Valacyclovir Hydrochloride (Page 4 of 13)

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.

Table 2. Incidence (%) of Laboratory Abnormalities in Herpes Zoster and Genital Herpes Trial Populations

LLN = Lower limit of normal.ULN = Upper limit of normal.
* Data were not collected prospectively.
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.

Pediatric Subjects Aged 12 to Less Than 18 Years (Cold Sores)

In clinical trials for the treatment of cold sores, the adverse reactions reported by adolescent subjects receiving valacyclovir tablets 2 grams twice daily for 1 day, or valacyclovir tablets 2 grams twice daily for 1 day followed by 1 gram twice daily for 1 day (n = 65, across both dosing groups), or placebo (n = 30), respectively, included headache (17%, 3%) and nausea (8%, 0%).

Pediatric Subjects Aged 1 Month to Less Than 12 Years

Adverse events reported in more than 1 subject across the 3 pharmacokinetic and safety trials in children aged 1 month to less than 12 years were diarrhea (5%), pyrexia (4%), dehydration (2%), herpes simplex (2%), and rhinorrhea (2%). No clinically meaningful changes in laboratory values were observed.