Lamictal 50mg GSK tablets treat epilepsy and prevent bipolar disorder (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Lamotrigine

Ingredient

Composition information	Content
Lamotrigine	50mg

Uses

indications

Lamictal medicine are indicated in the following cases:

epilepsy:

Adults (over 12 years old): Lamictal is appointed to use in combination or single therapy in the treatment of local epilepsy and total epilepsy, including spasms - convulsions and convulsions in Lennox syndrome - Gastaut.

Children (from 2 to 12 years old): The set and sequential epilepsy, including spasms - convulsions and seizures in Lennox - Gastaut syndrome.

Lamictal is indicated to use monomers for typical consciousness.

bipolar disorder:

Adults (from 18 years of age): Lamictal is indicated to prevent temperament changes in patients with bipolar disorders, mainly to prevent depression .

Pharmacology

lamotrigine is an inhibitor of sodium channels that depend on the use. Lamotrigine also inhibits the release of glutamate disease (amino acid plays a major role in the generation of seizures), as well as inhibiting the sudden outbreak of the Glutamate release voltage.

pharmacokinetics

Lamotrigine absorbs quickly and completely from the intestine, initially transformed through the liver is negligible. The drug is associated with plasma protein about 55%; It is likely that the occupation of plasma proteins leads to toxicity. UDP-Glucuronyl Transferase is enzyme responsible for transforming Lamotrigine.

Lamotrigine clearance is mainly in the form of metabolic with the next excretion of the substance combined with glucuronid in the urine. Under 10% of the drug is eliminated in the urine in the form of constant. Only about 2% of the metabolic substance of elimination drugs through feces.

Before taking Lamictal 50mg GSK tablets treat epilepsy and prevent bipolar disorder (3 blisters x 10 tablets)

How to use

should swallow both tablets, do not chew or grind.

If the dose cannot be divided into multiple tablets with a lower content for patients (such as for children with epilepsy or patients with liver impairment), the dosage should be used with the nearest low content of the whole pills.

Dosage

Epick treatment:

Adults (over 12 years):

The starting dose in single therapy is 25mg once a day for 2 weeks, followed by 50mg once a day for the next 2 weeks. After that, the dose should be increased, up to 50 to 100 mg every 1 to 2 weeks until the optimal response is achieved. Some patients need 500mg of Lamictal/day to achieve the expected response.

Children (2 years old to 12 years old):

Typical consciousness: week 1 - 2: 0.3mg/kg (divided 1 or 2 times). Week 3 - 4: 0.6mg/kg (divided 1 or 2 times). Maintenance dose: increase 0.6mg/kg every 1 to 2 weeks to reach the maintenance dose of 1 - 10mg/kg/day (divided 1 or 2 times) to a maximum of 200mg/day.

Valproate combination treatment: week 1 - 2: 0.15mg/kg (1 time/day). Week 3 - 4: 0.3mg/kg (1 time/day). Maintenance dose: increase 0.3mg/kg every 1 to 2 weeks to reach the maintenance dose of 1 - 5mg/kg/day (divided 1 or 2 times) to a maximum of 200mg/day.

Combined treatment does not use valproate:

Should be used with phenytoine , carbamazepine, phenobarbital, primidone or with other lamotrigine glucuronide induction drugs: week 1 - 2: 0.6 mg/kg (divided 2 times). Week 3 - 4: 1.2 mg/kg (divided 2 times). Maintenance dose: increase 1.2mg/kg every 1 to 2 weeks to reach the maintenance dose of 5 - 15mg/kg/day (divided 1 or 2 times) to up to 400 mg/day. Week 3 - 4: 0.6mg/kg (divided 1 or 2 times). Maintenance dose: increase 0.6mg/kg every 1 to 2 weeks to reach the maintenance dose of 1 - 10mg/kg/day (divided 1 or 2 times) to a maximum of 200mg/day.

Children under 2 years old:

Lamotrigine has not been studied for monomers in children under 2 years of age or combined treatment in children younger than 1 month old. It is unknown the safety and effectiveness of Lamotrigine in the treatment of local epilepsy in children from 1 month of age to 2 years old. Therefore, it should not be used for lamictal for children under 2 years old.

bipolar disorder:

Adults (from 18 years old):

Additional treatment with lamotrigine glucuronide inhibitors such as valproate: week 1 - 2: 12.5mg (drink 25mg daily). Week 3 - 4: 25mg (1 time/day). Week 5: 50mg (divided 1 or 2 times/day). Stable dose to be achieved (week 6): 100mg (divided 1 or 2 times/day) until the maximum dose is 200mg/day.

Additional treatment with lamotrigine glucuronide induction drugs in patients who do not use valproate (should use this dosage with phenytoin, carbamazepine, phenobarbital, primidone or with lamotrigine glucurigine induction drugs): week 1 - 2: 50mg (1 time/day). Week 3 - 4: 100mg (divided 2 times/day). Week 5: 200mg (divided 2 times/day). Stable dose to be achieved (week 6): 300mg/day, up to 400mg/day if necessary in the 7th week (divided 2 times/day).

Single treatment with Lamictal or additional treatment in patients who are taking other drugs without any inhibition or significant induction of Lamotrigine glucuronid: week 1 - 2: 25mg (1 time/day). Week 3 - 4: 50mg (divided 1 or 2 times/day). Week 5: 100mg (divided 1 or 2 times/day). Stable dose to be achieved (week 6): 200mg (from 100 to 400mg) (divided 1 or 2 times/day).

Children and teenagers (under 18 years old):

Do not be indicated because it has not established safety and effectiveness in this age group.

Patients with renal failure:

Lamotrigine concentration in plasma does not change significantly in the only dose studies in patients with end -stage renal impairment. However, there is a accumulation of glucuronid metabolites; Should be cautious when treating patients with renal failure.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? The overdose symptoms include eyeball vibration, loss of movement air conditioning, consciousness, great epilepsy and coma. Also observed that there is a wide range of QRS complexes on an overdose.

In case of overdose, patients should be hospitalized and treated appropriately according to clinical manifestations or instructions of the National Poison Control Center if any.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using lamictal pills , you may experience unwanted effects (ADR).

Common, very common: ADR> 1/100:

Skin: Ban on the skin;

Mental: irritable, irritated; Neurology: headache, drowsiness, insomnia, dizziness, tremor; Digestive: Nausea, vomiting, diarrhea ;

Body and on -site: Fatigue;

musculoskeletal joints: joint pain, back pain .

Rare, very rare: ADR

Skin and subcutaneous tissue: Stevens Johnson syndrome, poisoned epidermal necrosis, hair loss;

Hematology: leukopenia, anemia, thrombocytopenia, lymphadenopathy, blood cell syndrome; immune: Hypersensitivity syndrome;

Mental: Scrambling, hallucinations, confusion, nightmares;

Neurological: loss of movement air conditioner, eyeball vibration, sterile meningitis sterile, dancing, external impact, disease Parkinson worse, increased frequency of seizures;

Eyes: Song, blurred vision, conjunctivitis;

liver: liver dysfunction, liver failure;

musculoskeletal: Lupus reactions.

Instructions on how to handle ADR:

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindications:

Lamictal drugs for patients who have known hypersensitivity to lamotrigine or any ingredients of the drug.

Be cautious when using

The skin on the skin usually appears within 8 weeks after starting with lamictal treatment and most of these rashes are light and limited. However, there were also reports on severe hospitalized committee such as Stevens - Johnson syndrome and epidermal necrosis. Be cautious when using drugs for patients with a history of allergies or rashes when using other anti -epileptic drugs.

Bloody factor syndrome has occurred in patients using Lamictal.

Symptoms of depression and/or bipolar disorder may appear in epilepsy patients and have evidence of high risk of suicide in epilepsy and bipolar disorders.

It is necessary to closely monitor the deteriorating clinical signs (including new symptoms) and the risk of suicide in patients using Lamictal to treat bipolar disorders.

Patients using combined contraceptives in most cases need lamotrigine to maintain higher doses (to double) to achieve maximum treatment response. In addition, Lamictal can also reduce the effectiveness of birth control pills in some patients using hormone -containing preparations along with Lamictal.

Lamictal inhibits the excretion of renal tubular excretion through the protein oct 2, does not recommend simultaneously with the mainly eliminated substances through the OCT 2 path with a narrow treatment index such as dofetilide.

The Brugada ECG has been observed in patients taking the drug. Be careful when used in patients with Brugada syndrome.

Stop using sudden blue blue can cause reaction convulsions. Lamictal dose should be reduced slowly for 2 weeks unless it is necessary to stop sudden for safety reasons (such as rash).

The ability to drive and operate machinery

Two studies on volunteers show that the drug affects the delicate visual mobilization, eye movement, sway and subjective sedative impact is not different from placebo. Neurological side effects such as dizziness and market have been reported. Therefore, patients should consider how treatment will affect them before driving or operating machinery.

Pregnancy

data after bringing the drug to the market to record more than 8,700 women who use lamictal treatment in the first 3 months of pregnancy without suggesting a significant increase in the risk of serious birth defects, although the data from a small number of registered studies has an increase in the risk of an open -mouth deformity, when a controller has an increase Another serious congenital after using Lamotrigine.

Only use Lamictal during pregnancy when the benefits are superior to the risk of the body.

Physiological changes during pregnancy may affect lamotrigine levels and/or therapeutic effectiveness. There was a report on the reduced lamotrigine concentration during pregnancy. It is advisable to ensure the appropriate clinical management for pregnant women during the time of lamictal.

The period of breastfeeding

lamotrigine through breast milk with very changing concentrations, resulting in lamotrigine concentration in children up to nearly 50% of the mother's concentration. Therefore, in some breastfeeding babies, the lamotrigine level in serum reaches the level of pharmacological effects. The benefits of breastfeeding should be considered compared to the risk of side effects in children

Drug interaction

drugs that can cause induction or inhibition of glucuronids can affect the clearance of Lamotrigine. Medium or strong touch substances Cytochrome P450 3A4 (CYP3A4), which is also known to cause UDP-Glucuronyl Transferase touch may also increase the metabolism of Lamotrigine.

Therefore lamotrigine interacts with other anti-epileptic drugs such as Valproate (inhibiting lamotrigine glucuronide) and a group of anti-epileptic drugs that touch the cytochrom P450 enzymes, including UDP-glucuronyl transferase (Phenytoine, Carbamazepine, Phenobarbital, Primidone).

The use of contraceptives combined causes increased oral lamotrigine's clearance to about 2 times.

Storage

Do not store more than 30 ° C. Store in a dry place.

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