Penciclovir

> 10%

Milde erythema

1-10%

Application site reaction (1%)

Headache (5%)

<1%

Hypesthesia/local anesthesia

Erythematous rash

Local edema

Oropharyngeal edema

Paresthesia

Parosmia

Skin discoloration

Pain

Urticaria

Taste perversion

Pregnancy Category: B

Lactation: Not known if excreted in human milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

• Tell all of your health care providers that you take penciclovir. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not use longer than you have been told. A second infection may happen.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Penciclovir Cream 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.

Penciclovir Cream should be applied every 2 hours during waking hours for a period of 4 days. Treatment should be started as early as possible (i.e., during the prodrome or when lesions appear).

8.1 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.

8.3 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.

8.4 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.

8.5 Geriatric Use

In 74 patients ≥ 65 years of age, the adverse events profile was comparable to that observed in younger patients.

(pen SYE kloe veer)

Data not available

Data not available

Administration advice:
-For external use only; only use on herpes labialis on the lips and face.
-Do not apply to mucous membranes; use particular care to avoid applying in or near the eyes.
-Apply a layer of this drug to cover only the cold sore area (or area of tingling [or other symptoms] before appearance of cold sore); rub in until cream disappears.

Storage requirements:
-Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

Patient advice:
-Begin treatment at earliest sign of cold sore (e.g., tingling, redness, itching, bump).
-Wash hands before and after applying this drug.