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Pronunciation
(pen SYE kloe veer)
Generic Available (U.S.)
No
Brand Names: U.S.
Pharmacologic Category
Use: Labeled Indications
Topical treatment of recurrent herpes simplex labialis (cold sores)
Use: Dental
Topical treatment of recurrent herpes simplex labialis (cold sores)
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events have not been observed in animal reproduction studies following intravenous administration.
Lactation
Excretion in breast milk unknown/not recommended
Breast-Feeding Considerations
According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.
Contraindications
Hypersensitivity to the penciclovir or any component of the formulation
Warnings/Precautions
Special populations:
• Immunocompromised patients: The effect of penciclovir has not been established in immunocompromised patients.
Other warnings/precautions:
• Appropriate use: Should only be used on herpes labialis on the lips and face; because no data are available, application to mucous membranes is not recommended. Avoid application in or near eyes since it may cause irritation.
Adverse Reactions
>10%: Dermatologic: Mild erythema (50%)
1% to 10%:
Central nervous system: Headache (5%)
Local: Application site reaction (1%)
<1%: Local anesthesia (0.9%)
Postmarketing and/or case reports: Erythematous rash, local edema, oropharyngeal edema, pain, paresthesia, parosmia, pruritus, skin discoloration, urticaria
Metabolism/Transport Effects
None known.
Drug Interactions
There are no known significant interactions.
Storage
Store at controlled room temperature of 20°C to 25°C (68°F to 77°F).
Mechanism of Action
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. Penciclovir triphosphate inhibits HSV polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited
Pharmacodynamics/Kinetics
Absorption: Topical: None
Dosage
Children ≥12 years and Adults: Topical: Apply cream at the first sign or symptom of cold sore (eg, tingling, swelling); apply every 2 hours during waking hours for 4 days
Dental Usual Dosing
Treatment of herpes simplex labialis (cold sores): Children ≥12 years and Adults: Topical: Apply cream at the first sign or symptom of cold sore (eg, tingling, swelling); apply every 2 hours during waking hours for 4 days
Administration: Topical
Apply only to herpes labialis on the lips and face. Apply sufficient amount to cover lesions and gently rub into the affected area. Avoid application in or near eyes since it may cause irritation.
Monitoring Parameters
Reduction in virus shedding, negative cultures for herpesvirus; resolution of pain and healing of cold sore lesion
Patient Education
This is not a cure for herpes (recurrences tend to appear within 3 months of original infection), nor will this medication reduce the risk of transmission to others when lesions are present. For external use only. Wash hands before and after application. Apply this film over affected areas at first sign of cold sore. You may experience headache, mild rash, or taste disturbances.
Additional Information
Penciclovir is the active metabolite of the prodrug famciclovir. Penciclovir is an alternative to topical acyclovir for HSV-1 and HSV-2 infections. Neither drug will prevent recurring HSV attacks.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Teach patient appropriate application and use.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, topical:
Denavir®: 1% (1.5 g, 5 g)
Pricing: U.S. (www.drugstore.com)
Cream (Denavir)
1% (1.5): $98.99
References
Alrabiah FA and Sacks SL, “New Antiherpesvirus Agents. Their Targets and Therapeutic Potential,” Drugs, 1996, 52(1):17-32.
International Brand Names
Lexi-Comp.com
Last full review/revision November 2011
Content last modified November 2011
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