Valtrax 500mg (Valaciclovir Hydrochloride)

Adult dose

1. Adults 1) Herpes zoster Administer valacyclovir orally at a dose of 1,000 mg per dose 3 times daily for 7 days. 2) Genital herpes infection Administer this drug at a dose of 500 mg per dose twice 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 prodromal symptoms or the first signs/symptoms appear. When administered at the first signs/symptoms of recurrent genital herpes, this drug 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 per dose twice daily. A dose of 500mg 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 from divided doses of 250 mg of this drug twice daily (total daily dose of 500 mg). Treatment should be reassessed after 6 to 12 months of administration. (2) Immunocompromised patients: Administer this drug at a dose of 500 mg per dose twice daily. 4) Reducing 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 (especially 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 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 duration of treatment is 90 days, but treatment 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 per dose twice daily, 12 hours apart, for 1 day. Treatment should be started as soon as the early signs of a cold sore (e.g., tingling, itching, or burning) appear. The efficacy of this drug when administered after the clinical signs of a cold sore (e.g., papules, vesicles, or 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 reduced 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) No dose adjustment is required unless renal function is significantly impaired. Adequate hydration should be maintained. 4. Patients with renal impairment In patients with significantly impaired renal function, adjust the dose as follows. Adequate hydration should be maintained. 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 drug should be adjusted appropriately according to creatinine clearance. Herpes zoster Creatinine clearance 50 or higher: 1,000 mg per dose 3 times daily Creatinine clearance 30 or higher to less than 50: 1,000 mg per dose twice daily Creatinine clearance 10 or higher 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 higher: 500 mg per dose twice daily Creatinine clearance less than 30: 500 mg per dose once daily Genital herpes suppression - immunocompetent Creatinine clearance 30 or higher: 500 mg per dose once daily* Creatinine clearance less than 30: 250 mg per dose once daily Genital herpes suppression - immunocompromised Creatinine clearance 30 or higher: 500 mg per dose twice daily Creatinine clearance less than 30: 500 mg per dose once daily Cytomegalovirus prophylaxis Creatinine clearance 75 or higher: 2,000 mg per dose 4 times daily Creatinine clearance 50 or higher to less than 75: 1,500 mg per dose 4 times daily Creatinine clearance 25 or higher to less than 50: 1,500 mg per dose 3 times daily Creatinine clearance 10 or higher to less than 25: 1,500 mg per dose twice daily Creatinine clearance less than 10 or on dialysis: 1,500 mg per dose once daily Cold sores Creatinine clearance 50 or higher: 2,000 mg per dose twice daily Creatinine clearance 30 or higher to 49 inclusive: 1,000 mg per dose twice daily Creatinine clearance 10 or higher to less than 30: 500 mg per dose twice 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 from divided doses of 250 mg of this drug twice daily (total daily dose of 500 mg). 5. Patients receiving peritoneal dialysis There are no data on the administration of this drug in patients receiving peritoneal dialysis. The effects of chronic 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 found to be lower than that during 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 separate dose adjustment is necessary in patients with mild to moderate cirrhosis (with normal hepatic synthetic function). For patients with severe cirrhosis (with hepatic synthetic dysfunction and signs of portosystemic shunting), hemodynamic data indicate that no separate dose adjustment is necessary; however, clinical experience is limited. Therefore, administer high doses of this drug with caution in patients with hepatic impairment (see the section “Administration with caution in the following patients”).

Child dose

Prevention of cytomegalovirus infection in patients aged 12 years or older: Administer 2,000 mg of this medicine 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. Treatment is usually continued for 90 days, but may need to be extended in high-risk patients. Cold sores in patients aged 12 years or older: Administer 2,000 mg of this medicine twice daily, 12 hours apart, for 1 day. Begin treatment as soon as the initial signs of a cold sore (e.g., tingling, itching, burning) appear. The efficacy of this medicine has not been established when administered after clinical signs of a cold sore (e.g., papules, vesicles, ulcers) appear. Chickenpox in children aged 2 years or older and younger than 18 years: Administer 20 mg/kg of this medicine 3 times daily for 5 days. The total dose must not exceed 1,000 mg per dose, 3 times daily. Start treatment as soon as the initial signs or symptoms appear. Based on efficacy data from clinical trials of oral acyclovir, treatment should be started within 24 hours after the rash begins. There are no data on administration of this medicine to pediatric patients with creatinine clearance below 50 mL/min/1.73m2.

This medication may pose a risk of serious blood disorders such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome when administered at high doses to patients with progressive HIV or those receiving allogeneic bone marrow and kidney transplants. Patients with allergies to this medication, its active metabolite acyclovir, or any component of this medication should not use it. Patients who are dehydrated or particularly elderly should take this medication with caution while ensuring sufficient fluid intake. Patients with impaired renal function may have difficulty excreting this medication, leading to an increased risk of side effects; therefore, the dosage should be reduced. Elderly patients may also have a risk of renal function impairment, necessitating dosage adjustments. The safety of high-dose administration of this medication has not been established in patients with moderate to severe hepatic impairment; caution is advised. While genital herpes patients using this medication preventively may reduce the risk of sexually transmitted infections, it does not completely eliminate them, hence safe sexual practices, especially condom use, are recommended. Women who are pregnant or may become pregnant, and nursing mothers should use this medication cautiously. Gastrointestinal side effects such as nausea, vomiting, and diarrhea may frequently occur with this medication. Rarely, hypersensitivity reactions such as thrombocytopenia, skin rash, itching, difficulty breathing, and anaphylaxis may occur. Renal function may be affected, and acute renal failure may occur, necessitating sufficient fluid intake; in severe cases, dialysis may be required. Nervous system symptoms such as headaches, dizziness, confusion, hallucinations, lowered consciousness may arise, primarily in patients with decreased renal function, and these symptoms recover upon discontinuation of the medication. Elderly patients or those with renal function impairment are at higher risk of neurological adverse reactions and should be monitored closely. In case of overdose, serious neurological symptoms such as acute renal failure, confusion, hallucinations, and seizures may occur, thus the dosage must be adhered to accurately and blood dialysis may be used to remove the drug if necessary. This medication is recommended for the treatment of cold sores in children aged 12 and older, and for treating chickenpox in children aged 2 to under 18; its safety and efficacy are not established for younger ages. Caution should be exercised when driving or operating machinery while taking this medication, considering the patient's condition and the occurrence of adverse reactions. While clinically significant interactions have not been reported between this medication and other drugs, careful monitoring of blood concentration changes is advised when used with other medications excreted through the kidneys. When used during pregnancy, this medication should only be administered when the benefits outweigh the risks, and in nursing mothers, caution is advised as the drug may be transmitted through breast milk.

Thrombotic Thrombocytopenic Purpura, Hemolytic Uremic Syndrome, Nausea, Abdominal Discomfort, Vomiting, Diarrhea, Thrombocytopenia, Rash including Photosensitivity Reaction, Itching, Urticaria, Angioedema, Dyspnea, Anaphylaxis, Kidney Dysfunction, 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, Cramping, Erythema Multiforme, Dysmenorrhea, Depression, Arthralgia, Nasopharyngitis, Upper Respiratory Tract Infection, Diarrhea, Fever, Dehydration, Simple Herpes, 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, Interstitial Pneumonitis, Acute Pancreatitis, Increased BUN, Indigestion, Hiccups

This medication is susceptible to the effects of air and humidity; therefore, it should be stored in a tightly sealed container. It is best to maintain room temperature between 1 degree and 30 degrees Celsius.

Appearance

Biconvex white rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle