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19035 W. Capitol Drive, Suite 102
Brookfield, WI 53045

Phone: 262-373-1050
The Mortar & Pestle
MD Custom Rx's monthly e-newsletter
August 2013 
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Protect your Access to Compounded Medications

 

The Senate will soon vote S.959 that would unduly restrict access to custom compounded medications. We support actions to improve safety and protect patients everywhere. However, S.959 has unintended consequences that will deny access to important medications prepared by reputable professional compounding pharmacies such as ours. Please contact your Senators and Representatives today and SPEAK OUT TO OPPOSE BILL S.959. 


Click here for your Senator's contact info.

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Thank you for entrusting in the compounding services at MD Custom Rx to help meet the unique medication needs of your patients.  We are excited to share with you our monthly newsletter and look forward to continuing to be your medication problem solvers.  Please don't ever hesitate to let us know how we can be of further assistance to you and your practice.
 
Sincerely,
John, Dan and Monica
Fluconazole Mouthrinse for Candidiasis
  
   Candidiasis is one of the most common oral fungal infections in humans. This is an opportunistic infection, often affecting individuals who are debilitated by another disease. Oral candidiasis affects 65-93 % of elderly patients wearing dentures. Localized oral candidiasis should be managed initially with local treatment confined to the site of involvement before systemic antifungal drugs are used. Recognition of the potential risk and early treatment of oral candidiasis may prevent serious morbidity in high-risk patients. A study evaluated the efficacy of fluconazole mouthrinse compared to clotrimazole mouthpaint in the treatment of oral candidiasis.
  
   43 patients were treated with fluconazole mouthrinse (Group A) and 46 patients were treated with clotrimazole mouthpaint (Group B). Group A used a suspension of 2 mg/ml of fluconazole in distilled water (with no sweetness and flavor) which was prepared by a hospital pharmacist, stored in brown bottles and kept refrigerated. Each patient in this group was instructed to rinse 5 ml of the treatment solution for 2-3 minutes and then swallow. Mouthrinse was used three times daily for two weeks. Patients were instructed to avoid consuming water and food for at least two hours after rinsing, and to maintain their oral hygiene. Group B patients were treated with commercially available clotrimazole 1% mouthpaint (Candid Mouthpaint 1%, Glenmark Pharmaceuticals) which was dispensed in small amber-colored bottles. Patients were advised to apply the mouthpaint to affected areas with the index finger three times daily for two weeks.
  
   The clinical resolution rates in Group A and Group B were 96% and 78%, respectively. More fluconazole-treated patients remained disease-free during the 15 day follow-up than those treated with clotrimazole. Both treatment regimens were well tolerated. Only one patient in Group A reported mild gastrointestinal discomfort three days after ingesting the rinse; the discomfort resolved spontaneously and did not require any medical intervention.
  
   The advantages of mouthrinses over other type of applications are as follows:
  • In patients with dry mouth, tablets given to dissolve in the mouth may be poorly soluble. Epstein reported that fluconazole is detected in saliva two hours after systemic administration. On the other hand, fluconazole mouthrinse enhances the drug exposure to the oral mucosa immediately, and lasts for four hours, compared with the same dose administered systemically. Because the pathogenic microorganisms in oral candidiasis are usually in the superficial layers of the oral mucosa, the effectiveness of this mouthrinse may be attributed to the temporarily higher concentration at the affected site, resulting in improved efficacy.
  • Mouthrinses may reduce the risk of systemic adverse effects and drug interactions.
  Although the number of patients in the present study was small, the outcome was promising. Additionally, the dose of fluconazole used per day was only 30 mg, which is less than one-third of the standard oral dose of fluconazole (100 mg).
  
Note: Mouthrinse and mouthpaint may not be effective in the treatment of widespread severe oral candidiasis in immuno-compromised patients.
  
    Using pharmaceutical grade bulk powders as a source of active ingredients (antibiotics, anesthetics, etc.) to compound mouthrinses offers numerous advantages versus the common practice of combining commercially available products:
  • Palatability - Compounded preparations do not contain multiple groups of excipients (such as preservatives and suspending agents) that may not be compatible and can create a chalky or unpleasant feel when multiple preparations are combined.
  • Flavor (different products have different flavors, which may not taste good together)
  • Dyes used to color liquid preparations may stain the oral mucosa and can be removed when the preparation is compounded.
   Compounding allows multiple active ingredients to be incorporated into customized dosage forms such as mouthrinses, gels, lozenges, etc. For example, antibiotics can be formulated as a mouthrinse or added to an oral adhesive paste to treat periodontal disease. We can compound medications that are sugar-free to reduce cariogenic potential and for diabetic patients.
 
Urea for Non-Surgical Nail Removal 
  Urea plasters have been shown to be effective for non-surgical removal of traumatized, dystrophic, or diseased nails. Although surgical excision is the most popular method for removing nails, the use of urea plasters may be superior. Surgery has inherent disadvantages - necessity for anesthesia, risk of infection and hemorrhage, and significant postoperative pain. In contrast, the use of urea plasters can be much less costly, several nails can be treated in one session, and the procedure is essentially painless. Because there is essentially no risk of infection or hemorrhage, the procedure is ideal for treating diabetics and others with vascular insufficiency and peripheral neuropathy. Urea is non-toxic and non-allergenic, and may also possess antibacterial, antifungal, and antipruritic properties.
 
  Urea compounds have been used to remove toenails and fingernails from many patients whose problems included onychomycosis, psoriasis, bacterial infection, traumatic injuries, and structural nail dystrophies. Urea's action in these cases results from its ability to denature protein and its hydrating and keratolytic properties, allowing easy removal of the diseased portion of the nail. Cloth adhesive tape is used to cover the normal skin surrounding the affected nail plate and the urea compound is applied liberally to the affected nail surface and covered with an occlusive dressing. Most diseased nails can be removed in 5 to 10 days. The only adverse effects reported in these studies were mild irritation, slight pinpoint bleeding, and tape contact dermatitis.          
 
 
Therapy for Onychomycosis
  
    In the treatment of onychomycosis, compliance, drug interactions and the potential for adverse events associated with antifungal therapy are important considerations. Diabetic patients frequently take concomitant medications, and therefore, topical therapy may be preferred. Most antifungal medications are not used topically and are not commercially available as topical preparations due to concerns about lack of penetration. However, we can solve this problem by dissolving the preferred antifungal agent in pharmaceutical grade DMSO (a penetrant enhancer). Because topical therapy results in lower systemic blood levels of medications, topical therapy reduces the potential for serious adverse events associated with oral antifungal therapy.
  
   At the Nail Disease Centre, Cannes, France, 13 patients with onychomycosis, aged 25-78 years, most with involvement of the matrix region, were treated with a solution of 1% fluconazole and 20% urea in a mixture of ethanol and water, applied once daily at bedtime. In four patients there was complete resolution of the condition; four patients who had involvement of one nail only demonstrated a 90% improvement. Of the four patients who had presented with involvement of both big toenails, two showed 50% improvement bilaterally and in the remaining two patients there was a 90% improvement in one nail and a 50% improvement in the other.
  
   A randomized, double-blind study enrolled 70 patients with onychomycosis of the finger and toenails and compared treatment regimens of fluconazole 1% and fluconazole 1% with urea 40%. These results indicated topical treatment of onychomycosis with a combination of fluconazole 1% and urea 40% was more effective (82.8%) than fluconazole 1% (62.8%) nail lacquer alone. Fluconazole was well tolerated and side effects were negligible. At the end of therapy and the end of the 6-month follow-up, fluconazole 1% and urea 40% demonstrated statistically significant superiority in clinical and mycological responses.
  
Cholesterol and the Great American Health Scam - FREE SEMINAR!
Dr. John Whitcomb, M.D.
Dr. John Whitcomb, M.D., Board Certified in Holistic and Integrative Medicine
  
Wednesday
August 7, 2013
6:30pm - 8:30pm 
 
MD Custom Rx
19035 W Capitol Dr. Suite 105
Brookfield, WI 53045
 
PART II:
  • A summary of statins: benefits and risks
  • What studies show statins help
  • Who should take statins? (HINT: very, very few)
  • Why, oh why, are we so tortured to take them? (HINT: $$$) 
  •  
Call 262-373-1050 to register.
Space is limited!

 

PART I was presented at our July Seminar:
  • How we got to this obsession about cholesterol.
  • How does cholesterol actually get elevated?
  • What's the real cause of heart disease?