Penciclovir clinical pharmacology: Difference between revisions

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Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n=12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose).
Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n=12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose).
'''Pediatric Patients''': The systemic absorption of penciclovir following topical administration has not been evaluated in patients < 18 years of age.
'''Pediatric Patients''': The systemic absorption of penciclovir following topical administration has not been evaluated in patients < 18 years of age.<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>
 
===Microbiology===
 
Antiviral Activity:  In cell culture studies, penciclovir has antiviral activity against the following [[herpes viruses]]: [[HSV]]-1 and [[HSV]]-2. The antiviral activity of penciclovir against wild type strains grown on human foreskin fibroblasts was assessed with a plaque reduction assay and staining with crystal violet 3 days postinfection for [[HSV]]. The median EC50 values of penciclovir against laboratory and clinical isolates of [[HSV]]-1 and [[HSV]]-2 were 2 µM (range 1.2 to 2.4 µM, n=7) and 2.6 µM (range 1.6 to 11 µM, n=6), respectively.
 
Resistance: Penciclovir-resistant mutants of [[HSV]] can result from mutations in viral thymidine kinase (TK) and DNA polymerase genes.  Mutations in the viral TK gene may lead to complete loss of TK activity (TK negative), reduced levels of TK activity (TK partial), or alteration in the ability of viral TK to phosphorylate the drug without an equivalent loss in the ability to phosphorylate thymidine (TK altered). The median EC50 values observed in a plaque reduction assays with penciclovir resistant [[HSV]]-1 and [[HSV]]-2 were 69 µM (range 14 to 115 µM, n=6) and 46 µM (range 4 to > 395 µM, n=9), respectively.  The possibility of viral resistance to penciclovir should be considered in patients who fail to respond or experience recurrent viral shedding during therapy.
 
Cross-resistance:  Cross-resistance has been observed among [[HSV]] DNA polymerase inhibitors. The most commonly encountered acyclovir-resistant mutants that are deficient in viral thymidine kinase (TK negative) are also resistant to penciclovir.
 
==References==
==References==
{{Reflist}}
{{Reflist}}

Latest revision as of 15:38, 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 Pharmacology

Pharmacokinetics

Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n=12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose). Pediatric Patients: The systemic absorption of penciclovir following topical administration has not been evaluated in patients < 18 years of age.[1]

References

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

Adapted from the FDA Package Insert.

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