HSV-1

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References

  1. Arduino PG, Porter SR. Herpes simplex virus type I infection: overview on relevant clinic-pathological features. J Oral Pathol Med. 2008;37:107-121.
  2. Boon R, Goodman JJ, Martinez J, et al, for the Penciclovir Cream Herpes Labialis Study Group. Penciclovir cream for the treatment of sunlight-induced herpes simplex labialis: a randomized, double-blind, placebo-controlled trial. Clin Ther. 2000;22:76-90.
  3. Cernik C, Gallina K, Brodell RT. The treatment of herpes simplex infections: an evidenced-based review. Arch Intern Med. 2008;168:1137-1144.
  4. Denavir (penciclovir, cream 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.
  5. Earnshaw DL, et al. Mode of antiviral action of penciclovir in MRC-5 cells infected with herpes simplex virus type 1 (HSV-1), HSV-2, and varicella-zoster virus. Antimicrob Agents Chemother. 1992;36:2747-2757.
  6. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.
  7. Raborn GW, Martel AY, Lassonde M, et al; on behalf of the Worldwide Topical Penciclovir Collaborative Study Group. Effective treatment of herpes simplex labialis with penciclovir cream: combined results of two trials. J Am Dent Assoc. 2002;133:303-309.
  8. Schillinger JA, et al. National seroprevalence and trends in herpes simplex virus type I in the United States, 1976-1994. Sex Transmit Dis. 2004:31:753-760.
  9. Woo S, Challacombe SJ. Management of recurrent oral herpes simplex infections. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007;103(suppl 1):S12.e1-S12.e18.
  10. Young TB, et al. Cross-sectional study of recurrent herpes labialis: prevalence and risk factors. Am J Epidemiol. 1988;127:612-625.

Expand Safety Information

Denavir® (penciclovir cream, 1%) is indicated for the treatment of recurrent herpes labialis
(cold sores) in adults and children 12 years of age and older.

Important Safety Information

Denavir should only be used on herpes labialis on the lips or face. Application to mucous membranes is not recommended. Denavir should not be used in patients with known hypersensitivity to the product or any of its ingredients.

There are no adequate and well-controlled Denavir studies in pregnant women; therefore, Denavir should be used during pregnancy only if clearly needed. There is no information on whether Denavir is excreted in human milk after topical administration; a decision whether to discontinue Denavir should take into account the importance of the drug to the mother. The effect of Denavir has not been established in immunocompromised patients. Denavir does not cure cold sores.

In clinical studies, the most common adverse reaction with Denavir was headache, which occurred in 5.3% of patients who received Denavir and 5.8% of patients who received placebo. Other adverse reactions with Denavir occurred in less than 2% of patients and included application site reaction, decreased sensitivity to touch/local anesthesia, taste perversion, and rash.

Other reported adverse reactions have included swelling of the mouth or throat, pain, alterations in sense of smell, abnormal touch sensation, itching, skin discoloration, and hives.

Denavir is available by prescription only. Please see the Full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.