Valcyclovir Tablet 500mg (Valacyclovir Hydrochloride Hydrate)

Adult dose

1) Herpes zoster: Administer valacyclovir 1,000 mg per dose orally 3 times daily for 7 days. 2) Genital herpes infection: Administer 500 mg per dose of this medicine twice daily. For recurrent episodes, 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; 250 mg per dose may be administered twice daily. Administration of 500mg per dose once daily is also effective, particularly for 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 reassessed after 6 to 12 months of administration. (2) Immunocompromised patients: Administer 500 mg per dose of this medicine 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 per dose 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 per dose of this medicine 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. Treatment is usually continued for 90 days, but may need to be extended in high-risk patients. 6) Cold sores: The recommended dose of this medicine for treatment of cold sores is 2,000 mg 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, burning) appear. Patients with renal impairment: Herpes zoster, creatinine clearance 50 or more: 1,000 mg per dose 3 times daily Herpes zoster, creatinine clearance 30 or more to less than 50: 1,000 mg per dose twice daily Herpes zoster, creatinine clearance 10 or more to less than 30: 1,000 mg per dose once daily Herpes zoster, creatinine clearance less than 10: 500 mg per dose once daily Genital herpes, creatinine clearance 30 or more: 500 mg per dose twice daily Genital herpes, creatinine clearance less than 30: 500 mg per dose once daily Genital herpes suppression-immunocompetent, creatinine clearance 30 or more: 500 mg per dose once daily* Genital herpes suppression-immunocompetent, creatinine clearance less than 30: 250 mg per dose once daily Genital herpes suppression-immunocompromised, creatinine clearance 30 or more: 500 mg per dose twice daily Genital herpes suppression-immunocompromised, creatinine clearance less than 30: 500 mg per dose once daily Cytomegalovirus prevention, creatinine clearance 75 or more: 2,000 mg per dose 4 times daily Cytomegalovirus prevention, creatinine clearance 50 or more to less than 75: 1,500 mg per dose 4 times daily Cytomegalovirus prevention, creatinine clearance 25 or more to less than 50: 1,500 mg per dose 3 times daily Cytomegalovirus prevention, creatinine clearance 10 or more to less than 25: 1,500 mg per dose twice daily Cytomegalovirus prevention, creatinine clearance less than 10 or on dialysis: 1,500 mg per dose once daily Cold sores, creatinine clearance 50 or more: 2,000 mg per dose twice daily Cold sores, creatinine clearance 30 or more to 49 inclusive: 1,000 mg per dose twice daily Cold sores, creatinine clearance 10 or more to less than 30: 500 mg per dose twice daily Cold sores, creatinine clearance less than 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

Prevention of cytomegalovirus infection (age 12 years and older): Take 2,000 mg per dose of this medicine 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. Treatment is usually continued for 90 days, but may need to be extended in high-risk patients. Cold sores (age 12 years and older): The recommended dose for treatment of cold sores is 2,000 mg per dose of this medicine twice daily, 12 hours apart, for 1 day. Treatment should begin as soon as the initial signs of cold sores (e.g., tingling, itching, burning) appear. Chickenpox (age 2 years and older to under 18 years): Administer 20 mg per kg of body weight per dose of this medicine 3 times daily for 5 days; the total dose must not exceed 1,000 mg per dose, 3 times daily.

This medicine carries a risk of severe blood disorders if given in high doses to patients with progressive HIV or those who have undergone bone marrow or kidney transplantation. It should not be used in patients who are allergic to this product, its active metabolite acyclovir, or any of its ingredients. It contains lactose, so patients with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. Caution is needed when administering this medicine to dehydrated patients, especially elderly patients, ensuring adequate hydration. Patients with impaired kidney function may have delayed excretion of this medicine, so the dosage should be reduced, and renal function should be assessed in elderly patients for appropriate dosage adjustments. Patients with poor liver function or who have undergone liver transplantation should use caution when taking high doses of this medicine. For patients with genital herpes using this medicine prophylactically, it is advisable to practice safe sexual methods such as using condoms. Women who are pregnant or may become pregnant and nursing mothers should use this medicine with caution. Elderly patients are at a higher risk of neurological reactions and decreased kidney function, requiring careful monitoring and dosage adjustments. Gastrointestinal symptoms may occur, such as nausea, vomiting, and diarrhea, as well as rare allergic reactions such as blood abnormalities, skin rashes, itching, and difficulty breathing. Symptoms related to kidney impairment or acute renal failure may arise, making sufficient fluid intake very important. Symptoms of central nervous system disturbances including headache, confusion, hallucination, and seizures have been reported, primarily in patients with kidney dysfunction. Caution is required while driving or operating machinery during treatment; if central nervous system symptoms appear, administration should be stopped immediately. In cases of overdose, renal failure and neurological symptoms may occur, and appropriate treatment such as dialysis should be performed as directed by a physician. This medicine should be kept out of reach of children and should not be transferred to other containers. When used during pregnancy, it should only be administered if the benefits outweigh the risks, and caution is advised for nursing mothers. This medicine is recommended only for treating herpes labialis in children over 12 years and treating varicella in children aged 2 to less than 18 years; safety and efficacy in other age groups or indications have not been established.

Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, photosensitivity reactions including rash, itching, urticaria, angioedema, dyspnea, anaphylaxis, renal impairment, acute renal failure, renal pain, reversible elevation of liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremors, ataxia, stuttering, seizures, encephalopathy, coma, facial edema, seizures, erythema multiforme, dysmenorrhea, depression, arthralgia, rhinitis, upper respiratory tract infection, diarrhea, fever, dehydration, herpes simplex, runny nose, hypertension, tachycardia, aggressive behavior, anxiety, coma, mania, delusions, paralysis, decreased consciousness, auditory hallucinations, visual hallucinations, seizures, psychosis, visual disturbances, hepatitis, jaundice, liver dysfunction, elevated 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 (DRESS), interstitial pneumonia, acute pancreatitis, elevated BUN, dyspepsia, hiccups, confusion, hallucinations, anxiety, decreased consciousness, coma, nausea, vomiting, headache, confusion, hallucinations, anxiety, seizures, coma

This medicine may be sensitive to air and moisture, so it should be stored in a tightly closed container. The best storage temperature is between 1°C to 30°C room temperature. This will help maintain the safety and efficacy of the medicine.

Appearance

White, double convex, rectangular film-coated tablet

Package unit

42 tablets (6 tablets/PTP × 7)