Valacyclovir Tablet 500mg (Valacyclovir Hydrochloride 1.5 Hydrate)

Adult dose

1. Adults 1) Herpes zoster Administer valacyclovir 1,000 mg orally 3 times daily for 7 days. 2) Genital herpes infection Administer this medication 500 mg twice 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 prodromal symptoms or the first signs/symptoms appear. When this medication is administered at the first signs/symptoms of recurrent genital herpes, it may prevent progression of the lesions. 3) Suppression of recurrent genital herpes infection (1) Immunocompetent patients: The total daily dose is 500 mg of this medication, which may be administered as 250 mg twice daily. Administration of 500 mg once daily is also effective, particularly in patients with fewer than 10 recurrences per year. Some patients who experience 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg twice daily (total daily dose 500 mg). Treatment should be reassessed after 6 to 12 months. (2) Immunocompromised patients: Administer 500 mg of this medication twice daily. 4) Reducing 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 medication once daily to reduce transmission to a sexual partner who is negative for Herpes Simplex Virus-2 (HSV-2) antibodies. Safer sexual practices (particularly condom use) should be maintained, and sexual contact should be avoided when lesions are present. 5) Prevention of cytomegalovirus infection Take 2,000 mg of this medication 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. 6) Cold sores The recommended dose of this medication for the treatment of cold sores is 2,000 mg twice 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. The efficacy of this medication when administered after clinical signs of a cold sore (e.g., papules, vesicles, ulcers) have appeared has not been established. 3. Elderly patients 1) Increased exposure to acyclovir, the active metabolite of this medication, may increase the risk of neuropsychiatric symptoms or renal impairment. In patients with renal impairment or reduced renal function, and in elderly patients, adjust the dosing interval and dose of this medication and administer with caution while monitoring the patient's clinical condition. 2) Dose adjustment is not necessary unless renal function is severely impaired. Adequate hydration should be maintained. 4. Patients with renal impairment In patients with significant renal impairment, the dose should be adjusted as follows. Adequate hydration should be maintained. For patients receiving hemodialysis, administer after hemodialysis is completed. 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 medication should be adjusted appropriately according to creatinine clearance. Herpes zoster, creatinine clearance 50 or above: 1,000 mg 3 times daily Herpes zoster, creatinine clearance 30 or above to less than 50: 1,000 mg twice daily Herpes zoster, creatinine clearance 10 or above to 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 above: 500 mg twice daily Genital herpes, creatinine clearance less than 30: 500 mg once daily Genital herpes suppression - immunocompetent, creatinine clearance 30 or above: 500 mg once daily* Genital herpes suppression - immunocompetent, creatinine clearance less than 30: 250 mg once daily Genital herpes suppression - immunocompromised, creatinine clearance 30 or above: 500 mg twice daily Genital herpes suppression - immunocompromised, creatinine clearance less than 30: 500 mg once daily Cytomegalovirus prevention, creatinine clearance 75 or above: 2,000 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 50 or above to less than 75: 1,500 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 25 or above to less than 50: 1,500 mg 3 times daily Cytomegalovirus prevention, creatinine clearance 10 or above to less than 25: 1,500 mg twice daily Cytomegalovirus prevention, creatinine clearance less than 10 or during dialysis: 1,500 mg once daily Cold sores, creatinine clearance 50 or above: 2,000 mg twice daily Cold sores, creatinine clearance 30 or above and 49 or below: 1,000 mg twice daily Cold sores, creatinine clearance 10 or above and less than 30: 500 mg twice daily Cold sores, creatinine clearance less than 10: 500 mg once daily *Some patients who experience 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg twice daily (total daily dose 500 mg). 5. Patients receiving peritoneal dialysis There is no information on the use of this medication in patients receiving peritoneal dialysis. The effects of chronic 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 found to be lower than that during 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 dosing of this medication is not required after CAPD or CAVHD (see the section “Use with caution in the following patients”). 6. Patients with hepatic impairment No dose adjustment is necessary in patients with mild to moderate cirrhosis (patients with normal hepatic synthetic function). For patients with severe cirrhosis (patients with hepatic synthetic dysfunction or signs of portal-systemic shunting), hemodynamic data indicate that no dose adjustment is necessary; however, clinical experience is limited. Therefore, administer this medication with caution at high doses to patients with hepatic impairment (see the section “Use with caution in the following patients”).

Child dose

Age 12 years and older, prevention of cytomegalovirus infection: Take 2,000 mg of this medicine per dose 4 times daily. Start treatment within 72 hours after transplantation or as soon as oral administration is possible. The dose should be reduced according to creatinine clearance. Treatment usually lasts 90 days, but may need to be extended in high-risk patients. Age 12 years and older, cold sores: The recommended dose for treatment of cold sores is 2,000 mg of this medicine per dose twice daily, 12 hours apart, for 1 day. Begin treatment as soon as the initial signs of cold sores (e.g., tingling, itching, burning) appear. The efficacy of this medicine when administered after the clinical signs of cold sores (e.g., papules, vesicles, ulcers) appear has not been established. Chickenpox in children aged 2 years to under 18 years: 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. Begin 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 stem cell and kidney transplant recipients, as it may lead to serious hematologic conditions such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome. Patients with allergies to this drug, acyclovir, or any of its components should not take it. It should be administered cautiously with adequate hydration, especially in dehydrated or elderly patients. Patients with decreased kidney function may have difficulty excreting this medication, thus increasing the risk of side effects and necessitating closer observation and possible dose adjustments. When using this medication in patients with impaired liver function at high doses, care must be taken to prevent worsening of liver function. Although preventive use of this medication in genital herpes patients can reduce the risk of transmission, it does not eliminate it entirely; therefore, safe sexual practices, including condom use, are recommended. Pregnant women, women who may become pregnant, and nursing mothers should carefully weigh the risks and benefits of using this medication. Elderly patients are at increased risk of adverse effects on the kidneys and central nervous system, hence dose adjustments and careful monitoring are necessary. Gastrointestinal symptoms such as nausea are common, and occasionally vomiting or diarrhea may occur. Skin reactions such as rashes or itching may occur, and in severe cases, there may be allergic reactions like urticaria, angioedema, dyspnea, or anaphylaxis; if unusual symptoms arise, consult a healthcare provider immediately. Adequate fluid intake is crucial to minimize kidney function impact, and acute renal failure may necessitate dialysis. Neuropsychiatric reactions such as headache, dizziness, confusion, hallucinations, or seizures may occur, particularly in patients with reduced kidney function or those receiving high doses. If any adverse reactions occur during treatment, inform a healthcare provider immediately and adjust treatment as necessary. In cases of overdose, acute renal failure and neurological symptoms may manifest, so caution is advised, and the drug can be removed via dialysis. Keep this medication out of reach of children, and avoid transferring it to other containers, which could lead to accidents or degradation of quality. There is insufficient research on the effects of this medication on driving or machinery operation; hence caution is advised if side effects occur. Use during pregnancy has limited data and should only be utilized when the benefits of treatment outweigh the risks; during breastfeeding, caution is advised as the drug may pass to the infant.

Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, rash including photosensitivity reactions, pruritus, urticaria, angioedema, dyspnea, anaphylaxis, renal impairment, acute kidney failure, renal colic, reversible increase in liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremors, ataxia, stuttering, seizures, encephalopathy, coma, facial swelling, convulsions, erythema multiforme, dysmenorrhea, depression, arthralgia, nasopharyngitis, 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, erythema multiforme, alopecia, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction (DRESS), interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to keep the storage temperature between 1°C and 30°C at room temperature. This will help maintain the medication's effectiveness for a longer duration.

Appearance

Biconvex, slender, long white film-coated tablet

Package unit

30 tablets/bottle