GUANGSHENGTANG HEGANDING Lamivudine Tablets For Hepatitis 0.1g*14

[Drug Name]
Generic Name: Lamivudine Tablets
Trade Name: Heganding
English Name: Lamivudine Tablets
Chinese Pinyin: LaMiFuDingPian

[Ingredients]
The main ingredient of this product is lamivudine.

[Properties]
This product is a film-coated tablet that appears white after removal of the film coating.

[Indications]
It is indicated for chronic hepatitis B with hepatitis B virus replication.

[Dosage]
Oral administration: Adults, 0.1g once daily.

[Adverse Reactions]
Common adverse reactions include upper respiratory tract infection-like symptoms, headache, nausea, malaise, abdominal pain, and diarrhea. Symptoms are generally mild and resolve spontaneously.

[Contraindications]
1. This product is contraindicated in patients with allergies.
2. This product should be used with caution in patients within three months of pregnancy. Breastfeeding women should suspend breastfeeding while taking this product.

[Precautions]
1. During treatment, the patient's clinical condition and virological parameters should be regularly monitored.
2. A small number of patients may experience worsening of hepatitis after discontinuation of this drug. Therefore, if this drug is discontinued, the patient should be closely observed. If hepatitis worsens, re-initiation of treatment should be considered.
3. Renal impairment can affect the excretion of lamivudine. This drug is not recommended for patients with a creatinine clearance of 30 ml/min. Liver damage does not affect the metabolism of lamivudine.
4. During treatment, this drug cannot prevent the patient from transmitting the hepatitis B virus to others through sexual contact or blood-borne transmission. Therefore, appropriate protective measures should still be taken.
5. Currently, there is no data demonstrating that this drug can inhibit mother-to-child transmission of the hepatitis B virus when taken by pregnant women. Therefore, routine hepatitis B vaccination should still be performed on newborns.

[Use in Special Populations]
Precautions for Children: Efficacy and safety data are currently unavailable for patients under 16 years of age.

Precautions for Pregnancy and Lactation: Use with caution in patients within 3 months of pregnancy.

Precautions for Elderly Patients: Lamivudine metabolism does not significantly change in elderly patients with decreased renal excretion due to aging. Lamivudine metabolism is only affected when the creatinine clearance is 30 ml/min.

[Drug Interactions]
1. When lamivudine is used concomitantly with drugs that share the same excretion mechanism (such as trimethoprim and sulfamethoxazole), lamivudine blood concentrations may increase by 40%. This is not clinically significant, but patients with renal impairment should exercise caution. 2. Coadministration with zidovudine may increase the latter's peak blood concentration (Cmax), but does not affect the elimination or area under the concentration-time curve of either drug.

[Pharmacological Actions]
Lamivudine is a nucleoside antiviral drug. It has a strong inhibitory effect on hepatitis B virus (HBV) in vitro and in experimentally infected animals. Lamivudine is metabolized in HBV-infected and normal cells to form lamivudine triphosphate, the active form of lamivudine, which is both an inhibitor and substrate of HBV polymerase. Lamivudine triphosphate incorporates into viral DNA chains, blocking viral DNA synthesis. Lamivudine triphosphate does not interfere with normal cellular deoxynucleoside metabolism. It has a weak inhibitory effect on mammalian DNA polymerases a and b and has little effect on mammalian cellular DNA content. Lamivudine has no significant toxicity to mitochondrial structure, DNA content, or function. Serum HBV DNA testing in most hepatitis B patients demonstrates that lamivudine rapidly inhibits HBV replication, with this inhibitory effect persisting throughout treatment, while also reducing serum aminotransferase levels to normal.

Storage: Store below 30°C.

Specifications: 0.1g

Packaging: 0.1g x 14 tablets

Expiration Date: 24 months

Approval Number: National Medicine Standard H20113025

Manufacturer: Fujian Guangshengtang Pharmaceutical Co., Ltd.