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Compounding Solutions for Rectal Conditions

Perianal Crohn’s disease, ulcerative proctitis, radiation proctitis—these conditions can be difficult for sufferers to discuss, but worse to live with. The bottom line is that rectal problems are painful. Fortunately, Pavilion Compounding Pharmacy has a specific set of tools and knowledge to help these patients.

CROHN’S DISEASE :Crohn’s disease is a chronic inflammatory-bowel disease of the intestines, especially the colon and ileum, associated with ulcers and fistulae. The term “perianal Crohn’s” disease (PCD) is used when inflammation occurs near or at the anus. It is a morbid condition that decreases quality of life, and as a last resort, surgery may be required. However, non-surgical interventions can help with a number of symptoms.

Articles have been published on the use of topical tacrolimus as a non-surgical option for the treatment of PCD and ulcerative proctitis (UP). Case studies within this literature showed positive results usually in one to four weeks of therapy.²

Pavilion Compounding Pharmacy has formulated topical preparations that contain tacrolimus which may be suitable for patients with fissures associated with PCD. Our formulas contain MucoLox, an ingredient exclusive to PCCA member pharmacies, which improves proximity and contact time of the drug to the rectal mucosa.

ULCERATIVE PROCTITIS Another problematic rectal condition is UP, a subcategory of ulcerative colitis that only involves the rectum and is characterized by inflammation and ulceration of the lining of the rectum.

Standard drug treatment options for inflammatory-induced UP include: topical aminosalicylates (Sulfasalazine, mesalamine), oral aminosalicylates, or topical steroids. Many cases, however, are resistant to these standard treatments, but topical tacrolimus has shown promise for the treatment of resistant UP. Lidocaine can also be added to formulations to help with painful inflammation and ulceration. Additionally, Glutamine can be added to rectal formulations to help improve the integrity of the bowel walls.

RADIATION PROCTITIS A third condition requiring rectal therapy is radiation proctitis (RP). Radiation therapy causes production of matrix metalloproteases (MMPs) and reactive oxygen species (ROS) that cause tissue degradation and damage to the endothelial lining of the rectum. This most commonly occurs after radiation treatment for cancers such as those of the cervix, prostate and colon.

The diarrhea from RP is commonly treated with oral opioids.⁵ However, Pavilion Compounding Pharmacy can provide an alternative to this therapy, potentially providing symptomatic relief without the systemic side effects from oral opioids. Our trained compounding pharmacists can prepare a rectal gel using PCCA's MucoLox muco-adhesive base and Loperamide HCL.

Treatment of the degradation in the rectal lining caused by ROS is one way to improve healing and resolution of symptoms. Studies have shown that β-(1-3)-D-glucan has the ability to activate macrophages to remove cellular debris resulting from oxidative damage, thus allowing for faster tissue recovery.⁶ Pavilion Compounding Pharmacy can add Beta Glucan to any of our rectal formulations.

The common denominator in our rectal formulations is MucoLox. In addition to improving and extending contact time of active medications to the mucosal surface, MucoLox contains sodium hyaluronate to help hydrate the epithelial lining and improve healing. Treatment of inflammatory bowel conditions may also require reduction and/or elimination of pro-inflammatory food intake, along with a complete gut repair protocol, which includes, but is not limited to, high quality probiotics and glutamine. A high-fiber diet and plenty of water are usually helpful for these patients as well.

Please give Pavilion Compounding Pharmacy a call or e-mail if you have any questions. Ask us for our studies showing how MucoLox can benefit you!

p: (404) 350-5780

f: (404) 350-5640

staff@pavilionrx.com

¹ de Zoeten, E.F., Pasternak, B.A., Mattei, Peter, Kramer, R.E., & Kader, H.A. (2013). Diagnosis and treatment of perianal crohn disease: NASPGHAN clinical report and consensus statement. Journal of Pediatric Gastroenterology and Nutrition, 57(3), 401-412. doi:10.1097/MPG.0b013e3182a025ee

² Sandborn, W.J., Present, D.H., Isaacs, K.L., Wolf, D.C., Greenberg, E., Hanauer, S.B., . . . Sandler, R.S. (2003). Tacrolimus for the treatment of fistulas in patients with Crohn’s disease: A randomized, placebo-controlled trial. Gastroenterology, 125(2), 380–388; Hart, A.L., Plamondon, S., & Kamm, M.A. (2007). Topical tacrolimus in the treatment of perianal Crohn’s disease: Exploratory randomized controlled trial. Inflammatory Bowel Diseases 13(3), 245–253.

³ Regueiro, M.D. (2004). Diagnosis and treatment of ulcerative proctitis. Journal of Clinical Gastroenterology 38(9), 733-740.

⁴ Navas-López, V.M., Blasco-Alonso, J., Girón Fernández-Crehuet, F., Serrano Nieto, M.J., Gallego-Gutiérrez, S., Luque Pérez, S., & Sierra Salinas, C. (2014). Successful treatment for ulcerative proctitis with rectal tacrolimus in an 8-yearold girl with intolerance to mesalamine. Clinical Journal of Gastroenterology, 7(4), 320-323. doi:10.1007/s12328-014-0506-2; Lawrance, I.C., & Copeland, T.S. (2008). Rectal tacrolimus in the treatment of resistant ulcerative proctitis. Alimentary Pharmacology and Therapeutics, 28(10), 1214-1220. doi:10.1111/ j.1365-2036.2008.03841.x

⁵ Fuccio, L., Guido, A., & Andreyev, H.J. (2012). Management of intestinal complications in patients with pelvic radiation disease. Clinical Gastroenterology and Hepatology 10(12), 1326–1334. doi:10.1016/j.cgh.2012.07.017

⁶ Vetvicka, V., Vetvickova, J. (2011). β(1-3)-D-glucan affects adipogenesis, wound healing and inflammation. Oriental Pharmacy and Experimental Medicine, 11(3), 169-175. doi:10.1007/s13596-011-0024-4

⁷ Klimberg, V.S., Salloum, R.M., Kasper, M., Plumley, D.A., Dolson, D.J., Hautamaki, R.D., Souba, W.W. (1990). Oral glutamine accelerates healing of the small intestine and improves outcome after whole abdominal radiation. Archives of Surgery, 125(8), 1040-1045. (JAMA Surgery, formerly Archives of Surgery). doi:10.1001/archsurg.1990.01410200104017

PCCA Consultant's Corner Feb. 2016 issue

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