DECENBER 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: Trigeminal Neuralgia 2 Pain due to Peripheral Blood Flow Disorders 3 PRESCRIPTION COMPOUNDING FOR PAIN MANAGEMENT Hemorrhoidectomy Pain 4 757 Norland Avenue, Suite 105 Chambersburg, PA 17201 Phone: (717) 217-6790 Fax: (717) 217-6925 Web: www.norlandavenuepharmacy.com
Page 2 TRIGEMINAL NEURALGIA The following clinical study results suggest that misoprostol is effective and safe in the treatment of this specific type (multiple sclerosis) of refractory trigeminal neuralgia - Misoprostol in the treatment of trigeminal neuralgia associated with multiple sclerosis (J Neurol. 2003 May;250(5):542-5). ABSTRACT: Multiple sclerosis can be associated with trigeminal neuralgia which is often difficult to treat in this specific condition. We performed an open prospective trial on the efficacy and safety of the prostaglandin-e1-analogue misoprostol (600 microg per day) in the reduction of attack frequency and pain intensity in patients with refractory trigeminal neuralgia associated with multiple sclerosis. Eighteen patients completed the study period and 14 of them showed a reduction of more than 50 % in attack frequency and intensity beginning five days after treatment onset. There were only mild and transient drug related side effects in three patients. One patient stopped taking misoprostol after the study period because of severe menorrhagia. Our results suggest that misoprostol is effective and safe in the treatment of this specific type of refractory trigeminal neuralgia. PMID: 12736732 This case report states that misoprostol relieved pain in six of seven patients who had failed to respond to conventional pharmacologic therapy - Trigeminal neuralgia in multiple sclerosis relieved by a prostaglandin E analogue (Neurology. 1995 Jun;45 (6):1097-100). ABSTRACT: Trigeminal neuralgia is an uncommon but troublesome symptom of multiple sclerosis that can be refractory to conventional treatments. Misoprostol, a long-acting prostaglandin E1 analogue, relieved pain in six of seven patients who had failed to respond to conventional pharmacologic therapy. PMID: 7783870 With our state of the art compounding lab and pharmaceutical knowledge and experience, we have the ability to compound misoprostol into a transdermal gel. This form of delivery may decrease the systemic side effects associated with oral dosing. Misoprostol 0.006% Transdermal Gel 30ml Apply 0.5ml locally BID
Page 3 PAIN DUE TO PERIPHERAL BLOOD FLOW DISORDERS The following study found that a topically dosed 8% lidocaine pump spray produced prompt analgesia in patients with PBFD-related pain without severe side effects - 8% Lidocaine pump spray relieves pain associated with peripheral blood flow disorders (Clin J Pain. 2009 Feb;25(2):107-10). OBJECTIVES: It is often difficult to reduce pain associated with peripheral blood flow disorders (PBFD) using standard analgesics. We assessed the analgesic effects of a metered-dose 8% lidocaine in patients with PBFD. METHODS: Twenty-four patients with PBFD-related pain were enrolled in this double-blind placebo-controlled crossover study. Patients were randomized to receive either 8% lidocaine or saline on the painful site with a metered-dose spray. After a 3-day period, patients were crossed over to receive the alternative treatment. Pain was assessed with a visual analog scale (VAS) before and 15 minutes after the treatment. Patients were also asked to record the time at which pain appeared again. The blood concentration of lidocaine was measured at 15, 30, and 60 minutes after lidocaine application. RESULTS: There were no significant differences in VAS before treatment between the placebo and lidocaine treatments. However, lidocaine significantly decreased VAS at rest from 5.5+/-3.1 cm (mean+/-sd) to 0.6+/-0.9 cm and on movement from 8.4+/- 2.0 cm to 1.7+/-1.7 cm, resulting in a significant difference between the 2 sprays. The median time to recurrence of pain was 3 hours. The blood concentration of lidocaine was less than 0.3 microg/ml in all patients. DISCUSSION: A metered-dose 8% lidocaine pump spray produced prompt analgesia in patients with PBFD-related pain without severe side effects. PMID: 19333154 We have the ability to compound lidocaine into a topically dosed spray that can be applied directly to the site of pain. Lidocaine 8% Topical Spray 60ml Spray 1-2 sprays onto affected area every 3H PRN
Page 4 HEMORRHOIDECTOMY PAIN The following clinical papers discuss the safety and effectiveness of utilizing an ointment containing nifedipine and lidocaine for reducing pain after hemorrhoidectomy. Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study (Can J Surg. 2010 Feb;53(1):17-24). BACKGROUND: Spasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy, a common and distressing experience. We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter. METHODS: We conducted a multicentre randomized, doubleblind trial to compare the efficacy of 0.3% nifedipine and 1.5% lidocaine ointment versus 1.5% lidocaine ointment alone in reducing pain after hemorrhoidectomy. A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale (ACCS) at baseline; soon after surgery; at 2, 4, 6, 8 and 24 hours after surgery; on day 7 after surgery; and at a final visit 14 days after surgery. The physician also noted the time to first analgesic administration within 24 hours after surgery. RESULTS: In all, 135 patients per group participated (270 total). Evaluation of the delta ACCS score versus basal value, a covariate for rescue analgesic administration time, revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 (p < 0.011 and p < 0.054, respectively). We noticed no difference between groups for time of administration of rescue analgesic, blood pressure, heart rate or frequency of headache. CONCLUSIONS: Although there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy, the patients' assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery. Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended. Further research focusing on these outcomes is warranted. PMID: 20100408 Pharmacokinetics of anorectal nifedipine and lidocaine ointment following hemorrhoidectomy: an open-label, single-dose, phase IV clinical study (Clin Drug Investig. 2009;29(4):243-56). OBJECTIVES: This study aimed to assess whether topical anorectal application of an ointment containing nifedipine (0.3% w/w) and lidocaine (lignocaine) [1.5% w/w] to patients undergoing Milligan-Morgan hemorrhoidectomy achieves pharmacologically relevant serum concentrations of the active ingredients and has any hemodynamic effects or adverse effects. CONCLUSIONS: This study demonstrates that single-dose topical application of an ointment containing nifedipine (0.3% w/ w) and lidocaine (1.5% w/w) to patients undergoing Milligan- Morgan hemorrhoidectomy is safe to use. Following application onto damaged anorectal mucosa, nifedipine and lidocaine are absorbed into the bloodstream in small quantities that do not have any major implications for the safety of the product. Further studies are required to evaluate nifedipine and lidocaine concentrations in serum using a multiple-dose regimen. PMID: 19301938 With our state of the art compounding laboratory and pharmaceutical knowledge and experience, we have the ability to compound nifedipine and lidocaine into one topical ointment. Nifedipine 0.3%/Lidocaine 1.5% Topical Ointment 30gm Apply small amount to rectum BID as directed
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 Trigeminal Neuralgia [ ] Misoprostol 0.006% Transdermal Gel Quantity 30ml Directions: Apply 0.5ml locally BID Pain due to Peripheral Blood Flow Disorders [ ] Lidocaine 8% Topical Spray Quantity 60ml Hemorrhoidectomy Pain Directions: Spray 1-2 sprays onto affected area every 3H PRN [ ] Nifedipine 0.3%/Lidocaine 1.5% Topical Ointment Quantity 30gm Directions: Apply small amount to rectum BID as directed Directions Prescriber s Signature Refills: 1 2 3 4 5 6 7 8 9 10 11 12 NR 757 Norland Avenue, Suite 105 Chambersburg, PA 17201 Phone: (717) 217-6790 Fax: (717) 217-6925