GMP Certified/ Lamotrigine Extended-Release Tablets 200mg

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 200mg
• Model NO.: Tablet
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Lamotrigine Extended-Release Tablets 200mg
Strength	200mg
Packing	3*10 tablets /box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Lamotrigine Extended-Release Tablets 200mg

Character:
200 mg, A blue circular film coated tablet with an "A" engraved above "986" on one side and plain on the other.

Indications:
Lamotrigine sustained-release tablets are indicated for the adjunctive treatment of primary generalized tonic-clonic seizures and partial seizures in patients 13 years of age and older, with or without secondary flooding.

Adverse reactions:
Prolonged release of lamotrigine can cause a severe rash that requires hospitalization and discontinuation of treatment. The incidence of these rashes (including Stevens-Johnson syndrome) is approximately 0.8% (8 cases per 1,000) in pediatric patients (2 to 16 years of age) receiving quick-release lamotrigine as adjunctive therapy for epilepsy, compared to 0.3% (3 cases per 1,000) in adults undergoing adjunctive therapy for epilepsy. In a prospective cohort of 1,983 pediatric epilepsy patients (ages 2 to 16 years) who took adjuvant quick-release lamotrigine, there was one rash-related death. Lamotrigine extended release is not indicated for patients younger than 13 years of age. In aftermarket experience worldwide, few cases of toxic epidermal necrosis and/or rash-related deaths have been reported in adults and pediatric patients, but the number is too small to accurately estimate its incidence.

The risk of severe rash from lamotrigine sustained release therapy was not different from the expected risk of rapid release lamotrigine. However, the relatively limited treatment experience with lamotrigine sustained-release therapy makes it difficult to characterize the frequency and risk of severe rashes caused by lamotrigine sustained-release therapy.

Factors other than age that are not yet predictable can predict the risk of lamotrigine-induced development or the severity of the rash. The risk of rash may also be increased by (1) prolonged release of lamotrigine with valproate salts (including valproic acid and divalproate), (2) prolonged release of lamotrigine beyond the recommended initial dose, or (3) dose escalation beyond the recommended extended release of lamotrigine. However, cases have occurred in the absence of these factors.

Almost all cases of life-threatening rashes caused by immediately released lamotrigine occur within 2 to 8 weeks after the start of treatment. However, isolated cases have occurred after prolonged treatment (e.g. 6 months). Therefore, the duration of treatment cannot be relied upon as a means of predicting the potential risk of the first appearance of the rash.

Although benign rashes are also caused by prolonged release of lamotrigine, it is impossible to reliably predict which rashes will prove to be severe or life-threatening. Therefore, unless the rash is clearly unrelated to the drug, the extended release of lamotrigine should usually be stopped at the first signs of rash. Stopping treatment may not prevent the rash from becoming life-threatening or permanently disfigured or disfigured.

Pharmacology and toxicology:
1. Pharmacological effect
Mechanism of action:
The results of pharmacological studies suggest that lamotrigine is a sodium ion high channel blocker with closed voltage application compliance. In cultured nerve cells, it produces an application - and voltage-dependent block of persistent repeated discharge, while inhibiting the release of pathological glutamate, an amino acid that plays a key role in the formation of seizures, as well as inhibiting the burst of glutamate-induced action potentials.
Pharmacodynamics:
In a trial to evaluate the effect of the drug on the central nervous system, healthy volunteers took 240mg of lamotrigine and the results were no different from placebo. However, both 1000mg phenytoin and 10mg Diazepam significantly impaired subtle visual motor coordination and eye movement, increased body swing and produced subjective sedation.
In another study, a single dose of 600mg oral carbamazepine significantly impaired fine visual motor coordination and eye movement, with increased body wobble and heart rate; However, with 150mg and 300mg doses of lamotrigine, there was no difference in results from placebo.
3. Toxicological studies
Mutability:
The results of a wide range of mutagenicity tests indicate that this product has no genetic risk to humans.
Carcinogenicity:
In the long-term study of rats and mice, this product has no carcinogenicity.

Storage:
Store below 30ºC in a dry place.