trospium chloride
Pharmaranks rates Trospium Chloride 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Trospium Chloride is a cholinergic muscarinic antagonist used to treat Overactive Urinary Bladder, Urge Urinary Incontinence.
Cholinergic Muscarinic Antagonist · by Granules
Generic of Sanctura
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Trospium Chloride
- Drug class
- Cholinergic Muscarinic Antagonist
- Form
- Capsule, extended release, Tablet
- Strength
- Trospium Chloride 60MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Granules
- What the pharmacy pays
- ~$7.08 for 30 — not your price
- FDA application
- ANDA213185
What is Trospium Chloride?
From the FDA label:Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8- azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25 H 30 ClNO 3 and its molecular weight is 428. The structural formula of trospium chloride is represented below: Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: corn starch, ethylcellulose, FD&C Blue# 1, FD&C Red# 40, FD&C Yellow# 6, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triacetin and triethyl citrate. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. trospium-structure
How to use
Trospium Chloride is sold in more than one form (Capsule, extended release and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA213185 — follow the label that came with the product you were actually prescribed.
The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Warnings and Precautions (5.6) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ]. • The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. (2) •Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). (2)
Side effects
The most common adverse reactions (greater than or equal to 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. 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=1,165). These studies included overactive bladder patients of ages 21 to 90 years, of which 86% were female and 85% were Caucasian. Patients received 60 mg daily doses of Trospium Chloride Extended-Release Capsules. Patients in these studies were eligible to continue treatment with Trospium Chloride Extended-Release Capsules 60 mg for up to one year. From both these controlled trials combined, 769 and 238 patients received treatment with Trospium Chloride Extended-Release Capsules for at least 24 and 52 weeks, respectively. There were 157 (27.2%) Trospium Chloride Extended-Release Capsules…
Warnings
Important safety information
Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. ( 5.1 , 5.3 ) • Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. ( 5.2 ) • In patients with narrow angle glaucoma, Trospium Chloride Extended-Release Capsules should be used only with careful monitoring. ( 5.4 ) • Central Nervous System Effects: Somnolence has been reported with Trospium Chloride Extended-Release Capsules. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Extended-Release Capsules affects them. ( 5.5 ) • Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). ( 5.6 ) • Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration. ( 5.7 ) 5.1 Risk of Urinary Retention Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [ see Contraindications (4) ]. 5.2 Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. 5.3 Decreased Gastrointestinal Motility Trospium Chloride Extended-Release Capsules should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [ see Contraindications (4) ]. Trospium Chloride Extended-Release Capsules, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis. 5.4 Controlled Narrow-angle Glaucoma In patients being treated for narrow-angle glaucoma,Trospium Chloride Extended-Release Capsules should only be used if the potential benefits outweigh the risks, and in that circumstance only with careful monitoring [see Contraindications (4 ) ]. 5.5 Central Nervous System Effects Trospium Chloride Extended-Release Capsules and Trospium Chloride Immediate Release Capsules are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.2 ) ]. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Extended-Release Capsules affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. 5.6 Patients with Severe Renal Impairment Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Dosage and Administration (2) , Use in Specific Populations (8.6), and Clinical Pharmacology (12.3 ) ]. 5.7 Alcohol Interaction Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration. In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.
Who should not take Trospium Chloride
Trospium Chloride Extended-Release Capsules are contraindicated in patients with: • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported. Trospium Chloride Extended-Release Capsules are contraindicated in • Patients with urinary retention, gastric retention, or uncontrolled narrow- angle glaucoma, and in patients who are at risk for these conditions ( 4 ) • Patients with known hypersensitivity (4)
Overdose — what happens if you take too much
Overdosage with antimuscarinic agents, including Trospium Chloride Extended-Release Capsules, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, ECG monitoring is recommended.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with Trospium Chloride Extended-Release Capsules. However, some drugs which are actively secreted by the kidney may interact with Trospium Chloride Extended-Release Capsules by competing for renal tubular secretion. The concomitant use of Trospium Chloride Extended-Release Capsules with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic effects may increase the frequency and/or severity of such effects. Trospium Chloride Extended-Release Capsules may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. • Some drugs which are actively secreted by the kidney may interact with Trospium Chloride Extended-Release Capsules by competing for renal tubular secretion. ( 7 ) • Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) • Exposure to trospium on average was comparable in the presence of and without antacid, however, some individuals demonstrated increases or decreases in trospium exposure in the presence of antacid. The clinical relevance of these findings is not known. ( 7.2 ) • Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.3 ) 7.1 Digoxin Concomitant use of trospium chloride 20mg twice daily and digoxin did not affect the pharmacokinetics of either drug [see Clinical Pharmacology (12.3 ) ]. 7.2 Antacid While the systemic exposure of trospium on average was comparable with and without antacid containing aluminum hydroxide and magnesium carbonate, 5 out of 11 individuals in a drug interaction study demonstrated either an increase or decrease in trospium exposure, in presence of antacid. The clinical relevance of these findings is not known [see Clinical Pharmacology (12.3) ]. 7.3 Metformin Co-administration of 500 mg metformin immediate release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC (0-24) and by 34% for mean C max . The effect of a decrease in trospium exposure on the efficacy of Trospium Chloride Extended-Release Capsules is unknown. The steady-state pharmacokinetics of metformin were comparable when administered with or without 60 mg Trospium Chloride Extended-Release Capsules once daily under fasted condition. The effect of metformin at higher doses on trospium PK is unknown [ see Clinical Pharmacology (12.3 ) ].
Storing Trospium Chloride, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store trospium chloride tablet at room temperature, 68° to 77°F (20° to 25°C).”
Drug class
How this class works, per Muscarinic Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
Dosage forms
Capsule, extended release and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Trospium Chloride treat?
- Trospium Chloride (Trospium Chloride) may be used to treat overactive urinary bladder, urge urinary incontinence, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Trospium Chloride work?
- Trospium Chloride is a cholinergic muscarinic antagonist. These drugs block muscarinic receptors, the docking sites for the nerve signal acetylcholine. By preventing acetylcholine from acting, they calm the 'rest-and-digest' nervous system, which can dry secretions, relax airway and bladder muscles, and speed up the heart, depending on the drug.
- How is Trospium Chloride rated?
- pharmaranks gives Trospium Chloride a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Trospium Chloride cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $7.08 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Oxytrol — about $1.42 on the same basis.
- Is there a coupon or discount for Trospium Chloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Trospium Chloride. To pay less, Trospium Chloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Trospium Chloride?
- Trospium Chloride is marketed by Granules. You can see Granules's full profile, rating, and other products on pharmaranks.
- Is Trospium Chloride a brand-name or generic drug?
- Trospium Chloride is a generic medication; its active ingredient is Trospium Chloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Trospium Chloride available over the counter?
- No. Trospium Chloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Trospium Chloride come in?
- Trospium Chloride is currently marketed as capsule, extended release and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Trospium Chloride?
- Trospium Chloride is classified as cholinergic muscarinic antagonist, per the FDA's Established Pharmacologic Class.
- Is Trospium Chloride FDA-registered?
- Trospium Chloride is on record with the U.S. FDA under application number ANDA213185. You can verify this on its official FDA label.
- Has Trospium Chloride been recalled by the FDA?
- Trospium Chloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Trospium Chloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Trospium Chloride a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Trospium Chloride?
- Trospium Chloride's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (greater than or equal to 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc.,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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trospium chloride
72/100