Medication info

Valtrex 500 mg (Valacyclovir Hydrochloride Hydrate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Valaciclovir Hydrochloride Hydrate›597.6mg / 1 tablet
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
Oblong white film-coated tablet
Packaging
PTP - 42 tablets/box [6 tablets/PTP x 7]
Approval status
Approval withdrawn

MFDS item code 201007252 · Notified 2010.11.29

This product's status changed to Approval withdrawn on 2024.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of herpes and chickenpox; suppression of recurrence and transmission of genital herpes; prevention of cytomegalovirus infection
Who takes it
Adults · Children
Adult dose
1. Adults 1) Herpes zoster: Administer 1,000 mg of valacyclovir orally 3 times daily for 7 days. 2) Genital herpes infections: Administer 500 mg of this drug 2 times daily. For recurrent episodes, administer for 5 days; for an initial episode, treatment may be continued for up to 10 days if symptoms are severe. 3) Suppression of recurrent genital herpes infections (1) Patients with normal immune function: The total daily dose is 500 mg of this drug, which may be administered as 250 mg 2 times daily. A dose of 500mg once daily is also effective, particularly in patients with fewer than 10 recurrences per year. Some patients with 10 or more recurrences per year without treatment may obtain additional benefit when 250 mg of this drug is administered in divided doses 2 times daily (total daily dose of 500 mg). Treatment should be reassessed after 6 to 12 months of administration. (2) Immunocompromised patients: Administer 500 mg of this drug 2 times daily. 4) Reduction of transmission of genital herpes: In immunocompetent heterosexual adults with 9 or fewer recurrences per year, the infected sexual partner should take 500 mg of this drug once daily to reduce transmission to a sexual partner who is negative for Herpes Simplex Virus-2 (HSV-2) antibodies. 5) Prevention of cytomegalovirus infection: Take 2,000 mg of this drug 4 times daily, starting within 72 hours after transplantation or as soon as oral administration is possible. The dose should be reduced according to creatinine clearance. The treatment period is usually 90 days, but may need to be extended in high-risk patients. 6) Cold sores: The recommended dose of this drug for the treatment of cold sores is 2,000 mg 2 times daily, 12 hours apart, for 1 day. Treatment should be started as soon as the initial signs of a cold sore (e.g., tingling, itching, burning) appear. 4. Patients with renal impairment: The dosage should be adjusted in patients with significant renal impairment. Adequate hydration should be maintained. In patients receiving hemodialysis, administer the dose after hemodialysis is completed. Creatinine clearance should be monitored frequently during periods of rapidly changing renal function, and the dosage of this drug should be adjusted appropriately according to creatinine clearance. Herpes zoster, creatinine clearance 50 or higher: 1,000 mg 3 times daily Herpes zoster, creatinine clearance 30 or higher ~ less than 50: 1,000 mg 2 times daily Herpes zoster, creatinine clearance 10 or higher ~ less than 30: 1,000 mg once daily Herpes zoster, creatinine clearance less than 10: 500 mg once daily Genital herpes, creatinine clearance 30 or higher: 500 mg 2 times daily Genital herpes, creatinine clearance less than 30: 500 mg once daily Genital herpes suppression-normal immune function, creatinine clearance 30 or higher: 500 mg once daily* Genital herpes suppression-normal immune function, creatinine clearance less than 30: 250 mg once daily Genital herpes suppression-impaired immune function, creatinine clearance 30 or higher: 500 mg 2 times daily Genital herpes suppression-impaired immune function, creatinine clearance less than 30: 500 mg once daily Cytomegalovirus prevention, creatinine clearance 75 or higher: 2,000 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 50 or higher and less than 75: 1,500 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 25 or higher and less than 50: 1,500 mg 3 times daily Cytomegalovirus prevention, creatinine clearance 10 or higher and less than 25: 1,500 mg 2 times daily Cytomegalovirus prevention, creatinine clearance less than 10 or on dialysis: 1,500 mg once daily Cold sores, creatinine clearance 50 or higher: 2,000 mg 2 times daily Cold sores, creatinine clearance 30 or higher and 49 or lower: 1,000 mg 2 times daily Cold sores, creatinine clearance 10 or higher and less than 30: 500 mg 2 times daily Cold sores, creatinine clearance less than 10: 500 mg once daily *Some patients with 10 or more recurrences per year without treatment may obtain additional benefit when 250 mg of this drug is administered in divided doses 2 times daily (total daily dose of 500 mg). 5. Patients receiving peritoneal dialysis: Supplemental administration of this drug is not required after CAPD or CAVHD. 6. Patients with hepatic impairment: No dosage adjustment is required in patients with mild to moderate cirrhosis or severe cirrhosis.
Child dose
2. Pediatric Patients Prevention of cytomegalovirus infection (12 years and older): Take 2,000 mg of this medicine per dose 4 times daily, starting within 72 hours after transplantation or as soon as oral administration is possible. The dose should be reduced according to creatinine clearance. The duration of treatment is usually 90 days, but may need to be extended in high-risk patients. Cold sores (12 years and older): Take 2,000 mg of this medicine per dose twice daily, 12 hours apart, for 1 day. Treatment should begin as soon as the initial signs of cold sores (e.g., tingling, itching, or burning) appear. Chickenpox (2 years to under 18 years): Take 20 mg of this medicine per kg of body weight per dose 3 times daily for 5 days. The total dose should not exceed 1,000 mg per dose, 3 times daily.

Ingredients

Manufacturer
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of herpes and chickenpox; suppression of recurrence and transmission of genital herpes; prevention of cytomegalovirus infection

  • Shingles
  • primary and recurrent genital herpes infections
  • recurrence of genital herpes infections
  • cytomegalovirus infection after kidney transplantation
  • herpes labialis
  • chickenpox
View approved original text

This medication is used for the treatment of shingles and herpes simplex infections, including genital herpes. It also suppresses the recurrence of genital herpes and can be used as a preventive treatment to reduce transmission during safe sexual practices. It helps to prevent cytomegalovirus infection in patients who have received kidney transplants. Additionally, it is used for chickenpox treatment in children aged 2 years and older with normal immune function. This medication is thus widely used for various viral diseases and infection prevention.

How to take

Adult dose

1. Adults 1) Herpes zoster: Administer 1,000 mg of valacyclovir orally 3 times daily for 7 days. 2) Genital herpes infections: Administer 500 mg of this drug 2 times daily. For recurrent episodes, administer for 5 days; for an initial episode, treatment may be continued for up to 10 days if symptoms are severe. 3) Suppression of recurrent genital herpes infections (1) Patients with normal immune function: The total daily dose is 500 mg of this drug, which may be administered as 250 mg 2 times daily. A dose of 500mg once daily is also effective, particularly in patients with fewer than 10 recurrences per year. Some patients with 10 or more recurrences per year without treatment may obtain additional benefit when 250 mg of this drug is administered in divided doses 2 times daily (total daily dose of 500 mg). Treatment should be reassessed after 6 to 12 months of administration. (2) Immunocompromised patients: Administer 500 mg of this drug 2 times daily. 4) Reduction of transmission of genital herpes: In immunocompetent heterosexual adults with 9 or fewer recurrences per year, the infected sexual partner should take 500 mg of this drug once daily to reduce transmission to a sexual partner who is negative for Herpes Simplex Virus-2 (HSV-2) antibodies. 5) Prevention of cytomegalovirus infection: Take 2,000 mg of this drug 4 times daily, starting within 72 hours after transplantation or as soon as oral administration is possible. The dose should be reduced according to creatinine clearance. The treatment period is usually 90 days, but may need to be extended in high-risk patients. 6) Cold sores: The recommended dose of this drug for the treatment of cold sores is 2,000 mg 2 times daily, 12 hours apart, for 1 day. Treatment should be started as soon as the initial signs of a cold sore (e.g., tingling, itching, burning) appear. 4. Patients with renal impairment: The dosage should be adjusted in patients with significant renal impairment. Adequate hydration should be maintained. In patients receiving hemodialysis, administer the dose after hemodialysis is completed. Creatinine clearance should be monitored frequently during periods of rapidly changing renal function, and the dosage of this drug should be adjusted appropriately according to creatinine clearance. Herpes zoster, creatinine clearance 50 or higher: 1,000 mg 3 times daily Herpes zoster, creatinine clearance 30 or higher ~ less than 50: 1,000 mg 2 times daily Herpes zoster, creatinine clearance 10 or higher ~ less than 30: 1,000 mg once daily Herpes zoster, creatinine clearance less than 10: 500 mg once daily Genital herpes, creatinine clearance 30 or higher: 500 mg 2 times daily Genital herpes, creatinine clearance less than 30: 500 mg once daily Genital herpes suppression-normal immune function, creatinine clearance 30 or higher: 500 mg once daily* Genital herpes suppression-normal immune function, creatinine clearance less than 30: 250 mg once daily Genital herpes suppression-impaired immune function, creatinine clearance 30 or higher: 500 mg 2 times daily Genital herpes suppression-impaired immune function, creatinine clearance less than 30: 500 mg once daily Cytomegalovirus prevention, creatinine clearance 75 or higher: 2,000 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 50 or higher and less than 75: 1,500 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 25 or higher and less than 50: 1,500 mg 3 times daily Cytomegalovirus prevention, creatinine clearance 10 or higher and less than 25: 1,500 mg 2 times daily Cytomegalovirus prevention, creatinine clearance less than 10 or on dialysis: 1,500 mg once daily Cold sores, creatinine clearance 50 or higher: 2,000 mg 2 times daily Cold sores, creatinine clearance 30 or higher and 49 or lower: 1,000 mg 2 times daily Cold sores, creatinine clearance 10 or higher and less than 30: 500 mg 2 times daily Cold sores, creatinine clearance less than 10: 500 mg once daily *Some patients with 10 or more recurrences per year without treatment may obtain additional benefit when 250 mg of this drug is administered in divided doses 2 times daily (total daily dose of 500 mg). 5. Patients receiving peritoneal dialysis: Supplemental administration of this drug is not required after CAPD or CAVHD. 6. Patients with hepatic impairment: No dosage adjustment is required in patients with mild to moderate cirrhosis or severe cirrhosis.

Child dose

2. Pediatric Patients Prevention of cytomegalovirus infection (12 years and older): Take 2,000 mg of this medicine per dose 4 times daily, starting within 72 hours after transplantation or as soon as oral administration is possible. The dose should be reduced according to creatinine clearance. The duration of treatment is usually 90 days, but may need to be extended in high-risk patients. Cold sores (12 years and older): Take 2,000 mg of this medicine per dose twice daily, 12 hours apart, for 1 day. Treatment should begin as soon as the initial signs of cold sores (e.g., tingling, itching, or burning) appear. Chickenpox (2 years to under 18 years): Take 20 mg of this medicine per kg of body weight per dose 3 times daily for 5 days. The total dose should not exceed 1,000 mg per dose, 3 times daily.

Precautions

Caution is required when this medication is administered in high doses to patients with progressive HIV or those who have received allogeneic hematopoietic stem cell or kidney transplants, as it may cause severe side effects such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome. This medication should not be administered to patients who are allergic to it or to its active metabolite acyclovir, or any of its constituents. In dehydrated or elderly patients, hydration should be ensured during administration. The dosage should be adjusted for patients with impaired kidney function. Caution is also required during high-dose administration in patients with reduced liver function, as the safety of this medication has not been sufficiently verified in cases of liver dysfunction. This medication does not completely eliminate the risk of infection transmission in patients with genital herpes; therefore, safe sexual practices, especially condom use, are recommended during treatment. Special caution is needed when administering this medication to pregnant or potentially pregnant women, nursing mothers, and the elderly. This medication may cause gastrointestinal symptoms such as nausea or vomiting, diarrhea, and rarely, it may induce allergic reactions such as thrombocytopenia, rash, itching, urticaria, or respiratory distress. Adequate hydration is crucial as it may affect kidney function, and immediate medical consultation is advised if acute renal failure or kidney pain occurs. Neurological symptoms such as headache, dizziness, confusion, hallucinations, or seizures may occur, particularly more frequently in patients with impaired kidney function or the elderly. This medication is also used in children and adolescents, but is not recommended for the treatment of cold sores in those under 12 years or genital herpes in those under 18 years. In cases of overdose, renal failure or central nervous system symptoms may occur, so it is crucial to adhere to the prescribed dosage and avoid excess intake; hemodialysis may be indicated if necessary. Starting treatment promptly is important as rapid therapeutic effects can be anticipated in the early stages of symptoms. The effects of this medication on driving or operating machinery have not been investigated; however, caution should be exercised if neurological symptoms are present. In pregnant or nursing women, the use of this medication may impact the fetus or newborn, so consultation with a physician is essential prior to administration. This medication should be stored out of the reach of children and should not be transferred to other containers for safety.

Side effects

Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, photosensitivity reaction causing rash, pruritus, urticaria, angioedema, dyspnea, anaphylaxis, renal impairment, acute renal failure, renal pain, reversible elevation of liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremor, ataxia, stuttering, seizures, encephalopathy, coma, facial edema, seizures, erythema multiforme, dysmenorrhea, depression, arthralgia, nasopharyngitis, upper respiratory infection, fever, dehydration, herpes simplex, rhinorrhea, hypertension, tachycardia, aggressive behavior, anxiety, coma, mania, delusions, paralysis, decreased consciousness, auditory hallucinations, visual hallucinations, seizures, visual disturbances, hepatitis, jaundice, liver dysfunction, increased creatinine, interstitial nephritis, aplastic anemia, leukocytoclastic vasculitis, panhypoplasia, agranulocytosis, disseminated intravascular coagulation syndrome, thrombocytopenic purpura, leukopenia, erythema multiforme, hair loss, toxic epidermal necrolysis, mucocutaneous syndrome, drug reaction (DRESS), interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups, anxiety, hallucinations, confusion, nonsense speech, seizures, encephalopathy

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

Storage

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture, at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

Oblong white film-coated tablet

Package unit

PTP - 42 tablets/box [6 tablets/PTP x 7]

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.