Adefovir Dipivoxil Capsules

1. Chronic toxicity: In animal experiments, tubular nephropathy characterized by histological changes and/or increased urea nitrogen and serum creatinine is the main dose-limiting toxic reaction of adefovir dipivoxil. The exposure observed in animal experiments for renal toxicity is about 3 to 10 times that of the recommended human therapeutic dose (10 mg/day). 2. Genotoxicity: In the in vitro mouse lymphocytoma test (with or without metabolic activation), adefovir dipivoxil has a mutagenic effect. In the human peripheral blood lymphocyte test, adefovir dipivoxil can induce chromosomal aberrations without metabolic activation. The results of the mouse micronucleus test of adefovir dipivoxil were negative, and the results of the Ames test of adefovir with or without metabolic activation were negative. 3. Reproductive toxicity: When the exposure is about 19 times the exposure at the human therapeutic dose, no effect on rat fertility is observed. Rats and rabbits were orally given adefovir dipivoxil (exposures are approximately 23 and 40 times the human therapeutic dose of 10 mg/day, respectively), and no embryotoxicity and teratogenicity were observed. Pregnant rats were given adefovir intravenously, and at doses that could produce significant maternal toxicity (equivalent to 38 times the human exposure), the incidence of embryotoxicity and fetal malformations (systemic edema, sunken eyelids, umbilical hernia and tail kinking) increased. No adverse effects were observed at intravenous doses equivalent to 12 times the human exposure. 4. Carcinogenicity: No carcinogenic effect was observed when mice and rats were orally given adefovir dipivoxil at doses equivalent to 10 times and 4 times the human therapeutic dose, respectively.

The main ingredient of this product is adefovir dipivoxil.

This product is a hard capsule, and the contents are white or off-white granules or powder.

This product is suitable for the treatment of adult patients with chronic hepatitis B who have evidence of active replication of hepatitis B virus and compensated liver function with persistent elevation of serum amino acid transferase (ALT or AST) or active liver histological lesions.

Patients must use this product under the guidance of a physician who has experience in treating chronic hepatitis B. 1. The recommended dose for adults (18 to 65 years old) is 10 mg once a day, orally before or after meals. 2. The best course of treatment has not yet been determined. Do not exceed the recommended dose. 3. Patients should regularly monitor hepatitis B biochemical indicators, virological indicators and serum markers, at least once every 6 months.

Weakness, headache, abdominal pain, nausea, flatulence, diarrhoea, and indigestion.

Adefovir dipivoxil is contraindicated in patients with confirmed hypersensitivity to any component of this product.

Precautions for children: The efficacy and safety of adefovir dipivoxil in patients under 18 years of age have not been determined. This product should not be used in children and adolescents. Precautions for pregnancy and lactation: The effects of pregnant women and adefovir dipivoxil on mother-to-child transmission of HBV have not been studied. Therefore, infants should be immunized to prevent them from being infected with hepatitis B virus. It is not known whether adefovir is secreted into human breast milk. Lactating women should avoid breastfeeding when using this product. Precautions for the elderly: The efficacy and safety of adefovir dipivoxil in elderly patients over 65 years of age have not been determined.

1. Adefovir dipivoxil is rapidly converted to adefovir in the body. At concentrations significantly higher than those observed in vivo (4000 times), adefovir has no inhibitory effect on any of the following common human CYP450 enzymes: CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Adefovir is not a substrate for these enzymes. However, it is not clear whether adefovir induces CYP450 enzymes. 2. Based on the results of in vitro experiments and the renal elimination pathway of adefovir, the possibility of adefovir interacting with other drugs mediated by CYP450 as an inhibitor or substrate is very small. Adefovir is excreted through the kidneys by glomerular filtration and active tubular secretion. The combined use of 10 mg of adefovir dipivoxil with other drugs secreted by the renal tubules or drugs that change the secretory function of the renal tubules can increase the serum concentration of adefovir dipivoxil or the combined drug. The pharmacokinetic properties of both drugs are unchanged when 10 mg of adefovir dipivoxil is co-administered with 100 mg of lamivudine. Caution should be exercised when 10 mg of adefovir dipivoxil is co-administered with drugs that are actively secreted by the renal tubules, because the two drugs compete for the same elimination pathway, which may cause an increase in the serum concentration of adefovir or the co-administered drug.

Store in a cool, sealed container.

10 mg

24 months

CHIA TAI Tianqing Pharmaceutical Group Co., Ltd.

• Founded in:

  1997-04-16

• Address:

  No. 369, Yuzhou South Road, Lianyungang City, Jiangsu Province

• Tax NO.:

  91320000608398264T

• Registered Funds:

  890 million yuan

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