Valbirus 500 mg (Valaciclovir hydrochloride 1.5 hydrate)

Adult dosage

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 medicine per dose 2 times daily. For recurrent episodes, administer for 5 days; for an initial episode, treatment may be given 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 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. In some patients with 10 or more recurrences per year without treatment, additional benefit may be obtained by administering 250 mg of this medicine in divided doses 2 times daily (total daily dose of 500 mg). Treatment should be reassessed after 6 to 12 months of administration. Suppression of recurrent genital herpes infection (immunocompromised patients): Administer 500 mg of this medicine per dose 2 times daily. 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 medicine 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 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: The recommended dose of this medicine for the treatment of cold sores is 2,000 mg per dose 2 times daily at 12-hour intervals for 1 day. Administration should begin as soon as the early signs of cold sores (e.g., tingling, itching, burning) appear. In patients with renal impairment or decreased renal function, and in elderly patients, adjust the dosing interval and dose of this medicine and administer cautiously while monitoring the patient's clinical status. Dose adjustment is not necessary unless renal function is significantly impaired. For patients with significantly impaired renal function, adjust the dose as follows: Herpes zoster, creatinine clearance 50 or greater: 1,000 mg per dose 3 times daily Herpes zoster, creatinine clearance 30 or greater to less than 50: 1,000 mg per dose 2 times daily Herpes zoster, creatinine clearance 10 or greater to less than 30: 1,000 mg per dose once daily Herpes zoster, creatinine clearance less than 10: 500 mg per dose once daily Genital herpes, creatinine clearance 30 or greater: 500 mg per dose 2 times daily Genital herpes, creatinine clearance less than 30: 500 mg per dose once daily Genital herpes suppression—immunocompetent, creatinine clearance 30 or greater: 500 mg per dose once daily* Genital herpes suppression—immunocompetent, creatinine clearance less than 30: 250 mg per dose once daily Genital herpes suppression—immunocompromised, creatinine clearance 30 or greater: 500 mg per dose 2 times daily Genital herpes suppression—immunocompromised, creatinine clearance less than 30: 500 mg per dose once daily Cytomegalovirus prevention, creatinine clearance 75 or greater: 2,000 mg per dose 4 times daily Cytomegalovirus prevention, creatinine clearance 50 or greater to less than 75: 1,500 mg per dose 4 times daily Cytomegalovirus prevention, creatinine clearance 25 or greater to less than 50: 1,500 mg per dose 3 times daily Cytomegalovirus prevention, creatinine clearance 10 or greater to less than 25: 1,500 mg per dose 2 times daily Cytomegalovirus prevention, creatinine clearance less than 10 or during dialysis: 1,500 mg per dose once daily Cold sores, creatinine clearance 50 or greater: 2,000 mg per dose 2 times daily Cold sores, creatinine clearance 30 or greater to 49 inclusive: 1,000 mg per dose 2 times daily Cold sores, creatinine clearance 10 or greater to less than 30: 500 mg per dose 2 times daily Cold sores, creatinine clearance less than 10: 500 mg per dose once daily *In some patients with 10 or more recurrences per year without treatment, additional benefit may be obtained by administering 250 mg of this medicine in divided doses 2 times daily (total daily dose of 500 mg). For patients receiving hemodialysis, administer 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 medicine should be adjusted appropriately according to creatinine clearance. There is no information on the administration of this medicine 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 lower than that observed 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 medicine are not needed after CAPD or CAVHD. No separate dose adjustment is necessary in patients with mild to moderate cirrhosis (patients with normal hepatic synthetic function). Hemodynamic data indicate that no separate dose adjustment is necessary in patients with severe cirrhosis (patients with hepatic synthetic dysfunction or signs of portosystemic shunting), but clinical experience is limited. Therefore, administer this medicine cautiously at high doses to patients with hepatic impairment.

Children's dosage

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 period is usually 90 days, but may need to be extended in high-risk patients. Herpes labialis (12 years and older): The recommended dose for treatment of herpes labialis is 2,000 mg of this medicine per dose, twice daily at 12-hour intervals for 1 day. Treatment should begin as soon as early signs of herpes labialis (e.g., tingling, itching, burning) 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 medication poses a risk of serious hematological disorders such as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome when administered in high doses to progressive HIV patients or allogenic bone marrow and kidney transplant recipients. Do not take this medication if you are allergic to it, acyclovir, or any of its components. It contains lactose, so patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. Patients at risk of dehydration or with poor kidney function need to drink enough fluids and may require dosage adjustments while taking this medication. Caution is needed when administering high doses to patients with impaired liver function, and those with liver disease should use this medication cautiously. While this medication provides a preventive effect for genital herpes patients, it is not a complete cure or a barrier against transmission, thus safe sexual practices should continue. Special precautions are required for pregnant women, those who may become pregnant, breastfeeding mothers, and the elderly when taking this medication. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur, and rare allergic reactions such as thrombocytopenia, skin rash, itching, and difficulty breathing may arise. In cases of decreased kidney function, acute renal failure may occur, requiring sufficient fluid intake and possibly hemodialysis until kidney function recovers. Central nervous system symptoms such as headaches, dizziness, confusion, hallucinations, and seizures may appear, especially in patients with impaired kidney function or the elderly, necessitating careful monitoring. Overdose can lead to acute renal failure and neurological symptoms, so it is crucial to adhere strictly to the prescribed dosage, and hemodialysis may be beneficial in cases of overdose. This medication should be stored out of the reach of children, and transferring it to another container can adversely affect its quality, so it should be avoided. Due to limited safety data, pregnant or breastfeeding women should consult with their doctor before taking this medication if necessary. This medication is recommended only for children aged 12 years and older, and its use is not recommended for children under 12 or for certain infections. Elderly patients may have an increased likelihood of decreased kidney function, necessitating dosage adjustments and monitoring for adverse reactions. Although no studies exist on the effects of this medication on driving or operating machinery, caution is advised based on clinical conditions and potential adverse effects.

Thrombotic Thrombocytopenic Purpura, Hemolytic Uremic Syndrome, Nausea, Abdominal Discomfort, Vomiting, Diarrhea, Thrombocytopenia, Photosensitivity Reactions Including Rash, 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, Convulsions, Erythema Multiforme, Dysmenorrhea, Depression, Arthralgia, Rhinitis, Upper Respiratory Infection, Diarrhea, Fever, Dehydration, Herpes Simplex, Rhinorrhea, Hypertension, Tachycardia, Aggressive Behavior, Anxiety, Coma, Mania, Delusions, Paralysis, Decreased Consciousness, Auditory Hallucinations, Visual Hallucinations, Seizures, Psychosis, 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 Pneumonia, Acute Pancreatitis, Increased BUN, Dyspepsia, Hiccups, Confusion, Hallucinations, Anxiety, Decreased Consciousness, Coma, Nausea, Vomiting, Headache, Seizures

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees in a room to preserve its effectiveness.

Appearance

White oblong film-coated tablet

Package unit

30 tablets per bottle, 42 tablets per bottle