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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
December 2013 
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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
Suppositories-Rectal and Vaginal Therapy
 
   The rectal route of administration can be used effectively when other routes of administration (oral, topical, injectable) are inadequate or unsuitable, or not acceptable to the patient; or to treat local infection, disease, or inflammation. Many hospice patients who are no longer able to take oral medications benefit from rectal administration, which may offer an alternative to intravenous therapy or IM or SC injections.  Medications that have been administered rectally include analgesics, antibiotics, anti-seizure medications, corticosteroids and anesthetics, healing agents to treat radiation induced proctitis, and therapy for inflammatory disease or hemorrhoids.
 
   Vaginal suppositories (pessaries) are particularly useful for local administration of hormones (for vaginal dryness or atrophy, or to maintain pregnancy) or antibiotics. Suppositories melt or soften at body temperature and are less messy than creams.
 
   Because pharmacokinetics vary between routes of administration, dosage adjustments are frequently required. Also, formulation is key to bioavailablity. For example, adjuvants, such as glyceride mixtures or non-ionic surface agents, have increased the rectal absorption of penicillins, cephalosporins and macrolides.
 
    When drugs are administered orally, they are absorbed from the gastrointestinal tract into the portal venous circulation and pass through the liver (first pass) where the process of drug metabolism begins. Suppositories, like intravenous (IV), intramuscular (IM), and other transdermal methods of administration, bypass the "first pass" effect and go directly into the bloodstream without first encountering liver metabolism. This can be an important consideration when patients have fluctuating or declining hepatic function.
 
Mesalamine (5-ASA) Suppositories in Remission Maintenance of Ulcerative Proctitis
 
   In a 24-month, multicenter, double-blind trial, 65 patients with ulcerative proctitis in clinical and endoscopic remission were randomized to receive either a single nightly 500 mg rectal mesalamine suppository or matching placebo as sole therapy. The proportion of placebo-treated patients (86% at 12 months) who relapsed was significantly greater than mesalamine-treated patients (32%). The results demonstrated that mesalamine suppositories are efficacious, well tolerated, and safe for the long-term maintenance of remission of ulcerative proctitis.  
 
Topical Therapy for Anal Fissure
 
     Chronic anal fissures can be simply and effectively treated medically without the risk of incontinence associated with sphincterotomy. Topical therapy is directed at reversibly decreasing resting anal pressure, with a goal of allowing fissure healing without permanent sphincter damage. Recent studies show healing rates of 25-50%. Ask our compounding pharmacist for more information about medications that can be used to treat anal fissures.
 
   A double-blind placebo-controlled clinical trial assessed the safety and efficacy of a glyceryl trinitrate (GTN) 0.2% suppository in the healing of chronic anal fissure. Thirty-four patients with symptomatic chronic anal fissures were assigned to receive a GTN suppository (n = 21) or placebo (n = 13). They were assessed at two-week intervals for six weeks. Then, they started a washout period of one month and after that were crossed over for another six weeks. Complete healing at six weeks was achieved in 12 of 21 patients (57 percent) in the glyceryl trinitrate group and 5 of 13 patients (38 percent) in the placebo. At the end of study, 26 of 34 patients achieved healing of the anal fissure. The study concluded that use of glyceryl trinitrate 0.2% suppositories represents a new, promising, and effective treatment for chronic anal fissure.
Oxybutynin Rectal Suppositories for Treatment of Detrusor Instability
 
    At the Evanston Continence Center, Northwestern University, a retrospective chart review of 25 women diagnosed with detrusor instability and treated with oxybutynin rectal suppositories was conducted to determine whether oxybutynin hydrochloride suppositories can be used as a treatment for incontinence in patients who have not been able to tolerate oral medications which frequently have side effects. Patients were started on one suppository, containing 5 mg oxybutynin, twice daily and the dose was titrated as tolerated. The range of the total daily dose was 5-20 mg. Nine of 25 women (36%) had greater than a 50% overall subjective improvement and 3 (12%) had some improvement. Seven of the 12 responders (58%) continued to use the suppositories for a prolonged period of time (> 90 days). The most common side effects reported were dry mouth 48% and constipation 14.3%. One patient with polymyositis developed a serious anticholinergic reaction which required hospitalization. It was concluded that patients who are unable to tolerate oral anticholinergic and antispasmodic agents for the treatment of detrusor instability, which is a cause of incontinence, may benefit from oxybutynin rectal suppositories.
 
Progesterone Vaginal Suppositories for the Prevention of Preterm Birth
 
   The incidence of preterm delivery (PTD) continues to increase and now exceeds 12% of all pregnancies in the United States, and is a leading cause of infant mortality and cerebral palsy. In a double-blind, placebo-control, randomized trial, a daily 100 mg progesterone vaginal suppository decreased the incidence of preterm delivery. Mean gestational age at enrollment (beginning of progesterone suppository therapy) was 26.5 weeks. Among 142 women who had one prior preterm birth, prophylactic cerclage, or uterine malformation, daily use of a 100-mg vaginal progesterone suppository compared with placebo significantly decreased the likelihood of preterm delivery prior to 37 weeks from 28.5% (placebo group) to 13.8%. Delivery prior to 34 weeks' gestation was reduced from 18.5% to 2.7%.