Famciclovir 250 mg Tablets

Adult dose

1. Treatment of herpes zoster Adults: Administer 250 mg of famciclovir 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 orally 3 times daily for 5 days. It is preferable to start treatment as soon as symptoms appear after infection. 3. Treatment of an acute recurrent episode of genital herpes Adults: Administer 125 mg of this medicine orally 2 times 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 orally 2 times daily. Discontinue treatment periodically every 6～12 months to assess whether the natural course of the disease has changed. 5. Patients with renal impairment: Since the clearance of this medicine decreases in patients with renal impairment, dose adjustment should be made with caution. 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㎡) 30～59: 250 mg per dose, 2 times daily 10～29: 250 mg per dose, once daily 2) Treatment of an acute recurrent episode of genital herpes: Creatinine clearance (mL/min/1.73㎡) 30～59: 125 mg per dose, 2 times daily 10～29: 125 mg per dose, once daily 3) Suppression of recurrent genital herpes: Creatinine clearance (mL/min/1.73㎡) 30～59: 250 mg per dose, 2 times daily 10～29: 125 mg per dose, 2 times daily 4) If only serum creatinine is known, creatinine clearance may be calculated using the following formulas. Men: {body weight (kg) × (140-age)}/ {72 × serum creatinine (mg/dL)} Women: 0.85 × the value calculated for men 5) Patients with renal impairment undergoing hemodialysis For patients undergoing hemodialysis, administration every 48 hours is preferable, taking the dialysis interval 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 necessary in patients with chronic compensated liver disease. There is insufficient treatment experience in patients with overt chronic decompensated liver disease; therefore, no clear recommended dose has been established.

This medicine should not be used in patients who are hypersensitive to this drug or its components, as well as to the active ingredient penciclovir. Caution should be exercised when administering this drug to patients with kidney problems, and dosage adjustment may be necessary. Mild to moderate symptoms such as headache or nausea may occur during treatment. Rarely, blood-related abnormalities such as decreased platelet count, as well as decreased white blood cell and neutrophil counts, have been reported. Neurological side effects may include headache, dizziness, confusion, drowsiness, and occasionally hallucinations, with drowsiness being common in older adults. Rarely, palpitations may occur in the cardiovascular system. Gastrointestinal side effects may commonly include nausea, vomiting, abdominal pain, and diarrhea. Liver function abnormalities may occur, with jaundice reported in rare cases. Skin reactions may include rashes and itching, and angioedema such as hives or swelling of the face, around the eyes, or in the throat may occur. Severe skin reactions or serious skin conditions like vasculitis have been reported rarely. Acute renal failure may occur rarely in patients with impaired kidney function; therefore, dosage should be adjusted considering renal function. This drug does not cure genital herpes, and it is important to avoid sexual contact and maintain safe sexual practices during treatment when symptoms are present. If symptoms such as dizziness, drowsiness, or confusion occur, driving or operating machinery should be avoided. Patients with mild liver dysfunction do not need special dosage adjustments, but severely impaired liver function may reduce the drug's efficacy. This drug has relatively few drug interactions, but caution should be taken in monitoring toxicity when used concurrently with drugs like probenecid, which may increase blood concentration. Pregnant women or those who may become pregnant should only use this drug when the benefits of treatment outweigh the risks. Breastfeeding women should only be given this drug when the therapeutic benefits outweigh the potential risks, as it may be excreted in breast milk. The safety and efficacy for pediatric patients under 18 years of age have not been established; therefore, it is advisable not to use this drug in such patients. Generally, older adults do not require dosage adjustment; however, dosage should be adjusted in cases of diminished kidney function. In cases of overdose, appropriate supportive care and symptomatic treatment are required, and hemodialysis can considerably lower the concentration of the active ingredient of this drug. This drug should be stored in a tightly closed container to prevent air and moisture from entering and should be kept in a dry place below 30 degrees Celsius. Transferring to another container may pose risks of accidents and quality degradation, so caution is advised.

• headache
• nausea
• thrombocytopenia
• leukopenia
• neutropenia
• dizziness
• confusion
• drowsiness
• hallucination
• palpitations

This drug should be stored in a tightly closed container to prevent air and moisture from entering, preferably in a dry place below 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness for a long time.

Appearance

White round film-coated tablet

Package unit

21 tablets/bottle