PMS Valacyclovir Tablet (Valacyclovir Hydrochloride)

Adult dose

1) Herpes zoster Administer valacyclovir orally at a dose of 1,000 mg 3 times daily for 7 days. 2) Genital herpes Administer this drug at a dose of 500 mg 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. In recurrent herpes simplex, treatment is most effective when started as soon as prodromal symptoms or the first signs/symptoms appear. Administration of this drug at the first sign/symptom of recurrent genital herpes may prevent progression of lesions. 3) Suppression of recurrent genital herpes (1) Patients with normal immune function: 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 with 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg twice daily (total daily dose 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 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 this drug at a dose of 500 mg 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 this drug at a dose of 2,000 mg 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 be started 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 symptoms of cold sores (e.g., papules, vesicles, ulcers) appear has not been established. For patients with significant renal impairment, the dose should be adjusted as follows. Adequate hydration should be maintained. In patients on 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 3 times daily Herpes zoster, creatinine clearance 30 or higher to less than 50: 1,000 mg twice daily Herpes zoster, creatinine clearance 10 or higher to less than 30: 1,000 mg once daily Herpes zoster, creatinine clearance less than 10: 500 mg once daily Genital herpes, creatinine clearance 30 or higher: 500 mg twice daily Genital herpes, creatinine clearance less than 30: 500 mg once daily Genital herpes suppression - normal immune function, creatinine clearance 30 or higher: 500 mg once daily* Genital herpes suppression - normal immune function, creatinine clearance less than 30: 250 mg once daily Genital herpes suppression - impaired immune function, creatinine clearance 30 or higher: 500 mg twice daily Genital herpes suppression - impaired immune function, creatinine clearance less than 30: 500 mg once daily Cytomegalovirus prevention, creatinine clearance 75 or higher: 2,000 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 50 or higher to less than 75: 1,500 mg 4 times daily Cytomegalovirus prevention, creatinine clearance 25 or higher to less than 50: 1,500 mg 3 times daily Cytomegalovirus prevention, creatinine clearance 10 or higher to less than 25: 1,500 mg twice daily Cytomegalovirus prevention, creatinine clearance less than 10 or on dialysis: 1,500 mg once daily Cold sores, creatinine clearance 50 or higher: 2,000 mg twice daily Cold sores, creatinine clearance 30 or higher to 49 inclusive: 1,000 mg twice daily Cold sores, creatinine clearance 10 or higher to less than 30: 500 mg twice daily Cold sores, creatinine clearance less than 10: 500 mg once daily *Some patients with 10 or more recurrences per year without treatment may obtain additional benefit from divided doses of 250 mg twice daily (total daily dose 500 mg).

Child dose

Prevention of cytomegalovirus infection (12 years of age and older): Take 2,000 mg of this medication 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 usual treatment duration is 90 days, but treatment may need to be extended in high-risk patients. Herpes labialis (12 years of age and older): The recommended dose for the treatment of herpes labialis is 2,000 mg of this medication per dose, administered twice daily at 12-hour intervals for 1 day. Treatment should be started as soon as the initial signs of herpes labialis (e.g., tingling, itching, burning) appear. The efficacy of this medication when administered after clinical signs of herpes labialis (e.g., papules, vesicles, ulcers) have appeared has not been established. Chickenpox in children 2 years of age and older and under 18 years of age: Administer 20 mg of this medication 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, treatment should be started within 24 hours after the rash begins.

Caution is advised for patients with advanced HIV or those who have undergone bone marrow or kidney transplants, as high doses may pose a risk of serious blood disorders. Patients with allergies to this medication or its components should not use it. In patients with dehydration symptoms or the elderly, this medication should be administered cautiously with sufficient hydration. Patients with renal impairment may have delayed elimination of this medication, thus dosing must be adjusted, and any adverse reactions should be closely monitored. Caution is also necessary when administering high doses in patients with liver function impairment, and monitoring of liver function is recommended during treatment. When using this medication preventively in patients with genital herpes, it is important to practice safe sexual activity, as this medication does not completely eliminate the treatment of genital herpes or the risk of transmission. Special attention is required when administering this medication to pregnant women, women who may become pregnant, nursing mothers, and the elderly. Gastrointestinal adverse effects such as nausea, vomiting, and diarrhea may occur during treatment. Rarely, hypersensitivity reactions such as thrombocytopenia, skin rashes, pruritus, and dyspnea may occur. Adequate hydration is essential as this medication may burden the kidneys, and if acute renal failure symptoms appear, immediate consultation with medical personnel is necessary. Central nervous system-related adverse effects such as headaches, dizziness, confusion, and hallucinations may also occur, and if such symptoms appear, use of the medication should be immediately discontinued and a doctor consulted. This medication requires adjustment of dose and interval when used in children and the elderly and must be managed particularly carefully in cases of renal impairment. In cases of overdose, symptoms related to renal failure or neurological issues may occur, thus strict adherence to the prescribed dosage is necessary, and treatment such as hemodialysis may be required. This medication should be stored out of reach of children, and transferring to another container could compromise its quality, so care should be taken. Caution is necessary when engaging in activities that require alertness, such as driving or operating machinery, as adverse reactions from this medication may have an impact.

Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, nausea, abdominal discomfort, vomiting, diarrhea, thrombocytopenia, rash including photosensitivity reactions, itching, urticaria, angioedema, dyspnea, anaphylaxis, kidney impairment, acute renal failure, renal colic, reversible increase in liver function tests, headache, dizziness, confusion, hallucinations, decreased consciousness, tremor, ataxia, stuttering, seizures, encephalopathy, coma, facial swelling, convulsion, erythema multiforme, dysmenorrhea, depression, arthralgia, rhinitis, upper respiratory tract infection, diarrhea, 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 reactions, interstitial pneumonia, acute pancreatitis, increased BUN, dyspepsia, hiccups

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is safe to store it at a temperature between 1 to 30 degrees Celsius.

Appearance

Blue rectangular film-coated tablet

Package unit

30 tablets/bottle