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Home , Trospium chloride

Trospium Chloride (Sanctura®) – New to the U.S. for Kaye K. Gaines

rospium chloride (Sanctura®) is an anti- Contraindications agent by Indevus Pharma- • Narrow angle glaucoma ceuticals that was approved by the FDA in • May 2004 for treatment of overactive blad- • Gastric retention Tder and its associated symptoms of urinary urgency, • Known hypersensitivity to trospium frequency, and incontinence. The drug has been in use in Europe for more than 10 years as both an Precautions antimuscarinic agent and an effective antispasmod- • Bladder outlet obstruction ic. • Chronic renal dysfunction • Hepatic impairment Description/Pharmacology • History of gastrointestinal blockage Trospium chloride is a quaternary ammonium • Myasthenia gravis compound derived from nortropanol. It is • Ulcerative colitis hydrophilic and highly charged. Trospium is • Tropical or hot environments absorbed slowly from the . is estimated at between 10% to 12% Adverse Effects in humans. Maximum plasma levels are reached 5 Most common side effects include dry mouth hours after oral administration, with half-life of and constipation. Less common side effects include approximately 20 hours. Trospium is not a substrate drowsiness or fatigue; headache; heartburn, gas, flat- or inhibitor of the system. The ulence, bloating; dry eyes, vision changes, blurred drug is metabolized in the liver and is eliminated vision; and upper abdominal pain/cramping. Rare primarily in the feces (85%) and the urine (6%) side effects include anaphylaxis; chest pain, cardiac (Medscape DrugInfo, 2004; Micromedex, 2004). arrhythmias; fever or heat stroke; hypertensive cri- sis; hallucinations; gastritis/vomiting; fainting; and Mechanism of Action dry skin. Trospium has a high affinity for peripheral mus- carinic receptors, but it minimally affects nicotinic Drug Interactions receptors. The drug’s effect primari- There have been no studies to assess drug-drug ly results from its relaxation of interactions. Trospium should not be used with smooth muscles. It decreases gastrointestinal and other anticholinergic agents. It may alter absorption urogenital tract tone and also of some drugs due to effect on decreasing gastric inhibits secretions (Indevus Pharmaceuticals, 2004; motility. There is potential interaction with other Micromedex, 2004). drugs eliminated by active tubular secretion includ- ing digoxin, procainamide, pancuronium, mor- Dosage/Administration phine, vancomycin, metformin, and tenofovir • Supplied as a 20 mg . (Micromedex, 2004; Nurse Practitioner Prescribing • Recommended dose is 20 mg twice daily. Reference, 2004). • Trospium should be taken 1 hour before meals or on an empty stomach. Nursing Considerations • Dosage should be modified to 20 mg once daily Instruct patients to avoid alcoholic beverages in patients with severe renal impairment and for while taking trospium (see page 65). Caution should elderly patients. be used in taking the drug with any potentially sedating drug. High-fat meals reduce absorption of the drug. Educate patients about importance of tak- ing trospium on an empty stomach. There are no Kaye K. Gaines, MS, RN, CS, CUNP, is a Urology Nurse well-controlled studies in pregnant women, so tro- Practitioner, Bay Pines VA Medical Center, Bay Pines, FL.

64 UROLOGIC NURSING / February 2005 / Volume 25 Number 1 Patient Education Information Trospium Chloride (Sanctura®)

What Is It? • Trospium chloride (Sanctura) is a medication used to treat symptoms of urinary urgency (the sudden need to urinate immediately), urinary frequency (the need to urinate often), and urge incontinence (involuntary leaking of urine when needing to urinate urgently). • This medication is classified as an anticholinergic and is supplied in the United States as a 20 mg tablet to be taken by mouth. How and When to Use It • Trospium should only be taken as directed. This medication is for use by adults. It has not been test- ed and is not approved for use by children. • The usual recommended dose is 20 mg twice daily on an empty stomach (1 hour before or 2 to 3 hours after eating). • If a dose is missed, take the next dose 1 hour before the next meal. • Do not double up on dosing if a dose is missed. • The dosage may be reduced for older patients or those with kidney problems. • Keep this drug in a cool, dry place and store away from extreme heat or light. Who Should NOT Use It? • Children should not take trospium. • Trospium is not recommended for pregnant women or nursing mothers. • If you have problems passing urine normally (urinary retention), do not take this drug. • If you already have problems with normal bowel functioning or digestion, use caution taking trospi- um. • If you have glaucoma (narrow angle), do not take this drug. • If you are allergic or have had any adverse reaction to any other medications used for urinary urgency, frequency, or incontinence, use caution with this medication. • If you have existing kidney or liver problems, use caution with trospium. • If you have ulcerative colitis, myasthenia gravis, or any history of intestinal blockage, do not take this medication. • Do not drink alcoholic beverages when taking trospium. What About Other Medications Being Taken? • Tell your health care provider about ALL medicines you take, including prescription and over-the- counter drugs, herbal products, and vitamins. • Other (drugs that may dry up secretions in the gastrointestinal tract, urinary tract, or mucous membranes) may not interact well with trospium. • Drugs that may interact with trospium include morphine, digoxin, procainamide, pancuronium, van- comycin, metformin, and tenofovir. What Are the Possible Side Effects? Most Common: • Dry mouth • Constipation

Less Common: • Upper abdominal pain/cramping • Dry eyes/vision changes/blurred vision • Fatigue • Headache • Heartburn/Gas or bloating • Dizziness Rare: • Dry skin • Fainting • Gastritis or vomiting • Severe blood pressure increase • Chest pain/Palpitations/Irregular heartbeat • Fever or heat stroke (in very hot climates) • Drowsiness • Hallucinations

Sources: Indevus Pharmaceuticals (2004); Medscape DrugInfo (2004); Thomson Micromedex (2004)

UROLOGIC NURSING / February 2005 / Volume 25 Number 1 65 spium should only be used in pregnancy when pos- sible benefit outweighs possible risk. Monitor elder- ly patients carefully. Trospium is generally well-tol- erated in the elderly, but anticholinergic side effects are usually increased in older patients (Indevus Pharmaceuticals, 2004; Micromedex, 2004). Cost Prices for trospium chloride 20 mg for 60 tablets (a 30-day supply at twice daily dosing) ranged from $88 to $90 in a random survey of three local phar- macies (conducted 12/20/04). Conclusion Trospium chloride weighs in as a somewhat costly new possibility for treating overactive blad- der. In multiple clinical studies, trospium proved effective in treating the symptoms, but in some instances, provided a better side-effect profile (less dry mouth, rapid onset of action, and fewer central nervous system effects) (Halaska et al., 2003; Staskin & Harnett, 2004; Todorova, Vonderheid-Guth, & Dimpfel, 2001).

References Halaska, M., Ralph, G., Weidemann, A., Primus, G., Ballering- Bruhl, B., Hofner, K., et al. (2003). Controlled, double-blind, multicentre clinical trial to investigate long-term tolerability and efficacy of trospium chloride in patients with detrusor instability. World Journal of Urology, 20(6), 392-399. Indevus Pharmaceuticals. (2004). Sanctura prescribing informa- tion. Lexington, MA: Author. Medscape DrugInfo. (2004). Trospium oral. Retrieved December 19, 2004, from www.medscape.com/druginfo/dosage ?drugid=91487&drugname=Trospium+Oral&monotype=def ault&cid= med Micromedex. (2004). Trospium Thomson Micromedex health- care series (vol. 122). Retrieved December 14, 2004, from http://micromedex.com/products/updates/drugdex_updates/ de/trospium.html Nurse Practitioner Prescribing Reference (NPPR). (2004). Sanctura. Prescribing alert. New York. Prescribing Reference Inc. Staskin, D., & Harnett, M. (2004). Effect of trospium chloride on somnolence and sleepiness in patients with overactive blad- der. Current Urology Reports, 5(6), 423-426. Todorova, A., Vonderheid-Guth, B., & Dimpfel, W. (2001). Effects of , trospium chloride, and on the central nervous system. Journal of Clinical Pharmacology, 41(6), 636-644.

66 UROLOGIC NURSING / February 2005 / Volume 25 Number 1 Susanne A. Quallich

Radical Cystectomy for Bladder Cancer available for absorbent products and the manner in Palapattu, G.S., Haisfield-Wolfe, M.E., Walker, J.M., which consumers are actually using the products. Brintzenhofeszoc, K., Trock, B., Zabora, J., & The authors recommend an increase in the col- Schoenberg, M. (2004). Assessment of perioper- laborative approach to designing continence prod- ative psychological distress in patients under- ucts, with input from clinicians, corporations, and going radical cystectomy for bladder cancer. academic investigators. They observe that this The Journal of Urology, 172(5, Part 1 of 2), should improve the knowledge base regarding feasi- 1814-1817. bility of production, create an evidence base, and Much literature exists to support that patients improve the variety of devices offered. with cancer, in general, experience a degree of Interstitial Cystitis in Young Women depression and anxiety. Patients faced with an impending cystectomy for their bladder cancer face Parsons, C.L., & Tatsis, V. (2004). Prevalence of additional stressors, such as the insult to their body interstitial cystitis in young women. Urology, image. This study sought to detail the specifics of 64(5), 866-870. the psychological stress of these patients. The authors evaluate interstitial cystitis (IC) in a This prospective, descriptive study enlisted very specific group in an attempt to generalize the patients with organ confined, muscle invasive, or incidence of IC: 3rd-year medical students at the carcinoma in situ. The Brief Symptom Inventory-18 University of California. The group was evaluated (BSI-18) was the tool used for assessment, after diag- using the Pelvic Pain and Urgency/Frequency nosis, and 4 to 6 weeks postoperatively. The mean Patient Symptom scale, and scores greater than patient age was 64, and of the 62 patients that com- seven went on to further analysis with urinalysis, pleted the study, 80% were married and 16.2% were culture, potassium sensitivity test (PST), and com- female. Postoperatively, 34% of the patients were plete history and physical. classified with psychological distress, but only anx- The results of the study initially identified IC in iety in males showed a significant increase from pre- 30.6% of the participants, which is in excess of pre- operative to postoperative levels. Only high-grade viously published and accepted rates of 22%. After vs. low-grade pathology provided any predictor of the PST, the incidence dropped to 10%. The study the stress level. also diagnosed IC in patients who were younger than Overall the authors reported a 44.6% prevalence the accepted age. The authors hypothesize that this of psychological distress in patients who were diag- may indicate IC is a chronic disease, and commonly nosed with bladder cancer, which is one of the high- underdiagnosed, in part because of its progressive est rates seen for cancer patients, second only to that nature, and that many women are not diagnosed seen with patients with lung cancer. because there is a failure (by patients and clinicians) to localize their complaints to the bladder. Managing Incontinence Hypogonadotropic Hypogonadism in Type 2 Newman, D.K., Fader., M., & Bliss, D.Z. (2004). Diabetes Managing incontinence using technology, devices and products: Directions for research. Dhindsa, S., Prabhakar, S., Sethi, M., Bandyopadhyay, Nursing Research, 53(6S), S42-S48. A., Chaudhuri, A., & Dandona, P. (2004). Frequent The authors provide not only an excellent occurrence of hypogonadotropic hypogonadism in overview of the varied products that are available to type 2 diabetes. The Journal of Clinical Endocrine address fecal and urinary incontinence, but make & Metabolism, 89(11), 5462-5468. some strong recommendations for future research. The authors sought to establish the specifics of Relative risks and benefits of the various devices are hypogonadism in diabetic men, as far as a primary discussed, along with relevant facts, such as there or secondary cause, since it has been previously are little data to guide recommendations for chang- established that many men with diabetes are clini- ing indwelling catheters. The authors detail the rel- cally suffering from low testosterone. This study ative benefits and lack of post-marketing research specifically measured free and total testosterone, FSH, LH, SHBG, and prolactin in a group of men with diabetes men. Susanne A. Quallich, APRN, BC, NP-C, CUNP, is a Nurse The average age of men in the study was 54.7, Practitioner, Division of Andrology and Microsurgery, with a mean body mass index of 33.4, and an aver- Michigan Urology Center, University of Michigan Health age testosterone level of 10.4 (range 10-30). A total of System, Ann Arbor, MI. 33% of the patients were hypogonadal, as defined

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