VESIcare


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solifenacin succinate

VESIcare, Vesicare (UK)

Pharmacologic class: Anticholinergic

Therapeutic class: Renal and genitourinary agent

Pregnancy risk category C

Action

Antagonizes muscarinic receptors, reducing urinary bladder smooth-muscle contractions

Availability

Tablets: 5 mg, 10 mg

Indications and dosages

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

Adults: 5 mg P.O. daily initially; may increase to 10 mg P.O. daily if well tolerated

Dosage adjustment

• Moderate hepatic impairment

• Severe renal impairment

• Concurrent use of potent CYP3A4 inhibitors (such as ketoconazole)

Contraindications

• Hypersensitivity to drug or its components

• Urinary retention

• Gastric retention

• Uncontrolled angle-closure glaucoma

Precautions

Use cautiously in:

• hepatic or renal impairment, bladder outflow obstruction, decreased GI motility, GI obstructive disorder, controlled angle-closure glaucoma, congenital or acquired QT interval prolongation

• increased risk of urinary retention or heat prostration

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Give with liquids, with or without food. Make sure patient swallows tablet whole.

Adverse reactions

CNS: dizziness, depression, fatigue, asthenia

CV: hypertension

EENT: dry eyes, blurred vision, dry throat, pharyngitis

GI: nausea, vomiting, constipation, upper abdominal pain, dyspepsia, dry mouth

GU: urinary tract infection, urinary retention

Respiratory: cough

Skin: dry skin, rash, pruritus

Other: influenza, leg or foot edema

Interactions

Drug-drug. Anticholinergics: increased frequency or severity of adverse reactions

CYP3A4 inhibitors (such as ketoconazole): increased solifenacin blood level

Patient monitoring

• Monitor GI, renal, and hepatic function frequently.

• Monitor patient for ophthalmic disorders, especially angle-closure glaucoma. If present, stop drug until condition stabilizes.

Patient teaching

• Instruct patient to take drug with liquids, with or without food, and to swallow tablet whole.

• Advise patient to contact prescriber if severe abdominal pain or constipation lasting 3 or more days occurs.

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

• Advise patient of risk for heat prostration; describe symptoms.

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

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

solifenacin

(so-li-fen-a-sin) ,

VESIcare

(trade name)

Classification

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

Indications

Overactive bladder with symptoms (urge incontinence, urgency, frequency).

Action

Acts as a muscarinic (cholinergic) receptor antagonist; antagonizes bladder smooth muscle contraction.

Therapeutic effects

Decreased symptoms of overactive bladder.

Pharmacokinetics

Absorption: Well absorbed (90%).
Distribution: Unknown.
Protein Binding: 98%.
Metabolism and Excretion: Extensively metabolized by the CYP3A4 enzyme system. 69% excreted in urine as metabolites, 22% in feces.
Half-life: 45–68 hr.

Time/action profile

ROUTEONSETPEAKDURATION
Oralunknown3–8 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Urinary retention;Gastric retention;Uncontrolled angle-closure glaucoma;Severe hepatic impairment; Lactation: Lactation.
Use Cautiously in: Concurrent use of CYP3A4 inhibitors (use lower dose/clinical monitoring may be necessary);Moderate hepatic impairment (lower dose recommended);Renal impairment (dose should not exceed 5 mg/day if CCr <30 mL/min);Bladder outflow obstruction;GI obstructive disorders, severe constipation, or ulcerative colitis;Myasthenia gravis;Angle-closure glaucoma; Obstetric: Use only if maternal benefit outweighs fetal risk; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • confusion
  • drowsiness
  • hallucinations
  • headache

Cardiovascular

  • palpitations
  • tachycardia

Ear, Eye, Nose, Throat

  • blurred vision

Gastrointestinal

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

Musculoskeletal

  • muscle weakness

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Drugs that induce or inhibit the CYP3A4 enzyme system may significantly alter levels; ketoconazole ↑ levels and risk of toxicity (do not exceed 5 mg/day).

Route/Dosage

Oral (Adults) 5 mg once daily, may be ↑ to 10 mg once daily; Concurrent use of ketoconazole or other potent CYP3A4 inhibitors—Dose should not exceed 5 mg/day.

Renal Impairment

(Adults) CCr <30 mL/min—Dose should not exceed 5 mg/day.

Hepatic Impairment

(Adults) Moderate hepatic impairment—Dose should not exceed 5 mg/day.

Availability

Tablets: 5 mg, 10 mg Cost: All strengths $703.66 / 90

Nursing implications

Nursing assessment

  • Monitor voiding pattern and assess symptoms of overactive bladder (urinary urgency, urinary incontinence, urinary frequency) to and periodically during therapy.

Potential Nursing Diagnoses

Impaired urinary elimination (Indications)

Implementation

  • Do not confuse Vesicare (solifenacin) with Vesanoid (oral tretinoin).
  • Oral: Administer once daily without regard to food. Tablets must be swallowed whole; do not break, crush, or chew.

Patient/Family Teaching

  • Instruct patient to take solifenacin as directed. Advise patient to read the Patient Information before starting therapy and with each prescription refill. If a dose is missed, skip dose and take next day; do not take 2 doses in same day.
  • Do not share solifenacin with others; may be dangerous.
  • May cause dizziness and blurred vision. Caution patient to avoid driving and other activities that require alertness until response to medication is known.
  • Advise patient to notify health care professional immediately if hives; rash; swelling or lips, face, tongue, or throat; trouble breathing occurs.
  • Inform patient of potential anticholinergic side effects (constipation, urinary retention, blurred vision, heat prostration 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.

Evaluation/Desired Outcomes

  • Decrease in symptoms of overactive bladder (urge urinary incontinence, urgency, frequency).
References in periodicals archive ?
* Anticholinergic drugs, such as oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), darifenacin (Enablex), trospium (Sanctura) or solifenacin (Vesicare)
Title: VESIcare Pants Agency: AbelsonTaylor Creative Director: Stephen Neale Senior Art Director: Therese Maginot Art Director: Chris Belford Senior Copywriters: Mike Fine, Andy Manilow Client: Astellas/GlaxoSmithKline
Overseas sales, which increased 17.2 billion yen to 111.1 billion yen, owed much of their strength to the good sales performances of Prograf, bladder treatment Vesicare, and Harnal for treating urinary disorder.
Tokyo, Japan, Apr 21, 2006 - (JCN) - Astellas Pharma announced on April 20 that it had obtained additional approval for Funguard for Infusion 50mg/75mg, its proprietary candin antifungal agents, and manufacturing approval for Vesicare Tablet, its proprietary agent for overactive bladder (OAB), from the Ministry of Health, Labor and Welfare.
New drugs are earmarked for launch during 2005 as Glaxo acts to recoup lost sales from its flagship anti-depressants - led by overactive bladder treatment Vesicare, which went on sale in the US last month.
New drugs are earmarked for launch during 2005 as Glaxo acts to recoup lost sales from its flagship anti-depressants ( led by overactive bladder treatment Vesicare, which went on sale in the US last month.
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.
Several key product launches expected in the next six months include Vesicare for over-active bladders, Avandaryl for type two diabetes and Requip for restless leg syndrome.
M2 PHARMA-April 24, 2019-Teva Launches Generic Version of VESIcare Tablets in the United States
M2 EQUITYBITES-April 24, 2019-Teva Pharmaceutical begins US launch of generic VESIcare tablets
Global Banking News-April 23, 2019-Teva Pharmaceutical launches generic version of VESIcare tablets in the US
For urge UI, anticholinergic medications, such as tolterodine (Detrol), darifenacin (Enablex), and solifenacin (Vesicare) are used.