Zostavax Tablets (Famciclovir)

Adult dose

1. Treatment of herpes zoster Adults: Administer famciclovir orally at a dose of 250 mg 3 times daily for 7 days. It is preferable to start treatment as soon as symptoms appear after infection. 2. Treatment of first-episode genital herpes Adults: Administer this drug orally at a dose of 250 mg 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 this drug orally at a dose of 125 mg 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 this drug orally at a dose of 250 mg 2 times daily. Temporarily discontinue treatment periodically every 6～12 months to assess whether the natural course of the disease has changed. 5. Patients with renal impairment: Because creatinine clearance of this drug is reduced in patients with renal impairment, dose adjustment should be undertaken with caution. The dosage and administration for these patients are as follows. 1) Treatment of herpes zoster and first-episode 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 acute recurrent 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 can be calculated using the following formula. Men: {weight (kg) × (140-age)}/ {72 × serum creatinine (mg/dL)} Women: 0.85 × the value calculated for men 5) Patients with renal impairment undergoing hemodialysis It is preferable to administer the drug every 48 hours, taking the interval between dialysis sessions into account. Because 4 hours of hemodialysis reduces the plasma concentration of this drug by approximately 75%, administer this drug 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, a clear recommended dose has not been established.

This drug should not be administered to patients with a history of hypersensitivity to this drug or its components, especially the active ingredient famciclovir. Additionally, since this drug contains lactose, it should not be used by patients with lactose intolerance or certain genetic metabolic disorders. Patients with renal impairment should use this drug with caution. During treatment with this drug, symptoms such as headache or nausea may occur, but most of them are mild to moderate. Blood-related abnormalities may rarely include decreased platelet count or reduced white blood cell and neutrophil counts. Caution is required as it may affect the central nervous system, leading to symptoms such as dizziness, drowsiness, confusion, and hallucinations. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhea may commonly occur. Liver function abnormalities such as jaundice and biliary tract issues have also been reported. Skin reactions such as rashes, itching, urticaria, and angioedema may appear, and serious skin reactions may occur rarely. In patients with impaired renal function, acute renal failure has been reported rarely, so caution is advised. This drug does not cure genital herpes, so it is recommended to avoid sexual contact when symptoms are present and to maintain safe sex practices. If dizziness or drowsiness occurs, avoid driving or operating machinery. Generally, elderly patients do not require dosage adjustments, but those with reduced renal function may need adjustments. In case of overdose, rapid medical action is necessary as appropriate treatment and hemodialysis can facilitate drug removal. During storage, keep in a sealed container to prevent effects from air or humidity, and store in a cool, dry place below 30 degrees Celsius, out of reach of children. Avoid transferring to other containers.

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

Store this medication in a tightly sealed container to prevent effects from air and moisture. It is also important to store it in a cool place at a temperature below 30 degrees Celsius and dry conditions.

Appearance

White round film-coated tablets

Package unit

21 tablets/bottle