There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. The mean renal clearance for trospium (29.07 L/hour) is 4-fold higher than average glomerular filtration rate, indicating that active tubular secretion is a major route of elimination. This document does not contain all possible drug interactions. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. Take it with water on an empty stomach, at least one hour before a meal. The incidence of serious adverse events was similar among patients receiving Trospium Chloride Extended-Release Capsules and patients receiving placebo. How to tell if the drug is working: Your symptoms of overactive bladder should improve. Never try to catch up by taking two doses at once. Dosage forms: oral capsule, extended release (60 mg), oral tablet (20 mg) Drug class: Urinary antispasmodics Medically reviewed by Drugs.com on Aug 11, 2022. Urgency. Trospium may decrease your urine flow and make these conditions worse. There may be competition for elimination with other compounds that are also renally eliminated [see DRUG INTERACTIONS (7)]. Trospium Chloride Extended-Release Capsules 60 mg. An overactive bladder can cause embarrassing symptoms. You may need to show airport staff the pharmacy label for your medication. Check with your doctor immediately if any of the following side effects occur: More common. Patients received 60 mg daily doses of Trospium Chloride Extended-Release Capsules. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Co-administration of 500 mg metformin immediate release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax. FDA pregnancy category C. It is not known whether trospium will harm an unborn baby. When flying, never put it into a checked bag. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. The most common side effects with Trospium Chloride Extended-Release Capsules are: Trospium Chloride Extended-Release Capsules may cause other less common side effects, including: Tell your doctor if you have any side effects that bother you or that do not go away. Be sure to ask your doctor about anything you do not understand. These highlights do not include all the information needed to use Trospium Chloride Extended-Release Capsules safely and effectively. Tell your doctor if your condition does not improve or if it worsens. View NDC Code(s)NEW! ChildrenUse and dose must be determined by your doctor. Excretion: The plasma half-life for trospium chloride following oral administration is approximately 20 hours. These side effects may go away during treatment as your body adjusts to the medicine. Trospium is used to treat overactive bladder and symptoms of urinary incontinence, frequency, and urgency. Mayo Clinic on Incontinence - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) [see DOSAGE AND ADMINISTRATION (2), USE IN SPECIFIC POPULATIONS (8.6), and CLINICAL PHARMACOLOGY (12.3)]. As illustrated in Table 5 and Figures 4 and 5, Trospium Chloride Extended-Release Capsules demonstrated statistically significantly (p<0.01) greater reductions in urinary frequency and incontinence episodes, and increases in void volume when compared to placebo at Weeks 4 and 12. The dose of this medicine will be different for different patients. This puts you at a greater risk of side effects. The above information is intended to supplement, not . Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. The data described below reflect exposure to Trospium Chloride Extended-Release Capsules in 578 patients for 12 weeks in two Phase 3 double-blind, placebo controlled trials (n = 1165). In Trospium Chloride Extended-Release Capsules subjects ages 65 and over compared to younger subjects, the following adverse reactions were reported at a higher incidence: dry mouth, constipation, abdominal pain, dyspepsia, urinary tract infection and urinary retention. Renal Impairment: The pharmacokinetics of Trospium Chloride Extended-Release Capsules in patients with severe renal impairment has not been evaluated. ChildrenUse and dose must be determined by your doctor. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Clinical Trials, It comes with serious risks if you dont take it as prescribed by your doctor. Mayo Clinic does not endorse companies or products. Tell your doctor right away if you have any serious side effects, including: eye pain, difficulty urinating, fast heartbeat, mental/mood changes (such as hallucinations, confusion). Do not take Trospium Chloride Extended-Release Capsules if you: Trospium Chloride Extended-Release Capsules have not been studied in children under the age of 18 years. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Gastrointestinal gastritis; Cardiovascular palpitations, supraventricular tachycardia, chest pain, syncope, hypertensive crisis; Immunological Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System dizziness, confusion, vision abnormal, hallucinations, somnolence, and delirium; Musculoskeletal rhabdomyolysis; General rash. Usual Adult Dose for Urinary Incontinence: Immediate-release formulation: 20 mg orally 2 times a dayExtended-release formulation:60 mg orally once a day in the morningUse: for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. It shouldnt be used in children younger than 18 years. Call your doctor for medical advice about side effects. Taking it again could be fatal (cause death). Drug information provided by: Merative, Micromedex. Also avoid drinking alcohol or taking any product containing alcohol for 2 hours before and after taking this medication. Select a condition to view a list of medication options. Your dosage, drug form, and how often you take the drug will depend on: Typical dosage: 20 mg taken two times per day (for a total of 40 mg per day). They can add to sleepiness caused by trospium. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. It is not known whether this drug is excreted into human milk. Ulcerative colitis (inflamed bowel)Use with caution. In this study, asymptomatic, non-specific T-wave inversions were observed more often in subjects receiving trospium chloride than in subjects receiving moxifloxacin or placebo following five days of treatment. If your kidneys arent working well, more of the drug can stay in your body longer and put you at risk for increased side effects. Dosage is based on your age, medical condition, and response to therapy. The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. Data taken from in vitro studies of human liver microsomes, investigating the inhibitory effect of trospium on seven cytochrome P450 isoenzyme substrates (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4), suggest a lack of inhibition at clinically relevant concentrations. A class of drugs is a group of medications that work in a similar way. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If your dose is different, do not change it unless your doctor tells you to do so. After administration of oral 14C-trospium chloride, the majority of the dose (85.2%) was recovered in feces and a smaller amount (5.8% of the dose) was recovered in urine; 60% of the radioactivity excreted in urine was unchanged trospium. It is also known. Taking it with food decreases the amount of the drug that gets absorbed by your body. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Extended-Release Capsules affects them. If you miss a dose, take it as soon as you remember, at least 2 hours after a meal or 1 hour before your next meal. Does Trospium CHLORIDE interact with other drugs you are taking? Take trospium on an empty stomach, at least 1 hour before a meal. Dispense in a tight container. Generic drugs usually cost less than brand-name drugs. In particular, patients should be informed not to take Trospium Chloride Extended-Release Capsules if they: Patients should be instructed regarding the recommended dosing and administration of Trospium Chloride Extended-Release Capsules: Patients should be informed that the most common side effects with Trospium Chloride Extended-Release Capsules are dry mouth and constipation and that other less common side effects include trouble emptying the bladder, blurred vision, and heat prostration. Symptoms can include: swelling of your face, lips, tongue, or throat that may make it harder to breathe (angioedema). Ask your pharmacist about using those products safely. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. https://www.mayoclinic.org/drugs-supplements/trospium-oral-route/side-effects/drg-20066543, Advertising and sponsorship opportunities, Intestinal atony (no movement in the intestines) or, Myasthenia gravis (severe muscle weakness) or, Stomach problems (eg, chronic constipation) or. A no effect level for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the MRHD (20 mg/kg/day in rats and rabbits). It is very important that you read and understand this information. Tell your doctor about all of your medical conditions including if you: Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Copyright: Merative US L.P. 1973, 2023. What to do if you miss a dose: If you forget to take your dose, take it as soon as you remember. The concomitant use of Trospium Chloride Extended-Release Capsules with other antimuscarinic agents that produce dry mouth and constipation and other anticholinergic effects may increase the frequency and/or severity of such effects. Symptoms can include: If you develop these symptoms, call 911 or go to the nearest emergency room. Carcinogenesis: Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. What are Trospium Chloride Extended-Release Capsules? This drug may make you dizzy or drowsy or blur your vision. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Data from healthy subjects suggests lower exposure in males compared to females. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that youre taking. Trospium is a prescription drug. How should I take Trospium Chloride Extended-Release Capsules? Can You Have Overactive Bladder at a Young Age? Trospium chloride - trospium chloride tablet, film coated. To help avoid interactions, your doctor should manage all of your medications carefully. This drug can also cause other side effects. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. Trospium may also be used for purposes not listed in this medication guide. The effect of metformin at higher doses on trospium PK is unknown. Cytochrome P450 does not contribute significantly to the elimination of trospium. Brand names: Sanctura, Sanctura XR, Regurin H-trospium chloride is distributed in plasma. Drug interactions may change how your medications work or increase your risk for serious side effects. Drowsiness and confusion can increase the risk of falling. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). By contrast, following a single 20 mg dose of an immediate-release formulation of trospium chloride, Cmax was 2.7 ng/mL. Use: for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Table 1 lists those treatment emergent adverse events from the trials that were assessed by the investigator as possibly related to study medication, reported in at least 1% of Trospium Chloride Extended-Release Capsules patients, and were more common for the Trospium Chloride Extended-Release Capsules group than for placebo. Make sure you tell your doctor if you have any other medical problems, especially: Take this medicine only as directed by your doctor. The following information includes only the average doses of this medicine. Use this medication regularly to get the most benefit from it. This content does not have an English version. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Trospium Chloride Extended-Release Capsules are supplied as 60 mg capsules (white opaque capsule, printed with PAD 0118): 60 mg capsule, 30 count, HDPE bottle: NDC 0574-0118-30. Always speak with your doctor or pharmacist about dosages that are right for you. Do not crush, chew, break, or open an extended-release capsule. An interaction is when a substance changes the way a drug works. Swallow it whole. Tell your doctor about all medications you use. PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label. This medicine may cause a dry mouth, nose, and throat. When they contract, youll feel the need to urinate right away. You may report side effects to the FDA at 1-800-FDA-1088. Adults20 milligrams (mg) 2 times per day. A very serious allergic reaction to this drug is rare. Older adults may be more sensitive to the side effects of this drug, especially constipation, dry mouth, drowsiness, confusion, or trouble urinating. Call your doctor right away if you have serious side effects. Frequency. What is Trospium used for? It relaxes the bladder muscles, which helps control muscle spasms. Be sure to ask your doctor about anything you do not understand. Trospium chloride is widely distributed, with an apparent volume of distribution > 600 L. Metabolism: The metabolic pathway of trospium in humans has not been fully defined. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Before using trospium, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Absorption: Mean absolute bioavailability of a 20 mg immediate-release dose is 9.6% (range 4.0 to 16.1%). You may no longer have a strong need to urinate or a need to urinate often. Adults20 milligrams (mg) 2 times per day. Do not open, crush, or chew it. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Take trospium on an empty stomach, at least 1 hour before a meal. All rights reserved. In Canada - Call your doctor for medical advice about side effects. Many people using this medication do not have serious side effects. 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