Valaciclovir 500 mg Tablet (Valaciclovir Hydrochloride Hemihydrate)

Adult dose

1. Adults 1) Herpes zoster Administer 1,000 mg of valacyclovir orally 3 times daily for 7 days. 2) Genital herpes infection 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 (1) Immunocompetent patients: 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. In some patients with 10 or more recurrences per year without treatment, additional benefit may be obtained by administering 250 mg of this drug 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 For 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 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 drug for the treatment of cold sores is 2,000 mg per dose, administered 2 times at a 12-hour interval over 1 day. Treatment should begin as soon as the initial signs of a cold sore (e.g., tingling, itching, burning) appear. 3. Older adults In patients with renal impairment or reduced renal function, and in older adults, adjust the dosing interval and dose of this drug and administer it cautiously while monitoring the patient's clinical condition. Dose adjustment is not required except in cases of particularly severe renal impairment. 4. Patients with renal impairment There are no data on the use of this drug in pediatric patients with creatinine clearance below 50 mL/min/1.73m2. In patients on hemodialysis, administer the drug after hemodialysis is completed. Indication | Creatinine clearance (mL/min) | Dose Herpes zoster | 50 or higher | 1,000 mg per dose 3 times daily Herpes zoster | 30 or higher to less than 50 | 1,000 mg per dose 2 times daily Herpes zoster | 10 or higher to less than 30 | 1,000 mg per dose once daily Herpes zoster | Less than 10 | 500 mg per dose once daily Genital herpes | 30 or higher | 500 mg per dose 2 times daily Genital herpes | Less than 30 | 500 mg per dose once daily Genital herpes suppression - immunocompetent | 30 or higher | 500 mg per dose once daily* Genital herpes suppression - immunocompetent | Less than 30 | 250 mg per dose once daily Genital herpes suppression - immunocompromised | 30 or higher | 500 mg per dose 2 times daily Genital herpes suppression - immunocompromised | Less than 30 | 500 mg per dose once daily Cytomegalovirus prevention | 75 or higher | 2,000 mg per dose 4 times daily Cytomegalovirus prevention | 50 or higher to less than 75 | 1,500 mg per dose 4 times daily Cytomegalovirus prevention | 25 or higher to less than 50 | 1,500 mg per dose 3 times daily Cytomegalovirus prevention | 10 or higher to less than 25 | 1,500 mg per dose 2 times daily Cytomegalovirus prevention | Less than 10 or on dialysis | 1,500 mg per dose once daily Cold sores | 50 or higher | 2,000 mg per dose 2 times daily Cold sores | 30 or higher to 49 or lower | 1,000 mg per dose 2 times daily Cold sores | 10 or higher to less than 30 | 500 mg per dose 2 times daily Cold sores | Less than 10 | 500 mg per dose once daily *In some patients with 10 or more recurrences per year without treatment, additional benefit may be obtained by administering 250 mg of this drug in divided doses 2 times daily (total daily dose of 500 mg). 5. Patients on peritoneal dialysis Supplemental administration of this drug is not necessary after CAPD or CAVHD. 6. Patients with hepatic impairment No dose adjustment is required in patients with mild to moderate cirrhosis (patients with normal hepatic synthetic function). Although hemodynamic data suggest that no dose adjustment is required in patients with severe cirrhosis (patients with hepatic synthetic dysfunction or signs of portosystemic shunting), clinical experience is limited. Therefore, this drug should be administered cautiously at high doses to patients with hepatic impairment.

Child dose

Prevention of cytomegalovirus infection in patients aged 12 years and older: Administer 2,000 mg of this medicine per dose, 4 times daily, and initiate treatment within 72 hours after transplantation or as soon as oral administration is possible. Reduce the dose according to creatinine clearance. The treatment period is usually 90 days, but may need to be extended in high-risk patients. Herpes labialis in patients aged 12 years and older: Administer 2,000 mg of this medicine per dose, twice daily at 12-hour intervals for 1 day. Treatment should begin as soon as the initial signs of herpes labialis (e.g., tingling, itching, or burning) appear. Chickenpox in children aged 2 years and older and younger than 18 years: Administer 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.

This medication should be used with caution in patients with progressive HIV or those with allogenic bone marrow or kidney transplants when administered in high doses due to the risk of serious blood disorders such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome. Patients with a history of allergic reactions to this medication or its active metabolite acyclovir, or any component contained in this medication should not use it. Additionally, this medication contains lactose, so patients with genetic metabolic disorders like lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid it. Patients who are dehydrated or elderly should take adequate fluids while on this medication, and those with reduced kidney function should have their dosage adjusted. Patients with impaired liver function or those who have undergone liver transplantation should also use this medication cautiously when administered in high doses. For patients with genital herpes, using this medication prophylactically may reduce the risk of transmission, but it does not completely treat or eliminate the risk of transmission, so safe sexual practices should be maintained. Women who are pregnant, may become pregnant, or are breastfeeding, as well as the elderly, should exercise special caution when taking this medication. Gastrointestinal symptoms such as nausea or vomiting may occur, and in rare cases, hypersensitivity reactions including thrombocytopenia, skin rash, itching, and dyspnea may occur. Patients with decreased kidney function may experience acute renal failure, making adequate hydration crucial, and in cases of severe renal failure, dialysis may be necessary. Neurological symptoms such as headaches, confusion, hallucinations, and seizures may occur, and immediate consultation with a physician is advised if these symptoms arise. This medication is most effective when administered promptly, and if no therapeutic effect is observed or symptoms worsen, discontinuation and alternative treatment should be considered. In cases of overdose, renal failure and neurological symptoms may occur, so dosages should be followed precisely, and in cases of suspected overdose, medical assistance should be sought immediately. This medication should be kept out of the reach of children, and transferring it to another container may cause a decline in quality or result in accidents, so caution is necessary. Women who are pregnant or breastfeeding should consult with a physician before taking this medication as its active metabolite can be transferred through breast milk, necessitating careful usage. Elderly patients or those with decreased kidney function may experience neurological side effects more frequently, thus dosage adjustment and monitoring are required. During the course of taking this medication, individuals should carefully observe their condition when performing attention-required activities such as driving or operating machinery.

Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, rash including photosensitivity reaction, pruritus, urticaria, angioedema, respiratory distress, anaphylaxis, renal impairment, acute renal failure, renal colic, 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, rhinopharyngitis, 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, 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 (DRESS), interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups, confusion, hallucinations, anxiety, decreased consciousness, coma, nausea, vomiting, headache, seizures

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage at a temperature between 1 to 30 degrees Celsius.

Appearance

White, biconvex, rectangular film-coated tablets

Package unit

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