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.

This product is light yellow, square-shaped tablets.

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 cessation of lamotrigine. Rare, serious, 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 have experienced irreversible scarring, and rare cases associated with death have occurred. Severe rashes have been reported, with an incidence of approximately 1:1000 in adults and children over 12 years of age. Children under 12 years of age may develop rashes.

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

Precautions for children: Monotherapy dose: Children aged two to twelve years: Because the data obtained from the corresponding studies on children are not sufficient, it is impossible to recommend the dose for monotherapy for children under twelve years old. Precautions for pregnancy and lactation: 1. Fertility: In animal reproduction experiments, this product does not impair fertility. There is no experience with the effect of this product on human fertility. 2. Teratogenicity: This product is a weak dihydrofolate reductase inhibitor. When pregnant mothers use folic acid inhibitors for treatment, there is a theoretical risk of fetal teratogenicity. However, in animal reproductive toxicity studies, lamotrigine doses exceeding human therapeutic doses did not cause teratogenic effects. 3. Pregnancy: There is insufficient data on the use of lamotrigine during human pregnancy, and its safety cannot be evaluated. Lamotrigine should not be used during pregnancy, or the pros and cons should be weighed. 4. Lactation: There is limited data on the use of lamotrigine during lactation. Preliminary data show that lamotrigine can enter breast milk, and its concentration can usually reach 40-60% of the plasma concentration. In the few infants known to be breastfed, Elderly Precautions: The pharmacokinetics of lamotrigine in the elderly do not differ significantly from those in younger adults, so no dose adjustment is required to the recommended regimen.

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.

25 mg

36 months

Sanjin Group Hunan Sanjin Pharmaceutical Co., Ltd.

• Founded in:

  2000-01-19

• Address:

  No. 320, Deshan Avenue, Chongde Residential Committee, Deshan Town, Changde Economic and Technological Development Zone

• Tax NO.:

  9143070072794757X4

• Registered Funds:

  160 million yuan

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