flavoxATE (Monograph)

Brand name: Urispas
Drug class: Genitourinary Smooth Muscle Relaxants
ATC class: G04BD02
VA class: GU201
Chemical name: 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride
CAS number: 3717-88-2

Introduction

Genitourinary antispasmodic.

Uses for flavoxATE

Overactive Bladder

Symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence associated with cystitis, prostatitis, urethritis, urethrocystitis, or urethrotrigonitis. Not indicated as definitive treatment, but is compatible with drugs used for treatment of urinary tract infections.

Has not been shown to be more effective in the treatment of these conditions than antimuscarinic agents.

flavoxATE Dosage and Administration

Administration

Oral Administration

Administer orally 3 or 4 times daily.

Dosage

Available as flavoxate hydrochloride; dosage expressed in terms of the salt.

Pediatric Patients

Oral

Children ≥12 years of age: 100 or 200 mg 3 or 4 times daily. May reduce dosage as symptoms improve.

Adults

Oral

100 or 200 mg 3 or 4 times daily. May reduce dosage as symptoms improve.

Special Populations

No special population dosage recommendations at this time.

Cautions for flavoxATE

Contraindications

• Pyloric or duodenal obstruction.

• Obstructive intestinal lesions or ileus.

• Achalasia.

• GI hemorrhage.

• Obstructive uropathies of the lower urinary tract.

Warnings/Precautions

Warnings

Glaucoma

Use with caution in patients with suspected glaucoma.

Specific Populations

Pregnancy

Category B.

Lactation

Not known whether flavoxate is distributed into milk. Caution if used in nursing women.

Pediatric Use

Safety and efficacy not established in children <12 years of age.

Geriatric Use

Possible increased incidence of mental confusion compared with younger adults.

Common Adverse Effects

Nausea, vomiting, dry mouth, vertigo, headache, mental confusion, drowsiness, nervousness, blurred vision.

Drug Interactions

No formal drug interaction studies to date.

flavoxATE Pharmacokinetics

Absorption

Bioavailability

Appears to be well absorbed from the GI tract.

Onset

Following oral administration in healthy males, onset of action was 55 minutes.

Duration

Following oral administration in healthy males, peak effect occurred at 112 minutes.

Distribution

Extent

Not known whether flavoxate is distributed into milk.

Elimination

Elimination Route

57% of an oral dose of flavoxate is excreted in urine within 24 hours.

Special Populations

Not known whether flavoxate is dialyzable.

Stability

Storage

Oral

Tablets

15–30°C.

Actions

• Exerts a direct spasmolytic (papaverine-like) action on smooth muscle of the urinary tract.

• Increases urinary bladder capacity in patients with evidence of bladder spasticity, possibly as a result of action on the detrusor muscle.

Advice to Patients

• Risk of drowsiness or blurred vision; use caution when driving, operating machinery, or participating in activities where alertness is required.

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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