Valtmax Tablet (Valaciclovir Hydrochloride)

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 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 the prodromal symptoms or symptoms/signs first appear. Administration of this drug when the symptoms/signs of recurrent genital herpes first appear 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 2 times daily. Administration of 500 mg once daily is also effective, particularly in patients who have fewer than 10 recurrences per year. Some patients who have 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg 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. 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 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 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) If exposure to acyclovir, the active metabolite of this drug, increases, the risk of neuropsychiatric symptoms or renal impairment may also increase. In patients with renal impairment or reduced renal function, and in older adults, adjust the dosing interval and dose of this drug, and administer cautiously while monitoring the patient's clinical condition. 2) Dose adjustment is not necessary unless renal function is significantly impaired. Adequate hydration should be maintained. 4. Patients with renal impairment In patients with clinically significant renal impairment, adjust the dose as follows. Adequate hydration should be maintained. For patients receiving hemodialysis, administer the dose after hemodialysis is completed. During periods of rapid changes in renal function (e.g., transplantation or immediately after 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 2 times 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 2 times 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 2 times 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 2 times daily Cytomegalovirus prevention / Less than 10 or on dialysis / 1,500 mg once daily Cold sores / 50 or more / 2,000 mg 2 times daily Cold sores / 30 or more to 49 inclusive / 1,000 mg 2 times daily Cold sores / 10 or more to less than 30 / 500 mg 2 times daily Cold sores / Less than 10 / 500 mg once daily *Some patients who have 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg 2 times daily (total daily dose of 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 hemodiafiltration/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 necessary after CAPD or CAVHD (see the section “Administration 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 portosystemic shunting), hemodynamic data indicate that no dose adjustment is necessary; however, clinical experience is limited. Therefore, this drug should be administered cautiously at high doses to patients with hepatic impairment (see the section “Administration with caution in the following patients”).

Child dose

1) Prevention of cytomegalovirus infection (ages 12 years and older): 2,000 mg per dose, 4 times daily; the treatment period is usually 90 days, but may need to be extended in high-risk patients. 2) Cold sores (ages 12 years and older): 2,000 mg per dose, twice daily at 12-hour intervals for 1 day. 3) Chickenpox in children aged 2 years to under 18 years: Administer 20 mg 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. There are no data on administration of this drug to pediatric patients with creatinine clearance below 50 mL/min/1.73m2.

This medication can pose a risk of serious blood disorders, which can be life-threatening, if administered in high doses to patients with progressive HIV or those who have undergone allogeneic bone marrow and kidney transplants. Patients with hypersensitivity to this medication or its active metabolite acyclovir, or any component of this medication should not use it. Hydration and dosage adjustments are necessary when administering this medication to dehydrated patients or those with impaired kidney function, particularly in the elderly. Patients with decreased liver function or those who have received a liver transplant should be cautious with high-dose administration. While the use of this medication reduces the transmission risk of genital herpes when used for prevention, it does not entirely eliminate treatment or transmission risk; safe sexual practices, especially condom use, are recommended. Women who are pregnant or may become pregnant, nursing mothers, and the elderly should use this medication with caution. During treatment, gastrointestinal symptoms such as nausea, vomiting, diarrhea, and neurological symptoms such as headache, dizziness, confusion, and hallucinations may occur, requiring careful monitoring. Adequate hydration is crucial as it may impact kidney function, and acute renal failure may necessitate dialysis. This medication may interact with other drugs at high doses, especially when co-administered with drugs excreted by the kidneys. Due to limited information on the use of this medication during pregnancy, it should only be administered if the therapeutic benefits outweigh the risks, and use during breastfeeding should be approached with caution due to potential effects on the infant. This medication is approved for use in children aged 12 and over for certain indications, and safety and efficacy have not been sufficiently established for children under the age of 12. Elderly patients are at higher risk of decreased kidney function and neurological adverse reactions; therefore, dosage adjustments and careful observation of their condition are necessary. In case of overdose, renal impairment and neurological symptoms may occur, so strict adherence to dosing is essential, and immediate consultation with healthcare professionals should be sought if symptoms arise. This medication should be stored out of reach of children, and transferring to another container may adversely affect quality and should be avoided. Finally, when using this medication, activities requiring judgment such as driving or operating machinery should be performed with caution, considering the potential for adverse reactions.

Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, rash including phototoxic reactions, itching, hives, angioedema, dyspnea, anaphylaxis, renal impairment, acute renal failure, kidney pain, reversible elevation of liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremor, ataxia, stuttering, seizures, encephalopathy, coma, facial swelling, spasms, erythema multiforme, dysmenorrhea, depression, arthralgia, dizziness, rhinitis, upper respiratory infection, fever, dehydration, herpes simplex, runny nose, hypertension, tachycardia, aggressive behavior, anxiety, ataxia, coma, confusion, stuttering, encephalopathy, mania, delusions, paralysis, decreased level of consciousness, auditory hallucinations, visual hallucinations, seizures, tremors, psychosis, 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, hair loss, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction, interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best stored at room temperature, between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance

A convex, long, white film-coated tablet with a rectangular shape on both sides.

Package unit

30 tablets per bottle