FOR U.S. RESIDENTS ONLY
|
 |

Penlac® Prescribing Information, Dermik Laboratories; 2006.
Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000;43:S70-S80.
Data on file, Dermik Laboratories.
Bohn M, Kraemer K. The dermatopharmacologic profile of ciclopirox 8% nail lacquer. J Am Podiatr Med Assoc. 2000;90:491-494.
Gupta AK, Plott T. Ciclopirox: a broadspectrum antifungal with antibacterial and anti-inflammatory properties. Int J Dermatol. 2004;43(suppl 1):3-8.
Kokjohn K, Bradley M, Griffiths B, Ghannoum M. Evaluation of in vitro activity of ciclopirox olamine, butenafine HCl and econazole nitrate against dermatophytes, yeasts and bacteria. Int J Dermatol. 2003;42(suppl 1):11-17.
Jue SG, Dawson GW, Brogden RN. Ciclopirox olamine 1% cream: a preliminary review of its antimicrobial activity and therapeutic use. Drugs. 1985;29:330-341.
Hänel H, Raether W, Dittmar W. Evaluation of fungicidal action in vitro and in a skin model considering the influence of penetration kinetics of various standard antimycotics. Ann N Y Acad Sci. 1988;544:329-337.
Gupta AK, Konnikov N, MacDonald P, et al. Prevalence and epidemiology of toenail onychomycosis in diabetic subjects: a multicentre survey. Br J Dermatol. 1998;139:665-671.
Robbins JM. Treatment of onychomycosis in the diabetic patient population. J Diabetes Complications. 2003;17:98-104.
Boyko WL, Doyle JJ, Ryu S, Gause DO. Onychomycosis and its impact on secondary infection development in the diabetic population [abstract]. Value Health. 1999;2:199. Abstract PDD5.
Doyle JJ, Boyko W, Ryu S, Gause D. Onychomycosis among diabetic patients: prevalence and impact of nonfungal foot infections [poster]. Diabetes. 2000;49(suppl 1):A195-A196. Poster 808-P.
|
Penlac®, part of a comprehensive management program, includes regular removal of the unattached, infected nail by a health care professional, especially for patients with diabetes. Clinical data regarding use of systemic antifungals and Penlac® is not available to support concomitant use. Penlac® is well-tolerated: treatment-related side effects were periungual erythema (5%) and nail disorders (2%).
Patients with insulin-dependent diabetes or those with diabetic neuropathy were not included in pivotal clinical trials with Penlac®.