Adult Dosing

Herpes labialis (cold sores)

• Apply q2 hrs during waking hours x 4 days

Pediatric Dosing

• Safety and effectiveness in pediatric patients <12 years of age have not been established

Herpes labialis (cold sores)

• >12 yrs
• Apply q2 hrs during waking hours x 4 days

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

See Supplemental Patient Information

• Penciclovir should only be used for herpes labialis on the lips and face; application to mucous membranes is not recommended
• Avoid application in or near the eyes as it may cause irritation
• If lesions do not improve, or worsen while on therapy, the patient should be evaluated for secondary bacterial infection

Caution: Use cautiously in

• Immune deficiency

Supplemental Patient Information

• Advise patient to wash hands and face before and after application, and apply a layer of cream to cover only the cold sore area or the area of tingling before the cold sore appears
• Advise patient to keep penciclovir out of reach of children

Pregnancy Category:B

Breastfeeding: Safety unknown. No published experience with penciclovir during breastfeeding is available, infant side effects are unlikely with maternal topical application to small areas of the mother's body away from the breast. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 May 2011).

• CNS: Headache
• LOCAL: Application site reaction
• DERM: Rash
• MISC: Hypesthesia

• Antiviral agent; selectively inhibit herpes simplex virus types 1 (HSV-1) and 2 (HSV-2), DNA synthesis and replication
• Metabolized by liver
• Excretion: Unknown
• Half-life: 2 hrs

US Trade Name(s)

• Denavir

US Availability

Denavir

• CRE: 1%

Canadian Trade Name(s)

• Denavir

Canadian Availability

Denavir

• CRE: 1%

UK Trade Name(s)

• Fenistil Cold Sore Cream
• Vectavir Cold Sore Cream

UK Availability

Fenistil Cold Sore Cream, Vectavir Cold Sore Cream

• CRE: 10 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Dermatologic Topical Agents

Antivirals

Antimicrobial Agents

Dermatologic Topical Agents

Antivirals

Infectious Disease

Dermatologic Topical Agents

Antivirals

Pricing data from www.DrugStore.com in U.S.A.

• Denavir 1 % CREA [Tube] (NEW AMERICAN THERAPEUTICS)
  5 % = $179.99
  15 % = $505.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.