Bacitravirin Tablet 500mg (Valacyclovir Hydrochloride)

Adult dose

Herpes zoster: Administer 1,000 mg of valacyclovir per dose orally 3 times daily for 7 days. Genital herpes infection: Administer 500 mg of this medication per dose 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. Suppression of recurrent genital herpes infection—immunocompetent patients: The total daily dose is 500 mg of this medication, which may be administered as 250 mg per dose twice daily. Administration of 500mg per dose 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 from divided doses of 250 mg twice daily (total daily dose of 500 mg). Treatment should be reassessed after 6 to 12 months. Suppression of recurrent genital herpes infection—immunocompromised patients: Administer 500 mg of this medication per dose twice daily. 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 medication per dose once daily to reduce transmission to a sexual partner who is negative for Herpes Simplex Virus-2 (HSV-2) antibodies. Prevention of cytomegalovirus infection: Take 2,000 mg of this medication 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 treatment is usually 90 days, but may need to be extended in high-risk patients. Cold sores: Administer 2,000 mg of this medication per dose twice daily, 12 hours apart, for 1 day. Treatment should begin as soon as the initial signs of cold sores appear. Patients with renal impairment—herpes zoster, creatinine clearance 50 or higher: 1,000 mg per dose 3 times daily Patients with renal impairment—herpes zoster, creatinine clearance 30 or higher to less than 50: 1,000 mg per dose twice daily Patients with renal impairment—herpes zoster, creatinine clearance 10 or higher to less than 30: 1,000 mg per dose once daily Patients with renal impairment—herpes zoster, creatinine clearance less than 10: 500 mg per dose once daily Patients with renal impairment—genital herpes, creatinine clearance 30 or higher: 500 mg per dose twice daily Patients with renal impairment—genital herpes, creatinine clearance less than 30: 500 mg per dose once daily Patients with renal impairment—genital herpes suppression, immunocompetent, creatinine clearance 30 or higher: 500 mg per dose once daily* Patients with renal impairment—genital herpes suppression, immunocompetent, creatinine clearance less than 30: 250 mg per dose once daily Patients with renal impairment—genital herpes suppression, immunocompromised, creatinine clearance 30 or higher: 500 mg per dose twice daily Patients with renal impairment—genital herpes suppression, immunocompromised, creatinine clearance less than 30: 500 mg per dose once daily Patients with renal impairment—cytomegalovirus prevention, creatinine clearance 75 or higher: 2,000 mg per dose 4 times daily Patients with renal impairment—cytomegalovirus prevention, creatinine clearance 50 or higher and less than 75: 1,500 mg per dose 4 times daily Patients with renal impairment—cytomegalovirus prevention, creatinine clearance 25 or higher and less than 50: 1,500 mg per dose 3 times daily Patients with renal impairment—cytomegalovirus prevention, creatinine clearance 10 or higher and less than 25: 1,500 mg per dose twice daily Patients with renal impairment—cytomegalovirus prevention, creatinine clearance less than 10 or on dialysis: 1,500 mg per dose once daily Patients with renal impairment—cold sores, creatinine clearance 50 or higher: 2,000 mg per dose twice daily Patients with renal impairment—cold sores, creatinine clearance 30 or higher and 49 or lower: 1,000 mg per dose twice daily Patients with renal impairment—cold sores, creatinine clearance 10 or higher and less than 30: 500 mg per dose twice daily Patients with renal impairment—cold sores, creatinine clearance less than 10: 500 mg per dose once daily *Some patients who experience 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg twice daily (total daily dose of 500 mg).

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 treatment duration is usually 90 days, but may need to be extended in high-risk patients. Cold sores (12 years and older): Administer 2,000 mg of this medicine per dose twice daily, 12 hours apart, for 1 day. Treatment should begin as soon as the initial signs of cold sores appear. Chickenpox (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 should not exceed 1,000 mg per dose, 3 times daily.

This drug should be used with caution in patients with progressive HIV or those receiving high doses after allogeneic hematopoietic stem cell or kidney transplants, as it may lead to serious blood disorders such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome. Patients allergic to this drug, its active metabolite acyclovir, or any component of this drug should not use it. For dehydrated patients or particularly elderly patients, careful administration with sufficient hydration is necessary. Patients with impaired renal function may experience delayed excretion of this drug; therefore, the dosage should be reduced and the patient's condition closely monitored. Due to a lack of safety data on high-dose administration in patients with liver dysfunction, caution is advised. In genital herpes patients, this drug may reduce the risk of transmission when used preventively, but it cannot completely cure or prevent transmission, so safe sexual practices are recommended. Particular caution is required when administering this drug to pregnant or potentially pregnant women, nursing mothers, and the elderly. This medication may cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea, and rarely hypersensitivity reactions like thrombocytopenia, skin rash, itching, and respiratory difficulties may occur. CNS symptoms including renal impairment, acute renal failure, liver function abnormalities, headache, dizziness, confusion, hallucinations may also be reported, and immediate consultation with medical personnel is necessary if these symptoms occur. Particularly in elderly patients or those with impaired renal function, CNS side effects may occur more frequently, so careful observation is necessary. This drug is most effective when taken early in the onset of disease, so it is advisable to start taking it immediately after symptoms appear. Overdose may result in serious neurological symptoms such as acute renal failure, confusion, hallucinations, and seizures; therefore, the dosage must be strictly adhered to, and treatment such as hemodialysis may be required in the event of overdose. This medication should be stored out of reach of children, and transferring to another container should be avoided as it can affect quality. When driving or operating machinery, caution should be taken to consider the possibility of cognitive impairment due to the drug's side effects. Clinically significant interactions with other drugs are rare, but when used with medications affecting renal excretion, careful monitoring of renal function changes is necessary. During pregnancy, this drug should only be administered if the benefits outweigh the risks, and in breastfeeding, caution is required as it may affect the infant. This medication is used for the treatment of cold sores in children over 12 years old and for chickenpox treatment in children aged 2 to under 18 years, but safety and efficacy have not been fully established for other pediatric age groups. Elderly patients may have an increased risk of side effects due to impaired renal function, necessitating dosage adjustment and patient condition monitoring.

Thrombotic Thrombocytopenic Purpura, Hemolytic Uremic Syndrome, Nausea, Abdominal Discomfort, Vomiting, Diarrhea, Thrombocytopenia, Rash including photosensitive reactions, Itching, Hives, Angioedema, Dyspnea, Anaphylaxis, Renal impairment, Acute renal failure, Renal pain, Reversible elevation of liver function tests, Headache, Dizziness, Confusion, Hallucinations, Decreased consciousness, Tremors, Dyskinesia, Stuttering, Seizures, Encephalopathy, Coma, Facial edema, Convulsions, Erythema Multiforme, Dysmenorrhea, Depression, Arthralgia, Rhinitis, Upper respiratory tract infection, Fever, Dehydration, Simple Herpes, Rhinorrhea, Hypertension, Tachycardia, Aggressive behavior, Anxiety, Coma, Mania, Delusion, Paralysis, Decreased consciousness, Auditory hallucinations, Visual hallucinations, Seizures, Visual disturbances, Hepatitis, Jaundice, Liver dysfunction, Increased creatinine, Interstitial nephritis, Aplastic anemia, Leukocyte destructive vasculitis, Pancytopenia, Agranulocytosis, Disseminated intravascular coagulation syndrome, Thrombocytopenic purpura, Leukopenia, Erythema Multiforme, Hair loss, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Drug reactions, Interstitial pneumonia, Acute pancreatitis, Increased BUN, Dyspepsia, Hiccups, Anxiety, Nonsensical speech

This drug should be stored in a tightly closed container to avoid exposure to air or moisture. Additionally, it is important to store it at room temperature, that is, between 1 degree and 30 degrees Celsius, to maintain its effectiveness.

Appearance

Biconvex, slender, and long white film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle