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Penciclovir: Drug information

Penciclovir: Drug information
(For additional information see "Penciclovir: Patient drug information" and see "Penciclovir: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Denavir
Pharmacologic Category
  • Antiviral Agent
Dosing: Adult
Herpes labialis

Herpes labialis (cold sores): Topical: Apply every 2 hours while awake for 4 days; initiate as early as possible (ie, onset of prodrome or when lesion appears).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Penciclovir: Pediatric drug information")

Herpes labialis

Herpes labialis (cold sores): Children ≥12 years and Adolescents: Topical: Cream: Apply every 2 hours during waking hours for 4 days; start at the first sign or symptom of cold sore (eg, tingling, redness, itching, swelling) or appearance of lesion.

Dosing: Kidney Impairment: Pediatric

All patients: There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

All patients: There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Dermatologic: Erythema (50%; mild)

1% to 10%:

Central nervous system: Headache (5%)

Local: Application site reaction (1%)

<1%, postmarketing, and/or case reports: Altered sense of smell, erythematous rash, local anesthesia, localized edema, oropharyngeal edema, pain, paresthesia, pruritus, skin discoloration, urticaria

Contraindications

Hypersensitivity to the penciclovir or any component of the formulation

Warnings/Precautions

Special populations:

• Patients who are immunocompromised: The effect of penciclovir has not been established in patients who are immunocompromised.

Other warnings/precautions:

• Appropriate use: Only to 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.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Denavir: 1% (5 g) [contains cetostearyl alcohol, propylene glycol]

Generic: 1% (5 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Denavir External)

1% (per gram): $194.88

Cream (Penciclovir External)

1% (per gram): $175.20 - $185.13

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: Apply only to herpes labialis on the lips and face. Clean and dry affected area prior to application. Apply sufficient amount to cover lesions or area of tingling (or other symptoms) before the lesion appears; gently rub into the affected area. Avoid application in or near eyes since it may cause irritation. Wash hands with soap and water after application.

Administration: Pediatric

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.

Use: Labeled Indications

Herpes labialis (cold sores): Topical treatment of recurrent herpes labialis (cold sores) adults and children ≥12 years of age

Medication Safety Issues
Sound-alike/look-alike issues:

Denavir may be confused with indinavir

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Talimogene Laherparepvec: Antiherpetic Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec. Risk C: Monitor therapy

Pregnancy Considerations

Penciclovir is not absorbed systemically following topical administration; exposure to the fetus is not expected.

Breastfeeding Considerations

Penciclovir is not absorbed systemically following topical administration; exposure to an infant via breast milk is not expected.

Monitoring Parameters

Resolution of symptoms and healing of cold sore lesion

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

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Resolution of pain: Adults: 3.5 days (Spruance 1997); Cutaneous healing: Adults: 4.8 days (Spruance 1997)

Absorption: Topical: None

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Famvir | Vectavir;
  • (AR) Argentina: Pentavir;
  • (AT) Austria: Famvir | Fenivir;
  • (BE) Belgium: Vectavir novartis cons.hlth;
  • (BR) Brazil: Famvir p | Herpigran | Penvir labia | Vectavir;
  • (CH) Switzerland: Fenivir;
  • (CN) China: Dan pu le | Fu tan | Heng ao pu kang | Li ke shuang | Li zhu jun le | Lizhu junle;
  • (CO) Colombia: Penvirox Labia;
  • (CZ) Czech Republic: Vectavir;
  • (DE) Germany: Fenistil pencivir bei lippenherpes | Pencivir | Vectavir;
  • (EE) Estonia: Fenivir | Vectavir;
  • (EG) Egypt: Pandrocear | Ploref;
  • (ES) Spain: Vectavir;
  • (FI) Finland: Vectavir;
  • (FR) France: Denavir;
  • (GB) United Kingdom: Fenistil cold sore cream | Vectavir;
  • (GR) Greece: Fenivir | Vectavir;
  • (HK) Hong Kong: Vectavir;
  • (IE) Ireland: Fenistil cold sore cream;
  • (IL) Israel: Vectavir;
  • (IT) Italy: Vectavir | Zilip;
  • (KW) Kuwait: Vectavir;
  • (LB) Lebanon: Vectavir;
  • (LT) Lithuania: Fenivir;
  • (LU) Luxembourg: Vectavir-nv-;
  • (LV) Latvia: Fenivir;
  • (MX) Mexico: Vectavir;
  • (NL) Netherlands: Fenistil Penciclovir | Vectavir;
  • (NO) Norway: Vectatone | Vectavir;
  • (NZ) New Zealand: Vectavir;
  • (PR) Puerto Rico: Denavir;
  • (PT) Portugal: Fenivir;
  • (RU) Russian Federation: Fenistil pencivir | Vectavir;
  • (SE) Sweden: Vectatone | Vectavir;
  • (SK) Slovakia: Vectavir;
  • (TR) Turkey: Ex lovir | Pensivir | Vectavir;
  • (UA) Ukraine: Aflubin penciclovir | Fenistil pencivir | Gerpestil | Labium | Pen-herpevir | Penciclovir phytopharm | Penciclovir zdorovye;
  • (ZA) South Africa: Fenivir
  1. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  2. Dekker CL, Prober CG. Pediatric uses of valacyclovir, penciclovir and famciclovir. Pediatr Infect Dis J. 2001;20(11):1079-1081. [PubMed 11734715]
  3. Denavir (penciclovir) [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; November 2018.
  4. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  5. Spruance SL1, Rea TL, Thoming C, Tucker R, Saltzman R, Boon R. Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group. JAMA, 1997; 277(17):1374-1379. [PubMed 9134943]
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