trospium

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trospium

(tros-pee-yum) ,

Sanctura

(trade name),

Sanctura XR

(trade name),

Trosec

(trade name)

Classification

Therapeutic: urinary tract antispasmodics
Pharmacologic: antimuscarinics
Pregnancy Category: C

Indications

Overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

Action

Antagonizes the effect of acetylcholine at muscarinic receptors in the bladder; this parasympatholytic action reduces bladder smooth muscle tone.

Therapeutic effects

Increased bladder capacity and decreased symptoms of overactive bladder.

Pharmacokinetics

Absorption: Less than 10% absorbed following oral administration; food significantly ↓ absorption.
Distribution: Mostly distributed to plasma.
Metabolism and Excretion: Of the 10% absorbed, 40% is metabolized. Unabsorbed drug is mainly excreted in feces. Of absorbed drug, 60% is eliminated in urine as unchanged drug via active tubular secretion.
Half-life: 20 hr.

Time/action profile (anticholinergic effects)

ROUTEONSETPEAKDURATION
POunknown5–6 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Gastric or urinary retention, uncontrolled angle-closure glaucoma or risk for these conditions.
Use Cautiously in: Bladder outflow obstruction;Gastrointestinal obstructive disorders (ulcerative colitis, intestinal atony, myasthenia gravis);Controlled angle-closure glaucoma (use only if necessary and with careful monitoring);CCr <30 mL/min (dose ↓ recommended);Moderate to severe hepatic impairment; Obstetric / Lactation: Use only if benefit justifies risks to fetus/newborn; Pediatric: Safety not established; Geriatric: May have↑ sensitivity to anticholinergic effects; ↓ dose may be required.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • confusion
  • dizziness
  • drowsiness
  • fatigue
  • hallucinations

Ear, Eye, Nose, Throat

  • blurred vision

Gastrointestinal

  • constipation (most frequent)
  • dry mouth (most frequent)
  • dyspepsia

Genitourinary

  • urinary retention
  • urinary tract infection

Miscellaneous

  • angioedema (life-threatening)
  • fever
  • heat stroke

Interactions

Drug-Drug interaction

May interact with other drugs that compete for tubular secretion.Metformin may ↓ levels.↑ risk of anticholinergic effects with other drugs having anticholinergic properties.

Route/Dosage

Oral (Adults) 20 mg twice daily or 60 mg once daily (XR dose form).
Oral (Adults ≥75 yr) Based on tolerability, dose may be ↓ to 20 mg once daily.

Renal Impairment

Oral (Adults) CCr <30 mL/min—20 mg once daily at bedtime.

Availability (generic available)

Tablets: 20 mg
Extended release tablets: 60 mg

Nursing implications

Nursing assessment

  • Monitor voiding pattern and intake and output ratios.

Potential Nursing Diagnoses

Impaired urinary elimination (Indications)

Implementation

  • Oral: Administer 1 hr prior to meals or on an empty stomach.

Patient/Family Teaching

  • Instruct patient to take as directed. If a dose is skipped, take next dose 1 hr prior to next meal.
  • May cause drowsiness, dizziness, and blurred vision. Caution patient to avoid driving and other activities requiring alertness until response to medication is known. Advise patient to avoid alcohol; may increase drowsiness.
  • Advise patient to notify health care professional immediately of signs and symptoms of angioedema (edema of the tongue or laryngopharynx, difficulty breathing) occur.
  • Caution patient that heat prostration (fever and heat stroke due to decreased sweating) may occur when trospium is taken in a hot environment.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding.

Evaluation/Desired Outcomes

  • Increased bladder capacity and decreased symptoms of overactive bladder.

trospium

an anticholinergic.
indication This drug is used to treat overactive bladder.
contraindications Uncontrolled narrow-angle glaucoma, urinary retention, gastric retention, and known hypersensitivity to this drug prohibit its use.
adverse effects Adverse effects of this drug include fatigue, dizziness, headache, dry eyes, vision abnormalities, flatulence, abdominal pain, and dyspepsia. Common side effects include constipation and dry mouth.
References in periodicals archive ?
Instead of trospium chloride, the microspheres are loaded with barium sulfate, which enables the analysis of the microstructure with a micro-computer tomography scanner ([micro]CT).
Karuna believes that the addition of trospium chloride may reduce the side effects typically seen with xanomeline alone.
Multicenter phase III trial studying trospium chloride in patients with overactive bladder.
Efficacy and tolerability of trospium chloride and tolterodine in 234 patients with urge-syndrome: a double-blind, placebo-controlled, multicentre clinical trial [abstract 85B].
Trospium chloride has no effect on memory testing and is assay undetectable in the central nervous system of older patients with overactive bladder.
for the Trospium Study Group: Once daily trospium chloride is effective and well tolerated for the treatment of Overactive Bladder: results from a multicenter phase III trial.
Sanctura[R] XR is a controlled release trospium chloride product indicated for the treatment of overactive bladder with symptoms of urge incontinence, urgency and urinary frequency.
ALKS 27 is an inhaled formulation of trospium chloride using Alkermes' proprietary AIR([R])pulmonary delivery system.
In addition, Esprit controls marketing rights to the recently approved SANCTURA([R]) XR, a novel, once-daily formulation of trospium chloride that has demonstrated outstanding clinical results in terms of efficacy and tolerability in the treatment of OAB.
Food and Drug Administration seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the expiration of a patent owned by Supernus Pharmaceuticals, Inc.
ALKS 27 is an inhaled formulation of trospium chloride based on Alkermes' proprietary AIR([R])pulmonary technology.