Penciclovir

Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology ( 12.4 )] .

• Penciclovir cream 1% is a deoxynucleoside 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 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older.ICD-10: B00.9

• Penciclovir is contraindicated in patients with known hypersensitivity to the product or any of its components. Contraindicated in patients with known hypersensitivity to the product or any of its components.contraindicated

Apply penciclovir cream 1% every 2 hours during waking hours for a period of 4 days. Start treatment as early as possible (i.e., during the prodrome or when lesions appear). Apply penciclovir cream 1% every 2 hours during waking hours for a period of 4 days. ( 2 ) Start treatment as early as possible (i.e., during the prodrome or when lesions appear). ( 2 )

Only for topical use of herpes labialis on the lips and face. ( 5 ) 5.1 General Penciclovir should only be used on herpes labialis on the lips and face. Because no data are available, application to human mucous membranes is not recommended. Particular care should be taken to avoid application in or near the eyes since it may cause irritation. Lesions that do not improve or that worsen on therapy should be evaluated for secondary bacterial infection. The effect of penciclovir has not been established in immunocompromised patients.

One or more local skin reactions were reported by 3% of the subjects treated with penciclovir and 4% of placebo-treated patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two double-blind, placebo-controlled trials, 1,516 patients were treated with penciclovir cream and 1,541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with penciclovir cream and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 1. TABLE 1: Local Adverse Reactions Reported in Phase III Trials Penciclovir N=1,516 % Placebo N=1,541 % Application site reaction Hypesthesia/Local anesthesia Taste perversion Rash (erythematous) 1 <1 <1 <1 2 <1 <1 <1 Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology. The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response.

8.1 Pregnancy Risk Summary Penciclovir is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary Penciclovir is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of the child to penciclovir. 8.4 Pediatric Use An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 subjects, ages 12 to 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 subjects ≥65 years of age, the adverse events profile was comparable to that observed in younger patients.

Metabolism

Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n=12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose). Pediatric Patients: The systemic absorption of penciclovir following topical administration has not been evaluated in patients <18 years of age.

Since penciclovir is poorly absorbed following oral administration, adverse reactions related to penciclovir ingestion are unlikely. There is no information on overdose.

• Sep 24, 1996NDANDA020629Mylan
• Nov 9, 2022ANDAANDA212710Teva Pharms Usa
• Aug 7, 2023ANDAANDA216981Torrent
• Sep 27, 2024ANDAANDA212368Padagis Israel
• Aug 22, 2025ANDAANDA214100Amneal

1. 1Drug Ineffective4513%
2. 2Headache308.5%
3. 3Fatigue287.9%
4. 4Diarrhoea257.1%
5. 5Pain257.1%
6. 6Hypertension226.2%
7. 7Chronic Kidney Disease205.6%
8. 8Cough205.6%
9. 9Vomiting205.6%
10. 10Condition Aggravated185.1%
11. 11Nausea185.1%
12. 12Back Pain174.8%
13. 13Anaemia164.5%
14. 14Anxiety164.5%
15. 15Hypoaesthesia164.5%

The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Penciclovir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• HOME-PE2 : Home Treatment Versus Hospitalization in Patients With Acute Pulmonary Embolism, no Clinical Severity Criteria, and Either Right Ventricular Dysfunction or Elevated Troponin: a Randomized Controlled Trial
  Not yet recruiting · Interventional · 568 enrolled · University Hospital, Angers
  NCT07506291updated 2026-04-01
• Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions
  Completed · Phase 2 · Interventional · 40 enrolled · University of Utah
  NCT06558838updated 2026-01-05
• Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.
  Completed · Phase 4 · Interventional · 32 enrolled · Second Affiliated Hospital of Xi'an Jiaotong University
  NCT06985589updated 2025-05-22
• Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
  Completed · Interventional · 28 enrolled · VA Office of Research and Development
  NCT04241094updated 2024-07-01
• Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery
  Completed · Observational · 88 enrolled · Centro Hospitalar do Baixo Vouga
  NCT02423668updated 2015-04-22
• Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects.
  Completed · Phase 1 · Interventional · 20 enrolled · National Research Council, Spain
  NCT02056496updated 2015-04-14
• Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
  Completed · Phase 3 · Interventional · 76 enrolled · EMS
  NCT01257074updated 2013-03-04
• A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
  Completed · Phase 4 · Interventional · 126 enrolled · Novartis
  NCT00820534updated 2012-04-20

Frequently asked questions

How does Penciclovir work?

Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology ( 12.4 )] .

What is Penciclovir used for?

According to FDA labeling, Penciclovir carries indications including: Penciclovir cream 1% is a deoxynucleoside 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 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Penciclovir?

Penciclovir is classified as Antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, DNA Polymerase Inhibitors, Nucleic Acid Synthesis Inhibitors, Decreased DNA Replication.

What are the brand names for Penciclovir?

Penciclovir is marketed under brand names including Denavir.

What are the contraindications for Penciclovir?

Penciclovir labeling lists contraindications including: Penciclovir is contraindicated in patients with known hypersensitivity to the product or any of its components. Contraindicated in patients with known hypersensitivity to the product or any of its components.. Always consult the full prescribing information and a clinician.