RxTriad V10 N04 Sample

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 VO L U M E 1 0

 N U M B E R 4

 N  AIL F UNGUS T REATMENTS

Nail fungus infections are difficult to treatbecause microorganisms live under thenail and are difficult to eradicate. Treat-ments require months to years for reso-lution. Left alone they will not go awayand generally spread to other nails. Oralmedications are not always the best choicefor a patient who may have alcoholismor who has liver damage due to a disease,as these drugs can be highly toxic to theliver. Topical treatments bypass the livermetabolism and are applied directly to thesource (nail) of the infection in the form ofa nail paint or lacquer.

Not all of us have nails that are just alike. Most nails infected with a fungus are hard,flaky, discolored, and uncomfortable andmay require different strengths of the med-ication in different penetration enhancingbases in order to get rid of the infection.

 There are many antifungal medicationsavailable commercially for oral therapybut only a few available in commerciallymanufactured topical products resultingin the need for individualized therapy tobe compounded.

During treatment, it is important to soakthe nail(s) and keep them short by clipping

or filing off loose nail material at least weekly. Topical treatments should be ap-plied to the nail(s) and the skin under andaround the nail(s) and allowed to dry for atleast 1 minute before putting on socks orstockings. This medication should not beapplied to any other parts of the patient’sbody. It is good to clean the nail weekly

 with a cotton ball or tissue that is soaked with alcohol.

Here are 2 case reports of the treatmentof nail fungus with compounded topicalanti fungal preparations rather than com-mercial oral treatments. Commercial oral

treatments can have many side effects thatcan be even more pronounced due to thelong-term therapy needed.

Here is a list of these plus other topicalnail solution preparations and one topical

cream preparation that podiatrists, handsurgeons, dermatologists, and familymedicine practitioners have shown success

 when prescribed:

• Terbinafine 1% in Dimethyl Sulfox-ide, USP

• Terbinafine 1.67% in Dimethyl Sulf-oxide, USP

• Terbinafine 2.5% Tincture• Ketoconazole 2% and Ibuprofen 2%

in Dimethyl Sulfoxide, USP• Fluconazole 16-mg/mL in Dimethyl

Sulfoxide, USP• Thymol 4% in Isopropyl Alcohol• Thymol 0.2% in Isopropyl Alcohol• Fluconazole, Tea Tree Oil, and Ibu-

profen in Dimethyl Sulfoxide, USP• Clotrimazole 2%, Ibuprofen 2%, and

 Tea Tree Oil 5% in Dimethyl Sulfox-ide, USP

• Itraconazole in place of clotrimazole,fluconazole, ketoconazole or terbin-afine in any of the formulas above

• Butenafine Hydrochloride 2% and Tea Tree Oil 5% in a cream base

 Although no documented studies supportthis, 6% ibuprofen added to the solutionshas been reported to help soften the nail.

R ESOURCES:

• Syed TA, Qureshi ZA, Ali SM et al. Treatment of toenail onychomycosis with 2% butenafine and 5% Malaleuca alternifolia (tea tree) oil in cream. Trop

 Med Intl Health 1999; 4: 284-287.

 The information for this article was compiled by various subscribers ofIJPC’s Compounders’ Network List between 2003-2005.

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C ASE R EPORT :

K ETOCONAZOLE  2%  AND  IBUPROFEN   2% IN   DIMETHYL 

SULFOXIDE, USP, T OPICAL N  AIL SOLUTION  FOR  

O NYCHOMYCOSIS

Barb Anliker, RPh Kathy Jackson, Pharmacy Technician Northwest Iowa Compounding Emmetsburg, Iowa

Luan Montag, Physician Assistant-Certified (PA-C)Patricia A. Banwart, DO

West Bend Medical Clinic, West Bend, Iowa

 A 47-year-old white woman who loved to wear sandals had been em-barrassed to do so for several years because her toenails had becomehard, yellow, and detached from the nail bed. Before coming toour clinic, she had been diagnosed as having a bilateral fungalinfection (onychomycosis) of the great toenails and was treated

 with terbinafine (Lamisil) and ketoconazole (Nizoral), both of which were administered orally. Neither of these therapies waseffective in eliminating the infection. In December 2001, shesought treatment from a member (PB) of the staff at the WestBend Medical Clinic. The patient was treated with three 1-weekcourses (pulse dosing) of itraconazole (Sporanox)1  (2 capsules

[100 mg per capsule] twice daily). Each week of therapy wasfollowed by a 3-week drug-free interval. At the conclusion ofthat protocol, the patient was to return to the clinic for furtherevaluation.

 When the patient’s toenails were reevaluated 3 weeks after shehad taken the last dose of itraconazole, it was determined thatoral treatment with that drug had been ineffective. One of thestaff members (LM) at the West Bend Medical Clinic had readabout a compounded terbinafine preparation that was appliedtopically to fingernails and toenails and that had been effec-tive in treating onychomycosis in several patients whose disease

 was refractory to conventional therapy.2 Our patient stated that

orally administered ketoconazole had produced the greatestamount of improvement in her onychomycosis. When LM haddetermined that our pharmacy could compound ketoconazole

RxTriad-A publication of the International Journal of Pharmaceutical Compounding. © 2007 IJPC. All rights reserved.

C ASE R EPORT :

 T ERBINA fi NE  1.67% T OPICAL 

 N  AIL SOLUTION  FOR  

O NYCHOMYCOSIS

Steve Toney, RPh Erin King, CPhT 

 MyrtleTowne Pharmacy 

Henderson Center Pharmacy Eureka, California

 A 55-year-old man was diagnosed ashaving a fungal infection (onychomy-cosis) on the thumb of his right hand.He saw his physician, who wanted toinitiate therapy with terbinafine (Lami-sil), an orally administered treatment.

 The dose of terbinafine usually usedto treat onychomycosis of the fingernail is one 250-mg tablet dailyfor 6 weeks. This patient has a high level of alcohol intake socially;his physician is aware of this. However, terbinafine oral therapy hasbeen associated with rare cases of liver failure that have occurred inindividuals with and without preexisting liver disease. The severity

of these hepatic events or their outcome may be worse in patients with active or chronic liver disease.1 The physician discussed his con-cerns with the patient, who asked if there were alternate routes ofadministration. Neither the cream nor the gel form of terbinafine

into a stable solution, she prescribed a compounded nail solution con-taining ketoconazole 2% and ibuprofen 2% in dimethyl sulfoxide,USP, 15 mL of which was dispensed in a brush applicator bottle ofthe type that contains nail polish. The patient was instructed to usethe brush to apply the solution twice daily on top of and under eachaffected toenail and to the surrounding tissue.

 This patient was very compliant. After 6 weeks of the topical therapydescribed, signs of improvement were evident; the nail had begun toreattach to the nail bed. The patient was to continue that treatmentuntil each toenail had completely reattached to its nail bed.

R EFERENCES

1. Olin BR, ed. Drug Facts and Comparisons . 56th ed. St. Louis, MO: Factsand Comparisons 2002: 1448-1454.

2. Toney S, King E. Terbinafine 1.67% topical nail solution for onychomyco-sis. RxTriad  2001; November.

in a 1% concentration is recommended for the treatment of nailfungus. Product information on the topical forms of terbinafine doesnot include a warning about the possibility of hepatic failure.1 Thepatient’s physician asked whether we could compound a formulationof terbinafine in a vehicle that could penetrate the nail and skin, and

 we recommended terbinafine 1.67% topical nail solution, which thephysician prescribed. The patient was instructed to apply the solutiontwice a day on top of and under the nail after washing his hands withantibacterial soap for 1 minute.

 After 4 weeks of therapy, signs of improvement were evident: Thenail had begun to reattach to the nail bed. At that time, treatment

 was interrupted for 4 weeks but was then reinitiated. Two weeks aftertherapy was reinitiated the nail had completely reattached to the nailbed, and no signs of a fungal infection remained. The treatment wasconsidered successful and was discontinued.

R EFERENCES

1. [No author listed.] Drug Facts and Comparisons . St. Louis, MO: Facts andComparisons, Inc.; 2001.

SUGGESTED READING

1. Buck DS, Nidorf DM, Addino JG. Comparison of two topical prepara-tions for the treatment of onychomycosis: Melaleuca alternifolia (tea tree)oil and clotrimazole. J Fam Pract  1994; 38: 601-605.

2. Castle SS, Duncan MC, Allman JG. Onychomycosis therapy: Continuingeducation. America’s Pharmacist 2001; July: 45-52.

Reprinted from November 2001 RxTriad.

 T EA  T REE OIL

 Tea tree oil is an essential volatile oil from the tea tree plant, Malaleuca alternifolia, said to have antiseptic properties. It is used for insect bites,nail fungus infections, acne, vaginal fungal infections, as a deodorant, mouthwash, and a shampoo.

Read more about this essential volatile oil in this article:

Bottoni DJ. Tea Tree Oil. IJPC  1998; 2(4): 284-285.