Clinical medicine profile
Penciclovir cream
Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- 4 CONTRAINDICATIONS 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.
Precautions
- 5 WARNINGS AND PRECAUTIONS 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.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
2 DOSAGE AND ADMINISTRATION 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 )
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.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- 1 INDICATIONS AND USAGE 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.
Adverse effects
- 6 ADVERSE REACTIONS 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.
- No evidence of sensitization was observed. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of penciclovir.
- Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- The following events have been identified from worldwide postmarketing use of penciclovir in treatment of recurrent herpes labialis (cold sores) in adults.
- These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to penciclovir.
- General : Headache, oral/pharyngeal edema, parosmia.
- Skin : Aggravated condition, decreased therapeutic response, local edema, pain, paresthesia, pruritus, skin discoloration, and urticaria.
Drug interactions
Open multi-drug checker ↗- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Mechanism & disposition
12.
Read complete mechanism
12.1 Mechanism of Action Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology ( 12.4 )] . Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
Product-specific
Product-specific
See product SmPC
of penciclovir following topical administration has not been evaluated in patients <18 years of age. 12.4 Microbiology Mechanism of Action: Penciclovir has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2). In cells infected with HSV-1 or HSV-2, the v...
of 10 hours in HSV-1 and 20 hours in HSV-2 infected cells grown in culture. However, the clinical significance of the intracellular half-life is unknown. Antiviral Activity: In cell culture studies, penciclovir has antiviral activity against the following herpes viruses: HSV-1 an...
Pregnancy, lactation & diet
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.
8.1 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.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.