Lamotrigine 50mg tablet Savi treatment of epilepsy (3 blisters x 10 tablets)

Should use this mode with phenytoin, carbamazepin, phenobarbital primidon or with other drugs that induce lamotrigin glucuronid.

Should gradually reduce the dose of Lamotrigin for 3 weeks when stopping using glucuronide induction drugs.

Maintain the necessary dose achieved in the process of increasing the dose when stopping other drugs.

Dosage: 200 mg/day, divided 2 times.

The dose is from 100 to 400 mg.

Note: In patients who are taking other anti -epileptic drugs without knowing whether or not to interact with lamotrigin or not, the treatment regime for Lamotrigin is at first maintain the current dose level and adjust the lamotrigin dose according to clinical response.

* can increase the dose to 400mg/day if needed.

Adjust the daily dose of lamotrigin for patients with bipolar disorders after taking additional drugs: no clinical experience in adjusting the daily dose of Lamotrigin after taking other drugs. However, based on studies on drug interaction, the drug can be used as proposed below:

Clinical trials

Lamotrigin has been evaluated for safety in patients with epilepsy and patients with bipolar disorders. The adverse reaction was reported to each patient population listed below. The adverse reactions have been excluded as overall to obtain information and inappropriate reasons for drug use.

epilepsy

The most common adverse reaction in all clinical studies when supporting support in adults with epilepsy:

The most common (≥ 5% of Lamotrigin's adverse reactions and more commonly common in placebo) is related to Lamotrigin during the testing phase when supporting support in adults and does not see the equivalent frequency in the placebo patient dizziness, loss of air conditioning, drowsiness, headache, double vision, nausea, vomiting and rash.

Dizziness, look, loss of air conditioning, vision blurring, nausea and vomiting are associated with dose. Dizziness, double view, loss of air conditioning and blurred vision occur more common in patients who receive carbamazepin along with Lamotrigin rather than in patients who receive other AEDs with Lamotrigin.

Clinical data shows that there is a higher proportion of rash, including a serious erythema in patients who receive Valproat simultaneously compared to patients who do not receive Valproat. About 11% of a total of 3,378 adult patients who receive abuse of abuse such as supplementary treatment therapy in clinical marketing trials must stop treatment due to adverse reactions. The most common side effects involved in the suspension are rash (3.0%), dizziness (2.8%), headache (2.5%). In a dose study in adults, the percentage of abuse of abuse due to dizziness, loss of air conditioning, double vision, vision, nausea and vomiting is related to the dose.

Single therapy in adults with epilepsy:

The most common (≥ 5% of Lamotrigin's adverse reactions and more commonly in the placebo) is related to the use of Lamotrigin in the monotherapy of the testing phase in adults without seeing the equivalent rate in the control group of vomiting, abnormal coordination, indigestion, nausea, dizziness, nose inflammation, anxiety, infection, pain, pain, and pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain, pain.

The most common (≥ 5% of the adverse reaction of Lamotrigin and more common in the drug compared to the placebo) is related to Lamotrigin while switching to the extra therapy (Addon) and does not see an equivalent frequency in the group of patients treated with low doses of Valproot dizziness, headache, nausea, abnormalities, vomiting, intensity, intensity, intensity, intensity, intensity, loss of trauma. Run, blurred vision, insomnia, eyeball, diarrhea, lymph nodes, itching and sinusitis.

About 10% of a total of 420 adult patients who receive Lamotrigin as single therapy in clinical trials before being launched to the market must stop treatment because of the adverse reaction. The most common adverse reactions related to the suspension are rash (4.5%), headache (3.1%) and weak body (2.4%).

Diphipitudes

The most common (≥ 5%) emergency emergency on adverse reactions is related to the use of lamotrigin as single therapy (100 to 400 mg/day) in adults (≥ 18 years old) with bipolar disorders in two controlled blind tests with placebo, 18 -month period and frequent frequency higher than patients who receive placebo.

The adverse reaction occurs in at least 5%of patients and frequencies more common in the lamotrigin's dose increasing stage in the tests (when the patient may have been treated with simultaneous medications) compared to the single -treatment period of headache (25%), rash (11%), dizziness (10%), diarrhea (8%), abnormal dreams (6%).

Mild -intensity adverse adverse reactions. Other reactions occur in 5% of patients or more, which are equal to or higher than the placebo groups are dizziness, manic, headache, infection, influenza, aches, injuries due to accidents, diarrhea and digestive disorders.

The adverse reaction occurs with a frequency lower than 5% and greater than 1% of patients who receive Lamotrigin and more often more common than placebo:

In 2 maintenance dose tests, there is no increase in severity of severity or adverse reactions in patients with bipolar disorder after sudden termination of treatment with Lamotrigin. In clinical trials with patients with bipolar disorder, two patients with convulsions immediately after sudden discontinuation of the abuse. However, there are also other factors that can contribute to the appearance of seizures in dipole disorders.

Symptoms of mild crazy/mild mood/mixed mood:

In double blind clinical trials, with placebo, the patient is transferred from psychotropic medicine to lamotrigin therapy (dose of 100 mg to 400 mg/ day) and monitored for 18 months, mild ratio or mixed mood stages are reported as adverse reactions at about 5% for patients treated with lamotrigin (n = 227) Lithi (n = 166) and 7% for patients treated with placebo (n = 190).

In all bipolar trials with control, adverse reactions such as mild mania (including mild mania and mixed mood stages) were reported at 5% of patients treated with lamotrigin (n = 956) 3% of patients treated with lithium (n = 280), and 4% of patients treated with placebo (n = 803).

Other adverse reactions are observed in all clinical trials

Lamotrigin has been used for 6,694 patients with complete adverse reaction data gathered all clinical trials, only a few of them are in control with placebo.

Common, ADR> 1/100

Precautions when using

* Consider the general dose standard

Warning about serious leather rash

There have been suggestions, although it has not been proven to be at risk of heavy rash, life -threatening, may increase when (1) sharing lamotrigin with Valproat, (2) an overdose to the original lamotrigin or (3) beyond the offer to increase the lamotrigin dose. However, there have been cases where the absence of these factors. Therefore, it is important that drug use recommendations should be closely monitored.

Nearly all cases of life -threatening rashes caused by Lamotrigin have occurred within 2 to 4 weeks of starting treatment. However, the particular case has occurred after prolonged treatment (for example 6 months). Accordingly, the treatment time may not be based on the means to predict the potential risk of the first appearance by the first appearance.

Therefore, it is advisable to stop Lamotrigin when there are the first signs of the rash, unless the rash is clearly not related to the drug. Stop unable to prevent rash becomes a threat of life or permanently disabled.

The risk of heavy rash appears in children in adults. The risk of non -serious rash may increase after the initial proposal and//or exceed the increase in lamotrigin's proposal and in patients with a history of allergies or rashes with other drugs. The dose in accordance with the proposed titration schedule for the first 5 weeks of treatment is based on medications used simultaneously for patients with epilepsy (> 12 years) and bipolar disorder (≥ 18 years old) is intended to help reduce the potential of rash.

It is recommended that Lamotrigin must not be reused for patients to stop the drug due to the previous rash with the previous treatment with Lamotrigin, unless the potential benefits are more clear than the risks. If the decision to reuse for a patient has stopped Lamotrigin for a period of time and longer than 5 semi -deceptive cycles of the drug, it is necessary to recommend and guide the use of the drug in the original lowest dose. Lamotrigin's half -life is affected by other simultaneous medications.

* multi -organ hypersensitivity reactions and physical weakness

Multi -organ hypersensitivity reaction, also known as drug reaction accompanied by eosinophilia and systemic symptoms (Dress = Drug Reaction with Eosinophilia and Systemic Symptons) occurred with Lamotrigin. Some have caused death or life -threatening. Dress symptoms, although not absolutely, manifested in the rash, fever and/or lymphatic disease related to the participation of other organs, such as hepatitis, hematitis, myocarditis or muscleitis, sometimes like an acute virus infection patient. Natural leukocytes often appear. This disorder may change in its manifestation and other organs not noted here can participate.

Cases of deaths related to multi -level viscera weakening and different levels of liver failure have been reported in 2 out of 3,796 adult patients and 4 out of 2,435 children have received Lamotrigin in clinical tests of epilepsy. The rare death from multi -organ failure has also been reported after being used in the market. A separate liver failure without a rash or the participation of other agencies has also been reported to Lamotrigin.

It is important to note that the early manifestation of hypersensitivity (such as fever, enlarged lymphadenopathy) may be present even though the rash is not clear. If there are such signs or symptoms, patients should be evaluated immediately. Lamotrigin should be stopped if there is an alternative to the signs or symptoms due to not being established.

Before starting treatment with lamotrigin, patients need to be instructed on rash or signs or symptoms of sensitivity (such as fever, enlarged lymphadenopathy) that can notice a serious medical event and patients should report any such event to the doctor immediately.

* Blood dyscrentias

There have been reports on blood disorders that may or may not be related to multi -organ hypersensitivity (also known as Dress symptoms). These symptoms include neutropenia, leukopenia, anemia, thrombocytopenia, non -regenerated anemia and rarity of property anemia and property cell property.

* The risk of suicide

Symptoms of depression and/or bipolar disorders may occur in epilepsy patients, and there has been evidence of high risk of suicide in epilepsy and bipolar disorders. About 25-50% of patients with bipolar disorder tries to commit suicide at least once and the symptoms of depression may worsen and/or appear and have suicidal behavior, whether used or not to treat bipolar disorders, including lamotrigin.

There is a report on the behavior and suicide of patients treated with anti -epileptic drugs when used for many indications, including indications for epilepsy and bipolar disorders. An analysis of random tests that are controlled with placebo on epilepsy medications (including Lamotrigin) shows that there is a slight increase in the risk and suicide behavior. It is unknown the mechanism that causes this risk and the available data does not rule out the possibility of increasing this risk when using lamotrigin.

Therefore, it is recommended to monitor the desired signs and suicide behavior of the patient. It should be recommended that patients (and patient care) come for medical advice if the signs of intentional or suicidal behavior appear.

* Using drugs in patients with bipolar disorders

acute treatment of mood changes

Safety and effectiveness of Lamotrigin in acute treatment of symptoms that change mood has not been established.

Children and teenagers under 18 years old

Safety and effectiveness of Lamotrigin in patients aged 18 with mood disorders that have not been established.

Clinical status worsens and the risk of suicide is related to bipolar disorder

Patients with bipolar disorder may worsen with depression symptoms and/or appear intentions and suicide behaviors (suicidality) whether they have or do not use bipolar disorders. Patients must be closely monitored about the deterioration of clinical (including the development of new symptoms) of suicide intentions and behaviors, especially at the beginning of the treatment process or at the time of dose changes. In addition, the patient has a history of suicide behavior or intention, the patient manifests the severity of suicide intentions before starting treatment and young people are at risk of increasing suicide thoughts or suicide behaviors should be monitored by kidneys during treatment.

It is necessary to consider changing the treatment regimen, including being able to stop the drug for the patient who has gone through the deteriorating clinical condition (including the development of new symptoms) and/or the appearance of suicidal intent/act, especially if these symptoms become serious, sudden onset or not part of the patient's symptoms.

LAMOTRIGIN prescription should only be done with the smallest tablet supply, suitable for good management of patients to reduce the risk of overdose. Overdose was reported to Lamotrigin, some of which died.

* Aseptic meningitis

Treatment with Lamotrigin has increased the risk of developing sterile meningitis. Because the potential for serious results of meningitis is not treated for other causes, patients also need to be assessed for other causes of meningitis and appropriate treatment. There have been reports of sterile meningitis after bringing the drug to the market in patients with children and adults to receive abuse of abuse.

These symptoms include headache, fever, nausea, vomiting and stiffness. In some cases, the rash has been recorded, fear of light, muscle pain, chills, a sense of change and drowsiness. These symptoms occur within 1 day to 45 days after the beginning of treatment. In most cases, symptoms are reported on themselves after stopping the drug. Repeating exposure will lead to these symptoms returning quickly (within 30 minutes to a day later to start treatment) and often worse. Some patients treated with Lamotrigin have developed aseptic sterile dysfunction, which is basically diagnosed with systemic erythema lupus or other autoimmune disease.

Cerebrospinal fluid analysis (CSF) at the time of clinical manifestations in cases shows that there are characteristics such as slightly increasing to the average increase in cerebrospinal fluid, normal glucose concentration and slight increase to medium protein content. The number of CSF lymphatic cells counted has a difference and shows the advantage of neutrophils in most cases, although there is a superiority of lymphocytes that have been reported in about 1, cases. Some patients also have new signs and symptoms with the participation of other organs (mainly the participation of the liver and kidneys) can show that in the case of sterile meningitis, there is a part of the hypersensitivity reaction.

* Use simultaneously with oral contraceptive pills (See also the dose part).

* Stopping epilepsy medicine

Similar to other anti -epileptic drugs (AEDS), sudden abuse should not stop pligin. Ability to increase the frequency of convulsions when stopping the drug in patients with epilepsy. In clinical trials in bipolar disorder patients, two patients have experienced seizures right after the sudden discontinuation of the abuse, but there are other factors that may have contributed to the appearance of seizures of dipole disorders. Unless there is a safety problem, it is necessary to stop the drug faster, the lamotrigin dose should be reduced for a period of at least 2 weeks (down about 50% per week).

* Sudden death of unknown cause in epilepsy (sudep)

During Lamotrigin's market development, there were reports of 20 cases of sudden death that was not explained in a study of over 4,700 patients with epilepsy (5,747 patients exposed to the whole year).

The effect of drugs on drivers and operating machinery

due to adverse effects such as vision loss, confusion ... when taking the drug. Patients with epilepsy or bipolar disorder being treated should limit driving and operating machinery.

Use drugs for women during pregnancy and lactation

Pregnancy

There is no adequate and well -controlled studies in pregnant women. Because animal studies are not always predictable to be responded by humans, this drug should be used during pregnancy only if the potential benefits are greater than the risk for the fetus.

Breastfeeding period

Lamotrigin has appeared in breastfeeding women's milk. Data from many small studies shows that lamotrigin concentration in lactating plasma is reported by 50% of serum concentration.

Babies and young children are at higher risk of serum because the serum and milk level of the mother may increase after birth to a high level if the lamotrigin dose has been increased during pregnancy. The benefits of breastfeeding should be considered compared to the risk of side effects in children.

Drug interaction

(A). Lamotrigin's drug interactions are summarized in the table below