Valaciclovir Tablets 500 mg (Valaciclovir Hydrochloride Monohydrate)

Adult dose

Adults Herpes zoster: The usual dose is 1,000 mg of valacyclovir per dose, administered orally 3 times daily for 7 days. Genital herpes: The usual dose is 500 mg of this drug per dose, administered 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. Treatment should be started as soon as possible. For recurrent herpes simplex, treatment is most effective when started as soon as the prodromal symptoms or signs/symptoms first appear. Administration of this drug at the first appearance of signs/symptoms of recurrent genital herpes can prevent lesion progression. Suppression of recurrent genital herpes - Immunocompetent patients: The total daily dose is 500 mg of this drug, which may be administered as 250 mg per dose 2 times daily. A dose of 500 mg 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 500 mg). Treatment should be reassessed after 6 months to 12 months. Suppression of recurrent genital herpes - Immunocompromised patients: Administer 500 mg of this drug per dose 2 times daily. 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. Safer sex practices (especially condom use) should be maintained, and sexual contact should be avoided when lesions are present. Prevention of cytomegalovirus infection: Take 2,000 mg of this drug 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: The recommended dose of this drug for the treatment of cold sores is 2,000 mg per dose, administered 2 times daily at 12-hour intervals for 1 day. Treatment should be started as soon as the initial signs of a cold sore (e.g., tingling, itching, burning) appear. The efficacy of this drug when administered after clinical signs of a cold sore (e.g., papules, vesicles, ulcers) have appeared has not been established. Elderly patients: If exposure to acyclovir, the active metabolite of this drug, is increased, the risk of neuropsychiatric symptoms or renal impairment may also increase. In patients with renal impairment or reduced renal function, and in elderly patients, adjust the dosing interval and dose of this drug and administer it cautiously while monitoring the patient's clinical condition. Dose adjustment is not necessary except in cases of significant renal impairment. Adequate hydration should be maintained. Patients with renal impairment: In patients with significantly impaired renal function, adjust the dose as follows. Adequate hydration should be maintained. There are no data on the use of this drug in pediatric patients with creatinine clearance below 50 mL/min/1.73m2. In patients receiving hemodialysis, administer the dose after hemodialysis. During periods of rapidly changing renal function (e.g., immediately after transplantation or kidney transplantation), creatinine clearance should be monitored frequently, and the dose of this drug should be adjusted appropriately according to creatinine clearance. Herpes zoster, creatinine clearance 50 or greater: 1,000 mg per dose 3 times daily Herpes zoster, creatinine clearance 30 or greater to below 50: 1,000 mg per dose 2 times daily Herpes zoster, creatinine clearance 10 or greater to below 30: 1,000 mg per dose once daily Herpes zoster, creatinine clearance below 10: 500 mg per dose once daily Genital herpes, creatinine clearance 30 or greater: 500 mg per dose 2 times daily Genital herpes, creatinine clearance below 30: 500 mg per dose once daily Genital herpes suppression - Immunocompetent, creatinine clearance 30 or greater: 500 mg per dose once daily* Genital herpes suppression - Immunocompetent, creatinine clearance below 30: 250 mg per dose once daily Genital herpes suppression - Immunocompromised, creatinine clearance 30 or greater: 500 mg per dose 2 times daily Genital herpes suppression - Immunocompromised, creatinine clearance below 30: 500 mg per dose once daily Cytomegalovirus prevention, creatinine clearance 75 or greater: 2,000 mg per dose 4 times daily Cytomegalovirus prevention, creatinine clearance 50 or greater to below 75: 1,500 mg per dose 4 times daily Cytomegalovirus prevention, creatinine clearance 25 or greater to below 50: 1,500 mg per dose 3 times daily Cytomegalovirus prevention, creatinine clearance 10 or greater to below 25: 1,500 mg per dose 2 times daily Cytomegalovirus prevention, creatinine clearance below 10 or during dialysis: 1,500 mg per dose once daily Cold sores, creatinine clearance 50 or greater: 2,000 mg per dose 2 times daily Cold sores, creatinine clearance 30 or greater to 49 inclusive: 1,000 mg per dose 2 times daily Cold sores, creatinine clearance 10 or greater to below 30: 500 mg per dose 2 times daily Cold sores, 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 when 250 mg of this drug is administered in divided doses 2 times daily (total daily dose 500 mg). Patients on peritoneal dialysis: There is no information on the use of this drug in patients receiving peritoneal dialysis. The effects of continuous ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on the pharmacokinetics of acyclovir have been studied. Acyclovir elimination after CAPD and CAVHD was lower than that observed with hemodialysis, and the pharmacokinetic parameters were very similar to those observed in patients with end-stage renal disease who were not receiving hemodialysis. Therefore, supplemental doses of this drug are not required after CAPD or CAVHD (see the section “Administer with caution in the following patients”). Patients with hepatic impairment: No dose adjustment is necessary in patients with mild to moderate cirrhosis (with normal hepatic synthetic function). Although hemodynamic data indicate that no dose adjustment is necessary in patients with severe cirrhosis (hepatic synthetic dysfunction or signs of portal-systemic shunting), clinical experience is limited. Therefore, administer high doses of this drug cautiously to patients with hepatic impairment (see the section “Administer with caution in the following patients”).

Child dose

Aged 12 years and older, prevention of cytomegalovirus infection: Take 2,000 mg per dose 4 times daily, starting within 72 hours after transplantation or as soon as oral administration is possible. Reduce the dose according to creatinine clearance. The duration of treatment is usually 90 days, but may need to be extended in high-risk patients. Aged 12 years and older, cold sores: Take 2,000 mg per dose twice daily, 12 hours apart, for 1 day. Start treatment as soon as the initial signs of a cold sore (e.g., tingling, itching, burning) appear. The efficacy of this medicine when administered after clinical signs of a cold sore (e.g., papules, vesicles, ulcers) have appeared has not been established. Children aged 2 years to under 18 years, chickenpox: Administer 20 mg/kg per dose 3 times daily for 5 days. The total dose should not exceed 1,000 mg per dose, 3 times daily. Start treatment as soon as the initial signs or symptoms appear. Based on efficacy data from clinical trials of oral acyclovir, treatment should be started within 24 hours after the rash begins.

This medication should be used with caution in patients with progressive HIV or those receiving high doses in the case of allogeneic bone marrow and kidney transplant recipients, as it may cause serious blood disorders such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome. Patients with hypersensitivity to this medication, its active metabolite acyclovir, or any component of this medication should not be administered this drug. Patients who are dehydrated or elderly should receive this medication with careful monitoring and adequate hydration, and those with impaired renal function should have their dosage reduced as the excretion of this drug is via the kidneys. In patients with liver dysfunction, caution is necessary for high-dose administration, as acyclovir levels may increase in cases of liver cirrhosis. While this drug may reduce the risk of transmission in patients with genital herpes when used proactively, it does not completely eliminate the risk of transmission; thus, the practice of safe sexual behavior is recommended. Women who are pregnant or may become pregnant, breastfeeding mothers, and elderly patients should also use this medication with caution. During the course of this medication, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur, along with rare hypersensitivity reactions like skin rash, itching, urticaria, and angioedema. Renal-related adverse reactions such as renal impairment, acute kidney injury, kidney pain may occur, making adequate hydration very important. Central nervous system reactions such as headache, dizziness, confusion, hallucinations, and altered consciousness may occur, particularly more often in patients with decreased renal function or those receiving high doses, thus careful observation is needed. This medication is most effective when taken at the first sign of symptoms, and if symptoms do not improve or worsen during the treatment period, patients should immediately consult a doctor. In case of overdose, acute kidney failure and central nervous system symptoms (confusion, hallucinations, seizures) may occur, necessitating immediate medical attention. When taking this medication, caution is needed when engaging in activities requiring judgment and concentration, such as driving or operating machinery, considering the possibility of adverse reactions. Data on the safety of this medication during pregnancy is limited, so it should only be used if the therapeutic benefits outweigh the risks, and if breastfeeding, caution is needed as some components may be passed into breast milk. In elderly patients, the concentration of this medication may increase due to decreased renal function, thereby heightening the risk of neuropsychiatric reactions or renal impairment, requiring dose adjustments and careful monitoring.

Thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, rash including photosensitivity reaction, pruritus, urticaria, angioedema, dyspnea, anaphylaxis, kidney dysfunction, acute renal failure, renal pain, elevated liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremor, ataxia, stuttering, seizures, encephalopathy, coma, facial edema, seizures, erythema multiforme, dysmenorrhea, depression, arthralgia, rhinitis, upper respiratory infection, fever, dehydration, herpes simplex, rhinorrhea, hypertension, tachycardia, aggressive behavior, agitation, 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 (DRESS), interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups

This medication may be sensitive to air and moisture, so it is important to store it in a tightly sealed container. Additionally, the drug should be kept away from excessively hot or cold locations, maintaining a storage temperature between 1 and 30 degrees Celsius.

Appearance

White, biconvex, rectangular film-coated tablet

Package unit

30 tablets/bottle