solifenacin


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Related to solifenacin: Solifenacin succinate

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).
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
* In February 2018, obtained approval in Europe for solifenacin (YM905) oral suspension for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 to 18 years.
(28.) Mahawar B, Mahawar V, Joajodia A, et al: Excellent response of solifenacin in chemotherapy-induced hemorrhagic cystitis in a child with non-Hodgkin's lymphoma.
In the BEYOND study, in which mirabegron 50 mg was compared with solifenacin 5 mg, the degree of improvement in key OAB symptoms were similar between the two groups and both classes of drug were well tolerated (47).
Novadoz Pharmaceuticals reported on Tuesday the receipt of US FDA approval to market the generic Solifenacin Succinate tablets in 5mg and 10mg tablets in 30 and 90 count bottles for treating symptoms of an overactive bladder, frequent or sudden urination and incontinence.
(1) Solifenacin succinate (SFS) is chemically butanedioic acid (3R)-1-azabicyclo[2.2.2]octan-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate and used as competitive muscarinic acetylcholine receptor (M3) antagonist.
Also in September, the FDA accepted a supplemental New Drug Application for review that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The clearest effect was associated with anticholinergics used to treat depression - for example, amitriptyline, dosulepin and paroxetine - and bladder conditions, such as tolterodine, oxybutynin and solifenacin.
These include anti-depressants amitriptyline, dosulepin and paroxetine; and bladder condition medications tolterodine, oxybutynin and solifenacin.
Solifenacin did cause embryo toxicity in pregnant mice.
In this study, approximately half of the patients received previous treatment and continued to present symptoms, and this observation is similar to those of the MATRIX study, despite the current availability of drugs such as solifenacin and mirabegron.