KONVULYSAN

Active material: Lamotrigine
When ATH: N03AX09
CCF: Anticonvulsants
ICD-10 codes (testimony): F31, G40
When CSF: 02.05.06
Manufacturer: Actavis hf. (Iceland)

DOSAGE FORM, STRUCTURE AND PACKAGING

Pills round, Valium, light yellow, Engraved “25” one side.

Excipients: magnesium carbonate, microcrystalline cellulose, povidone, пигмент светло-желтый (lactose monohydrate, iron oxide yellow), krospovydon (полиплаздон XL10), magnesium stearate.

10 PC. – blisters (3) – packs cardboard.

Pills round, Valium, light yellow, Engraved “50” one side.

Excipients: magnesium carbonate, microcrystalline cellulose, povidone, пигмент светло-желтый (lactose monohydrate, iron oxide yellow), krospovydon (полиплаздон XL10), magnesium stearate.

10 PC. – blisters (3) – packs cardboard.

Pills round, Valium, light yellow, Engraved “100” one side.

Excipients: magnesium carbonate, microcrystalline cellulose, povidone, пигмент светло-желтый (lactose monohydrate, iron oxide yellow), krospovydon (полиплаздон XL10), magnesium stearate.

10 PC. – blisters (3) – packs cardboard.

* – international non-proprietary name, recommended by the WHO – lamotrigine.

Pharmacological action

Anticonvulsants. Lamotrigine is a blocker of voltage-dependent sodium channels, подавляет патологическое высвобождение глутаминовой кислоты (amino acid, plays a key role in the development of epileptic seizures), а также ингибирует деполяризацию, induced by glutamate.

Pharmacokinetics

Absorption

After oral lamotrigine is rapidly and completely absorbed from the gastrointestinal tract, практически не подвергаясь пресистемному метаболизму при эффекте “first pass”. FROM_max plasma is approximately 2.5 h after dosing. The time to reach C_max slightly increased postprandial, but the extent of absorption remains unchanged. Pharmacokinetics lamotrigine is linear when receiving a single dose of 450 mg. Наблюдаются значительные межиндивидуальные колебания С_max at equilibrium, but with a few variations in each individual.

Distribution

Lamotrigine binds to plasma proteins about 55%. Unlikely, to release the drug from binding to the protein may lead to the development of toxic effects.

V_d is 0.92-1.22 l / kg.

Metabolism

В метаболизме ламотриджина принимает участие фермент уридиндифосфатглюкуронилтрансфераза (UDF-glucuronyltransferases). Метаболизируется до глюкуронидов. Lamotrigine a small extent increases its own metabolism in a dose dependent manner.

Deduction

У взрослых клиренс ламотриджина в состоянии равновесных концентраций составляет в среднем 39 ± 14 ml / min. Excreted in the urine as metabolites, less 10% the drug is excreted in urine as unchanged, about 2% – with feces. Clearance and T_1/2 not dose dependent. T_1/2 у взрослых составляет в среднем от 24 h to 35 no. На T_1/2 lamotrigine is greatly affected by drugs taken together.

Pharmacokinetics in special clinical situations

In children, the clearance of lamotrigine by weight of the body above, than in adults (наиболее высок у детей до 5 years). Children T_1/2 lamotrigine typically less, than in adults. Its average value is approximately equal to 7 ч при одновременном назначении с препаратами, stimulating glucuronidation, Takima how carbamazepine and phenytoin, and rises to an average of 45-50 ч при совместном назначении с вальпроатом.

Clinically relevant differences in the clearance of lamotrigine in elderly patients compared to younger patients are not found.

Patients with Gilbert syndrome was observed in the reduction in drug clearance 32%, but that does not go beyond the normal range for the general population.

Testimony

Epilepsy

— в качестве дополнительной или монотерапии эпилепсии (partial and generalized seizures, including tonic-clonic seizures, and seizures in the Lennox-Gastaut syndrome) in adults and children older than 12 years;

— в качестве дополнительной терапии эпилепсии (partial and generalized seizures, including tonic-clonic seizures, and seizures in the Lennox-Gastaut syndrome) in children 2 to 12 years (After achieving control epilepsy combined therapy, сопутствующие противоэпилептические препараты могут быть отменены и прием ламотриджина продолжен в качестве монотерапии);

- Monotherapy tipichnыh absansov.

Bipolar disorder

— для профилактики нарушений настроения (depression, mania, hypomania, mixed episodes) у взрослых с биполярными расстройствами.

Dosage regimen

The drug is taken orally. If the calculated dose of lamotrigine (eg, the appointment of children or patients with impaired liver function) не может быть разделена на целое количество таблеток, the patient must be assigned to this dose, which corresponds to the nearest whole value of the tablet in the lower dosage.

Because of the risk of rash should not exceed the initial dose and increase the dose recommended mode.

Epilepsy

Монотерапия у взрослых и детей старше 12 years

Начальная доза Конвульсана составляет 25 mg 1 time / day during the first 2 weeks, followed by increasing doses up to 50 mg 1 time / day for the next 2 weeks. Thereafter, the dosage should be increased by 50-100 mg every 1-2 of the week, until you reach the optimal therapeutic effect. Standard maintenance dose is 100-200 mg / day 1 or 2 admission. Некоторым пациентам для достижения терапевтического эффекта требуется назначение Конвульсана в дозе 500 mg / day.

Дополнительная терапия у взрослых и детей старше 12 years

При совместном применении Конвульсана с препаратами вальпроевой кислоты в сочетании с другими противоэпилептическими препаратами (PEP) or without начальная доза ламотриджина составляет 25 mg every other day for the first 2 weeks; subsequently - by 25 mg 1 time / day for the next 2 weeks. Thereafter, the dosage should be increased by up to 25-50 mg / day every 1-2 of the week, until you reach the optimal therapeutic effect. Standard maintenance dose is 100-200 mg / day 1 or 2 admission.

При совместном применении Конвульсана с противоэпилептическими препаратами или другими препаратами, стимулирующими глюкуронизацию ламотриджина, in combination with other AEDs or without (except valproate) начальная доза Конвульсана составляет 50 mg 1 time / day during the first 2 weeks, further - 100 mg / day 2 receiving in the next 2 weeks. Затем дозу повышают максимально на 100 mg every 1-2 недели до достижения оптимального терапевтического эффекта. Standard maintenance dose is 200-400 mg / day 2 admission. Некоторым пациентам может потребоваться доза до 700 mg / day.

При совместном применении Конвульсана с окскарбазепином в сочетании с какими-либо другими индукторами или ингибиторами глюкуронизапии ламотриджина или без них начальная доза ламотриджина составляет 25 mg 1 time / day during the first 2 weeks, further – 50 mg / day 1 receiving in the next 2 weeks. Then, the dose is increased by up to 50-100 mg every 1-2 недели до достижения оптимального терапевтического эффекта. Standard maintenance dose is 100-200 mg / day 1 or 2 admission.

Монотерапия у детей aged 2 to 12 years

Начальная доза Конвульсана при Monotherapy of typical absence seizures is 0.3 mg / kg body weight / day 1 or 2 receiving in the first 2 weeks, followed by increasing doses up to 0.6 mg / kg / day 1 or 2 receiving in the next 2 weeks. Thereafter, the dosage should be increased by up to 0.6 mg / kg every 1-2 недели до достижения оптимального терапевтического эффекта. The usual maintenance dose is from 1 to 15 mg / kg / day 1 or 2 admission, хотя некоторым пациентам требуются более высокие дозы.

Дополнительная терапия у детей в возрасте от 2 to 12 years

При совместном применении Конвульсана и препаратов вальпроевой кислоты в сочетании с другими ПЭП или без них начальная доза ламотриджина составляет 0.15 mg / kg 1 time / day during the first 2 weeks, further - 0.3 mg / kg 1 time / day for the next 2 weeks. Then, the dose should be increased by 0.3 mg / kg every 1-2 недели до достижения оптимального терапевтического эффекта. Standard maintenance dose is 1-5 mg / kg / day 1 or 2 admission. The maximum daily dose – 200 mg.

При совместном применении Конвульсана с противоэпилептическими препаратами или другими препаратами, стимулирующими глюкуронизацию ламотриджина, in combination with other AEDs or without (except valproate) начальная доза ламотриджина составляет 0.6 mg / kg / day 2 receiving in the first 2 weeks, further - 1.2 mg / kg / day 2 receiving in the next 2 weeks. Thereafter, the dosage should be increased by up to 1.2 mg / kg / day every 1-2 недели до достижения оптимального терапевтического эффекта. Standard maintenance dose is 5-15 мг/кг в сутки в 2 admission. The maximum daily dose – 400 mg.

При совместном применении Конвульсана с окскарбазепином без каких-либо других индукторов или ингибиторов глюкуронизации ламотриджина начальная доза ламотриджина составляет 0.3 mg / kg / day 1 or 2 receiving in the first 2 weeks, further – 0.6 mg / kg / day 1 or 2 receiving in the next 2 weeks. Then, the dose is increased by up to 0.6 mg / kg every 1-2 of the week, until you reach the optimal therapeutic effect. Standard maintenance dose is 1-10 mg / kg / day 1 or 2 admission. The maximum dose is 200 mg / day.

To be sure, that supported the therapeutic dose, necessary to control body weight of the child and to adjust the dose of the drug when it is modified. Точное дозирование при проведении начальной терапии Конвульсаном в таблетках по 5 мг невозможно, If the child's body weight is less than 17 kg.

Most likely, that children between the ages of 2 to 6 s largest maintenance doses will be required.

При отмене сопутствующих противоэпилептических препаратов для перехода на монотерапию Конвульсаном или при назначении на фоне приема Конвульсана других лекарственных средств или ПЭП необходимо принимать во внимание то, it may have an impact on the pharmacokinetics of lamotrigine.

Bipolar disorders adult

Please follow the dosage regimen Transitional, which comprises increasing within 6 weeks, the dose of lamotrigine to a maintenance stabilization dose (Table. 1), после чего при наличии показаний можно отменять другие психотропные и/или противоэпилептические препараты (Table 2).

Table 1. Рекомендуемая схема увеличения доз для достижения поддерживающей суточной стабилизирующей дозы при биполярных нарушениях у взрослых

Supporting roll dose varies depending on the clinical effect.

При совместном применении Конвульсана и других ПЭП, ингибирующих глюкуронизацию ламотриджина (eg, valproate), начальная доза ламотриджина составляет 25 mg every other day for the first 2 weeks, then – 25 mg 1 time / day for the next 2 weeks, on 5 week, the dose should be increased to 50 mg / day 1-2 admission. Stabiliziruyushtaya dose 6 Week of 100 mg / day 1-2 admission. The maximum daily dose – 200 mg.

При совместном применении Конвульсана и других ПЭП, стимулирующих глюкуронизацию ламотриджина (eg, phenytoin, Carbamazepine, phenobarbital, prymydon), patients, не получающих ингибиторы глюкуронизации ламотриджина (eg, valproate), начальная доза ламотриджина составляет 50 mg 1 time / day during the first 2 weeks, then – 100 mg / day 2 receiving in the next 2 weeks, on 5 week, the dose should be increased to 200 mg / day 2 admission. On 6 week the dose may be increased to 300 mg / day, However, stabilizing the dose to achieve optimal therapeutic effect is 400 mg / day 2 приема и назначается, beginning with 7 of the week.

At monotherapy Конвульсаном или при совместном применении Конвульсана с препаратами лития, bupropion, olanzapine, окскарбазепином или другими препаратами, не являющимися индукторами или ингибиторами глюкуронизации ламотриджина, начальная доза ламотриджина составляет 25 mg 1 time / day during the first 2 weeks, then – 50 mg / day 1 or 2 receiving in the next 2 weeks. Дозу следует увеличить до 100 mg / day 5 week. Stabiliziruyushtaya dose 6 Week of 200 mg / day 1-2 admission.

After reaching a daily maintenance dose of stabilizing other psychotropic medications may be canceled.

Table 2. Поддерживающая стабилизирующая суточная доза для лечения биполярных расстройств после отмены сопутствующих психотропных или противоэпилептических средств.

If necessary, the dose may be increased to 400 mg / day.

After the abolition of additional therapy inhibitors of lamotrigine glucuronidation (eg, valproate) anti initial dose of lamotrigine and doubles maintained at this level.

After the abolition of additional therapy inducers of lamotrigine glucuronidation (incl. phenytoin, karʙamazepinom, fenoʙarʙitalom, primidone) lamotrigine dose is gradually reduced over the 3 weeks depending on the initial maintenance dose.

After the cancellation of related psychotropic or anti-epileptic drugs, no significant pharmacokinetic interaction with lamotrigine (eg, lithium preparations, Bupropion, olanzapine, okskarʙazepin), должна быть сохранена стабилизирующая доза Конвульсана, reached during raising mode.

There is no clinical experience to correct daily doses of lamotrigine in patients with bipolar disorder after adding other drugs. However, based on studies on the interaction of these drugs can be given recommendations (Table. 3).

Table 3. Adjustments of daily doses of lamotrigine in patients with bipolar disorder after joining the therapy of other drugs

При прекращении терапии Конвульсаном у пациентов с биполярным расстройством отменять Конвульсан можно сразу, without gradual dose reduction.

In case of resumption of receiving lamotrigine doctor should assess the need to improve the maintenance dose in patients, who stopped taking the drug for any reason, because the high initial doses and exceeding the recommended doses are associated with a risk of severe rash. The more time has passed since the last dose, the more caution should be increased to a maintenance dose of. If the time after stopping exceeds 5 half-lives, the dose of lamotrigine should be increased to maintenance under the relevant scheme.

Lamotrigine therapy should not be reopened for patients, lamotrigine discontinuation of treatment which was associated with the appearance of the rash, except in cases, when the potential benefits of such therapy is obvious potential risk.

При назначении Конвульсана women, уже принимающим гормональные контрацептивы, нет необходимости в коррекции рекомендованных режимов повышения доз ламотриджина.

In the appointment of hormonal contraceptives patients, уже получающим поддерживающие дозы Конвульсана и не получающим индукторов глюкуронизации ламотриджина, may need to increase the maintenance dose of lamotrigine, but not more than 2 times, в зависимости от индивидуального клинического эффекта.

Upon termination of hormonal contraceptives use by patients, уже получающими поддерживающие дозы Конвульсана и не получающими индукторов глюкуронизации ламотриджина, may require dose reduction in lamotrigine 2 times depending on the individual clinical effect.

Correction mode in elderly patients (senior 65 years) not required.

At hepatic dysfunction average (Class B for Child-Pugh) and severe (class C Child-Pugh) primary, and increasing the maintenance dose should be reduced by approximately 50% and 75% respectively. Growing and maintenance doses should be adjusted depending on clinical response.

Пациентам со значительным снижением функции почек может быть рекомендовано снижение поддерживающей дозы.

Side effect

Information about adverse drug reactions is divided into 2 section: adverse reactions in patients with epilepsy and adverse reactions in patients with bipolar disorder. However, when considering the safety profile of lamotrigine is generally necessary to take into account the information of both sections.

We use the following classification of conventional frequency of adverse reactions: Often (>1/10), often (>1/100, <1/10), sometimes (>1/1000, < 1/100), rarely (>1/10 000, <1/1000), rarely (<1/10 000).

In patients with epilepsy

Dermatological reactions: monotherapy: Often – skin rashes; при других видах клинического применения: Often – skin rashes; rarely – Stevens-Johnson syndrome; rarely – toxic epidermal necrolysis.

Rash, mainly maculopapular nature, usually it appears for the first 8 weeks after initiation of therapy and goes after drug withdrawal.

There are reports of rare cases of severe, potentially life-threatening lesions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome). Although in most cases to remove the drug occurred regression of symptoms, some patients were irreversible scars, and in rare cases have been reported deaths, drug-related. The overall risk of rash was largely associated with high initial doses of lamotrigine and exceeding the recommended dose rate of increase of lamotrigine, with concomitant administration of valproate. Development of the rash was also seen as a manifestation of a hypersensitivity syndrome, associated with various systemic manifestations.

From the hematopoietic system: rarely – neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplasticheskaya anemia, agranulocytosis. Hematologic abnormalities may be, or may not be associated with hypersensitivity syndrome.

On the part of the immune system: rarely – hypersensitivity syndrome (including symptoms such as fever, lymphadenopathy, swelling of the face, disorders of the blood and liver function, DIC, multiorgan disorders). The rash is also seen as part of a hypersensitivity syndrome. It is important to note, that early manifestations of hypersensitivity (ie. fever, lymphadenopathy) can occur even in the absence of clear signs of a rash. With the development of these symptoms the patient should seek medical advice immediately and, if not installed another reason symptoms, lamotrigine should be abolished.

CNS: monotherapy: Often – irritability, headache; often – drowsiness, insomnia, dizziness, tremor; sometimes – ataxia, aggressiveness; rarely – tics, hallucinations, confusion; при других видах клинического применения: Often – headache, dizziness; often – irritability, nistagmo, tremor, ataxia, drowsiness, insomnia; sometimes – aggressiveness; rarely – tics, hallucinations, confusion, ažitaciâ, instability, movement disorders, worsening of symptoms of Parkinson's disease, extrapyramidal disorder, Choreoathetosis, increase in the frequency of seizures.

From the senses: Often – diplopia, blurred vision; rarely – conjunctivitis.

From the digestive system: monotherapy: often – nausea; при других видах клинического применения: often – nausea, diarrhea.

From the hepatobiliary system: очень редко – повышение уровней печеночных ферментов, abnormal liver function, hepatic failure. Liver dysfunction usually occurs in combination with symptoms hyperreactivity, but in a few cases were noted in the absence of overt signs of hypersensitivity.

Other: often – fatiguability; rarely – lupus-like syndrome.

У пациентов с биполярным нарушением

Dermatological reactions: Often – skin rash; rarely – Stevens-Johnson syndrome.

CNS: Often – headache; often – ažitaciâ, drowsiness, dizziness.

On the part of the musculoskeletal system: often – arthralgia, backache.

Other: often – pain.

Contraindications

- Children up to age 2 years;

- Hypersensitivity to lamotrigine or to any component of the drug.

FROM caution designate of renal failure.

Pregnancy and lactation

Конвульсан должен назначаться при беременности только в том случае, если ожидаемая терапевтическая польза для матери превышает потенциальный риск для плода. Physiological changes, developing during pregnancy, can influence the level of lamotrigine and / or therapeutic effects. Имеются сообщения о снижении концентрации ламотриджина при беременности.

Ламотриджин выделяется с грудным молоком и определяется в грудном молоке в концентрациях, components 40-60% от его концентрации в плазме матери. При необходимости назначения Конвульсана в период лактации следует соотносить потенциальную пользу грудного вскармливания и потенциальный риск развития побочных эффектов у ребенка.

Cautions

In children, the risk of severe skin rashes above, than in adults. According to reports the frequency of skin rash, required hospitalization, children, epileptics, It ranged from 1 on 300 to 1 on 100 children.

In children, the initial manifestation of the rash can be mistaken for an infection, therefore it is necessary to take into account the possibility of children's reactions to the drug, manifesting the development of rash and fever during the first 8 weeks of therapy.

Besides, суммарный риск развития сыпи в значительной мере связан с высокой начальной дозой Конвульсана и превышением рекомендуемой скорости повышения его, а также с сочетанным применением с препаратами вальпроевой кислоты.

If you notice a rash all patients (adults and children) They should be immediately examined by a doctor. Acceptance of lamotrigine should be discontinued immediately unless, when it is obvious, that the development of the rash is not related to the drug intake. It is not recommended to resume receiving lamotrigine in cases, when his previous appointment was revoked in connection with the development of skin reactions, unless the expected therapeutic effect of the drug is less than the risk of side effects.

Lamotrigine is a weak inhibitor of dihydrofolate reductase, so the drug for long-term therapy may affect the metabolism of folate. However, it was shown, что ламотриджин не вызывал серьезных изменений содержания гемоглобина, mean corpuscular volume, the concentration of folate in serum (at reception for up to 1 year) or red blood cells (at reception for up to 5 years).

If the patient is receiving any other drug, containing lamotrigine, то он не должен принимать Конвульсан без консультации врача.

Резкая отмена приема Конвульсана, as well as other AEDs, can trigger the development of seizures. If abrupt discontinuation of treatment is not a requirement of security (eg, the appearance of the rash), the dose of lamotrigine should be reduced gradually over 2 weeks.

There are reports, that severe convulsive seizures, including status epilepticus, can lead to rhabdomyolysis, multiorgan disorders and DIC sometimes fatal. Подобные случаи наблюдались и при лечении Конвульсаном.

Возможность совершения суицидальных попыток является характерной особенностью биполярных расстройств, поэтому лечение таких больных должно проводиться под тщательным наблюдением.

Effects on ability to drive vehicles and management mechanisms

Не рекомендуется в период применения препарата заниматься потенциально опасными видами деятельности, require high concentration and speed of psychomotor reactions.

Overdose

Сообщалось об однократном применении Конвульсана в дозе, in excess of the maximum therapeutic 10-20 time. Thus observed following symptoms: nistagmo, ataxia, impaired consciousness and coma.

Treatment: gastric lavage, госпитализация и проведение симптоматической терапии.

Drug Interactions

Average T_1/2 is reduced to approximately 14 ч при одновременном назначении с препаратами, stimulating glucuronidation, Takima how carbamazepine and phenytoin, and rises to an average of 70 ч при совместном назначении с вальпроатом. No data on the ability of lamotrigine to cause clinically significant induction or inhibition of hepatic oxidative enzymes. В этой связи взаимодействия между ламотриджином и препаратами, метаболизирующимися системой ферментов цитохрома Р450, unlikely. Lamotrigine can stimulate its own metabolism, но этот эффект выражен умеренно и не имеет клинически значимых последствий.

Table 4. The influence of other drugs on glucuronidation of lamotrigine

Effect of other oral contraceptives and hormone replacement therapy has not been studied, although they may have a similar effect on the pharmacokinetic parameters of lamotrigine.

Valproate, that inhibit glucuronidation of lamotrigine, reduce the rate of its metabolism and lengthen its average T_1/2 almost 2 times.

Certain antiepileptic drugs (such as phenytoin, Carbamazepine, phenobarbital and primidone), which stimulate metabolizing system in liver enzymes, accelerate the glucuronidation of lamotrigine and its metabolism. It was reported on the development of adverse effects from the CNS, include dizziness, ataksiyu, diplopia, blurred vision and nausea in patients, начавших принимать карбамазепин на фоне терапии Конвульсаном. These symptoms usually resolve after dose reduction carbamazepine. A similar effect was observed in the appointment of lamotrigine and oxcarbazepine in healthy volunteers, result of lower doses has not been studied.

Ламотриджин не вытесняет другие противоэпилептические препараты из связи с белками плазмы крови.

При одновременном приеме ламотриджина в дозе 200 mg dose of oxcarbazepine and 1200 mg, ни окскарбазепин, ни ламотриджин не нарушают метаболизм друг друга.

Lamotrigine dose 100 mg / day does not cause violations of the pharmacokinetics of anhydrous lithium gluconate (by 2 g 2 times / day for 6 days) при их совместном применении.

Multiple dose bupropion inside had no statistically significant effect on the pharmacokinetics of a single dose of lamotrigine and causes a slight increase in the AUC of lamotrigine glucuronide.

Olanzapine doze 15 mg reduces AUC and C_max lamotrigine average 24% and 20% respectively, clinically insignificant. Lamotrigine dose 200 мг не изменяет фармакокинетику оланзапина.

Inhibition of lamotrigine amitriptyline, bupropion, clonazepam, fluoxetine, haloperidol or lorazepam has minimal effect on the formation of the primary metabolite of lamotrigine 2-N-glucuronide.

The study of the metabolism of the liver microsomal enzymes bufuralola, isolated from humans, suggests, that lamotrigine does not reduce the clearance of drugs, predominantly metabolized isoenzymes CYP2D6. The results of in vitro studies also suggest, clozapine, phenelzine, risperidone, sertraline or trazodone are unlikely to affect the clearance of lamotrigine.

Acceptance of combined oral contraceptives, containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel, is approximately two-fold increase in clearance of lamotrigine (after ingestion), which leads to a decrease in AUC and C_max lamotrigine average 52% and 39% respectively. In a week, Free receiving active drug, observed increase in plasma concentrations of lamotrigine, wherein the concentration of lamotrigine, measured at the end of this week before the next dose, on average 2 times higher, than in the period of active treatment.

During equilibrium concentrations in a dose of lamotrigine 300 mg did not affect the pharmacokinetics of ethinyl estradiol – component of a combined oral contraceptive. It noted a slight increase in the clearance of the second component of the oral contraceptive – levonorgestrel, which leads to a decrease in AUC and C_max of levonorgestrel 19% and 12% respectively. Measurement of serum FSH, LH and oestradiol during the study showed a slight decrease in the suppression of ovarian hormonal activity in some women, although measurement of serum levels of progesterone, none of the 16 Women showed no hormonal evidence of ovulation. Effect of moderate increase in levonorgestrel clearance and changes in plasma levels of FSH and LH on ovarian ovulatory activity is not set. The influence of other doses of lamotrigine (Besides 300 mg / day) It has not been studied and studies with the inclusion of other hormonal preparations have not been conducted.

Rifampicin enhances clearance of lamotrigine and reduces its T_1/2 by stimulating the liver enzymes, responsible for glucuronidation. Patients, receiving rifampicin as concomitant therapy, lamotrigine assignment mode must match the pattern, Recommended with a joint appointment of lamotrigine and funds, stimulating glucuronidation.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 30 ° C. Shelf life – 3 year.