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ABOUT COLD SORES


Cold sores can be embarrassing, uncomfortable, and unpredictable. If you get cold sores, you’re not alone. Between 20% and 40% of Americans suffer from recurrent cold sores.11. Young TB, Rimm EB, D’Alessio DJ. Cross-sectional study of recurrent herpes labialis: prevalence and risk factors. Am J Epidemiol. 1988;127:612-625. Cold sore outbreaks often begin with tingling, itching, and/or burning sensations before any visible signs appear.2,32. Arduino PG, Porter SR. Herpes simplex virus type I infection: overview on relevant clinic-pathological features. J Oral Pathol Med. 2008;37:107-121.

3. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.


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ABOUT DENAVIR


There is currently no cure for cold sores or the virus that causes them.33. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763. But for adults and children 12 or older who have recurrent cold sores, Denavir® (penciclovir cream, 1%) can help them heal when they do reappear.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010. Denavir cream reduces the duration of cold sores and the duration of the pain they cause.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


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PATIENT BROCHURE


Be ready. Denavir can be started when you
first feel the tingle or when the blister forms. Have prescription Denavir on hand so you’ll be ready to start treatment when your next cold sore begins. Click on the link below to download important information for patients on the use of Denavir.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


Download Patient Brochure

 
   
 
 

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.

  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.


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