Sanctura


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Related to Sanctura: Trospium chloride, Sanctura XR

trospium chloride

Regurin (UK), Sanctura, Sanctura XR

Pharmacologic class: Anticholinergic, antimuscarinic

Therapeutic class: Renal and genitourinary agent, antispasmodic

Pregnancy risk category C

Action

Antagonizes effects of acetylcholine on muscarinic receptors in cholinergically innervated organs, reducing bladder smooth muscle tone

Availability

Capsules (extended-release): 60 mg

Tablets: 20 mg

Indications and dosages

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

Adults: 20 mg P.O. twice daily 1 hour before meals or on empty stomach, or 1 60-mg capsule daily in morning with water at least 1 hour before a meal

Dosage adjustment

• Severe renal impairment

• Patients age 75 and older

Contraindications

• Hypersensitivity to drug or its components

• Preexisting or risk of urinary or gastric retention or uncontrolled angle-closure glaucoma

Precautions

Use cautiously in:

• moderate renal impairment, moderate to severe hepatic impairment, decreased GI motility, controlled angle-closure glaucoma, clinically significant bladder outflow obstruction or GI obstructive disorders

• patients at risk for heat prostration

• elderly patients

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Give at least 1 hour before meals or on empty stomach.

Adverse reactions

CNS: headache, fatigue, syncope, hallucinations, delirium, dizziness, drowsiness

CV: tachycardia, chest pain

EENT: dry eyes, blurred vision, dry throat

GI: vomiting, constipation (new-onset or aggravated), upper abdominal pain, dyspepsia, flatulence, abdominal distention, dry mouth

GU: urinary retention

Skin: dry skin

Other: altered taste, heat prostration, angioedema

Interactions

Drug-drug. Anticholinergics: additive anticholinergic effects

Digoxin, metformin, morphine, pancuronium, procainamide, tenofovir, vancomycin: increased blood levels of both drugs

Drug-behaviors. Alcohol use: increased risk of drowsiness

Patient monitoring

• Monitor renal and hepatic function tests.

• Monitor patient for decreased GI motility and urinary retention.

If patient has controlled angle-closure glaucoma, stay alert for severe eye pain accompanied by nausea, rainbows around lights, red eye, and blurred vision. Be prepared to treat immediately, as appropriate.

Be aware that angioedema associated with life-threatening upper airway swelling may occur. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue drug and provide appropriate treatment.

Patient teaching

• Instruct patient to take tablet 1 hour before meals on an empty stomach or to take capsule in morning with water at least 1 hour before a meal.

• Instruct patient not to consume alcohol within 2 hours of taking extended-release capsule.

• Advise patient to consult prescriber before taking over-the-counter products such as antihistamines because these may increase risk of side effects.

• Inform patient that drug increases risk of heat prostration; describe symptoms and advise him to seek prompt medical attention if these occur.

• Caution patient to avoid driving and other hazardous activities until drug effects are known.

• Advise patient to avoid alcohol use.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

v

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

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.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
According to the company, the Trospium Chloride Extended-release Capsules is the generic equivalent to Allergan's Sanctura XR, which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
For the 12 months ending 31 July 2012, Sanctura XR had total US sales of about USD67m according to IMS Health data.
The company's marketed products include SANCTURA for overactive bladder and DELATESTRYL to treat male hypogonadism.
Sanctura must be taken on an empty stomach, twice a day, while Vesicare does not, is longer acting, and is taken once a day.
M2 PHARMA-October 15, 2012-Watson Pharmaceuticals Inc unveils FDA approved generic Sanctura XR(C)2012 M2 COMMUNICATIONS
Trospium chloride, marketed as Sanctura, was approved for the treatment of OAB last May.
Compared with older anticholinergics approved for OAB, Vesicare is a more selective muscarinic receptor blocker, as is Sanctura (trospium chloride), noted Richard Bercik, M.D, director of the division of urogynecology and reconstructive surgery at Yale University, New Haven.
* Special Considerations: The most common adverse events in patients who received Sanctura in two U.S.
says a federal court has asserted that five patent claims for Sanctura XR (trospium chloride extended-release capsules) are invalid, a favorable decision for the generic drug manufacturer.
The company raised USD27m through the sale of its TCD Royalty Subsidiary, which was formed in April 2008 to securitise royalties that were generated by Sanctura XR and Oracea.
Trospium chloride (Sanctura), which does not cross the blood-brain barrier and therefore has less effect on the central nervous system.