Comment
Author: Admin | 2025-04-28
Safety of valacyclovir tablets, USP for treatment of disseminated herpes zoster have not been established. 1.2 Pediatric Patients Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for the treatment of cold sores (herpes labialis) in pediatric patients 𕫥12 years of age. The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Chickenpox: Valacyclovir tablets, USP are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to [see Clinical Studies (14.4)]. 1.3 Limitations of Use The efficacy and safety of valacyclovir tablets, USP have not been established in: Immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients with a CD4+ cell count 𕫥100 cells/mm3. Patients Patients Patients Patients Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection. 2 Dosage And Administration Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3)]. Adult Dosage (2.1) Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients Alternate dose in patients with 𕫤9 recurrences/yr HIV-infected patients 1 gram once daily 500 mg once daily 500 mg twice daily Reduction of transmission 500 mg once daily Herpes Zoster 1 gram 3 times daily for 7 days Pediatric Dosage (2.2) Cold Sores (𕫥12 years of age) 2 grams every 12 hours for 1 day Chickenpox (2 to 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacyclovir tablets. (2.3) 2.1 Adult Dosing Recommendations Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir tablets for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). Genital Herpes: Initial Episode: The recommended dosage of valacyclovir tablets for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within
Add Comment