Valtem Tablets (Valaciclovir Hydrochloride)

Adult dose

1) Herpes zoster Administer valacyclovir 1,000 mg orally 3 times daily for 7 days. 2) Genital herpes infection Administer 500 mg of this drug twice daily. For recurrent infection, 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. Administration of this drug at the first signs/symptoms of recurrent genital herpes may prevent lesion progression. 3) Suppression of recurrent genital herpes infection (1) Immunocompetent patients: The total daily dose is 500 mg of this drug, which may be administered as 250 mg twice daily. A dose of 500mg 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 twice daily (total daily dose 500 mg). Treatment should be reassessed after 6 to 12 months of administration. (2) Immunocompromised patients: Administer 500 mg of this drug 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 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. 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 treatment 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 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 drug when administered after the clinical signs of a cold sore (e.g., papules, vesicles, ulcers) have appeared has not been established. 3. Older adults 1) Increased exposure to acyclovir, the active metabolite of this drug, may increase the risk of neuropsychiatric symptoms or renal impairment. In patients with renal impairment or reduced renal function, and in older adults, adjust the dosing interval and dose of this drug, and administer with caution while monitoring the patient's clinical condition. 2) Dose adjustment is not necessary except in cases of significant renal impairment. Adequate hydration should be maintained. 4. Patients with renal impairment In patients with significantly impaired renal function, adjust the dose as follows. Adequate hydration should be maintained. For patients receiving hemodialysis, administer after the hemodialysis session. During periods of rapid changes in 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. Indication / Creatinine clearance (mL/min) / Dose Herpes zoster / 50 or more / 1,000 mg 3 times daily Herpes zoster / 30 or more to less than 50 / 1,000 mg twice daily Herpes zoster / 10 or more to less than 30 / 1,000 mg once daily Herpes zoster / Less than 10 / 500 mg once daily Genital herpes / 30 or more / 500 mg twice daily Genital herpes / Less than 30 / 500 mg once daily Suppression of genital herpes - immunocompetent / 30 or more / 500 mg once daily* Suppression of genital herpes - immunocompetent / Less than 30 / 250 mg once daily Suppression of genital herpes - immunocompromised / 30 or more / 500 mg twice daily Suppression of genital herpes - immunocompromised / Less than 30 / 500 mg once daily Cytomegalovirus prevention / 75 or more / 2,000 mg 4 times daily Cytomegalovirus prevention / 50 or more to less than 75 / 1,500 mg 4 times daily Cytomegalovirus prevention / 25 or more to less than 50 / 1,500 mg 3 times daily Cytomegalovirus prevention / 10 or more to less than 25 / 1,500 mg twice daily Cytomegalovirus prevention / Less than 10 or on dialysis / 1,500 mg once daily Cold sores / 50 or more / 2,000 mg twice daily Cold sores / 30 or more to 49 inclusive / 1,000 mg twice daily Cold sores / 10 or more to less than 30 / 500 mg twice daily Cold sores / Less than 10 / 500 mg once daily *Some patients with 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 administration 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”). 6. Patients with hepatic impairment No dose adjustment is required 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 portosystemic shunting), hemodynamic data suggest that dose adjustment is not required; however, clinical experience is limited. Therefore, administer high doses of this drug with caution in patients with hepatic impairment (see the section “Administer with caution in the following patients”).

Child dose

Prevention of cytomegalovirus infection in patients aged 12 years and older: Take 2,000 mg per dose 4 times daily. Start within 72 hours after transplantation or as soon as oral administration is possible. The dose should be reduced according to creatinine clearance. The usual treatment duration is 90 days, but extension may be necessary in high-risk patients. Herpes labialis in patients aged 12 years and older: Take 2,000 mg per dose twice daily, 12 hours apart, for 1 day. Begin treatment as soon as the initial signs of herpes labialis (e.g., tingling, itching, burning) appear. The efficacy of this medicine has not been established when treatment is started after the clinical signs of herpes labialis (e.g., papules, vesicles, ulcers) appear. Chickenpox in children aged 2 years to under 18 years: Administer 20 mg/kg 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.

Caution is required because this medication can cause serious blood-related disorders when administered in high doses to patients with progressive HIV or those undergoing allogeneic hematopoietic stem cell and kidney transplantation. Patients allergic to this medication, its active metabolite acyclovir, or any of its components should not use this product. Patients at risk of dehydration, particularly the elderly, should take this medication carefully while maintaining adequate hydration. Patients with reduced kidney function may experience delayed excretion of this medication, and the dosage should be adjusted while closely monitoring their condition. Safety of high-dose administration in patients with poor liver function has not been established, so caution is needed. When used for prevention of genital herpes, this medication does not guarantee complete treatment or elimination of transmission risk, thus practicing safe sex is important. Women who are pregnant or may become pregnant, as well as nursing mothers, should use this medication cautiously due to limited information on its use during pregnancy. Elderly patients are at increased risk of kidney function decline and central nervous system adverse effects, necessitating dose adjustments and careful monitoring of their condition. During the use of this medication, side effects such as nausea, vomiting, diarrhea, headache, and dizziness may occur; if symptoms are severe, consult with healthcare professionals. In patients with reduced kidney function, serious renal issues such as acute renal failure may arise, making adequate hydration and regular kidney function tests essential. Central nervous system adverse reactions such as confusion, hallucinations, and seizures may occur; if these symptoms appear, the medication should be stopped immediately and medical attention sought. Overdosage may worsen kidney function and exacerbate neurological symptoms; therefore, adherence to the prescribed dosage is crucial. This medication is also indicated for children, but caution is necessary as safety and efficacy have not been established for certain indications in children under 12 years of age. Patients receiving this medication should consider the potential for neurological side effects when engaging in activities requiring sound judgment such as driving or operating machinery. Although drug interactions are not widely reported, kidney function should be vigilantly monitored when used along with other medications eliminated through the kidneys. Store this medication out of reach of children and do not transfer it to other containers.

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 colic, reversible elevation of liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremors, coordination impairment, stuttering, seizures, encephalopathy, coma, facial swelling, spasms, erythema multiforme, dysmenorrhea, depression, arthralgia, rhinitis, upper respiratory tract infection, fever, dehydration, herpes simplex, runny nose, hypertension, tachycardia, aggressive behavior, anxiety, coma, mania, delusions, paralysis, decreased awareness, 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, polymorphic erythema, hair loss, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reactions, interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups, anxiety, hallucinations, confusion, delirium, seizures, encephalopathy

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness for a longer duration.

Appearance

Biconvex, narrow, long white film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle