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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

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

Advice to Patients

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

flavoxATE Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

100 mg*

Urispas

Ortho-McNeil

AHFS DI Essentials™. © Copyright 2024, Selected Revisions September 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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