NORLAND AVENUE PHARMACY PRESCRIPTION COMPOUNDING FOR GENERAL PRACTICE

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1 JUNE 2011 NORLAND AVENUE PHARMACY PRESCRIPTION COMPOUNDING N ORLANDA VENUEP HARMACY. COM We customize individual prescriptions for the specific needs of our patients. INSIDE THIS ISSUE: Venous Leg Ulcers 2 Carpal Tunnel Syndrome 3 PRESCRIPTION COMPOUNDING FOR GENERAL PRACTICE Recurrent Urinary Tract Infections Norland Avenue, Suite 105 Chambersburg, PA Phone: (717) Fax: (717) Web:

2 Page 2 VENOUS LEG ULCERS This study found that oral pentoxifylline was effective in treating venous leg ulcers and that the majority of adverse effects were gastrointestinal disturbances - Pentoxifylline for treating venous leg ulcers (Cochrane Database Syst Rev Jul 18; (3):CD001733). BACKGROUND: Healing of venous leg ulcers is improved by the use of compression bandaging but some venous ulcers remain unhealed, and some people are unsuitable for compression therapy. Pentoxifylline, a drug which helps blood flow, has been used to treat venous leg ulcers. An earlier version of this review included 9 randomised controlled trials, but more research has been since been conducted and an updated review is required. OBJECTIVES: To assess the effects of pentoxifylline (oxpentifylline or Trental 400) for treating venous leg ulcers, compared with placebo, or other therapies, in the presence or absence of compression therapy. MAIN RESULTS: Twelve trials involving 864 participants were included. The quality of trials was variable. Eleven trials compared pentoxifylline with placebo or no treatment; in seven of these trials patients received compression therapy. In one trial pentoxifylline was compared with defibrotide in patients who also received compression. Combining 11 trials that compared pentoxifylline with placebo or no treatment (with or without compression) demonstrated that pentoxifylline is more effective than placebo in terms of complete ulcer healing or significant improvement (RR 1.70, 95% CI 1.30 to 2.24). Significant heterogeneity was associated with differences in sample populations (hard-to-heal samples compared with "normal" healing samples). Pentoxifylline plus compression is more effective than placebo plus compression (RR 1.56, 95% CI 1.14 to 2.13). Pentoxifylline in the absence of compression appears to be more effective than placebo or no treatment (RR 2.25, 95% CI 1.49 to 3.39). A comparison between pentoxifylline and defibrotide found no statistically significant difference in healing rates. More adverse effects were reported in people receiving pentoxifylline (RR 1.56, 95% CI 1.10 to 2.22). Nearly threequarters (72%) of the reported adverse effects were gastrointestinal. AUTHORS CONCLUSIONS: Pentoxifylline is an effective adjunct to compression bandaging for treating venous ulcers and may be effective in the absence of compression. The majority of adverse effects were gastrointestinal disturbances. PMID: The following study suggests that pentoxifylline is effective in treating venous leg ulcers - Pentoxifylline for treatment of venous leg ulcers: a systematic review (Lancet May 4;359 (9317):1550-4). INTRODUCTION: Venous ulcers are usually treated with compression therapy, but, because this treatment may not be effective for some people, adjuvant therapy could be beneficial. We did a systematic review of randomised controlled trials that compared pentoxifylline (with and without compression treatment) with placebo, or other treatments, in patients with venous leg ulcers. METHODS: Eight trials were identified (547 adults), five of which compared pentoxifylline and compression with placebo and compression (n=445), and three of which compared pentoxifylline alone with placebo (102). Our main aim was to determine whether pentoxifylline, with or without compression, was effective in treatment of venous leg ulcers. Analysis was by intention to treat. FINDINGS: Pentoxifylline was more effective than placebo in complete healing or substantial improvement of venous leg ulcers (relative risk 1.49, 95% CI ). Pentoxifylline with compression was also more effective than placebo and compression in complete healing (1.30, ). Patients taking pentoxifylline had no more adverse events than those on placebo (1.25, ). The most frequent adverse event was mild gastrointestinal disturbance (43%). INTERPRETATION: Our results suggest that pentoxifylline gives additional benefit to compression for venous leg ulcers, and is possibly effective for patients not receiving compression. PMID: We can compound pentoxifylline into a topical cream. This form of delivery may lead to fewer systemic side effects and increased patient compliance. Pentoxifylline 5% Topical Cream 120gm Apply to affected area TID

3 Page 3 CARPAL TUNNEL SYNDROME The following clinical paper found gabapentin to be effective in the reduction of pain and the reduction of severity of symptoms in patients suffering from CTS - The efficacy and safety of gabapentin in carpal tunnel patients: open label trial (Med Clin (Barc) Mar 22;130(10):371-3). BACKGROUND AND OBJECTIVE: To evaluate the analgesic efficacy and safety of gabapentin in the treatment of carpal tunnel syndrome (CTS), as well as the electromyographic (EMG) evolution after 6 months. PATIENTS AND METHOD: A prospective study with a 6- month follow-up of patients with EMG diagnosis of primary CTS starting treatment with 1,800 mg/day of gabapentin. At baseline visit and after 6 months of treatment a complete clinical evaluation and an EMG study were performed. Adverse effects of gabapentin were also registered. RESULTS: Twenty-five patients were included, mean age (standard deviation) (7.69) years. After 6 months of treatment, a statistically significant reduction of pain (p = 0.001) and improvement of severity of symptoms (p = 0.008) were observed, although functional capacity did not change. EMG was performed in 19 patients at 6 months. Compared to baseline EMG: 52.6% patients showed no changes in EMG findings, while 5.3% patients showed improvement and in 26.3% the EMG was normal. Progression was only seen in 15.8% of patients after 6 months of treatment. In 28% of the patients gabapentin was stopped because of side effects. CONCLUSIONS: In our series, gabapentin was effective in the reduction of pain and improvement of the severity of the symptoms. Results of EMG after 6 months of treatment showed no changes, with improvement and/or remission in 84.2% of the cases. The drug was safe and well tolerated. PMID: With our state of the art compounding lab we have the ability to compound gabapentin into a transdermal cream that can be applied directly to the area of pain. This form of delivery may provide relief at a much lower dose, and help to limit the systemic side effects associated with the oral dosing form. Gabapentin 10% Transdermal Cream 60gm Apply sparingly BID-TID

4 Page 4 RECURRENT URINARY TRACT INFECTIONS The following clinical papers state that there is evidence to suggest that estrogens can provide prophylaxis against recurrent urinary tract infections - The role of estrogen supplementation in lower urinary tract dysfunction (Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(4):258-61). ABSTRACT: The female lower urinary and genital tracts both arise from the primitive urogenital sinus and develop in close anatomical proximity. Sex hormones have a substantial influence on the female lower urinary tract throughout adult life, with fluctuations in their level leading to macroscopic, histological and functional changes. Urinary symptoms may therefore develop during the menstrual cycle, in pregnancy and following the menopause. Estrogen deficiency, particularly when prolonged, is associated with a wide range of urogenital complaints, including frequency, nocturia, incontinence, urinary tract infections and the 'urge syndrome'. Estrogen supplementation subjectively improves urinary stress incontinence but there is no objective benefit when given alone; however, estrogen given in combination with phenylpropanolamine may be clinically more useful. Hormone replacement therapy does appear to treat postmenopausal irritative urinary symptoms such as frequency and urgency, possibly by reversing urogenital atrophy, and there is also evidence to suggest that estrogens can provide prophylaxis against recurrent urinary tract infections. However, the 'best' type of estrogen, route of administration and duration of therapy are at present unknown. PMID: This clinical paper states that vaginal estrogen administration seems to be effective for preventing recurrent urinary tract infections - Estrogen therapy in older patients with recurrent urinary tract infections: a review (Int J Fertil Womens Med Mar- Apr;49(2):71-4). ABSTRACT: Although urogenital complaints, such as recurrent lower urinary tract infections (UTI), and dysuria, are commonly encountered in elderly women, few women have participated in randomized studies of estrogen therapy for this condition. This is a paradox in view of the often cited beneficial effect of estrogen in reducing the incidence of UTI. Present evidence documents that in postmenopausal women, hormone replacement therapy using topical estrogen normalizes the vaginal flora and greatly reduces the risk of vaginal atrophy. Similarly, vaginal estrogen administration seems to be effective for preventing recurrent urinary tract infections (UTI). PMID: With our state of the art compounding laboratory and pharmaceutical knowledge and experience, we have the ability to compound estradiol into a vaginal cream. Estradiol 0.02% Vaginal Cream 30gm 1gm intravaginally HS 2-3x week

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 Bill Insurance Plan: ID# All topical compound %s are per 1 ml or 1 gm unless otherwise noted Venous Leg Ulcers [ ] Pentoxifylline 5% Topical Cream Quantity 120gm Directions: Apply to affected area TID Carpal Tunnel Syndrome [ ] Gabapentin 10% Transdermal Cream Quantity 60gm Directions: Apply sparingly BID-TID Recurrent Urinary Tract Infections [ ] Estradiol 0.02% Vaginal Cream Quantity 30gm Directions: 1gm intravaginally HS 2-3x week Directions Prescriber s Signature Refills: NR 757 Norland Avenue, Suite 105 Chambersburg, PA Phone: (717) Fax: (717)