Valacyclovir Hydrochloride (Page 4 of 13)
Suppression of Recurrent Genital Herpes in HIV-1–Infected Subjects
In HIV-1–infected subjects, frequently reported adverse reactions for valacyclovir tablets (500 mg twice daily; n = 194, median days on therapy = 172) and placebo (n = 99, median days on therapy = 59), respectively, included headache (13%, 8%), fatigue (8%, 5%), and rash (8%, 1%). Post-randomization laboratory abnormalities that were reported more frequently in valacyclovir subjects versus placebo included elevated alkaline phosphatase (4%, 2%), elevated ALT (14%, 10%), elevated AST (16%, 11%), decreased neutrophil counts (18%, 10%), and decreased platelet counts (3%, 0%), respectively.
Reduction of Transmission
In a clinical trial for the reduction of transmission of genital herpes, the adverse reactions reported by subjects receiving valacyclovir tablets 500 mg once daily (n = 743) or placebo once daily (n = 741), respectively, included headache (29%, 26%), nasopharyngitis (16%, 15%), and upper respiratory tract infection (9%, 10%).
Herpes Zoster
In 2 clinical trials for the treatment of herpes zoster, the adverse reactions reported by subjects receiving valacyclovir tablets 1 gram 3 times daily for 7 to 14 days (n = 967) or placebo (n = 195), respectively, included nausea (15%, 8%), headache (14%, 12%), vomiting (6%, 3%), dizziness (3%, 2%), and abdominal pain (3%, 2%). For the incidence of laboratory abnormalities see Table 2.
| LLN = Lower limit of normal.ULN = Upper limit of normal. | ||||||||
| ||||||||
| Laboratory Abnormality | Herpes Zoster | Genital Herpes Treatment | Genital Herpes Suppression | |||||
| Valacyclovir Tablets 1 gram 3 Times Daily (n = 967) | Placebo (n = 195) | Valacyclovir Tablets 1 gram Twice Daily (n = 1,194) | Valacyclovir Tablets 500 mg Twice Daily (n = 1,159) | Placebo (n = 439) | Valacyclovir Tablets 1 gram Once Daily (n = 269) | Valacyclovir Tablets 500 mg Once Daily (n = 266) | Placebo (n = 134) | |
| Hemoglobin (< 0.8 x LLN) | 0.8% | 0% | 0.3% | 0.2% | 0% | 0% | 0.8% | 0.8% |
| White blood cells (< 0.75 x LLN) | 1.3% | 0.6% | 0.7% | 0.6% | 0.2% | 0.7% | 0.8% | 1.5% |
| Platelet count (< 100,000/mm3) | 1.0% | 1.2% | 0.3% | 0.1% | 0.7% | 0.4% | 1.1% | 1.5% |
| AST (SGOT) (> 2 x ULN) | 1.0% | 0% | 1.0% | 0.5% | 4.1% | 3.8% | 3.0% | |
| Serum creatinine (> 1.5 x ULN) | 0.2% | 0% | 0.7% | 0% | 0% | 0% | 0% | 0% |
6.2 Clinical Trials Experience in Pediatric Subjects
The safety profile of valacyclovir tablets has been studied in 177 pediatric subjects aged 1 month to less than 18 years. Sixty-five of these pediatric subjects, aged 12 to less than 18 years, received oral tablets for 1 to 2 days for treatment of cold sores. The remaining 112 pediatric subjects, aged 1 month to less than 12 years, participated in 3 pharmacokinetic and safety trials and received valacyclovir oral suspension. Fifty-one of these 112 pediatric subjects received oral suspension for 3 to 6 days. The frequency, intensity, and nature of clinical adverse reactions and laboratory abnormalities were similar to those seen in adults.
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