trospium

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Related to Sanctura XR: Trospium chloride

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 ?
The compounds in development include SANCTURA XR, the once- daily formulation of SANCTURA, NEBIDO for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, IP 751 is for interstitial cystitis, pagoclone for stuttering, and aminocandin, which the company recently out-licensed to Novexel.
In this research, Frost & Sullivan's expert analysts thoroughly examine the following: Detrol, Detrol LA, Ditropan, Ditropan XL, Enablex, Oytrol, Sanctura, Sanctura XR, VESIcare, and emerging therapies.
For the twelve-months ended March 31, 2009, Sanctura XR had total U.
Sanctura XR is a registered trademark of Allergan, Inc.
SANCTURA XR is indicated for the once-daily treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
SANCTURA XR, the once-daily formulation of SANCTURA(R), is a unique quaternary ammonium compound in a class of anticholinergic compounds known as muscarinic receptor antagonists.
Cost of product revenue relates primarily of the costs to produce SANCTURA XR and royalty payments to Madaus and Supernus, all of which are reimbursed by Allergan, as well as the cost of product related to the sale of VANTAS, SUPPRELIN LA and DELATESTRYL.
0 million related to the approval milestone for SANCTURA XR from Allergan.
For this report we interviewed twenty-four urologists regarding trends in the treatment of OAB and the potential role of next-generation Sanctura XR
Based on the data from the Phase II trial, we anticipate that once-daily Sanctura XR will demonstrate a safety and efficacy profile comparable to the original twice-daily Sanctura formulation and support its FDA approval in mid/late 2007.
Importantly, this transaction does not cover royalties on SANCTURA XR that we expect to receive on sales in Europe and other territories around the world.
The positive results of our SANCTURA XR and pagoclone for stuttering trials in addition to the rapid completion of enrollment in our NEBIDO trial and the initiation of our pagoclone for premature ejaculation trial demonstrate the tremendous opportunity we have at Indevus.