Baclear Tablets 500 mg (Valacyclovir Hydrochloride)

Adult dose

1. Adults 1) Herpes zoster Administer 1,000 mg of valacyclovir per dose orally 3 times daily for 7 days. 2) Genital herpes infection Administer 500 mg of this medicine per dose 2 times daily. For recurrent infection, administer for 5 days; for an initial episode, treatment may be given for up to 10 days if symptoms are severe. 3) Suppression of recurrent genital herpes infection (1) Patients with normal immune function: The total daily dose is 500 mg of this medicine, which may be administered as 250 mg per dose 2 times daily. Administration of 500mg per dose 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 when 250 mg of this medicine is administered in divided doses 2 times daily (total daily dose 500 mg). Treatment should be reassessed after 6 to 12 months. (2) Immunocompromised patients: Administer 500 mg of this medicine per dose 2 times 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 medicine 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 medicine per dose 4 times daily, starting within 72 hours after transplantation or as soon as 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 medicine for the treatment of cold sores is 2,000 mg per dose 2 times 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, or burning) appear. 3. Elderly patients In patients with renal impairment or reduced renal function, and in elderly patients, adjust the dosing interval and dose of this medicine, and administer with caution while monitoring the patient's clinical condition. Dose adjustment is not necessary except in cases of significant renal impairment. 4. Patients with renal impairment The dose should be adjusted as follows in patients with significantly impaired renal function. For patients receiving hemodialysis, administer after the hemodialysis session 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 medicine should be adjusted appropriately according to creatinine clearance. Herpes zoster Creatinine clearance 50 or more: 1,000 mg per dose 3 times daily Creatinine clearance 30 or more to less than 50: 1,000 mg per dose 2 times daily Creatinine clearance 10 or more to less than 30: 1,000 mg per dose once daily Creatinine clearance less than 10: 500 mg per dose once daily Genital herpes Creatinine clearance 30 or more: 500 mg per dose 2 times daily Creatinine clearance less than 30: 500 mg per dose once daily Genital herpes suppression - normal immune function Creatinine clearance 30 or more: 500 mg per dose once daily* Creatinine clearance less than 30: 250 mg per dose l time daily Genital herpes suppression - immunocompromised Creatinine clearance 30 or more: 500 mg per dose 2 times daily Creatinine clearance less than 30: 500 mg per dose once daily Cytomegalovirus prevention Creatinine clearance 75 or more: 2,000 mg per dose 4 times daily Creatinine clearance 50 or more and less than 75: 1,500 mg per dose 4 times daily Creatinine clearance 25 or more and less than 50: 1,500 mg per dose 3 times daily Creatinine clearance 10 or more and less than 25: 1,500 mg per dose 2 times daily Creatinine clearance less than 10 or on dialysis: 1,500 mg per dose once daily Cold sores Creatinine clearance 50 or more: 2,000 mg per dose 2 times daily Creatinine clearance 30 or more and 49 or less: 1,000 mg per dose 2 times daily Creatinine clearance 10 or more and less than 30: 500 mg per dose 2 times daily Creatinine clearance less than 10: 500 mg per dose once daily *Some patients with 10 or more recurrences per year without treatment may obtain additional benefit when 250 mg of this medicine is administered in divided doses 2 times daily (total daily dose 500 mg). 5. Patients receiving peritoneal dialysis Supplemental administration of this medicine is not necessary after CAPD or CAVHD. 6. Patients with hepatic impairment No dose adjustment is necessary in patients with mild to moderate cirrhosis (patients with normal hepatic synthetic function). Based on hemodynamic data, 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 medicine should be administered with caution at high doses to patients with hepatic impairment.

Child dose

2. Children 1) Prevention of cytomegalovirus infection (aged 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 usual treatment duration is 90 days, but may need to be extended in high-risk patients. 2) Cold sores (aged 12 years and older) The recommended dose for the 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 a cold sore (e.g., tingling, itching, or burning) appear. 3) 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. There are no data on the administration of this medicine to pediatric patients with creatinine clearance below 50 mL/min/1.73m2.

This medication should be used with caution in patients with progressive HIV or in patients who have undergone allogeneic bone marrow and kidney transplants, as it may cause serious blood disorders such as thrombocytopenic purpura or hemolytic uremic syndrome when administered in high doses. It should not be administered to patients with an allergy to this medication, acyclovir, or any of its components. Patients who are dehydrated, especially elderly patients, should receive enough hydration and careful administration. For patients with impaired renal function or elderly patients, the elimination of this medication can be delayed, thus the dosage should be adjusted and careful monitoring should be conducted for any neurological adverse reactions. Moderate to severe caution is required for patients with significantly impaired liver function when administering high doses. It is important for patients with genital herpes to maintain safe sexual practices even when using this medication prophylactically, as it cannot completely cure genital herpes or eliminate the risk of transmission. Women who are pregnant or may become pregnant, nursing mothers, and the elderly require special caution when administering this medication. This medication may cause gastrointestinal symptoms (nausea, vomiting, diarrhea), blood abnormalities (thrombocytopenia), skin rashes and allergic reactions, renal impairment, liver function abnormalities, and neurological symptoms (headaches, confusion, hallucinations, etc.), thus immediate consultation with healthcare professionals is necessary if these symptoms appear. Particularly in patients with renal issues or the elderly, central nervous system symptoms may occur more frequently, hence close monitoring is essential. Starting this medication early enhances the therapeutic effect; if symptoms do not improve or worsen, treatment should be discontinued and alternative therapies considered. Overdosage can cause severe neurological symptoms such as renal failure, confusion, hallucinations, seizures, thus strict adherence to dosing is necessary, and if needed, the drug can be removed via hemodialysis. Caution is needed when driving or operating machinery as this medication may affect mental or physical conditions. This medication has potential interactions with other drugs, so it is vital to inform healthcare professionals, especially if taking other medications that may impact renal function or acyclovir. During pregnancy or while breastfeeding, this medication should only be administered after consulting with healthcare providers regarding potential impacts on the fetus or neonate. This medication is used for treating cold sores in children over 12 years and for treating chickenpox in children aged 2 years and older but specific age groups and conditions may not have established safety and efficacy, so consulting with a specialist is necessary. Elderly patients may be at higher risk for side effects due to impaired renal function; therefore, dose adaptations and monitoring of their condition are crucial. This medication should be kept out of reach of children and it is advisable not to transfer it to another container.

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 pain, reversible elevation of 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, hair loss, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction (DRESS), interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups, acute renal failure, confusion, hallucinations, anxiety, decreased consciousness, coma, nausea, headache

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature at room temperature between 1 and 30 degrees Celsius to ensure the longevity of its effectiveness.

Appearance

Biconvex, white, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle