VESIcare


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) solifenacin,

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).