Universal reference book for medicines
Product name: LAMOLEP ® (LAMOLEP ® )

Active substance: lamotrigine

Type: Anticonvulsant drug

Manufacturer: GEDEON RICHTER (Hungary)
Composition, form of production and packaging
Tablets
white or almost white, round, biconcave, with engraved "L25" on one side.

1 tab.

lamotrigine 25 mg

Excipients: silicon dioxide colloidal anhydrous 0.1 mg, magnesium stearate 0.4 mg, sodium carboxymethyl starch (type A) 3 mg, povidone 2.5 mg, lactose monohydrate 16.25 mg, microcrystalline cellulose 32.75 mg.

10 pieces.
- blisters (3) - packs of cardboard.
Tablets are white or almost white, round, biconvex, with engraved "L50" on one side.

1 tab.

lamotrigine 50 mg

Excipients: silicon dioxide colloidal anhydrous 0.2 mg, magnesium stearate 0.8 mg, sodium carboxymethyl starch (type A) 6 mg, povidone 5 mg, lactose monohydrate 32.5 mg, microcrystalline cellulose 65.5 mg.

10 pieces.
- blisters (3) - packs of cardboard.
Tablets are white or almost white, round, biconvex, with engraved "L100" on one side.

1 tab.

lamotrigine 100 mg

Excipients: silicon dioxide colloidal anhydrous - 0.4 mg, magnesium stearate - 1.6 mg, sodium carboxymethyl starch (type A) - 12 mg, povidone - 10 mg, lactose monohydrate - 65 mg, microcrystalline cellulose 131 mg.

10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Antiepileptic drug.
Stabilizes the potential-dependent sodium channels of cell membranes. It blocks the release of neurotransmitters, mainly glutamic amino acids (which plays a key role in the development of epileptic seizures).
The efficacy of lamotrigine in the prevention of mood disorders in patients with bipolar disorders has been demonstrated in two clinical studies.
When analyzing the results of these studies, it was found that lamotrigine increases the duration of remission in bipolar disorders, exerting a more pronounced effect on depression.
PHARMACOKINETICS

Suction

After oral administration, it is quickly and completely absorbed from the intestine, is not significantly affected by the effect of "first passage".
C max is achieved 2.5 hours after ingestion. Eating somewhat slows down absorption, but does not affect its degree. Pharmacokinetics of the drug after a single dose at a dose not exceeding 450 mg, is linear. Concentration in the equilibrium state has a pronounced individual character.
Distribution

Binding to plasma proteins is 55%.
It is unlikely that the displacement of lamotrigine from binding to proteins can cause toxic effects. V d is 0.92-1.22 l / kg body weight.
Metabolism

Biotransformiruetsya in the liver under the action of uridine diphosphate-glucuronyl transferase.
N-glucuronides predominate among metabolites (65%). Lamotrigine in a moderate degree and dose-dependent induces its own metabolism.
Excretion

The clearance in the equilibrium state in healthy adults is 39 ± 14 ml / min.
It is excreted in the urine in the form of a conjugate of glucuronide, less than 10% in unchanged form, about 2% with feces. Clearance and T 1/2 do not depend on the dose. T 1/2 in healthy volunteers is 24-35 hours.
Pharmacokinetics in special clinical cases

The weight, counted per kg of body weight, is higher in children than in adults.
T 1/2 in children usually shorter than in adults. T 1/2 in children with simultaneous application with inducers of enzymes is 7 hours, with sodium valproate - 45-60 hours.
The lamotrigine clearance in the elderly and younger patients is minimal.

In patients with renal insufficiency, the initial dose of lamotrigine should be calculated according to the standard dosage regimen of antiepileptic drugs.
Dose reduction may be required only with a significant decrease in kidney function.
The initial, increasing and maintenance doses should be reduced by 50% for patients with moderate hepatic impairment and 75% for patients with severe hepatic insufficiency.
The dose increase and the maintenance dose are selected based on the clinical effect.
In patients with Gilbert's syndrome, the average lamotrigine clearance was 32% lower than in the control group, but these indices did not differ from those observed in the general population.

INDICATIONS

Epilepsy

for adults and children over 12 years

- as a monotherapy or in combination with other antiepileptic drugs for the treatment of partial and generalized seizures (including tonic-clonic seizures and convulsive seizures in the Lennox-Gastaut syndrome);

Bipolar disorders

for adults (18 years and over)

- for the prevention of mood disorders (mainly, episodes of depression).

DOSING MODE

The drug is taken orally, without chewing and washing with a small amount of water.

In cases where the calculated dose includes an incomplete tablet (only those suffering from epilepsy to children or patients with hepatic insufficiency), a dose equal to the whole number of tablets should be given.

Monotherapy for epilepsy

In adults and children older than 12 years, the initial dose is 25 mg 1 time / day for 2 weeks;
in the next 2 weeks - 50 mg 1 time / day. In the future, every 1-2 weeks you can increase the daily dose by 50-100 mg until the optimal effect is achieved. Usually the maintenance daily dose, distributed on 1 or 2 admission, is 100-200 mg.In a few cases, the desired effect was provided with a dose of 500 mg / day.
Table 1. Scheme of increasing doses with monotherapy for adults and children over 12 years.

1-2 weeks 3-4 weeks Maintenance dose

25 mg 1 time / day 50 mg 1 time / day 100-200 mg (for 1 or 2 appointments).
To achieve a maintenance dose every 1-2 weeks, the dose is increased by 50-100 mg.
To avoid the appearance of skin rashes, the above doses and the rates of their increase should be observed.

Combined therapy of epilepsy

In adults and children older than 12 years , taking valproic acid in combination with other antiepileptic drugs or without them, the initial daily dose of lamotrigine for 2 weeks is 25 mg every other day;
for the next 2 weeks, daily take 25 mg 1 time / day. In the future, every 1-2 weeks the dose can be increased by 25-50 mg until the optimal effect is achieved. Usually the maintenance daily dose, distributed on 1 or 2 admission, is 100-200 mg.
In patients taking an antiepileptic drug - an inductor of microsomal oxidation enzymes in the liver in combination with other antiepileptic drugs or without them, but not taking valproic acid, the initial daily dose of lamotrigine for 2 weeks is 50 mg 1 time / day;
for the next 2 weeks at 100 mg / day, divided into 2 doses. In the future, every 1-2 weeks, you can increase the dose by no more than 100 mg to obtain the optimal effect. The usual maintenance daily dose is 200-400 mg in 2 divided doses.In isolated cases, a dose of 700 mg / day is required.
In the case of treatment with an antiepileptic drug whose pharmacokinetic interaction with lamotrigine is not known, the dose of lamotrigine should be increased in smaller doses according to the scheme described for those taking valproic acid.

Table 2. Scheme of dose increase in combination therapy for adults and children over 12 years of age

Additional drug 1-2 weeks 3-4 weeks Recommended maintenance dose

Valproic acid ± another antiepileptic agent 25 mg (every other day) 25 mg (1 time / day) 100-200 mg (in 1-2 divided doses).
The maintenance dose is selected by increasing the daily dose by 25-50 mg every 1-2 weeks.
Antiepileptic agent - inducer of microsomal oxidation enzymes in the liver ± another drug * (without valproic acid) 50 mg (1 time / day) 100 mg (in 2 divided doses) 200-400 mg (in 2 divided doses).
The maintenance dose is selected, increasing the dose by 100 mg every 1-2 weeks.
Antiepileptic agent, not interacting with lamotrigine The dose of lamotrigine is increased according to the scheme for valproic acid.

* - for example, phenytoin, carbamazepine, phenobarbital and primidone.

To avoid skin rashes, the recommended initial doses should not be exceeded and do not exceed the indicated rates of dose increase.

General recommendations for epilepsy

If, after the abolition of any antiepileptic drug taken simultaneously, treatment is continued only with Lamolep ® , and if the therapy containing the Lamolep ® drug is supplemented with another antiepileptic drug, the effects of the drugs on the pharmacokinetics of lamotrigine should be taken into account.
a dose adjustment may be required.
Cancel lamotrigine in the treatment of epilepsy

The abrupt withdrawal of the drug Lamolep ® , as well as other antiepileptic drugs, can provoke the development of seizures.
If abrupt discontinuation of therapy is not a safety requirement (for example, with the appearance of a rash), the dose of lamotrigine should be reduced gradually over 2 weeks.
Bipolar disorders

In the case of bipolar disorders, the appointment of lamotrigine is recommended for the prevention of episodes of depression.

To prevent depression, the following dosage regimen should be observed.
In case of short-term treatment, the dose of lamotrigine should be increased gradually, within 6 weeks, until a stabilizing maintenance dose is reached (see Table 3), and then a psychotropic and / or other antiepileptic agent can be discontinued in the appropriate clinical picture of the disease. Table 4).
To prevent episodes of mania, adjuvant therapy may be necessary, since
The effectiveness of lamotrigine in the case of mania and manic states is ambiguous.
Table 3. Scheme of selection of a maintenance stabilizing daily dose in the treatment of adults (over 18 years) with bipolar disorders

Therapy 1-2 weeks 3-4 weeks 5 weeks The recommended maintenance dose

Valproic acid ± another antiepileptic agent 25 mg (every other day) 25 mg (1 time / day) 50 mg (in 1 or 2 doses) 100 mg (in 1-2 doses per day), maximum daily dose of 200 mg

Antiepileptic means - inducer of microsomal oxidation enzymes in the liver (carbamazepine, phenobarbital) ± another drug (without valproic acid) 50 mg (1 time / day) 100 mg (in 2 divided doses) 200 mg (in 2 divided doses) 300 mg on the 6th week, if necessary, the daily dose at the 7th week can be increased to 400 mg (in 2 divided doses)

An antiepileptic agent pharmacokinetically not interacting with lamotrigine (eg, lithium, bupropion) or monotherapy with lamotrigine 25 mg (1 time / day) 50 mg (in 1 or 2 doses) 100 mg (in 1 or 2 doses per day) 200 mg (in 1 or 2 doses per day), the usual dose is 100-400 mg

In case of treatment with an antiepileptic drug whose pharmacological interaction with lamotrigine has not been studied, the dose of Lamolep ® should be increased according to the scheme indicated for lamotrigine with valproic acid.

A).
Doses for administration in combination with inhibitors of microsomal oxidation enzymes in the liver, for example, valproic acid
For patients taking an inhibitor of microsomal oxidation enzymes in the liver, for example valproic acid, the initial dose of lamotrigine for 2 weeks is 25 mg every other day;
for the next two weeks - 25 mg 1 time / day. At the 5th week, the daily dose should be increased at a time to 50 mg, divided into 1-2 doses. Usually, to achieve the optimal therapeutic effect, a dose of 100 mg / day (1-2 treatments) is required. The maximum daily dose should not exceed 200 mg.
B).
Doses for administration in combination with inducers of microsomal oxidation enzymes in the liver, for example, carbamazepine and phenobarbital, but without valproic acid
For patients taking an antiepileptic agent - an inductor of microsomal oxidation enzymes in the liver (carbamazepine, phenobarbital), but not taking valproic acid, the initial daily dose of lamotrigine for 2 weeks is 50 mg 1 time / day;
then over the next 2 weeks - 100 mg / day, distributed in 2 divided doses.
At the 5th week the daily dose should be increased to 200 mg (in 2 divided doses).
At the 6th week, the daily dose may reach 300 mg, although an average dose of 400 mg, divided into 2 doses, is required to achieve the optimal effect; The use of the drug in this dose can begin with the 7th week of taking the drug.
AT).
Doses for monotherapy, as well as for appointments in combination with drugs, whose pharmacological interaction with lamotrigine is either unknown, or is possible, for example, with lithium, bupropion
In case of treatment with an antiepileptic drug whose pharmacokinetic interaction with lamotrigine is not known, or is possible, and also in case of monotherapy with lamotrigine, the initial daily dose in the first 2 weeks is 25 mg 1 time / day;
during the next two weeks - 50 mg / day (in 2 divided doses). At the 5th week the dose is raised to 100 mg / day. Usually, the optimal daily dose is 200 mg for 1-2 doses. In clinical studies, doses of 100-400 mg / day were used.
After reaching an effective maintenance stabilizing dose, psychotropic drugs can be canceled according to the following scheme.

Table 4. Supporting stabilizing daily doses after the abolition of simultaneously used psychotropic or antiepileptic drugs for the treatment of bipolar disorders

Therapy 1 week 2 weeks From 3 weeks (maximum dose = 400 mg / day)

After the abolition of the inhibitor of microsomal oxidation enzymes in the liver, for example, valproic acid, the stabilizing dose is doubled, not more than 100 mg per week, i.e.
in the first week the dose should be 200 mg / day The increased dose is prescribed as a maintenance dose (200 mg / day, divided into 2 doses)
After the induction of the inducer of microsomal oxidation enzymes in the liver (eg, carbamazepine), depending on the initial dose of 400 mg 300 mg 200 mg

300 mg 225 mg 150 mg

200 mg 150 mg 100 mg

After the abolition of psychotropic or antiepileptic drugs, probably not having a pharmacokinetic effect on lamotrigine (eg, lithium, bupropion). An increased dose is prescribed as a maintenance dose (200 mg / day, divided into 2 doses), the recommended dose is 100-400 mg / day

After the antiepileptic remedy has been withdrawn, not interacting with lamotrigine, the dose of Lamolep ® should be increased according to the scheme indicated for valproic acid.

A).
After the abolition of the inhibitor of microsomal oxidation enzymes in the liver (eg, valproic acid) prescribed in combination, the initial stabilizing dose of lamotrigine should be doubled.
B).
After the inducer of microsomal oxidation enzymes in the liver (eg, carbamazepine) prescribed in combination is withdrawn, the dose of lamotrigine should be reduced gradually, within 3 weeks.
AT).
After the abolition of psychotropic and antiepileptic drugs (for example, lithium, bupropion), pharmacokinetic interaction of which with lamotrigine is not established, it is necessary to continue taking the selected dose.
Correction of the daily dose of lamotrigine after the introduction of additional drugs for the treatment of bipolar disorders

Despite the lack of clinical experience in titrating doses of lamotrigine after the use of additional medications, it is recommended to prescribe below the indicated doses, established on the basis of the results of the study of drug interactions (see Table 5).

Table 5. Correction of the dose of lamotrigine in bipolar disorders after the administration of additional medications

Additional drug Stabilizing dose of the drug Lamolep ® (mg / day) 1 week (mg / day) 2 weeks (mg / day) C 3 weeks (mg / day)

Inhibitor of microsomal oxidation enzymes in the liver (eg, valproic acid), depending on the initial dose of the drug Lamolep ® 200 100 The reduced dose achieved in the first week (100 mg / day)

300 150 Reduced dose achieved in the first week (150 mg / day)

400 200 Reduced dose achieved in the first week (200 mg / day)

Inductor of microsomal oxidation enzymes in the liver (eg, carbamazepine) depending on the initial dose of the drug Lamolep® (without valproic acid) 200 200 300 400

150 150 225 300

100 100 150 200

Psychotropic or antiepileptic drugs with unknown pharmacokinetic interaction with the drug Lamolept ® (eg, lithium, bupropion) The dose achieved during the dose increase (200 mg / day), within the range of 100-400 mg)

Antiepileptic drugs with unknown pharmacokinetic interaction with lamotrigine: see the section on valproic acid intake.

Cancel lamotrigine in the treatment of bipolar disorders

Termination of lamotrigine treatment does not require a gradual dose reduction.

Correction of dose in elderly patients (> 65 years) is not required, because
the pharmacokinetics of the drug is not significantly different from that observed in young patients.
For hepatic insufficiency of an average degree (class B on the Child-Pugh scale), the initial and maintenance doses, as well as the dose increase, should be 50% lower than usual;
with severe hepatic insufficiency (class C on the Child-Pugh scale) - 75% lower than usual. The dose increase and the maintenance dose depend on the clinical effect.
The drug should be administered with caution in renal failure .
In the terminal stage of renal failure, the initial dose of lamotrigine is calculated according to the standard regimen for prescribing an antiepileptic drug; with a marked decrease in renal function, a reduction in the maintenance dose may be required.
SIDE EFFECT

Side reactions are presented separately for each disease; to evaluate the side effects of the drug should be taken into account both groups.
Side effects are classified into categories depending on their frequency of occurrence: very common (> 1/10), common (> 1/100 - <1/10), uncommon (> 1/1000 - <1/100), rarely (> 1/10 000 - <1/1 000), very rare (<1/10 000).
Epilepsy is
part of the skin: as monotherapy (in clinical trials) very often - in the first 8 weeks of treatment, skin rash (often maculo-papular), disappears after discontinuation of lamotrigine; combination therapy is very often - skin rash, rarely - Stevens-Johnson syndrome; very seldom - toxic epidermal necrolysis (Lyell's syndrome, in some cases, recovery from scarring).
From hemopoiesis system: very rarely - neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis, lymphadenopathy. These symptoms may or may not be associated with the hypersensitivity syndrome.
Immune system:skin rash was a component hypersensitivity syndrome flowing with varying degrees of severity. Very rarely - hypersensitivity syndrome (including syndromes such as fever, lymphadenopathy, swelling of the face, disorders of the blood and liver, a disseminated intravascular coagulation (DIC), multiple organ failure). Importantly, early manifestations of hypersensitivity (fever, lymphadenopathy) may occur even in the absence of obvious signs of rash. With the development of these symptoms the patient should be immediately examined by a doctor and, if not installed another cause of symptoms, lamotrigine should be discontinued.
Psychiatric disorders: often - irritability, aggressiveness, very rarely - tics, hallucinations, confusion.
From the nervous system: as monotherapy in clinical trials - often - headache, often - drowsiness, insomnia, dizziness, tremor, rarely - ataxia; rarely - nystagmus. In the combination therapy - often - headache, dizziness, drowsiness, ataxia, often - nystagmus, tremor, insomnia, very rarely - aseptic meningitis, agitation, loss of balance, movement disorders, worsening of Parkinson's disease, extrapyramidal symptoms, choreoathetosis, increased convulsive seizures. There have been reports that lamotrigine may worsen parkinsonian extrapyramidal symptoms in patients with concomitant Parkinson's disease, and in rare cases cause extrapyramidal symptoms and choreoathetosis in patients with no prior violations.
From the senses:monotherapy rarely - diplopia, blurred vision; combination therapy is very often - diplopia, blurred vision, rarely - conjunctivitis.
Cardio-vascular system: Infrequent - "tides", hypertension, palpitations, postural (orthostatic) hypotension, syncope (fainting), tachycardia, vasodilatation.
From the digestive system:monotherapy in clinical trials often - nausea, vomiting, diarrhea; combination therapy is very often - nausea, vomiting; often - diarrhea; very rare - increase in liver enzymes, liver function abnormalities, liver failure. Disorders of the liver, usually, are part of a hypersensitivity syndrome, however, is not always accompanied by other symptoms of hypersensitivity.
From endocrine system: rarely - Struma (goitre), hypothyroidism.
On the part of the musculoskeletal system: very rarely - lupus-like reactions.
Other dose-related: often - increased fatigue.
bipolar disorder
The following side effects should be evaluated along with the above-mentioned side reactions, detected in epilepsy.
For the skin: very often - skin rash, rarely - Stevens-Johnson syndrome.
From the nervous system: very often - headache, often - agitation, somnolence, dizziness.
On the part of the musculoskeletal system: often - arthralgia.
From the digestive system: often - dryness of the oral mucosa.
Other dose-related: myalgia, back pain.
CONTRAINDICATIONS

- severe hepatic dysfunction;
- bipolar disorder in patients under the age of 18 years;
- children's age till 12 years;

- lactose intolerance, lactase deficiency, malabsorption syndrome glucose / galactose;
- Hypersensitivity to the components of the drug.

With caution should be prescribed to patients with renal failure (because of the possible accumulation of metabolite glucuronide).
PREGNANCY AND LACTATION

Clinical safety data, the use of lamotrigine during pregnancy is not enough. There are reports of increased risk of congenital abnormalities of the oral cavity.Lamotrigine should be used during pregnancy only if the expected therapeutic benefit to the mother outweighs the potential risk to the fetus. Physiological changes during pregnancy may affect the concentration of lamotrigine and / or therapeutic effect. It has been reported to reduce the concentration of lamotrigine during pregnancy. Appointment of lamotrigine pregnancy should be provided as appropriate management of patients.
Lamotrigine penetrates to varying degrees in the breast milk, infant lamotrigine concentration may reach about 50% of the concentration recorded in the mother. Thus, in some children who are breastfed serum concentration of the drug may reach values at which the pharmacological effects are manifested. It should be carefully weighed the potential benefits of breast-feeding and the potential risk of adverse effects in infants.
Studies on the effect of lamotrigine on fertility have not been conducted in humans.
APPLICATION FOR FUNCTIONS OF THE LIVER

Caution must be exercised when administering the drug to patients with renal insufficiency.
The drug should be prescribed with caution in renal failure . In end-stage renal failure initial dose of lamotrigine calculated in accordance with the standard assignment scheme antiepileptic drug; with marked reduction in renal function may require a reduction of the maintenance dose.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Not use this drug in severe hepatic dysfunction.
In liver failure stredney degree (class B Child-Pugh) initial and maintenance doses, as well as increasing the dose should be 50% lower than usual; with hepatic severe failure (class C Child-Pugh) - 75% below normal. Increasing the dose and maintenance doses depend on the clinical effect.
APPLICATION FOR CHILDREN

Do not use this prepraty in children younger than 12 years and in bipolar disorder in patients under the age of 18 years.
APPLICATION IN ELDERLY PATIENTS

A correction mode in elderly patients (over 65 years) is not required (since the pharmacokinetics in this age group does not differ from that of adults).
SPECIAL INSTRUCTIONS

During the first 8 weeks of treatment possible skin reaction as the side effects of lamotrigine. Skin rashes, usually expressed in mild spontaneously disappear, however, there may be severe, requiring hospitalization and discontinuation of therapy with lamotrigine, for example, a potentially life-threatening Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
Among adults suffering from epilepsy and treated in clinical trials recommended dose, the frequency of severe skin reactions was 1: 500. Among them, Stevens-Johnson syndrome observed in half of the cases (1: 1000).
Children are more likely to develop severe skin reactions.
According to numerous clinical observations incidence of skin reactions requiring hospitalization of children was 1: 300-1: 100.
Early rash in children can easily be confused with a rash of infectious diseases, so if high fever and rash occur in the first 8 weeks of treatment, it must be assumed drug reaction.
Probably, the overall risk of skin reactions in adults is strongly correlated with high initial doses and prescribed acceleration rate increasing doses of lamotrigine, and as with the simultaneous reception of valproic acid.
Caution is needed when assigning lamotrigine patients with a history of allergic reaction or rash in response to receiving other antiepileptic drugs, since the frequency of rash development (not classified as serious) in patients with a history of observed 3 times more often when assigning lamotrigine than patients with without a history of history.
If a rash every patient, regardless of age, should be immediately and thoroughly inspect, lamotrigine treatment should be discontinued, except in cases when a rash is not uniquely associated with taking the drug. Rash may be accompanied by different manifestations of systemic hypersensitivity (fever, lymphadenopathy, swelling of the face, the reaction of the liver and hematopoietic system). The severity of hypersensitivity reactions may be different, in rare cases, disseminated intravascular coagulation (DIC) with multiple organ failure. It should be borne in mind that the early signs of hypersensitivity (eg, fever, lymphadenopathy) is not always accompanied by a skin rash. If they can not be explained by another cause,lamotrigine treatment should be discontinued immediately.
Combined preparation ethinylestradiol / levonorgestrel (30 g / 150 g) in about 2 times increase the clearance of lamotrigine in plasma. If during treatment with the drug Lamolep ® patients start or stop taking hormonal contraceptives, you may need a dosage adjustment of lamotrigine.
Prolonged treatment lamotrigine may modify the metabolism of folic acid, as Lamotrigine is a weak inhibitor of dihydrofolate reductase. However, the long, 12-month treatment lamotrigine does not significantly affect the rate of hemoglobin, mean corpuscular volume, folate concentration in plasma and erythrocytes, after 5 years of treatment - on folic acid concentrations in erythrocytes.
Abnormal liver function, generally, are part of the hypersensitivity syndrome, however, is not always accompanied by other symptoms of hypersensitivity.
In clinical studies, lamotrigine concentrations in blood of patients in end stage renal disease, has not changed after a single dose.
When treating patients with renal failure who are on hemodialysis, it should be borne in mind that on average, during the 4-hour hemodialysis of the body is derived 20% of lamotrigine.
Lamotrigine should not be administered to patients already receiving any other preparations containing lamotrigine without consulting a doctor.
Epilepsy
Objective criterion of efficacy is the ability to reduce the frequency of spikes in the EEG to 78-98%.
Like other antiepileptic drugs, abrupt discontinuation of lamotrigine treatment provoke epileptic seizures ( "ricochet" syndrome). Except in special cases, e.g., occurrence of skin rash that require the immediate cessation of treatment, removal of the drug must be carried out gradually, with a smooth, within 2 weeks, dose reduction.
Based on published data, severe convulsive seizures including status epilepticus may lead to rhabdomyolysis, multiple organ dysfunction and disseminated intravascular coagulation, sometimes with fatal outcome. Similar cases have occurred in connection with the use of lamotrigine.
Symptoms of depression and / or bipolar disorder may occur in patients with epilepsy. Patients with epilepsy and associated bipolar disorder are at high risk of suicide, so the treatment of patients with an increased tendency to suicide should be accompanied by careful monitoring of the patient.
Impact on the ability to drive vehicles and manage mechanisms

In the initial period of treatment to control the car and working mechanisms it is prohibited in the following duration and extent of restrictions determined by the physician on an individual basis.
OVERDOSE

It reported once received doses 10-20 times the maximum therapeutic.
Symptoms: nystagmus, ataxia, dizziness, headache, drowsiness, vomiting, impaired consciousness, coma.
Treatment: hospitalization, conduct of symptomatic and supportive treatment, in accordance with clinical guidelines or the national poison center.
DRUG INTERACTION

UDP-glucuronyl the main metabolizing enzyme lamotrigine. No data on the ability of lamotrigine cause clinically significant inhibition or induction of hepatic microsomal enzymes. In this regard, the interaction between lamotrigine and drugs metabolized by cytochrome P450 isozymes is unlikely. Lamotrigine may induce its own metabolism but the effect is moderate and does not have clinically significant consequences.
The effect of other drugs on glucuronidation of lamotrigine
powerful inhibitors glyukuronirovaniya lamotrigine powerful inductors glyukuronirovaniya lamotrigine means, little affecting the glucuronidation of lamotrigine
valproic acid, carbamazepine, lithium Drugs
Phenytoin Bupropion
Olanzapine Primidone
Phenobarbital Oxcarbazepine
Rifampicin felbamate
Lopinavir / ritonavir gabapentin
Atazanavir / ritonavir levetiracetam
combined preparation ethinyl estradiol / levonorgestrel Pregabalin
topiramate
zonisamide
valproic acid , which inhibits glucuronidation of lamotrigine, reduces the rate of its metabolism and lengthens its average T 1/2 is almost 2 times.
Some antiepileptics such as phenytoin, carbamazepine, phenobarbital and primidone that induce hepatic microsomal enzymes accelerate glucuronidation of lamotrigine and its metabolism.
Carbamazepine.Reported on the development of undesirable effects the central nervous system, include dizziness, ataxia, diplopia, blurred vision and nausea in patients taking carbamazepine who started against the background of lamotrigine therapy. Reducing the dose of carbamazepine is usually led to the disappearance of these symptoms.
Phenobarbital reduces lamotrigine concentration of 40%.
Rifampicin enhances clearance of lamotrigine and reduces its T 1/2 due to induction of hepatic microsomal enzymes responsible for the glucuronidation. Patients taking rifampicin as concomitant therapy, lamotrigine assignment mode must match the schema recommended during co-administration of lamotrigine and for inducing enzymes microsome
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