Trospamexin Uses

• Trospamexin indications
• Uses of Trospamexin in details
• Trospamexin description
• Trospamexin dosage
• Trospamexin interactions
• Trospamexin side effects
• Trospamexin contraindications

What is Trospamexin?

Trospamexin is used to treat the symptoms of an overactive bladder, such as a frequent need to urinate or incontinence (loss of bladder control). It helps to relax the muscles in the bladder and reduce the daily episodes of incontinence. Trospamexin is a urinary antispasmodic agent.

Trospamexin is available only with your doctor's prescription.

Trospamexin indications

Trospamexin is used in the management of urinary frequency, urgency and incontinence in detrusor instability or detrusor hyperreflexia.

Trospamexin is used as an antispasmodic in genito-urinary tract disorders.

How should I use Trospamexin?

Use Trospamexin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Trospamexin. Talk to your pharmacist if you have questions about this information.
• Take Trospamexin by mouth with water on an empty stomach at least 1 hour before eating, preferably in the morning or as directed by your doctor.
• If you miss a dose of Trospamexin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Trospamexin.

Uses of Trospamexin in details

This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, Trospamexin improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. Trospamexin belongs to a class of drugs known as antispasmodics. It is also known as an antimuscarinic.

How to use Trospamexin

Read the Patient Information Leaflet provided by your pharmacist before you start using Trospamexin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth on an empty stomach at least 1 hour before a meal, usually once daily or as directed by your doctor.

Swallow the capsule whole. Do not crush or chew the capsule. Also avoid drinking alcohol or taking any product containing alcohol for 2 hours before and after taking this medication. Alcohol can destroy the long action of the drug and may increase side effects.

If you cannot swallow the capsule, you may open the capsule and place the beads in a small amount of water or directly onto the tongue. Do not crush or chew the beads because doing so may cause the drug to be released too quickly, increasing side effects. Swallow all of the beads right away.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Dosage is based on your medical condition and response to treatment.

Tell your doctor if your condition does not improve or if it worsens.

Trospamexin description

Trospamexin also contains the following inactive ingredients: Tablet Core: Wheat starch, microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, stearic acid, anhydrous colloidal silica and talc. Tablet Coat: Sucrose, carmellose sodium, talc, anhydrous colloidal silica, calcium carbonate E170, macrogol 8000, titanium dioxide E171, yellow iron oxide hydrate E172, white beeswax and carnauba wax.

Note for Diabetics: One coated tablet corresponds to 0.06 g carbohydrate (equivalent to 0.005 bread units).

Trospamexin dosage

1 coated tablet twice daily (equivalent to Trospamexin 40 mg/day).

The coated tablet should be swallowed whole with a glass of water before the meals on empty stomach.

Patients with Severe Renal Impairment (Creatinine Clearance Between 10 mL/min/1.73 m² and 30 mL/min/1.73 m²): Recommended Dose: 1 coated tab/day or every 2nd day (equivalent to Trospamexin 20 mg/day or every 2nd day).

The need for continued treatment should be reassessed at regular intervals of 3-6 months.

Trospamexin interactions

See also:
What other drugs will affect Trospamexin?

Pharmacodynamic Interactions: The following potential pharmacodynamic interactions may occur: Potentiation of the effect of drugs with anticholinergic action (eg, amantadine, tricyclic antidepressants), enhancement of the tachycardic action of β-sympathomimetics; decrease in efficacy of prokinetic agents (eg, metoclopramide).

Since Trospamexin may influence gastrointestinal motility and secretion, the possibility cannot be excluded that the absorption of other concurrently administered drugs may be altered.

Pharmacokinetic Interactions: An inhibition of the absorption of Trospamexin with drugs like guar, cholestyramine and colestipol cannot be excluded. Therefore, the simultaneous administration of these drugs with Trospamexin is not recommended.

Metabolic interactions of Trospamexin have been investigated in vitro on cytochrome P-450 enzymes involved in drug metabolism (P-450, 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4). No influence on their metabolic activities was observed. Since Trospamexin is metabolised only to a low extent and since ester hydrolysis is the only relevant metabolic pathway, no metabolic interactions are expected.

Though Trospamexin was shown not to affect pharmacokinetics of digoxin, an interaction with other substances eliminated by active tubular secretion cannot be excluded.

Incompatibilities: Not applicable.

Trospamexin side effects

See also:
What are the possible side effects of Trospamexin?

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 safety of Trospamexin was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with Trospamexin (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received Trospamexin tablets 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with Trospamexin for at least 24 and 52 weeks, respectively.

In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving Trospamexin tablets 20 mg twice daily and 1.5% among patients receiving placebo. Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the Trospamexin group than in the placebo group.

The two most common adverse reactions reported by patients receiving Trospamexin tablets 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for Trospamexin, dry mouth, occurred in 20.1% of Trospamexin treated patients and 5.8% of patients receiving placebo. In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with Trospamexin tablets 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

Table 1. Incidence (%) of adverse reactions with Trospamexin, reported in greater than or equal to 1% of all patients treated with Trospamexin and more frequent with Trospamexin tablets (20 mg twice daily) than placebo in Studies 1 and 2 combined

Other adverse reactions from the U.S., placebo-controlled trials, occurring in greater than or equal to 0.5% and less than 1.0% of Trospamexin treated patients, and more common with Trospamexin than placebo are: tachycardia, vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Trospamexin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

Trospamexin contraindications

See also:
What is the most important information I should know about Trospamexin?

Patients with urinary retention, renal failure requiring dialysis (creatinine clearance <10 mL/min/1.72 m²), severe GI condition (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma and tachyarrhythmia.

Trospamexin is also contraindicated in patients who have demonstrated hypersensitivity to Trospamexin or to any of the excipients of Trospamexin.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Trospamexin.

Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency and with wheat allergy (different from coeliac disease) should not take Trospamexin. Apart from that, Trospamexin is suitable for people with coeliac disease.

Use in children: Since no data are available, the use in children <12 years is contraindicated.

Active ingredient matches for Trospamexin:

Trospium Chloride in Egypt.

References

1. DailyMed. "TROSPIUM CHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "Trospium". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Trospium". http://www.drugbank.ca/drugs/DB00209 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology