Valtrex Tablet (Valaciclovir Hydrochloride)

Adult dose

1) Herpes zoster Administer 1,000 mg of valacyclovir orally 3 times daily for 7 days. 2) Genital herpes infections Administer 500 mg of this drug 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 the prodrome or symptoms/signs first appear. Administration of this drug at the first appearance of symptoms/signs of recurrent genital herpes can prevent lesion progression. 3) Suppression of recurrent genital herpes infections (1) Immunocompetent patients: The total daily dose is 500 mg of this drug, which may be administered as 250 mg twice daily. Administration of 500mg 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 when 250 mg of this drug is administered in divided doses 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 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 begin 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 cold sores (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 decreased 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 unless renal function is particularly 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. Adequate hydration should be maintained. For patients on hemodialysis, administer after the hemodialysis session has ended. 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. Herpes zoster: Creatinine clearance 50 or more, 1,000 mg 3 times daily; 30 or more to less than 50, 1,000 mg twice daily; 10 or more to less than 30, 1,000 mg once daily; less than 10, 500 mg once daily Genital herpes: Creatinine clearance 30 or more, 500 mg twice daily; less than 30, 500 mg once daily Genital herpes suppression—immunocompetent: Creatinine clearance 30 or more, 500 mg once daily*; less than 30, 250 mg once daily Genital herpes suppression—immunocompromised: Creatinine clearance 30 or more, 500 mg twice daily; less than 30, 500 mg once daily Cytomegalovirus prevention: Creatinine clearance 75 or more, 2,000 mg 4 times daily; 50 or more to less than 75, 1,500 mg 4 times daily; 25 or more to less than 50, 1,500 mg 3 times daily; 10 or more to less than 25, 1,500 mg twice daily; less than 10 or on dialysis, 1,500 mg once daily Cold sores: Creatinine clearance 50 or more, 2,000 mg twice daily; 30 or more to 49 inclusive, 1,000 mg twice daily; 10 or more to less than 30, 500 mg twice daily; less than 10, 500 mg once daily *Some patients who experience 10 or more recurrences per year without treatment may obtain additional benefit when 250 mg of this drug is administered in divided doses twice daily (total daily dose 500 mg). 5. Patients on 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 hemodialysis/hemofiltration (CAVHD) on the pharmacokinetics of acyclovir have been studied. Acyclovir elimination after CAPD and CAVHD was found to be lower than that 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). Hemodynamic data indicate that no dose adjustment is necessary in patients with severe cirrhosis (patients with hepatic synthetic dysfunction or signs of portosystemic shunting); however, clinical experience is limited. Therefore, this drug should be administered with caution at high doses to patients with hepatic impairment (see the section “Administration with caution in the following patients”).

Child dose

Prevention of cytomegalovirus infection (12 years and older): Take 2,000 mg of this medicine 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 administration is usually 90 days, but may need to be extended in high-risk patients. Cold sores (12 years and older): The recommended dose for treatment of cold sores is 2,000 mg of this medicine per dose, administered 2 times at a 12-hour interval over 1 day. Treatment should be started as soon as the initial signs of cold sores (e.g., tingling, itching, burning) appear. The efficacy of this medicine when administered after clinical signs of cold sores (e.g., papules, vesicles, ulcers) appear has not been established. Chickenpox in children 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. Treatment should be started as soon as the initial signs or symptoms appear. Based on efficacy data from clinical trials of oral acyclovir, administration should begin within 24 hours after the rash starts.

This medication can cause serious hematologic abnormalities such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome when administered in high doses to patients with advanced HIV or recipients of allogeneic bone marrow and kidney transplants, so caution is needed. Patients with allergy to this drug or its active metabolite acyclovir, or any of its components should not use this medication. Patients in a dehydrated state, particularly the elderly, should be administered with caution while ensuring adequate hydration. Patients with impaired renal function may have delayed excretion of this medication, thus requiring a reduction in dosage and close monitoring of their condition. Elderly patients may also have impaired renal function, necessitating dosage adjustments. Safety of high-dose administration of this medication has not been sufficiently established in patients with moderate to severe hepatic dysfunction, hence caution is required. While preventive use of this medication can reduce the risk of transmission of genital herpes in infected patients, it does not completely eliminate it, thus practicing safe sexual behaviors is important. Women who are pregnant or may become pregnant, as well as breastfeeding women, should use this medication with caution and should only be administered during pregnancy if the benefits outweigh the risks as assessed by a physician. This medication can also be used in children, but caution is advised because its safety and efficacy have not been established in certain age groups and conditions: under 12 years for herpes labialis, under 18 years for genital herpes or herpes zoster, and under 2 years for chickenpox. Elderly patients are at higher risk of renal impairment and central nervous system adverse reactions, so close monitoring and dosage adjustments are essential. Overdose may result in central nervous system symptoms such as renal failure, confusion, hallucinations, and seizures, hence dosage must be strictly adhered to, and any abnormal symptoms should be reported immediately to healthcare professionals. During the administration of this medication, rare adverse reactions such as nausea, vomiting, diarrhea, headache, dizziness, skin rash, etc., may occur, hence consultation with healthcare professionals is recommended for severe or persistent symptoms. As this medication is excreted via the kidneys, it is important to ensure adequate hydration, and patients with impaired renal function may require treatments such as dialysis. Caution is needed when driving or operating machinery due to its central nervous system effects. While the interaction with other medications is minimal, renal-affecting drugs need careful monitoring of renal function when administered concurrently. Keep 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, urticaria, angioedema, dyspnea, anaphylaxis, renal impairment, acute kidney failure, renal colic, reversible elevation of liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremor, ataxia, stuttering, convulsions, encephalopathy, coma, facial edema, convulsions, erythema multiforme, dysmenorrhea, depression, arthralgia, rhinitis, upper respiratory infection, fever, dehydration, herpes simplex, runny nose, hypertension, tachycardia, aggressive behavior, anxiety, coma, mania, delusion, paralysis, decreased consciousness, auditory hallucinations, visual hallucinations, seizure, visual disturbance, hepatitis, jaundice, liver dysfunction, increased creatinine, interstitial nephritis, aplastic anemia, leukocytoclastic vasculitis, pancytopenia, agranulocytosis, disseminated intravascular coagulation syndrome, thrombocytopenic purpura, leukopenia, alopecia, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction (DRESS), interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups, confusion, hallucinations, anxiety, decreased consciousness, coma, nausea, vomiting, headache, seizure

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a temperature between 1°C and 30°C during storage. This helps preserve the effectiveness and safety of the medication.

Appearance

A white, oblong, film-coated tablet with a convex surface on both sides.

Package unit

30 tablets/bottle