Medication info

Daewoong Famciclovir Tablet 750mg

Prescription medicationApproval withdrawn
Ingredient · strength
Famciclovir›Strength being verified
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
White rectangular film-coated tablet
Packaging
Company packaging unit
Approval status
Approval withdrawn

MFDS item code 200607727 · Notified 2006.07.11

This product's status changed to Approval withdrawn on 2023.03.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of herpes zoster virus infection
Who uses it
Adults
Adult dosage
1. Treatment of herpes zoster Adults: Administer famciclovir 250 mg orally per dose 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 this drug 250 mg orally per dose 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 125 mg orally per dose 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 250 mg orally per dose 2 times daily. Temporarily discontinue treatment periodically every 6~12 months to assess any change in the natural course of the disease. 5. Patients with renal impairment 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 Creatinine clearance (mL/min/1.73㎡) 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 Creatinine clearance (mL/min/1.73㎡) 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 Creatinine clearance (mL/min/1.73㎡) 10~29: 125 mg per dose 2 times daily 4) If only serum creatinine is known, creatinine clearance may 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 undergoing hemodialysis For patients undergoing hemodialysis, administration every 48 hours is preferable, taking the interval between dialysis sessions into consideration. A 4-hour hemodialysis session reduces the plasma concentration of this drug by approximately 75%; therefore, 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 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.

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of herpes zoster virus infection

  • Herpes zoster virus infection
View approved original text

Herpes zoster is a disease caused by herpes zoster virus infection, characterized by painful rashes and blisters on the skin. This medication is used for the treatment of herpes zoster virus infections.

Dosage and Administration

Adult dosage

1. Treatment of herpes zoster Adults: Administer famciclovir 250 mg orally per dose 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 this drug 250 mg orally per dose 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 125 mg orally per dose 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 250 mg orally per dose 2 times daily. Temporarily discontinue treatment periodically every 6~12 months to assess any change in the natural course of the disease. 5. Patients with renal impairment 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 Creatinine clearance (mL/min/1.73㎡) 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 Creatinine clearance (mL/min/1.73㎡) 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 Creatinine clearance (mL/min/1.73㎡) 10~29: 125 mg per dose 2 times daily 4) If only serum creatinine is known, creatinine clearance may 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 undergoing hemodialysis For patients undergoing hemodialysis, administration every 48 hours is preferable, taking the interval between dialysis sessions into consideration. A 4-hour hemodialysis session reduces the plasma concentration of this drug by approximately 75%; therefore, 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 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.

Precautions

This medicine should not be used in patients who are allergic to this medicine or its main ingredients. This medicine contains lactose, so it should not be taken by patients with genetic disorders causing lactose intolerance. Caution is needed when using this medication in patients with poor kidney function. After taking this medicine, symptoms such as headaches or nausea may occur, but most are mild to moderate in severity. Since blood cell counts may decrease, consult a physician if any unusual symptoms appear. Symptoms such as dizziness, drowsiness, and confusion may occur, so caution is needed while driving or operating machinery. Liver dysfunction, skin rash, and itching have been reported, so if symptoms are severe, inform medical personnel immediately. In patients with reduced kidney function, acute renal failure may rarely occur, so caution is advised. This medicine does not cure genital herpes, and it is recommended to avoid sexual contact when symptoms are present. There may be interactions with other medications, so inform your healthcare provider of any medications you are currently taking. Women who are pregnant or may become pregnant, as well as breastfeeding women, should carefully consider the benefits and risks of using this medication. Children under 18 years old should avoid use as safety and efficacy have not been confirmed. Elderly patients may require dosage adjustments based on their kidney function. In case of overdose, seek medical care immediately for appropriate treatment, and blood dialysis can decrease the drug concentration. This medicine should be stored in a cool and dry place and kept out of reach of children. Transferring to another container may cause accidents or degradation of the medication's quality, so caution is advised.

Side effects

headache

Not everyone experiences these, and they can vary from person to person.

Storage

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It is also important to store it in a cool and dry place, specifically below 30 degrees Celsius.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

Company packaging unit

Same-ingredient medicines

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.