Penciclovir clinical studies: Difference between revisions

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==Clinical Studies==
==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, 1516 patients were treated with DENAVIR (penciclovir cream) and 1541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with DENAVIR and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 1.
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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.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = DENAVIR (PENCICLOVIR) CREAM [PRESTIUM PHARMA, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=14d60b68-e5dd-475a-8517-576eb7894683#nlm34067-9 | publisher =  | date =  | accessdate = 6 January 2014 }}</ref>
==References==
==References==
{{Reflist}}
{{Reflist}}

Latest revision as of 15:55, 6 January 2014

Penciclovir
DENAVIR® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [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, 1516 patients were treated with DENAVIR (penciclovir cream) and 1541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with DENAVIR and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 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.[1]

References

  1. "DENAVIR (PENCICLOVIR) CREAM [PRESTIUM PHARMA, INC.]". Retrieved 6 January 2014.

Adapted from the FDA Package Insert.