Gukje Pharmciclovir Tablets (Pharmaciclovir)

Adult dosage

1. Treatment of herpes zoster Adults: Administer famciclovir 250 mg 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 first-episode 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 phase 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. Periodically discontinue treatment every 6～12 months to assess whether the natural course of the disease has changed. 5. Patients with renal impairment: Since clearance of this medicine is reduced in patients with renal impairment, use caution when adjusting the dose. The dosage for these patients is as follows. 1) Treatment of herpes zoster and first-episode genital herpes: Creatinine clearance (mL/min/1.73㎡) 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㎡) 30～59: 125 mg per dose twice 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 twice daily 10～29: 125 mg per dose twice daily 4) If only serum creatinine is known, creatinine clearance may be calculated using the following formula. 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 on hemodialysis, administration every 48 hours is preferable, taking the dialysis interval into account. Four hours of hemodialysis 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. Since there is insufficient treatment experience in patients with obvious chronic decompensated liver disease, no clear recommended dose has been established.

This medication should not be administered to certain patients. Specifically, patients who are allergic to this medication or its components, as well as those allergic to its active ingredient, penciclovir, should not take it. Additionally, since it contains lactose, patients with lactose intolerance or specific genetic metabolic disorders should also avoid this medication. Caution is needed for patients with decreased kidney function, and dosage adjustment may be required. During treatment, side effects such as headaches, dizziness, nausea, and skin rashes may occur, and rarely, blood-related anomalies or cardiac arrhythmias may also arise. This medication does not cure genital herpes, thus there is a risk of transmission during sexual contact, making it important to maintain safe sexual practices. Caution is necessary when driving or operating machinery if symptoms like dizziness or drowsiness occur. In patients with severely impaired liver function, the efficacy may be reduced, thus it should be used with caution. This medication has a low potential for drug interactions, but caution is still necessary as blood concentrations may change when used in combination with certain medications. Pregnant or breastfeeding women should carefully weigh the benefits and risks of use. Safety and efficacy in children under 18 years have not been established, so use is not recommended. Generally, elderly patients do not need dosage adjustment; however, dosage adjustments may be necessary in those with decreased kidney function. In cases of overdose, proper treatment along with blood dialysis may be helpful. This medication should be stored in a cool, dry place below 30 degrees Celsius, kept away from children, and it is advisable not to transfer it to another container.

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

This medication may be sensitive to air or moisture, thus it must be stored in a sealed container. Additionally, it should be kept in a cool and dry place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White round film-coated tablet

Package unit

Company packaging unit