Valtrix Tablets 500 mg (Valaciclovir Hydrochloride Hydrate)

Adult dose

1. Adults 1) Herpes zoster Administer valacyclovir orally at a dose of 1,000 mg 3 times daily for 7 days. 2) Genital herpes infection Administer this drug at a dose of 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. 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. In some patients who experience 10 or more recurrences per year without treatment, additional benefit may be obtained by administering 250 mg of this drug twice daily (total daily dose 500 mg). Treatment should be reassessed after 6 to 12 months. (2) Immunocompromised patients: Administer this drug at a dose of 500 mg twice daily. 4) Reduction of transmission of genital herpes In 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 treatment period 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 cold sores (e.g., tingling, itching, burning) appear. 3. Older adults Dose adjustment is not necessary unless renal function is significantly impaired. Adequate hydration should be maintained. 4. Patients with renal impairment In patients with significantly impaired renal function, the dose should be adjusted as follows. For patients on hemodialysis, administer the dose 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 drug should be adjusted appropriately according to creatinine clearance. Indication: Herpes zoster, creatinine clearance 50 or higher — 1,000 mg per dose 3 times daily Indication: Herpes zoster, creatinine clearance 30 or higher to less than 50 — 1,000 mg per dose 2 times daily Indication: Herpes zoster, creatinine clearance 10 or higher to less than 30 — 1,000 mg per dose once daily Indication: Herpes zoster, creatinine clearance less than 10 — 500 mg per dose once daily Indication: Genital herpes, creatinine clearance 30 or higher — 500 mg per dose 2 times daily Indication: Genital herpes, creatinine clearance less than 30 — 500 mg per dose once daily Indication: Genital herpes suppression- immunocompetent, creatinine clearance 30 or higher — 500 mg per dose once daily* Indication: Genital herpes suppression- immunocompetent, creatinine clearance less than 30 — 250 mg per dose once daily Indication: Genital herpes suppression- immunocompromised, creatinine clearance 30 or higher — 500 mg per dose 2 times daily Indication: Genital herpes suppression- immunocompromised, creatinine clearance less than 30 — 500 mg per dose once daily Indication: Cytomegalovirus prevention, creatinine clearance 75 or higher — 2,000 mg per dose 4 times daily Indication: Cytomegalovirus prevention, creatinine clearance 50 or higher to less than 75 — 1,500 mg per dose 4 times daily Indication: Cytomegalovirus prevention, creatinine clearance 25 or higher to less than 50 — 1,500 mg per dose 3 times daily Indication: Cytomegalovirus prevention, creatinine clearance 10 or higher to less than 25 — 1,500 mg per dose 2 times daily Indication: Cytomegalovirus prevention, creatinine clearance less than 10 or on dialysis — 1,500 mg per dose once daily Indication: Cold sores, creatinine clearance 50 or higher — 2,000 mg per dose 2 times daily Indication: Cold sores, creatinine clearance 30 or higher to 49 or lower — 1,000 mg per dose 2 times daily Indication: Cold sores, creatinine clearance 10 or higher to less than 30 — 500 mg per dose 2 times daily Indication: Cold sores, creatinine clearance less than 10 — 500 mg per dose once daily *In some patients who experience 10 or more recurrences per year without treatment, additional benefit may be obtained by administering 250 mg of this drug twice daily (total daily dose 500 mg). 5. Patients on peritoneal dialysis Supplemental administration of this drug is not required after CAPD or CAVHD.

Child dose

2. Pediatrics 1) Prevention of cytomegalovirus infection (12 years and older): Take 2,000 mg 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 treatment period is usually 90 days, but may need to be extended in high-risk patients. 2) Herpes labialis (12 years and older): Take 2,000 mg per dose twice daily, 12 hours apart, for 1 day. Treatment should begin as soon as the initial signs of herpes labialis (e.g., tingling, itching, or burning) appear. 3) Chickenpox in children aged 2 years to under 18 years: Take 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.

This medication should be used with caution in patients with progressive HIV or those receiving high-dose treatment following allogeneic stem cell or kidney transplantation, as serious blood disorders may occur. Patients with allergies to this medication or its components, as well as those with genetic lactose metabolism disorders, should not use it. Elderly patients, those at risk of dehydration, or patients with diminished kidney function should monitor hydration and dosage adjustments closely while using this medication, and the occurrence of adverse reactions should be observed carefully. While this medication is helpful in preventing genital herpes, it cannot provide complete treatment or eliminate the risk of transmission, so safe sexual practices are recommended. Women who are pregnant or may become pregnant, and nursing mothers should consult with their doctor before using this medication and should use it with caution. This medication may cause gastrointestinal symptoms (nausea, vomiting, diarrhea), skin rashes, renal dysfunction, and neurological symptoms (headache, confusion, hallucinations), so healthcare providers should be notified immediately if symptoms occur. Patients with deteriorating kidney function or elderly patients should adjust the dosage and closely observe any adverse reactions, and if neurological side effects arise, the medication should be discontinued. In case of overdose, symptoms of renal failure or central nervous system disturbances may appear, so it is important to adhere to the prescribed dosage; treatment such as dialysis may be required in cases of overdose. This medication should be kept out of reach of children and should not be transferred to other containers to maintain its quality. Caution should be exercised when driving or operating machinery, and consultation with a specialist is advisable when taking this medication with others due to potential drug interactions.

Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, rash including photosensitivity reactions, itching, urticaria, angioedema, dyspnea, anaphylaxis, renal impairment, acute renal failure, renal colic, reversible increase in liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremors, ataxia, stuttering, seizures, encephalopathy, coma, facial edema, convulsions, erythema multiforme, dysmenorrhea, depression, arthralgia, rhinitis, upper respiratory infection, fever, dehydration, herpes simplex, rhinorrhea, hypertension, tachycardia, aggressive behavior, anxiety, coma, 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, hair loss, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction (DRESS), interstitial pneumonia, acute pancreatitis, elevated BUN, dyspepsia, hiccups

This medication may be sensitive to air or humidity, so it should be stored in a sealed container. It is best to keep it at room temperature between 1 to 30 degrees Celsius, away from excessive heat or cold.

Appearance

White, biconvex, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle