Famciclovir Tablets

1. This product is rapidly converted into the antiviral compound penciclovir in the body, which has an inhibitory effect on herpes simplex virus type Ⅰ (HSV-1), herpes simplex virus type Ⅱ (HSV-2) and varicella zoster virus (VZV). In cell culture studies, the inhibitory effect of penciclovir on the following viruses is ranked in the order of HSV-1, HSV-2, and VZV. 2. The mechanism of action is as follows: In cells infected with the above viruses, viral thymidine kinase phosphorylates penciclovir into penciclovir monophosphate, which is then converted into penciclovir triphosphate by cellular kinase. In vitro studies have shown that penciclovir triphosphate inhibits the activity of HSV-2 polymerase by competing with guanosine triphosphate, thereby selectively inhibiting the synthesis and replication of herpes virus DNA. 3. Carcinogenicity experiments on rats and mice for up to 2 years have confirmed that the incidence of breast cancer in female rats receiving 600 mg/kg/day (equivalent to the recommended human dose of 500 mg, or 125 mg, 1.5 to 9 times twice a day) increased. Testicular toxicity was found in male rats, mice and dogs after taking this product. No reproductive toxicity was observed in female rats taking 1000 mg/kg/day of this product.

The main ingredient of this product is famciclovir.

This product is a film-coated tablet, which appears white or off-white after removing the film coating.

Suitable for herpes zoster and primary genital herpes.

Oral administration, 0.25g each time for adults, 3 times a day, for 7 consecutive days. Patients with renal insufficiency should adjust the usage and dosage according to their renal function. The recommended dose is as follows: Creatinine clearance ≥60ml/min, dose: Adults 0.25g each time, once every 8 hours Creatinine clearance 40-59ml/min, dose: Adults 0.25g each time, once every 12 hours Creatinine clearance 20-39ml/min, dose: Adults 0.25g each time, once every 24 hours Creatinine clearance <20ml/min, dose: Adults 0.125g each time, once every 48 hours Patients with compensated liver disease do not need to adjust the dose, and pharmacokinetic studies have not been conducted on patients with decompensated liver disease.

Common adverse reactions are headache and nausea. In addition, the following reactions may be seen: 1. Nervous system: dizziness, insomnia, drowsiness, paresthesia, etc. 2. Digestive system: diarrhea, abdominal pain, indigestion, anorexia, vomiting, constipation, flatulence, etc. 3. Systemic reactions: fatigue, pain, fever, chills, etc. 4. Other reactions: rash, itchy skin, sinusitis, pharyngitis, etc. 5. Laboratory abnormalities may include increased ALT, AST, increased blood lipase, increased amylase, increased bilirubin, decreased white blood cells, decreased neutrophils, and occasionally increased blood creatinine. It has been reported that patients with renal impairment who use large doses of this product can cause acute renal failure.

Patients who are allergic to this product or penciclovir are contraindicated.

Precautions for children: The safety and effectiveness of this product for patients under 18 years of age have not been determined. Precautions for pregnancy and lactation: No abnormalities were observed in the development of the fetuses of pregnant rats and rabbits after taking this product, but there is a lack of human clinical data. Pregnant women should fully weigh the pros and cons of using this product. Rat experiments have confirmed that the concentration of penciclovir, the precursor of this product, in breast milk is higher than the plasma concentration, but whether it is secreted through human milk is still inconclusive. Lactating women should stop breastfeeding when using this product. Precautions for the elderly: The types and incidence of adverse reactions after taking this product in the elderly over 65 years old are similar to those in young people, but renal function should be monitored before taking the medicine and the dosage should be adjusted in time.

1. When this product is used in combination with probenecid or other drugs that are mainly excreted by the renal tubules, it may lead to an increase in the concentration of penciclovir in plasma. 2. It may interact with other drugs that are metabolized by aldehyde oxidase.

Store in sealed container (10～30℃).

0.25g

30 months

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

• Founded in:

  2001-11-30

• Address:

  Luoqi Road, Linyi High-tech Industrial Development Zone, Shandong Province

• Tax NO.:

  913700002658705037

• Registered Funds:

  60.96 million yuan

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