Famciclovir Tablet 250 mg (Famciclovir)

Adult dose

1. Treatment of herpes zoster Adults: Administer 250 mg of famciclovir per dose orally 3 times daily for 7 days. It is preferable to start treatment as soon as symptoms appear after infection. 2. Treatment of an initial episode of genital herpes Adults: Administer 250 mg of this medicine per dose orally 3 times daily for 5 days. It is preferable to start treatment as soon as symptoms appear after infection. 3. Treatment of acute recurrent genital herpes Adults: Administer 125 mg of this medicine per dose orally twice daily for 5 days. It is preferable to start treatment during the prodromal period or as soon as symptoms appear after infection. 4. Suppression of recurrent genital herpes Adults: Administer 250 mg of this medicine per dose orally twice daily. Temporarily discontinue treatment at regular intervals every 6～12 months to assess whether the natural course of the disease has changed. 5. Patients with renal impairment: Because the creatinine clearance of this medicine is reduced in patients with renal impairment, dose adjustment should be undertaken with care. The dosage and administration for these patients are as follows. 1) Treatment of herpes zoster and an initial episode of genital herpes: Creatinine clearance (mL/min/1.73㎡) Dose 30～59 250 mg per dose twice daily 10～29 250 mg per dose once daily 2) Treatment of acute recurrent genital herpes: Creatinine clearance (mL/min/1.73㎡) Dose 30～59 125 mg per dose twice daily 10～29 125 mg per dose once daily 3) Suppression of recurrent genital herpes infection: Creatinine clearance (mL/min/1.73㎡) Dose 30～59 250 mg per dose twice daily 10～29 125 mg per dose twice daily 4) If only the serum creatinine is known, creatinine clearance can be calculated using the following equations. Men: {body weight (kg) × (140-age)}/ {72 × serum creatinine (mg/dL)} Women: 0.85 × the value calculated for men 5) Patients with renal impairment receiving hemodialysis For patients on hemodialysis, administration every 48 hours is preferable, taking the interval between dialysis sessions into account. A 4-hour hemodialysis session reduces the plasma concentration of this medicine by approximately 75%; therefore, administer this medicine immediately after dialysis. The recommended dose is 250mg for patients with herpes zoster and 125mg for patients with genital herpes. 6. Patients with hepatic impairment: No dose adjustment is required in patients with chronic compensated liver disease. There is insufficient treatment experience in patients with overt chronic decompensated liver disease; therefore, a clear recommended dose has not been established.

This medication should not be administered to certain patients. Patients who are allergic to this medication or its ingredients should not take it. Additionally, it contains lactose, so patients with genetic disorders that impair lactose digestion should not use it. Patients with poor kidney function should be cautious when taking this medication. Mild side effects such as headache or nausea may occur with this medication, but they are usually of minor severity. Rarely, hematological side effects such as thrombocytopenia may occur, and there may be a risk of decreased white blood cell count. Central nervous system side effects may include dizziness, confusion, drowsiness, and, rarely, hallucinations. Gastrointestinal side effects may commonly include nausea, vomiting, abdominal pain, and diarrhea. Liver function anomalies or, rarely, jaundice may also occur. Dermatological side effects like rash and pruritus are common, and, rarely, serious skin reactions have been reported. Acute kidney failure may occur rarely in patients with impaired kidney function. This medication does not completely cure genital herpes, and it is important to avoid sexual contact during symptoms and maintain safe sexual practices. If symptoms such as dizziness or drowsiness occur, driving or operating machinery should be avoided. For patients with mild to moderate liver dysfunction, no special dose adjustments are necessary, but safety in patients with severe liver dysfunction is uncertain. This medication has a low potential for drug interactions; however, caution is needed since blood concentrations may change when used with certain medications. Particularly, when used with drugs that affect renal excretion, toxicity may need to be monitored and dose adjustments may be necessary. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of using this medication. Nursing mothers should also consult a physician before taking this medication. Safety and effectiveness in children under 18 years have not been established, so it is advisable not to use this medication in that age group. In elderly patients, generally, no dose adjustment is needed, but caution should be taken to adjust the dosage if kidney function is impaired. In case of overdose, seek medical attention immediately for appropriate treatment, and blood dialysis may remove some of the medication. This medication should be stored in a cool, dry place below 30 degrees Celsius and kept in a safe location out of reach of children. Transferring to another container may not be good for maintaining quality, so caution is advised.

• headache
• nausea
• thrombocytopenia
• leukopenia and neutropenia
• dizziness
• confusion
• drowsiness
• hallucinations
• palpitations
• vomiting

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. Furthermore, it should be kept in a cool, dry place below 30 degrees Celsius to maintain stability.

Appearance

White round film-coated tablet

Package unit

21 tablets (21 tablets/PTP packaging x 1)