to 12 years (partial and generalized seizures, including tonic-clonic convulsions, as well as seizures associated with Lennox-Gastaut syndrome). After achieving epilepsy control against the background of combined therapy, concomitant antiepileptic drugs (PEP) can be canceled, and lamotrigine is continued as monotherapy.
Monotherapy of typical absences.
- As a monotherapy or complementary therapy in the treatment of bipolar disorders in adults.

Contraindications:- hypersensitivity to lamotrigine or excipients,
- Children's age up to 3 years,
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption

Carefully:Chronic renal failure, chronic hepatic insufficiency.

Pregnancy and lactation:Lamotrigine should be administered during pregnancy only if the expected therapeutic benefit for the mother exceeds the potential risk to the fetus.There are reports that when taking lamotrigine during the first months of pregnancy, the risk of developing the cleft lip and the upper palate in the fetus increases. Interruption of treatment without consulting a doctor is not recommended, as a sudden discontinuation of the drug may lead to the resumption of seizures.
Studies in animals have not revealed a decrease in fertility due to lamotrigine. However, it is noted that lamotrigine reduces the concentration of folic acid in the embryo of rats. Deficiency of folate is believed to increase the risk of congenital malformation, both in animals and in humans.
Physiological changes that develop during pregnancy can affect the concentration of lamotrigine and / or its therapeutic effect. There are reports of a decrease in the concentration of lamotrigine during pregnancy. Lamotrigine is excreted in breast milk and is determined in breast milk in concentrations of 40-60% of its concentration in the mother's plasma. For the duration of lamotrigine treatment, breastfeeding should be discontinued.

Dosing and Administration:Inside, not liquid, squeezed a little water.If the calculated dose of lamotrigine (for example, when administered to children or patients with impaired liver function) can not be divided into a whole number of lower dosage tablets, then the patient should be given a dose that corresponds to the nearest value of the whole tablet at a lower dosage.
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.
Epilepsy
Table 1. Recommended dosage regimen for the treatment of epilepsy in adults and children over 12 years of age

1-2 weeks	3-4 weeks	Supportive doses of the drug
Monotherapy
25 mg 1 time / day	50 mg 1 time / day	100-200 mg / day (in 1 or 2 administrations). To achieve a therapeutic effect, the dose can be increased by 50-100 mg every 1-2 weeks. Some patients require a dose of 500 mg / day.
Combination therapy with valproic acid preparations
25 mg every other day	25 mg 1 time / day	100-200 mg / day (in 1 or 2 administrations). To achieve a therapeutic effect, the dose can be increased by 25-50 mg every 1-2 weeks.
Combination therapy without valproic acid preparations, but with lamotrigine glucuronide inducers
50 mg 1 time / day	100 mg / day (in 2 divided doses)	200-400 mg / day (in 2 divided doses). To achieve a therapeutic effect, the dose can be increased by 100 mg every 1-2 weeks. Some patients require a dose of 700 mg / day.
Combination therapy without valproic acid preparations and without lamotrigine glucuronide inducers
25 mg 1 time / day	50 mg 1 time / day	100-200 mg / day (in 1 or 2 administrations). To achieve a therapeutic effect, the dose can be increased by 50-100 mg every 1-2 weeks.

Table 2. Recommended dosage regimen in the treatment of epilepsy in children aged 3 to 12 years

1-2 weeks	3-4 weeks	Supportive doses of the drug
Monotherapy of typical absences
0.3 mg / kg (in 1 or 2 administration)	0.6 mg / kg (in 1 or 2 administration)	1-15 mg / kg / day (in 1 or 2 administration). Increase the dose by no more than 0.6 mg / kg / day every 1-2 weeks until the maintenance dose is reached
Combination therapy with valproic acid preparations
0,15 mg / kg 1 time / day	0.3 mg / kg 1 time / day	1-5 mg / kg / day (in 1 or 2 administration). Increase the dose by no more than 0.3 mg / kg / day every 1-2 weeks until therapeutic effect is achieved. The maximum maintenance dose of 200 mg / day

Combination therapy without valproic acid preparations, but with lamotrigine glucuronide inducers
0.6 mg / kg / day (in 2 divided doses)	1.2 mg / kg / day (in 2 divided doses)	5-15 mg / kg / day (in 1 or 2 administration). Increase the dose by no more than 1.2 mg / kg / day every 1-2 weeks until the therapeutic effect is achieved. Maximum maintenance dose of 400 mg / day
Combination therapy without valproic acid preparations and without lamotrigine glucuronide inducers
0,3 mg / kg / day (in 1 or 2 admission)	0.6 mg / kg / day (in 1 or 2 administration)	1-10 mg / kg / day (in 1 or 2 administration). Increase the dose by no more than 0.6 mg / kg / day every 1-2 weeks until the therapeutic effect is achieved. The maximum maintenance dose of 200 mg / day

If the calculated maintenance dose in children is less than 25 mg / day, LAMOTRIX® should not be prescribed. Children with a body weight of less than 25 kg.
To achieve the optimal therapeutic effect, it is necessary to systematically monitor the weight of the child's body and adjust the dose of the drug when it changes. Most likely, children between the ages of 3 to 6 years will need the largest maintenance doses.
Bipolar disorders in adults
It is necessary to follow a transitional dosing regimen that includes increasing the dose of lamotrigine for 6 weeks to a maintenance stabilizing dose, after which, if there are indications, other psychotropic drugs and / or PET can be discarded.
Table 3.The recommended dose increase scheme to achieve a maintenance daily stabilizing dose for bipolar disorders in adults

1-2 weeks	3-4 weeks	5 week	Target stabilizing dose (from 6 weeks)
Monotherapy with lamotrigine or combination therapy without valproic acid preparations and without lamotrigine glucuronide inducers
25 mg (1 time per day)	50 mg / day (in 1 -2 admission)	100 mg / day (in 1-2 divided doses)	200 mg / day. The maximum daily dose of 400 mg (in 1-2 divided doses)
Combination therapy with valproic acid preparations
25 mg (across day)	25 mg (1 time per day)	50 mg / day (in 1 to 2 administration)	100 mg / day (in 1-2 divided doses). The maximum daily dose of 200 mg
Combination therapy without valproic acid preparations, but with lamotrigine glucuronide inducers (phenytoin, carbamazepine, phenobarbital, primidon, rifampicin, lopinavir / ritonavir)

50 mg (1 time per day)

100 mg / day (in 2 divided doses)

200 mg / day (in 2 divided doses)

300 mg / day for 6 weeks of therapy.

Supportive dose of 400 mg / day (in 2 divided doses) with 7 weeks of therapy

Table 4. Supportive stabilizing daily dose for the treatment of bipolar disorders after withdrawal of concomitant drugs

The current stabilizing daily dose of lamotrigine (before cancellation)	1 week (after cancellation)	2 weeks	3 weeks and more
After the withdrawal of valproic acid preparations, depending on the initial dose of lamotrigine
100 mg / day	200 mg / day	Preserves a dose of 200 mg / day (in 2 divided doses)
200 mg / day	300 mg / day	400 mg / day	Preserves a dose of 400 mg / day
After abolition of inducers of glucuronin glucuridin, depending on the initial dose of lamotrigine
400 mg / day	400 mg / day	300 mg / day	200 mg / day
300 mg / day	300 mg / day	225 mg / day	150 mg / day
200 mg / day	200 mg / day	150 mg / day	100 mg / day
After the abolition of drugs little effect on glucuronin lamotrigine
Maintain the target dose achieved during the regimen (200 mg / day in 2 divided doses from 100 mg to 400 mg)

Table 5. Correction of daily doses of lamotrigine in patients with bipolar disorder after adherence to therapy with other drugs

The current stabilizing daily dose of lamotrigine	1 Week	2 weeks	3 weeks and more
Attachment of valproic acid preparations, depending on the initial dose of lamotrigine
200 mg / day	100 mg / day	Preserve the dose of 100 mg / day
300 mg / day	150 mg / day	Preserve the dose of 150 mg / day
400 mg / day	200 mg / day	Save the dose of 200 mg / day
The addition of lamotrigine glucuronide inducers in patients not receiving valproic acid, depending on the initial dose of lamotrigine
200 mg / day	200 mg / day	300 mg / day	400 mg / day
150 mg / day	150 mg / day	225 mg / day	300 mg / day
100 mg / day	100 mg / day	150 mg / day	200 mg / day
The adherence of drugs that have little effect on gluturidine glucuronin
Maintain the target dose achieved in the course of the regimen (200 mg / day, the dose range from 100 mg to 400 mg)

LAMOTRIX® can be abolished immediately, without a gradual dose reduction.
General recommendations for dosing in specific categories of patients
Women taking hormonal contraceptives
a) appointment to patients already taking hormonal contraceptives: there is no need to correct the regimens for increasing lamotrigine doses;
b) the appointment of hormonal contraceptives to patients receiving maintenance doses of lamotrigine and NOT RECEIVING lamotrigine glucuronide inductors: it may be necessary to increase the maintenance dose
lamotrigine, but no more than 2 times, depending on the individual clinical effect;
c) discontinuation of taking hormonal contraceptives by patients who are already receiving maintenance doses of lamotrigine and NOT receiving lamotrigine glucuronide inductors: it may be necessary to reduce the maintenance dose of lamotrigine, but no more,than in 2 times depending on individual clinical effect.
Patients of advanced age (over 65 years)
Correction of the dose selection mode is not required.
Dysfunction of the liver
The initial, increasing and maintenance doses are reduced by approximately 50% and 75% in patients with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic insufficiency, respectively. Increasing and maintenance doses should be adjusted to the clinical effect.
Impaired renal function
Patients with severe renal failure may need a reduction in maintenance dose.

Side effects:The information is divided into adverse reactions in patients with epilepsy and adverse reactions in patients with bipolar disorder. However, to consider the lamotrigine safety profile as a whole, it is necessary to take into account the information of both sections.
The following conditional classification of the frequency of unwanted effects is used: very often (> 1/10), often (> 1/100, <1/10), sometimes (> 1/1000, <1/100), rarely (> 1/10000, <1/1000), very rarely (<1/10000).
Epilepsy
From the skin and subcutaneous tissue: very often - skin rashes, rarely-malignant exudative erythema (Stevens-Johnson syndrome); very rarely-toxic epidermal necrolysis.
A rash, mostly maculopapular, usually appears within the first 8 weeks of initiating therapy and passes after the drug is discontinued.
The increased risk of rash is largely due to the high initial dose of lamotrigine and the excess of the recommended rates of dose build-up, as well as the increased half-life of lamotrigine when taken together with valproic acid. The development of rash can also be considered as a manifestation of hypersensitivity syndrome. Children have a higher risk of developing severe skin rashes than adults.
From the organs of hematopoiesis and lymphatic system: Very rarely - neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis. Hematologic disorders may be associated with hygiene and other factors.
From the immune system: very rarely - a syndrome of hypersensitivity (including such symptoms as skin rash, fever,lymphadenopathy, facial puffiness, blood disorders and liver function, disseminated intravascular coagulation syndrome (DIC syndrome), polyorganism disorders).
Early manifestations of hypersensitivity (fever, lymphadenopathy) can occur even in the absence of obvious signs of rash. With the development of such symptoms, the patient should be examined by a doctor and, unless another cause of the symptoms is established, lamotrigine should be canceled.
From the nervous system: often - headache, dizziness, drowsiness or insomnia, irritability, nystagmus, tremor; sometimes - ataxia, aggressiveness, very rarely - tics, hallucinations, confusion, agitation, instability, motor disorders, worsening symptoms of Parkinson's disease, extrapyramidal disorders, choreoathetosis, increased frequency of convulsive seizures.
From the sense organs: often - diplopia, blurred vision, rarely - conjunctivitis.
From the digestive system: often - nausea, vomiting, diarrhea; very rarely, an increase in the activity of "liver" enzymes, a violation of liver function, liver failure.Dysfunctions usually develop in combination with symptoms of ginsreactivity, but in isolated cases they were also noted in the absence of obvious signs of hypersensitivity.
From the musculoskeletal system: often fatigue; very rarely, a lump-like syndrome, arthralgia.
Bipolar disorder
From the skin and subcutaneous tissue: very often - skin rash; rarely Stevens-Johnson syndrome.
From the nervous system: very often - headache; often - agitation, drowsiness, dizziness.
From the musculoskeletal system: often - arthralgia, back pain.

Overdose:There are reports of a single dose, exceeding the maximum therapeutic dose by 10-20 times.
Symptoms: nystagmus, ataxia, impaired consciousness, coma.
Treatment: gastric lavage, hospitalization and symptomatic therapy.

Interaction:When taken together with drugs that induce glucuronidation, such as fsitioin and carbamazepine, the half-life is reduced to an average of 14 hours, and when taken together with valproic acid (has a pronounced suppressive effect on lamotrigine glucuronin) - increases to 70 hours in adults and up to 45-55 hours in children.
The main enzyme that metabolizes lamotrigine, is uridipdiphosphate-glucuronyltransferase. There is no evidence of the ability of lamotrigine to cause clinically significant induction or inhibition of liver oxidative enzymes. In this connection, the interaction between lamotrigine and drugs, which are destabilized by the cytochrome P450 enzyme system, is unlikely. Lamotrigine can induce its own metabolism, but this effect is moderately expressed and has no clinically significant effects.
Carbamazepine, phenytoin, primidon, phenobarbital, rifampicin, the combined drug ethinyl estradiol / levonorgestrel exert a stimulating effect on the glucuronidation of lamotrigine and its metabolism.
Influence of hormonal contraceptives on the pharmacokinetics of lamotrigine.
The intake of combined oral contraceptives containing 30 μg of ethylesterediol and 150 μg of levonorgestrel causes, on average, a twofold increase in lamotrigine clearance (after oral administration), which leads to a decrease in its AUC (area under the pharmacokinetic curve) and C_max by 52% and 39%, respectively. During the following week, after the abolition of combined oral contraceptives, there is an increase in the concentration of lamotrigine in the plasma.At the same time, the concentration of lamotrigine, measured at the end of this week before taking the next dose, is on average 2 times higher than in the period of active therapy.
The influence of lamotrigine on the pharmacokinetics of hormonal contraceptives.
Lamotrigine in a dose of 300 mg does not affect the pharmacokinetics of ethinyl estradiol-a component of a combined oral contraceptive. There was a slight increase in the clearance of the second component of levonorgestrel, the second component of the contraceptive, which led to a decrease in AUC and C_max levonorgestrel by 19% and 12%, respectively. Measurement of follicle-stimulating hormone, luteinizing hormone and estradiol during the study revealed a slight decrease in suppression of ovarian hormonal activity in some women, although measurement of plasma progesterone in none of the 16 women revealed hormonal evidence of ovulation. The effect of a moderate increase in levonorgestrel clearance and a change in plasma concentrations of follicle-stimulating and luteinizing hormones on ovarian ovarian activity has not been established.
Preparations of lithium, bupropion, olanzapine, oxcarbamazepine do not exert a significant inhibitory effect on glucuronin glucuronin.
Lamotrigine at a dose of 100 mg / day does not violate the pharmacokinetics of anhydrous lithium gluconate (2 g 2 times a day for 6 days) when taken together. Multiple administration of bupropion does not have a statistically significant effect on the pharmacokinetics of a single dose of lamotrigine and causes a slight increase in lamotrigine AUC glucuronide.
Olanzapine at a dose of 15 mg reduces AUC and C_max lamotrigine an average of 24% and 20%, respectively, which is clinically insignificant. Lamotrigine in a dose of 200 mg does not change the kinetics of alanzapine.
Inhibition of lamotrigine with amitriptyline, bupropion, clonazepam, fluoxetine, haloperidol or lorazepam has minimal effect on the formation of the primary metabolite lamotrigine-2-N-glucuronide. The study of the metabolism of bifurol with microsomal liver enzymes isolated in humans indicates that lamotrigine does not reduce the clearance of drugs that eliminate predominantly CYP2D6 isoenzymes. The results of in vitro studies also suggest that clozapine, phenelzine, risperidone, sertraline or trazodone also do not affect the clearance of lamotrigine.
There are reports of adverse effects from the CNS, including dizziness, ataxia, diplopia, blurred vision, nausea in patients taking carbamazepine on the background of lamotrigine therapy. These symptoms usually occurred after a reduction in the dose of carbamazepine. A similar effect was noted with the appointment of oxcarbamazepine against the background of lamotrigine in healthy volunteers.
Lamotrigine does not displace other PEPs from their connection with plasma proteins. With the simultaneous use of lamotrigine in a dose of 200 mg and oxcarbamazepine at a dose of 1200 mg pi, one of them does not interfere with the metabolism of the other.
Rifampicin increases the clearance of lamotrigine and reduces its half-life due to the induction of microsomal liver enzymes responsible for glucuronidation. The lamotrigine prescribing regimen should in this case correspond to the scheme recommended for the joint administration of lamotrigine and glucuronin inducing agents.
When lopinavir / ritonavir was used, a decrease of about 50% of lamotrigine plasma concentration was observed, possibly due to the induction of glucurcopy.In patients taking concomitant treatment with loyiovir / ritonavir, a lamotrigine dosage regimen with concomitant glucuronucleation inducers should be recommended.
In a study in healthy volunteers, taking atazanavir / ritonavir (300 mg / 100 mg) led to a decrease in AUC and C_max lamotrigine (in a single dose of 100 mg) by approximately 32% and 6%, respectively.
The results of in vitro studies have shown that lamotrigine, has a potential for inhibiting the transfer of organic cations higher than that of cimetidine. The joint use of lamotrigine with kidney excreted drugs that are substrates of organic cationic vectors (for example, metformin, gabapeptin and varenicline) can lead to an increase in the concentration of these drugs in the plasma. The clinical significance of this is not clearly defined, nevertheless, care should be taken when using these drugs at the same time.

Special instructions:Skin rash
There are data on the development of unwanted skin reactions, which were usually noted during the first 8 weeks after the onset of lamotrigine treatment.In most cases, skin rashes are not very pronounced and go away on their own, but at the same time there have been serious cases that require hospitalization and withdrawal of lamotrigine (for example, Stevens-Johnson syndrome and Lyell syndrome).
Severe skin reactions in adults receiving lamotrigine in accordance with generally accepted recommendations, develop with a frequency of approximately 1 in 500 patients with epilepsy. Approximately half of these cases reported Stevens-Johnson syndrome (1 per 1000). In patients with bipolar disorders, the frequency of severe skin rashes but according to clinical studies is approximately 1 per 1000 patients.
In children, the risk of skin rashes is higher than in adults.
In children, the initial appearance of the rash may be mistaken for infection, so it should be taken into account the possibility of children reacting to the drug, which develop a rash and fever during the first 8 weeks of therapy. The increased risk of rash is largely due to the high initial dose of lamotrigine and the excess of the recommended rates of dose build-up, as well as to the increased half-life of lamotrigine when taken together with valproic acid.
Caution is necessary when appointing patients who have a history of allergic reactions or a rash in response to taking other antiepileptic drugs, since the incidence of rash in patients with such an anamnesis was observed 3 times more often with lamotrigine than in patients with a history of unhealthy history.
If there is a rash, you should immediately examine the patient and cancel the drug (except when there is evidence that skin rashes are not associated with taking the drug).
Rash is also seen as part of the hypersensitivity syndrome associated with various systemic manifestations, including fever, lymphadenopathy, facial puffiness, blood disorders and liver function, and aseptic meningitis.
Aseptic meningitis
It was reported that in children and adults receiving lamotrigine, there is an increased risk of aseptic meningitis. In case of symptoms and signs of meningitis, you should immediately consult a doctor. In case of the appearance of symptoms of meningitis and with the exclusion of other factors of the development of this disease, the drug should be canceled and the appropriate treatment started.
With the withdrawal of the drug in most cases, the symptoms of meningitis disappeared, but in some patients they resumed with the re-appointment of lamotrigine. Do not resume appointments to patients who stopped taking the drug due to aseptic meningitis associated with a previous lamotrigine intake.
Clinical impairment and risk of suicide
Suicidal thoughts and suicidal behavior were noted in patients taking PEP for several indications. The mechanism of this action is unknown, and the available data do not exclude the possibility of an increased risk of suicide when lamotrigine is used. Patients receiving lamotrigine, should be carefully monitored for suicidal thoughts and behavior. Patients and carers should be informed of the need for medical advice in the event of such symptoms.
Dihydrofolate reductase
Lamotrigine is a weak inhibitor of dihydrofolate reductase, so there is a chance that the drug will influence the metabolism of folates with prolonged therapy. However, it was shown that lamotrigine did not cause significant changes in the concentration of hemoglobin, the average volume of erythrocytes, at folate concentration in the serum with long-term therapy up to 1 year and did not reduce the folate concentration in erythrocytes with therapy duration of 5 years.
Epilepsy
With the abrupt withdrawal of lamotrigine, as with other PEP, the manifestation of epilepsy is possible, therefore, it should be canceled gradually, within 2 weeks (except for cases requiring immediate discontinuation of the drug - if skin rashes appear). There are reports that severe epileptic seizures, including epileptic status, can lead to the development of rhabdomyolysis, polyorganism disorders, DIC-syprom, sometimes fatal. Similar conditions were noted also on the background of lamotrigine therapy.
Bipolar disorders
Patients with bipolar disorder may experience clinical worsening and / or aggravation of suicidal ideation and suicidal behavior when taking medications for the treatment of bipolar disorder, including lamotrigine. In patients receiving lamotrigine for the treatment of bipolar disorder,it is necessary to carefully monitor the symptoms of clinical deterioration (including the appearance of new symptoms) and the risk of suicide, especially at the beginning of the course of treatment or at the time of dose change. Patients who have a history of suicidal ideation or suicidal behavior are in a high-risk group for suicidal ideation or suicidal behavior, and should also be closely monitored during treatment.
Patients and caregivers should be warned about the need to monitor any worsening of the patient's condition, including the appearance of new symptoms and / or the appearance of suicidal thoughts / behaviors or thoughts of harm to themselves and seek medical help immediately if these symptoms are present.
In this case, you should assess the situation and make changes in the dosing regimen, including the possibility of drug discontinuation.
Renal insufficiency
A single appointment of lamotrigine to patients with a terminal stage of renal failure did not reveal significant changes in the concentration of the drug. However, the accumulation of a glucuronide metabolite is very likely,therefore it is necessary to exercise caution in the treatment of patients with renal insufficiency.
Patients taking other drugs containing lamotrigine
Do not administer LAMOTRIX® to patients who are already receiving other drugs containing lamotrigine, without consulting a doctor.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Tablets of 25 mg, 50 mg, 100 mg and 200 mg.

Packaging:For 10 tablets in a blister of PVC / aluminum foil.
For 3 blisters together with instructions for use in a cardboard box.

Storage conditions:Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001094

Date of registration:03.11.2011

Expiration Date:03.11.2016

The owner of the registration certificate:MEDSERV, LLC MEDSERV, LLC Russia

Manufacturer: & nbsp

MEDOCHEMIE, Ltd. Cyprus

Representation: & nbspMEDOKEMI LTD. MEDOKEMI LTD. Cyprus

Information update date: & nbsp2016-10-20

Illustrated instructions

Instructions

Lamotriks® (Lamotrix)