Lamotrigine Tablets

Pharmacological studies have shown that lamotrigine is a sodium channel blocker that blocks voltage-dependent high-frequency discharges in cultured neurons, inhibits pathological glutamate release (an amino acid that plays a key role in the formation of epileptic seizures), and also inhibits the burst of action potentials induced by glutamate.

The chemical name of lamotrigine is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine.

Anti-epileptic treatment is used for simple partial seizures; complex partial seizures; secondary generalized tonic-clonic seizures; primary generalized tonic-clonic seizures. It can also treat Lennox-Gastaut syndrome in refractory epilepsy.

Usage: Oral administration, spread in a small amount of water or swallow the whole tablet with a small amount of water. Dosage: Monotherapy: Patients over 12 years old: Starting dose 25mg/day, once, for 14 consecutive days. Then 50mg/day, once, for 14 consecutive days. Thereafter, increase the dose every 14 days, the maximum increase is 50-100mg, and can be increased to 100-200mg/day, once or twice. It can be increased or decreased as appropriate according to the condition, see the instructions or follow the doctor's advice for details.

In double-blind, add-on clinical trials, the incidence of rash was as high as 10% in patients taking lamotrigine and 5% in patients taking placebo. Rash led to discontinuation of lamotrigine treatment in 2% of patients. This rash is generally maculopapular in appearance, usually appears in the first 8 weeks of treatment, and disappears after discontinuation of lamotrigine. Rare, severe, and potentially life-threatening rashes have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome). Although most patients recover after discontinuation of the drug, some patients experience irreversible scarring, and rare cases associated with death have occurred. Reports of severe rash, such as adults and children over 12 years old, have an incidence of about 1:1000. Children under 12 years old are at higher risk than adults. Studies have shown that the rate of rash and hospitalization in children under 12 years old is 1:300 to 1:100. Children's initial rash may be mistaken for infection; in the first 8 weeks of treatment with this product, if a child develops rash and fever, the doctor should consider the possibility of a drug reaction. In addition, the overall risk of developing a rash is strongly associated with the following factors: the initial dose of lamotrigine is too high and the subsequent dose increase exceeds the recommended dose. Concomitant use of sodium valproate. All patients (adults and children) who develop a rash should be evaluated promptly and lamotrigine should be discontinued immediately unless it can be confirmed that the rash is not related to the drug. There are also reports that the rash is part of an allergic syndrome with various forms of systemic symptoms, including fever, lymphadenopathy, facial edema, and blood and liver abnormalities. The severity of the clinical reaction caused by this syndrome varies greatly; disseminated intravascular coagulation (DIC) and multi-organ failure are rare. Even if the rash is not obvious, it is very important to pay attention to the early manifestations of allergic reactions (such as fever, lymphadenopathy). If symptoms and signs occur, the patient should be informed to seek medical attention immediately. If signs and symptoms of early reactions occur, the patient should be evaluated immediately; if no other cause can be determined, the product should be discontinued. In the trial of Lamictal monotherapy, adverse reactions reported included headache, fatigue, rash, nausea, dizziness, drowsiness and insomnia. Other adverse experiences include diplopia, blurred vision, conjunctivitis, dizziness, drowsiness, headache, fatigue, gastrointestinal disturbances (including vomiting and diarrhea), irritability/aggression, ataxia, anxiety, confusion and hallucinations. There have been reports of hematological abnormalities related to or unrelated to allergic syndrome, including neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia and very rare aplastic anemia and agranulocytosis. There have been reports of movement disorders such as convulsions, restlessness, ataxia, nystagmus and tremors. There have been reports of patients with pre-existing Parkinson's disease taking this product to aggravate their Parkinson's symptoms, and individual reports of extrapyramidal effects and chorea and athetosis. There have been reports of elevated liver function tests, and rare reports of liver function abnormalities including liver failure. The appearance of abnormal liver function is usually related to allergic reactions, but there have also been reports of individual cases without obvious signs of allergy.

Contraindicated in patients with known hypersensitivity to lamotrigine or any of the ingredients in this product.

Antiepileptic drugs that induce hepatic drug-metabolizing enzymes (such as phenytoin, carbamazepine, phenobarbital, and primidone) will enhance the metabolism of lamotrigine and require an increased dose. Sodium valproate competes with lamotrigine for hepatic drug-metabolizing enzymes, which can reduce the metabolism of lamotrigine and increase the average half-life of lamotrigine by nearly two times. There is no evidence that lamotrigine can produce clinically significant induction or inhibition of hepatic oxidative drug-metabolizing enzymes. Lamotrigine can induce its own metabolism, but this effect is limited and has no obvious clinical significance. Although changes in the plasma concentrations of other antiepileptic drugs when used in combination with this product have been reported, controlled studies have not shown that this product has any effect on the plasma concentrations of other combined antiepileptic drugs. In vitro test results show that lamotrigine cannot displace other antiepileptic drugs from protein binding sites. Patients who are taking carbamazepine have reported central nervous system reactions after taking lamotrigine, including headache, nausea, blurred vision, dizziness, diplopia, and ataxia. These reactions usually disappear after reducing the carbamazepine dose. In a study of 12 female volunteers, lamotrigine did not affect plasma concentrations of ethinyl estradiol and levonorgestrel after oral contraceptive administration. However, any changes in menstrual bleeding should be reported to the physician in patients taking oral contraceptives while on other chronic therapy.

Store below 30℃ in a dry place.

100 mg/tablet