Penciclovir Side Effects

6 ADVERSE REACTIONS One or more local skin reactions were reported by 3% of the subjects treated with penciclovir and 4% of placebo-treated patients.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc.

at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In two double-blind, placebo-controlled trials, 1,516 patients were treated with penciclovir cream and 1,541 with placebo.

One or more local adverse reactions were reported by 3% of the patients treated with penciclovir cream and 4% of placebo-treated patients.

The rates of reported local adverse reactions are shown in Table

TABLE 1: Local Adverse Reactions Reported in Phase III Trials Penciclovir N=1,516 % Placebo N=1,541 % Application site reaction Hypesthesia/Local anesthesia Taste perversion Rash (erythematous) 1 <1 <1 <1 2 <1 <1 <1 Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology.

The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response.

No evidence of sensitization was observed.