Pharmacy Pearl 6 FEBRUARY 2001

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A local physician writes a prescription for a MTF patient with toenail onychomycosis for terbinafine [Lamisil®] and ciclopirox nail lacquer [Penlac®]. When you call him asking why the necessity of combined therapy, he states that his impression is that it works faster and clears the nail more quickly.

Do you fill both prescriptions or not? Why or why not?

SELECT  here for discussion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DISCUSSION 6 FEBRUARY 2001

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No.

Going back to another Pearl, the first thing would be to make sure there is a definitive diagnosis of a fungal infection using KOH, PAS stain, or fungal culture. There was a study in CUTIS (1999;64:407-10) as many as 35% of patients empirically diagnosed with onychomycosis did not have onychomycosis, but some other type of onychodystrophy.  Once onychomycosis is definitively diagnosed and oral therapy is to begin, terbinafine is a very good choice for toenail onychomycosis. The recommended course of therapy is 250mg po QD for 12 weeks (6 weeks for fingernails). Although not FDA approved, pulse therapy with terbinafine (250mg po BID for 1 week a month, 2 pulses for fingers, 3 pulses for toes) has been evaluated. The efficacy rate of pulse dosed terbinafine appears to be close to that achieved with standard QD dosing.  

Ciclopirox nail lacquer [Penlac®] is a recently approved topical antifungal nail lacquer for the treatment of onychomycosis. When used alone, the nail lacquer should be applied daily (8 hours before washing) to the entire nail plate. Weekly nail trimming by the patient and as frequently as monthly removal of the unattached, infected nail by a health care professional is an important adjunct to the success of this therapy. Therapy should be continued for at least 48 weeks. Even with this 'labor intensive' regimen, clinical studies showed less than 12% of patients achieved a completely clear or almost clear toenail. (Penlac® package insert).  

In answering the question at hand, the Penlac® package insert states "No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of [Penlac®] and systemic antifungal agents for onychomycosis, is NOT recommended." Local experts state combination is not included in their treatment of onychomycosis. They state there is little, if any, published literature to support this practice. 

Bottom line - based on the info available today, the combination of systemic and topical therapy for onychomycosis is not indicated for the treatment of onychomycosis. 

· Mehregan DR, et al. The cost effectiveness of testing for onychomycosis versus empiric treatment of onychodystrophies with oral antifungal agents. CUTIS. 1999;64:407-10.

· Penlac® product package insert. Dermik Laboratories. Jan 2000.

This Pearl is meant for academic and educational purposes only. This Pearl is meant to raise important points regarding the safe and cost-effective pharmacotherapy of patients. It is not meant to be the definitive reference for the treatment or prophylaxis of various diseases. Although every effort is taken to ensure this Pearl is correct and factual, errors may occur. The Pharmacoeconomic Center assumes no liability for incorrect information or harm that may occur from the use of the information included in this Pearl.

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