solifenacin

Absorption: 90% absorbed following oral administration.

Distribution: Extensively distributed to tissues.

Protein Binding: 98%.

Metabolism/Excretion: Extensively metabolized by liver via the CYP3A4 isoenzyme. 69% excreted in urine as metabolites, 22% in feces.

Half-Life: Tablets: 45–68 hr; Suspension: 26 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
Oral	unknown	3–8 hr	24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Urinary retention;
Gastric retention;
Uncontrolled angle-closure glaucoma;
Severe hepatic impairment;
History of QT interval prolongation or concurrent use of QT interval prolonging medications.

Use Cautiously in:

Moderate hepatic impairment (lower dose recommended);
Renal impairment;
Bladder outflow obstruction;
GI obstructive disorders, severe constipation, or ulcerative colitis;
Myasthenia gravis;
Angle-closure glaucoma;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children 2 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: palpitations, QT interval prolongation, tachycardia

EENT: blurred vision

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

GU: urinary tract infection

MS: muscle weakness

Neuro: confusion, drowsiness, hallucinations, headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A4 inhibitors, including ketoconazole, may significantly ↑ levels and risk of toxicity.
QT interval prolonging medications may ↑ risk of QT interval prolongation; avoid concurrent use.

Route/Dosage ⬆ ⬇

Overactive Bladder

PO (Adults ): Tablets: 5 mg once daily, may ↑ to 10 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Tablets: Not to exceed 5 mg once daily.

Renal Impairment

PO (Adults ): CCr <30 mL/min: Tablets: Not to exceed 5 mg once daily.

Hepatic Impairment

PO (Adults ): Moderate hepatic impairment: Tablets: Not to exceed 5 mg once daily.

Neurogenic Detrusor Overactivity

PO (Children ≥2 yr and >60 kg): Suspension: 5 mg once daily, may ↑ to 10 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 5 mg once daily.
PO (Children ≥2 yr and 46–60 kg): Suspension: 4 mg once daily, may ↑ to 8 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 4 mg once daily.
PO (Children ≥2 yr and 31–45 kg): Suspension: 3 mg once daily, may ↑ to 6 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 3 mg once daily.
PO (Children ≥2 yr and 16–30 kg): Suspension: 3 mg once daily, may ↑ to 5 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 3 mg once daily.
PO (Children ≥2 yr and 9–15 kg): Suspension: 2 mg once daily, may ↑ to 4 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 2 mg once daily.

Renal Impairment

PO (Children ≥2 yr): CCr <30 mL/min: >60 kg: Not to exceed 5 mg once daily (suspension); 46–60 kg: Not to exceed 4 mg once daily (suspension); 16–45 kg: Not to exceed 3 mg once daily (suspension); 9–15 kg: Not to exceed 2 mg once daily (suspension).

Hepatic Impairment

PO (Children ≥2 yr): Moderate hepatic impairment: >60 kg: Not to exceed 5 mg once daily (suspension); 46–60 kg: Not to exceed 4 mg once daily (suspension); 16–45 kg: Not to exceed 3 mg once daily (suspension); 9–15 kg: Not to exceed 2 mg once daily (suspension).

Availability ⬆ ⬇

(Generic available)

Tablets (Vesicare): 5 mg; 10 mg
Oral suspension orange flavor (Vesicare LS): 1 mg/mL

Assessment ⬆ ⬇

Overactive Bladder: Monitor voiding pattern and assess symptoms of overactive bladder (urinary urgency, urinary incontinence, urinary frequency) to and periodically during therapy.
Neurogenic Detrusor Overactivity: Measure bladder capacity as directed.

Implementation ⬆ ⬇

PO: Administer once daily without regard to food. Tablets must be swallowed whole; do not break, crush, or chew.
- Administer suspension once daily followed by water or milk. Shake before use. Use calibrated measuring device to ensure accurate dose.

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. Overactive bladder: if a dose is missed, skip dose and take next day; do not take 2 doses in same day. Neurogenic Detrusor Overactivity: take missed doses as soon as remembered if within 12 hr; if >12 hr since missed dose, omit dose and take next dose at usual time.
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; or 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.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇