Penciclovir indications and usage: Difference between revisions
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==Indications And Usage== | ==Indications And Usage== | ||
DENAVIR is a nucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.<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> | DENAVIR is a nucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.USE IN SPECIFIC POPULATIONS | ||
===Pregnancy=== | |||
'''Category B'''<BR> | |||
There are no adequate and well-controlled studies in pregnant women. | |||
'''Animal Data'''<BR> | |||
No adverse effects on the course and outcome of pregnancy or on fetal development were noted in rats and rabbits following the intravenous administration of penciclovir at doses of 80 and 60 mg/kg/day, respectively (estimated human equivalent doses of 13 and 18 mg/kg/day for the rat and rabbit, respectively, based on body surface area conversion; the body surface area doses being 260 and 355x the maximum recommended dose following topical application of the penciclovir cream). Because animal reproduction studies are not always predictive of human response, penciclovir should be used during pregnancy only if clearly needed. | |||
===Nursing Mothers=== | |||
There is no information on whether penciclovir is excreted in human milk after topical administration. However, following oral administration of famciclovir (the oral prodrug of penciclovir) to lactating rats, penciclovir was excreted in breast milk at concentrations higher than those seen in the plasma. Therefore, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. | |||
There are no data on the safety of penciclovir in newborns. | |||
===Pediatric Use=== | |||
An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 patients, ages 12-17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established. | |||
===Geriatric Use=== | |||
In 74 patients ≥ 65 years of age, the adverse events profile was comparable to that observed in younger patients.<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== | ||
Latest revision as of 16:02, 6 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Indications And Usage
DENAVIR is a nucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.USE IN SPECIFIC POPULATIONS
Pregnancy
Category B
There are no adequate and well-controlled studies in pregnant women.
Animal Data
No adverse effects on the course and outcome of pregnancy or on fetal development were noted in rats and rabbits following the intravenous administration of penciclovir at doses of 80 and 60 mg/kg/day, respectively (estimated human equivalent doses of 13 and 18 mg/kg/day for the rat and rabbit, respectively, based on body surface area conversion; the body surface area doses being 260 and 355x the maximum recommended dose following topical application of the penciclovir cream). Because animal reproduction studies are not always predictive of human response, penciclovir should be used during pregnancy only if clearly needed.
Nursing Mothers
There is no information on whether penciclovir is excreted in human milk after topical administration. However, following oral administration of famciclovir (the oral prodrug of penciclovir) to lactating rats, penciclovir was excreted in breast milk at concentrations higher than those seen in the plasma. Therefore, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. There are no data on the safety of penciclovir in newborns.
Pediatric Use
An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 patients, ages 12-17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.
Geriatric Use
In 74 patients ≥ 65 years of age, the adverse events profile was comparable to that observed in younger patients.[1]
References
- ↑ "DENAVIR (PENCICLOVIR) CREAM [PRESTIUM PHARMA, INC.]". Retrieved 6 January 2014.
Adapted from the FDA Package Insert.