Product Overview
[Drug Name]
Generic Name: Entecavir Dispersible Tablets
Trade Name: Weiliqing
English Name: Entecavir Dispersible Tablets
Chinese Pinyin: EnTiKaWeiFenSanPian (WeiLiQing)
[Ingredients]
The main ingredient of this product is entecavir. Chemical Name: 2-Amino-9-[(1S,3S,4S)-4-hydroxy-3-hydroxymethyl-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one monohydrate. Molecular Weight: C₁₂H₁₅N₅O₃
[Properties]
This product is a white or off-white tablet.
[Indications]
This product is indicated for the treatment of chronic hepatitis B in adults with active viral replication, persistently elevated serum ALT, or active liver histological lesions.
[Dosage and Administration]
This product should be taken under the guidance of an experienced physician. Recommended Dose: Adults and adolescents 16 years and older should take 0.5 mg orally once daily. Patients who develop viremia or lamivudine-resistant mutations during lamivudine treatment should take 1 mg (two 0.5 mg tablets) once daily. This product should be taken on an empty stomach (at least 2 hours before or after a meal).
[Adverse Reactions]
In international studies, the most common adverse events with this product were headache, fatigue, dizziness, and nausea. Common adverse events in patients treated with lamivudine were headache, fatigue, and dizziness. In these four studies, 1% of patients treated with entecavir and 4% of patients treated with lamivudine withdrew from the study due to adverse events and abnormal laboratory test results, respectively.
[Contraindications]
This product is contraindicated in patients with allergies to any component of the active entecavir formulation.
[Precautions]
The information is not available. Please read the package insert carefully and use according to your doctor's instructions.
[Use in Special Populations]
Precautions for Children:
Safety and efficacy data for this product in children under 16 years of age have not been established.
Precautions During Pregnancy and Breastfeeding:
The effects of entecavir on pregnant women are inadequately studied. This drug should only be used after a thorough balance of potential risks and benefits to the fetus has been made. Currently, there are no data suggesting that this drug affects mother-to-child transmission of HBV. Therefore, appropriate interventions should be implemented to prevent neonatal HBV infection. Entecavir is secreted in rat milk. However, whether it is secreted in human milk remains unclear. Therefore, breastfeeding is not recommended for mothers taking this drug.
Precautions for Elderly Patients:
Due to the lack of sufficient clinical studies with patients aged 65 years and older, it is unclear whether elderly patients respond differently to this drug compared to younger patients. Other clinical trial reports have not found differences between elderly and younger patients. Entecavir is primarily excreted by the kidneys, and the risk of toxic reactions may be higher in patients with renal impairment. Because elderly patients often have decreased renal function, careful consideration should be given to drug dosage selection and renal function monitoring should be performed.
[Drug Interactions]
The metabolism of entecavir has been evaluated in vitro and in vivo. Entecavir is not a substrate, inhibitor, or inducer of the cytochrome P450 (CYP450) enzyme system. At concentrations approximately 10,000 times the human concentration, entecavir does not inhibit any of the major human CYP450 enzymes: 1A2, 2C9, 2C19, 2D6, 3A4, 2B6, and 2E1. At concentrations approximately 340 times the human concentration, entecavir does not induce the following human CYP450 enzymes: 1A2, 2C9, 2C19, 3A4, 3A5, and 2B6. Concomitant administration of drugs that inhibit or induce the CYP450 system has no effect on the pharmacokinetics of entecavir. Furthermore, concomitant administration of entecavir has no effect on the pharmacokinetics of known CYP substrates.
[Pharmacology]
This product is a guanine nucleoside analog that inhibits hepatitis B virus (HBV) polymerase. It can be phosphorylated to form an active triphosphate, which has a half-life of 15 hours in cells. By competing with the natural substrate of HBV polymerase, deoxyguanosine triphosphate, entecavir triphosphate can inhibit all three activities of viral polymerase (reverse transcriptase): (1) initiation of HBV polymerase; (2) formation of the negative strand of pregenomic mRNA reverse transcription; and (3) synthesis of the positive strand of HBV DNA. Entecavir triphosphate has a weak inhibitory effect on cellular α, β, δ DNA polymerases and mitochondrial γ DNA polymerase, with a KI value of 18 to greater than 160 μM.
[Storage] Sealed and stored in a dry place.
[Specification] 0.5 mg*7 tablets
[Packaging specification] Box
[Validity period] 24 months
[Approval number] National Medicine Standard H20100141
[Manufacturer] Company name: Jiangxi Kerui Pharmaceutical Co., Ltd.
