COMPOUNDING PHARMACY SOLUTIONS PRESCRIPTION COMPOUNDING FOR DERMATOLOGY

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1 JUNE 2012 COMPOUNDING PHARMACY SOLUTIONS PRESCRIPTION COMPOUNDING COM We customize individual prescriptions for the specific needs of our patients. INSIDE THIS ISSUE: Acne 2 Cutaneous Candidiasis 3 PRESCRIPTION COMPOUNDING FOR DERMATOLOGY Molluscum Contagiosum Beverly Hill Street Suite 201 Houston, TX Phone: (713) Fax: (713) Web:

2 Page 2 ACNE The following study found that topical 4% nicotinamide gel is of comparable efficacy to 1% clindamycin gel in the treatment of acne vulgaris. Because topical clindamycin, like other antimicrobials, is associated with emergence of resistant microorganisms, nicotinamide gel is a desirable alternative treatment for acne vulgaris - Topical nicotinamide compared with clindamycin gel in the treatment of inflammatory acne vulgaris (Int J Dermatol Jun;34(6):434-7). BACKGROUND: Systemic and topical antimicrobials are effective in the treatment of inflammatory acne vulgaris; however, widespread use of these agents is becoming increasingly associated with the emergence of resistant pathogens raising concerns about microorganism resistance and highlighting the need for alternative nonantimicrobial agents for the treatment of acne. Nicotinamide gel provides potent anti-inflammatory activity without the risk of inducing bacterial resistance. METHODS: In our double-blind investigation, the safety and efficacy of topically applied 4% nicotinamide gel was compared to 1% clindamycin gel for the treatment of moderate inflammatory acne vulgaris. Seventy-six patients were randomly assigned to apply either 4% nicotinamide gel (n = 38) or 1% clindamycin gel (n = 38) twice daily for 8 weeks. Efficacy was evaluated at 4 and 8 weeks using a Physician's Global Evaluation, Acne Lesion Counts, and an Acne Severity Rating. RESULTS: After 8 weeks, both treatments produced comparable (P = 0.19) beneficial results in the Physician's Global Evaluation of Inflammatory Acne; 82% of the patients treated with nicotinamide gel and 68% treated with clindamycin gel were improved. Both treatments produced statistically similar reductions in acne lesions (papules/pustules; -60%, nicotinamide vs. -43%, clindamycin, P = 0.168), and acne severity (-52% nicotinamide group vs. - 38% clindamycin group, P = 0.161). CONCLUSIONS: These data demonstrate that 4% nicotinamide gel is of comparable efficacy to 1% clindamycin gel in the treatment of acne vulgaris. Because topical clindamycin, like other antimicrobials, is associated with emergence of resistant microorganisms, nicotinamide gel is a desirable alternative treatment for acne vulgaris. PMID: With our state of the art compounding lab and pharmaceutical knowledge and experience, we can compound nicotinamide into a topical gel; in a variety of strengths to meet the unique needs of each of your patients. Nicotinamide 4% Topical Gel 60gm Apply sparingly to affected area(s) BID

3 Page 3 CUTANEOUS CANDIDIASIS The following clinical paper discusses the practicability of using ibuprofen, alone or in combination with azoles, in the treatment of cutaneous candidiasis, particularly when applied topically, taking advantage of the drug's antifungal and anti-inflammatory properties - Antifungal activity of ibuprofen alone and in combination with fluconazole against Candida species (J Med Microbiol Sep;49 (9):831-40). ABSTRACT: Ibuprofen, a non-steroidal anti-inflammatory drug, exhibited antimicrobial activity against Candida albicans and nonalbicans strains. At 10 mg/ml, ibuprofen showed a rapid cidal activity against exponential growth phase C. albicans, accompanied by rapid and extensive leakage of intracellular K+, permeation to propidium iodide, lysis of spheroplasts and severe membrane ultrastructural alterations. These results indicate that the killing of Candida cells is due to direct damage to the cytoplasmic membrane. At 5 mg/ml, ibuprofen inhibited growth; however, it did not kill the yeasts and did not directly affect the cytoplasmic membrane. Evaluation of yeast metabolic vitality with the fluorescent probe FUN-1 showed that growth inhibition induced by the fung- istatic drug concentration was due to metabolic alterations. The combination of ibuprofen with fluconazole resulted in synergic activity with eight of the 12 Candida strains studied, including four of the five fluconazole-resistant strains. The MICs of fluconazole for the fluconazole-resistant strains decreased fold when the drug was associated with ibuprofen. When in combination with fluconazole, MICs for ibuprofen decreased by up to 64-fold for all the 12 strains studied. These results point to the practicability of using ibuprofen, alone or in combination with azoles, in the treatment of candidosis, particularly when applied topically, taking advantage of the drug's antifungal and anti-inflammatory properties. PMID: With our state of the art compounding lab and pharmaceutical knowledge and experience, we can compound ibuprofen and fluconazole together as one topical cream. Ibuprofen 10%/Fluconazole 1% Topical Cream 60gm Apply to affected area(s) BID

4 Page 4 MOLLUSCUM CONTAGIOSUM The following clinical papers discuss the safety and effectiveness of potassium hydroxide in treating molluscum contagiosum. An open, randomized, comparative clinical and histological study of imiquimod 5% cream versus 10% potassium hydroxide solution in the treatment of molluscum contagiosum. (Ann Dermatol May;22(2):156-62) Double-blind, randomized, placebo-controlled trial of the use of topical 10% potassium hydroxide solution in the treatment of molluscum contagiosum. (Pediatr Dermatol May-Jun;23 (3):279-81) BACKGROUND: Although molluscum contagiosum (MC) resolves spontaneously, there are several reasons to treat this dermatological disorder. OBJECTIVE: To evaluate the safety and efficacy of 5% imiquimod cream versus 10% potassium hydroxide (KOH) solution in treating MC, and to propose the mechanism of cure by observing the histological findings. METHODS: Imiquimod or KOH were applied by the patient or a parent 3 days per week until all lesions cleared. The number of MC lesions was counted and side effects were evaluated at 5 points during the treatment (the initial visit, week 2, week 4, week 8, and week 12). Histological changes were compared between 2 patients of each group, before and after the 2 weeks of application. RESULTS: In both group, the mean lesion counts decreased all through to week 12, and the reduction in number of lesions were statistically significant in both groups (p <0.005). Over 40% of each group developed local side effects, and no systemic side effects were noted in either group. Before treatment, histological findings showed little or no dermal infiltrates. After treatment, specimens showed dense lymphocytic infiltrates, especially T cells, around the lesions which had resolved. CONCLUSIONS: Both 10% KOH solution and 5% imiquimod cream are effective and safe treatment of MC. PMID: ABSTRACT: Molluscum contagiosum is a common viral infection of the skin that frequently affects children. Lesions take between 6 and 18 months to resolve spontaneously and are a source of great embarrassment to both caretakers and children, often affecting attendance at school and limiting social activity. Treatment options to date have been poorly tolerated by children but recent studies have suggested that potassium hydroxide may be beneficial. This double-blind, randomized, placebo-controlled study compared 10% potassium hydroxide with placebo (normal saline). Twenty patients, aged 2 to 12 years, were recruited. Parents applied a solution twice daily to lesional skin until signs of inflammation appeared. Children were examined by the same observer on days 0, 15, 30, 60, and 90. Seventy percent of children receiving topical potassium hydroxide cleared, compared with 20% in the placebo group. Further dosing studies are required to identify whether weaker concentrations of potassium hydroxide are as efficacious, with less irritancy. PMID: Potassium Hydroxide 10% Topical Solution 30ml Apply BID on each lesion With our state of the art compounding lab and pharmaceutical knowledge and experience, we can compound potassium hydroxide into a topical solution in a variety of strengths.

5 Prescriber Name Prescriber Address City State Zip Phone Fax Date Patient Name DOB Address City/State/Zip Phone Patient will pick up at pharmacy Please ship to patient All topical compound %s are per 1 ml or 1 gm unless otherwise noted Acne [ ] Nicotinamide 4% Topical Gel Quantity 60gm Directions: Apply sparingly to affected area(s) BID Cutaneous Candidiasis [ ] Ibuprofen 10% / Fluconazole 1% Topical Cream Quantity 60gm Molluscum Contagiosum Directions: Apply to affected area(s) BID [ ] Potassium Hydroxide 10% Topical Solution Quantity 30ml Directions: Apply BID on each lesion Directions Prescriber s Signature Refills: NR 6105 Beverly Hill Street Suite 201 Houston, TX Phone: (713) Fax: (713)

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