Denavir
Temporary Tattoos May Put You at Risk »
"Spring break is on the way, or maybe summer vacation. Time to pack your swim suit, hit the beach, and perhaps indulge in a little harmless fun. What about getting a temporary tattoo to mark the occasion? Who could it hurt to get a temporary tatto"...
Denavir
CLINICAL PHARMACOLOGY
Microbiology
Mechanism of Antiviral Activity: The antiviral compound penciclovir has in vitro inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2). In cells infected with HSV-1 or HSV-2, viral thymidine kinase phosphorylates penciclovir to a monophosphate form which, in turn, is converted to penciclovir triphosphate by cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits HSV polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited.
Antiviral Activity In Vitro and In Vivo: In cell culture studies, penciclovir has antiviral activity against HSV-1 and HSV-2. Sensitivity test results, expressed as the concentration of the drug required to inhibit growth of the virus by 50% (IC50) or 99% (IC99) in cell culture, vary depending upon a number of factors, including the assay protocols. See Table 1.
Table 1
| Method of Assay | Virus Type | Cell Type | IC50 (mcg/mL) |
IC99 (mcg/mL) |
| Plaque Reduction | HSV-1 (c.i.) | MRC-5 | 0.2-0.6 | |
| HSV-1 (c.i.) | WISH | 0.04-0.5 | ||
| HSV-2 (c.i.) | MRC -5 | 0.9-2.1 | ||
| HSV-2 (c.i.) | WISH | 0.1-0.8 | ||
| Virus Yield Reduction | HSV-1 (c.i.) | MRC -5 | 0.4-0.5 | |
| HSV-2 (c.i.) | MRC-5 | 0.6-0.7 | ||
| DNA Synthesis Inhibition | HSV-1 (SC16) | MRC-5 | 0.04 | |
| HSV-2 (MS) | MRC-5 | 0.05 | ||
| (c.i.) = clinical isolates. The latent state of any herpes virus is not known to respond to any antiviral therapy. | ||||
Drug Resistance: Penciclovir-resistant mutants of HSV can result from qualitative changes in viral thymidine kinase or DNA polymerase. The most commonly encountered acyclovir-resistant mutants that are deficient in viral thymidine kinase are also resistant to penciclovir.
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.
Clinical Trials
Denavir (penciclovir) was studied in two double-blind, placebo (vehicle)-controlled trials for the treatment of recurrent herpes labialis in which otherwise healthy adults were randomized to either Denavir (penciclovir) or placebo. Therapy was to be initiated by the subjects within 1 hour of noticing signs or symptoms and continued for 4 days, with application of study medication every 2 hours while awake. In both studies, the mean duration of lesions was approximately one-half-day shorter in the subjects treated with Denavir (penciclovir) (N=1,516) as compared to subjects treated with placebo (N=1,541) (approximately 4.5 days versus 5 days, respectively). The mean duration of lesion pain was also approximately one-half-day shorter in the Denavir (penciclovir) group compared to the placebo group.
Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Denavir Information
Denavir - User Reviews
Denavir User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Denavir sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.
Updated & New
