Valcyclovir Tablets 500mg (Valacyclovir Hydrochloride)

Adult dose

1. Adults 1) Herpes zoster Administer valacyclovir 1,000 mg per dose orally 3 times daily for 7 days. 2) Genital herpes infection Administer 500 mg of this medicine per dose twice daily. For recurrent infection, administer for 5 days; for an initial episode, treatment may be given for up to 10 days if symptoms are severe. 3) Suppression of recurrent genital herpes infection (1) Immunocompetent patients: The total daily dose is 500 mg of this medicine, which may be administered as 250 mg per dose twice daily. Administration of 500 mg per dose 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 from divided doses of 250 mg of this medicine twice daily (total daily dose 500 mg). Treatment should be reevaluated after 6 to 12 months of administration. (2) Immunocompromised patients: Administer 500 mg of this medicine per dose twice daily. 4) Reduction of transmission of genital herpes For immunocompetent heterosexual adults with 9 or fewer recurrences per year: The infected sexual partner should take 500 mg of this medicine 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 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 administration is usually 90 days, but may need to be extended in high-risk patients. 6) Cold sores The recommended dose of this medicine for the treatment of cold sores is 2,000 mg per dose twice daily, 12 hours apart, for 1 day. Treatment should be started as soon as the initial signs of a cold sore appear (e.g., tingling, itching, or burning). 3. Older adults No dose adjustment is required unless renal function is particularly impaired. 4. Patients with renal impairment Herpes zoster Creatinine clearance 50 or higher: 1,000 mg per dose 3 times daily Creatinine clearance 30 or higher ～ below 50: 1,000 mg per dose twice daily Creatinine clearance 10 or higher ～ below 30: 1,000 mg per dose once daily Creatinine clearance below 10: 500 mg per dose once daily Genital herpes Creatinine clearance 30 or higher: 500 mg per dose twice daily Creatinine clearance below 30: 500 mg per dose once daily Genital herpes suppression - immunocompetent Creatinine clearance 30 or higher: 500 mg per dose once daily* Creatinine clearance below 30: 250 mg per dose once daily Genital herpes suppression - immunocompromised Creatinine clearance 30 or higher: 500 mg per dose twice daily Creatinine clearance below 30: 500 mg per dose once daily Cytomegalovirus prevention Creatinine clearance 75 or higher: 2,000 mg per dose 4 times daily Creatinine clearance 50 or higher and below 75: 1,500 mg per dose 4 times daily Creatinine clearance 25 or higher and below 50: 1,500 mg per dose 3 times daily Creatinine clearance 10 or higher and below 25: 1,500 mg per dose twice daily Creatinine clearance below 10 or on dialysis: 1,500 mg per dose once daily Cold sores Creatinine clearance 50 or higher: 2,000 mg per dose twice daily Creatinine clearance 30 or higher and 49 or lower: 1,000 mg per dose twice daily Creatinine clearance 10 or higher and below 30: 500 mg per dose twice daily Creatinine clearance below 10: 500 mg per dose once daily *Some patients with 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg of this medicine twice daily (total daily dose 500 mg).

Child dose

2. Children 1) 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 administration is usually 90 days, but may need to be extended in high-risk patients. 2) Cold sores (12 years and older) The recommended dose for the treatment of cold sores is 2,000 mg of this medicine per dose twice daily, 12 hours apart, for 1 day. Treatment should be started as soon as the initial signs of a cold sore appear (e.g., tingling, itching, or burning). 3) Chickenpox in children 2 years or older and under 18 years of age: Administer 20 mg of this medicine per kg of body weight per dose 3 times daily for 5 days. The total dose must not exceed 1,000 mg per dose 3 times daily. There are no data on the administration of this medicine to pediatric patients with creatinine clearance below 50 mL/min/1.73m2.

This drug, when administered in high doses to patients with progressive HIV, or to recipients of allogeneic bone marrow or kidney transplants, can cause serious blood disorders such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome, and caution is required. Administering this drug to patients with hypersensitivity to this drug, its active metabolite acyclovir, or any of its components is contraindicated. It should be administered with sufficient hydration and caution in patients at risk of dehydration, particularly the elderly. Patients with impaired kidney function may have increased risk of side effects due to difficulty in excretion, and dosage must be reduced and their condition closely monitored. Caution is also warranted in patients with liver dysfunction when high doses are used, and there is insufficient safety data for patients with moderate to severe liver impairment. While the preventive use of this drug in genital herpes patients can reduce the risk of transmission, it cannot completely eliminate it, and safe sexual practices are recommended. Caution is also required when administering this drug to pregnant women, women of childbearing potential, and nursing mothers, and it should only be used during pregnancy when the therapeutic benefits outweigh the risks. This drug can cause gastrointestinal adverse reactions such as nausea, vomiting, diarrhea, as well as central nervous system adverse effects such as headache, dizziness, confusion, and hallucinations. Especially in patients with reduced kidney function or in the elderly, psychiatric adverse reactions may occur more frequently, and close monitoring is essential. Acute renal failure can occur, so adequate hydration is necessary for all patients, and if renal function worsens, dialysis may be required. Administration of this drug is most effective when started at the onset of symptoms, and if symptoms do not improve during the treatment period, the physician should be consulted to reevaluate treatment. In case of overdose, severe neurological symptoms such as confusion, hallucinations, seizures, or coma may occur, so it is important to adhere strictly to the prescribed dosage. This medication should be stored out of reach of children, and transferring it to other containers can lead to quality degradation or accidents, so caution is advised. There is no research on how this drug affects driving or operating machinery, but caution is needed if adverse reactions occur. When this drug is administered in conjunction with other renally excreted drugs, blood concentration may increase, so renal function should be monitored closely. In the elderly, there is a higher risk of renal function decline and central nervous system adverse reactions, hence careful dosage adjustments and monitoring of their condition are essential. The use of this drug during pregnancy is limited, and caution is necessary during nursing, as some components may be transmitted in breast milk.

Thrombotic Thrombocytopenic Purpura, Hemolytic Uremic Syndrome, Nausea, Abdominal Discomfort, Vomiting, Diarrhea, Thrombocytopenia, Rash including photosensitivity reactions, Itching, Hives, Angioedema, Dyspnea, Anaphylaxis, Renal Impairment, Acute Renal Failure, Renal Pain, Elevated Liver Function Tests, Headache, Dizziness, Confusion, Hallucinations, Altered Consciousness, Tremors, Ataxia, Stuttering, Seizures, Encephalopathy, Coma, Facial Swelling, Erythema Multiforme, Dysmenorrhea, Depression, Arthralgia, Rhinitis, Upper Respiratory Infection, Fever, Dehydration, Herpes Simplex, Rhinorrhea, Hypertension, Tachycardia, Aggressive Behavior, Anxiety, Mania, Delusions, Paralysis, Decreased Consciousness, Auditory Hallucinations, Visual Hallucinations, Seizures, Visual Disturbances, Hepatitis, Jaundice, Liver Dysfunction, Increased Creatinine, Interstitial Nephritis, Aplastic Anemia, Leukocytoclastic Vasculitis, Pancytopenia, Agranulocytosis, Disseminated Intravascular Coagulation Syndrome, Thrombocytopenic Purpura, Leukopenia, Hair Loss, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Interstitial Pneumonia, Acute Pancreatitis, Increased BUN, Dyspepsia, Hiccup

This drug must be stored in a tightly closed container to protect it from air and moisture. Additionally, it should be stored at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance

White, oblong, film-coated tablets that are convex on both sides.

Package unit

30 tablets/bottle, 100 tablets/bottle