Penciclovir

Drug overview for PENCICLOVIR (penciclovir):

Generic name: PENCICLOVIR (pen-SYE-kloe-vir)
Drug class: Topical Antivirals
Therapeutic class: Dermatological

Penciclovir, a synthetic acyclic guanine nucleoside analog, is an antiviral agent active against various Herpesviridae, including herpes simplex virus types 1 and 2 (HSV-1 and HSV-2).

No enhanced Uses information available for this drug.

DRUG IMAGES

No Image Available

The following indications for PENCICLOVIR (penciclovir) have been approved by the FDA:

Indications:
Herpes labialis

Professional Synonyms:
Herpes simplex type 1 infection of the lip or nares
HSV type 1 infection of the lip or nares

Dosing information for PENCICLOVIR
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PENCICLOVIR 1% CREAM	Maintenance	Adults apply to the affected area(s) by topical route every 2 hours during waking hours for 4 days

Generic dosing information for PENCICLOVIR
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PENCICLOVIR 1% CREAM	Maintenance	Adults apply to the affected area(s) by topical route every 2 hours during waking hours for 4 days

Moderate List
No disease contraindications

The following adverse reaction information is available for PENCICLOVIR (penciclovir):

Overview
Severe
Less Severe

Adverse reaction overview.

In clinical trials, the incidence and type of adverse effects reported in patients treated with topical penciclovir 1% cream were similar to those reported in patients treated with vehicle control cream. In those treated with topical penciclovir 1% cream, application site reactions (localized irritation, hypesthesia/local anesthesia) occurred in 1-3% and taste perversion and erythematous rash occurred in less than 1%.

There are 0 severe adverse reactions.

There are 5 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder	Dysgeusia Erythema Hypoesthesia Skin rash

Rare/Very Rare
None.

The following precautions are available for PENCICLOVIR (penciclovir):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of penciclovir 1% cream have not been established in children younger than 12 years of age. Data are not available regarding safety of penciclovir in neonates. The frequency of adverse reactions following topical application of penciclovir 1% cream in children and adolescents 12-17 years of age with recurrent herpes labialis is similar to that reported in adults.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category B. (See Users Guide.) Penciclovir 1% cream should be used during pregnancy only if clearly needed. There are no adequate and controlled studies using topical penciclovir in pregnant women. No adverse effects on the course and outcome of pregnancy or on fetal development were evident in rats and rabbits following IV administration of penciclovir at dosages of 80 and 60 mg/kg daily, respectively (equivalent to estimated human dosages of 13 and 18 mg/kg daily, respectively, based on body surface area conversion).

It is not known whether penciclovir is distributed into human milk following topical application. Although systemic absorption is minimal following topical application of penciclovir 1% cream to skin, oral administration of famciclovir (the oral prodrug of penciclovir) in lactating rats results in penciclovir concentrations in milk that are higher than those in plasma. A decision should be made whether to discontinue nursing or penciclovir 1% topical cream, taking into account the importance of the drug to the mother.

The adverse effects profile of penciclovir 1% cream in adults 65 years of age or older is similar to that reported in younger adults.

Herpes labialis
B00.1	Herpesviral vesicular dermatitis