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Clinical Update CAREMARK Clinical Update Pharmaceutical Issues and Prescribing Trends for Today’s Professional Working in Healthcare AUGUST 2003 Onychomycosis Introduction treatment of onychomycosis, which cost the United Onychomycosis is a common fungal infection of the States healthcare system $43 million.6 Onychomycosis fingernails and toenails that accounts for about 30% also has a tremendous impact on an individual’s of all fungal infections found on the surface of the functioning and well-being. Rarely, in the elderly, skin.1,2 Although the world is full of yeasts, molds, onychomycosis can lead to complications such as and fungi, only a few cause skin problems. These cellulitis, an infection of the skin. If severe or if left agents, called “dermatophytes” or “skin fungi”, rarely untreated, it can spread into the lymph nodes and the invade deeper into the body and most live only on bloodstream (lymph nodes filter the cells that help human skin, hair, or nails.3 Onychomycosis is an fight infection and disease). Onychomycosis can also infection of the nail by fungi that include further compromise the limbs in those with peripheral dermatophyte, non-dermatophyte molds, and yeast vascular disease, a condition where there is decreased (mainly candida species).4 Onychomycosis makes the circulation to the legs or arms.4 nails look white and opaque, thickened, and brittle, and can lead to ultimate destruction of the nail plate.1 Incidence Additionally, onychomycosis is capable of spreading to The incidence of onychomycosis has been increasing. other toenails, fingernails, or even the skin. In rare This is attributed to increased awareness, the aging occasions, if this fungal condition is ignored, its spread population, more people with a weak immune system, could impair one’s ability to work or even walk. This as well as changing lifestyles with tight clothing/ happens because it is frequently accompanied by footwear and communal bathing at public swimming thickening of the nails, which cannot be easily pools.2 trimmed and may cause pain while wearing shoes.4 Treatment of Onychomycosis Reasons for Treatment Fungal infections may be difficult to treat for several The incidence of onychomycosis is high in the general reasons.8 Depending on where and how serious the population, especially in adults over 50 years of age. infection is, the length of treatment may range from However, the frequency of onychomycosis is higher in three to six months.7 Therefore, it is important to patients with weak immune systems and those obtain the correct diagnosis and select the appropriate suffering from diabetes mellitus.5 When an individual antifungal agent.8 suffers from diabetes, the blood circulation and the nerve supply to the feet can become impaired. Sporanox® (itraconazole) is a prescription medicine Therefore, any relatively minor injury to their feet, used to treat fungal infections of the toenails and including a nail fungal fingernails. It is also used to treat some types of Author: infection, can lead to a more fungal infections in other areas of the body. Sporanox Dena Kritikos, serious complication, such as has been associated with rare cases of serious liver PharmD an open sore (foot ulcer) that problems, including liver failure and death. Some of is difficult to heal.4 the individuals in these cases had neither prior liver Editorial Contact: disease nor a serious underlying medical condition. Dana Udovich, PharmD The cost of this disease has Common side effects of Sporanox include nausea, publications@ been extensively vomiting, rash, headache, and swelling of soft tissues caremark.com documented. For example, it has been reported that For past issues, 662,000 Medicare patients please visit us at made 1.3 million visits to www.caremark.com physicians in 1989 for the CAREMARK Clinical Update AUGUST 2003 as a result of excess water retention. Additionally, verification of high-dose prescriptions. Additionally, in Sporanox should not be taken by individuals with the Caremark CustomCare Mail program, clinical heart failure or if they are on certain medications that pharmacists verify for appropriate diagnosis and limit can lead to abnormal heartbeats.9 drug quantity to appropriate length of therapy based upon which nails are affected. In the Prior Another agent, Lamisil® (terbinafine) tablets, is Authorization program, Lamisil and Sporanox therapy indicated for the treatment of fungal infections of the is approved through diagnosis verification of “at risk” toenail or fingernail due to dermatophytes. Rare cases participants. Clients may choose coverage for these of liver failure, some leading to death or liver agents through their individual benefit designs. These transplant, have occurred with the use of Lamisil programs, in collaboration with the expertise of the tablets in individuals with or without prior liver Caremark clinical team, can help ensure proper and disease. Common adverse effects include diarrhea, cost-effective drug therapy for the participant with dyspepsia (upper abdominal pain, bloating, belching), onychomycosis. abnormal liver tests, rash, hives, itching, and taste disturbances. In general, the adverse effects have References been shown to be mild and transient.10 1. Joish VJ, Armstrong EP. Which antifungal agent for onychomycosis? A Pharmacoeconomic analysis. Pharmacoeconomics. 2001; 19(10):983-1002. Lamisil is dosed at 250 mg daily for 6 weeks and 12 2. Jain S, Sehgal VN. Onychomycosis: treatment perspective. weeks in fingernail and toenail infection, respectively.3 Int J Dermatol. January 2000; 39(1):10-14. Sporanox is dosed at 200 mg daily for 12 weeks 3. MedTerms Medical Dictionary Index. Found on the Internet at: continuously in toenail infection. Alternatively, for http://www.medterms.com/script/main/hp.asp. Accessed on July 10, 2003. fingernail infection, 200 mg twice daily is taken for 4. Roberts DT, Taylor WD, Boyle J. Guidelines for treatment of one week in a “pulse” dosing schedule. For the next onychomycosis. Br J Dermatol. 2003; 148:402-410. three weeks, no additional medication is required, 5. Haugh M, Helou, S, Boissel JP, Cribier BJ. Terbinafine in fungal since Sporanox is already at the site of infection. Two infections of the nails: a meta - analysis of randomized clinical “pulses” are recommended for fingernail infection.4,9 trials. Br J Dermatol 2002; 147:118-121. 6. Shaw JW, Joish VN, Coons SJ. Onychomycosis: health related Improved nails may not be obvious for several months quality of life considerations. Pharmacoeconomics. 2002; 20(1):23-36. after the treatment period is finished since it usually 7. Cribier BJ, Paul C. Long - term efficacy of antifungals in toenail takes about 6 months to grow a new fingernail or 12 onychomycosis: a critical review. Br J Dermatol. 2001; months to grow a new toenail.9 145:446-452. 8. Gupta AK, Baran R, and Summerbell R. Onychomycosis: strategies Of note, published clinical studies have shown Lamisil to improve efficacy and reduce recurrence. JEADV. 2002; to be more effective than Sporanox for the treatment 16:579-586. of dermatophyte onychomycosis. However, Sporanox 9. Sporanox package insert. Titusville, NJ: Janssen Pharmaceutica Products, LP; 2002 October. is the most effective agent for the treatment of 10. Lamisil package insert. East Hanover, NJ: Novartis; 2001 October. onychomycosis caused by candida. Both agents are 11 11. Darkes MJM, Scott LJ, and Goa KL. Terbinafine a review of its use generally well-tolerated. in onychomycosis in adults. Am J Clin Dermatol. 2003; 4(1):39-65. Clinical Initiatives The Caremark Clinical Update is provided as reference material and is The treatment of onychomycosis can be lengthy, based in part on information derived from third parties. Caremark challenging, and costly, often with limited success. does not assume any liability or responsibility for the accuracy or One Caremark clinical program, SecureCare, helps to completeness of any third party material footnoted in this piece. ensure that antifungal drugs are appropriately dispensed and utilized. This is accomplished through monitoring of refills, drug-drug interactions, and ©2003 Caremark Inc. All rights reserved..
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