Medication info
Oravir Tablets (Famciclovir)

Oravir Tablets (Famciclovir)

Prescription medicationTabletOral
Ingredient · strength
Famciclovir›250mg / 1 tablet
Manufacturer / importer
Genupharm Co., Ltd.
Appearance
White oblong film-coated tablet
Packaging
21 tablets/bottle
Approval status
Active

MFDS item code 200501120 · Notified 2005.08.10 · Insurance code 698000910

Summary

Main use
Treatment of herpes zoster; treatment and suppression of recurrence of genital herpes; treatment and suppression of herpes simplex
Who takes it
Adults
Adult dose
1. Treatment of herpes zoster Adults: Administer 250 mg of famciclovir orally per dose, 3 times daily for 7 days. It is advisable to start treatment as soon as symptoms appear after infection. 2. Treatment of first-episode genital herpes Adults: Administer 250 mg of this medicine orally per dose, 3 times daily for 5 days. It is advisable to start treatment as soon as symptoms appear after infection. 3. Treatment of acute recurrent genital herpes Adults: Administer 125 mg of this medicine orally per dose, twice daily for 5 days. It is advisable 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 per dose, twice 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 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 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 can 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 advisable, taking the dialysis interval into account. A 4-hour hemodialysis session reduces the plasma concentration of this medicine by approximately 75%, so 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 for 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.

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

Treatment of herpes zoster; treatment and suppression of recurrence of genital herpes; treatment and suppression of herpes simplex

  • Herpes zoster virus infection
  • genital herpes infection
  • recurrent genital herpes
  • herpes zoster virus infection in immunocompromised patients
  • herpes simplex virus infection in immunocompromised patients
  • herpes simplex virus infection.
View approved original text

This medication is used to treat viral infections such as herpes zoster and genital herpes and to prevent recurrence. It is particularly effective for treating herpes zoster and herpes simplex in immunocompromised patients. It also helps in treating herpes simplex around the lips (cold sores). It is available in various dosages as tablets and cream formulations to be used according to the situation. This medicine is recommended as a necessary treatment to alleviate herpes virus infections and prevent recurrence.

How to take

Adult dose

1. Treatment of herpes zoster Adults: Administer 250 mg of famciclovir orally per dose, 3 times daily for 7 days. It is advisable to start treatment as soon as symptoms appear after infection. 2. Treatment of first-episode genital herpes Adults: Administer 250 mg of this medicine orally per dose, 3 times daily for 5 days. It is advisable to start treatment as soon as symptoms appear after infection. 3. Treatment of acute recurrent genital herpes Adults: Administer 125 mg of this medicine orally per dose, twice daily for 5 days. It is advisable 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 per dose, twice 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 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 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 can 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 advisable, taking the dialysis interval into account. A 4-hour hemodialysis session reduces the plasma concentration of this medicine by approximately 75%, so 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 for 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.

Precautions

This medication should not be used in patients who have allergic reactions to certain ingredients or genetic issues like lactose intolerance. Care should be taken when administering this medication to patients with impaired kidney function. Side effects such as headache, dizziness, nausea, vomiting, and skin rash may occur, and if these symptoms arise, consulting a healthcare professional is necessary. This medication does not completely cure genital herpes, so it is important to avoid sexual contact and maintain safe sex practices while symptoms are present. Symptoms such as dizziness or drowsiness may occur, so care should be taken while driving or operating machinery if these symptoms appear. Patients with mild liver impairment do not require special dosage adjustments, but safety has not been established for those with severe liver impairment. There may be interactions with other medications, so it is crucial to inform healthcare professionals of any other medications being taken. Pregnant or breastfeeding women should carefully consider the benefits and risks before using this medication, and it is not recommended for use in children due to safety concerns. Generally, elderly patients do not require dosage adjustments; however, dosage may need to be adjusted in patients with decreased kidney function. In case of overdose, appropriate treatment is necessary, and hemodialysis can lower the drug concentration. This medication should be stored in a dry place below 30 degrees and kept out of the reach of children, and it is advisable not to transfer it to another container.

Side effects

  • Headache
  • nausea
  • thrombocytopenia
  • leukopenia
  • neutropenia
  • dizziness
  • confusion
  • drowsiness
  • hallucinations
  • palpitations
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  • vomiting
  • abdominal pain
  • diarrhea
  • abnormal liver function tests
  • jaundice
  • skin rash
  • itching
  • hives
  • angioedema
  • acute kidney failure
  • upper abdominal pain
  • constipation
  • liver dysfunction
  • abdominal bloating
  • dyspepsia
  • facial swelling
  • fatigue
  • pain
  • leukopenia
  • insomnia
  • shortened menstruation
  • difficulty urinating

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

Storage

This medicine may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is also advisable to keep it in a cool, dry place below 30 degrees.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

21 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.