Medication Guide App

Flavoxate Hydrochloride

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
Brands: Urispas

Introduction

Genitourinary antispasmodic.a b

Uses for Flavoxate Hydrochloride

Overactive Bladder

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

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

Flavoxate Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer orally 3 or 4 times daily.a b

Dosage

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

Pediatric Patients

Oral

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

Adults

Oral

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

Special Populations

No special population dosage recommendations at this time.b

Cautions for Flavoxate Hydrochloride

Contraindications

  • Pyloric or duodenal obstruction. a b

  • Obstructive intestinal lesions or ileus.a b

  • Achalasia.a b

  • GI hemorrhage.a b

  • Obstructive uropathies of the lower urinary tract.a b

Warnings/Precautions

Warnings

Glaucoma

Use with caution in patients with suspected glaucoma. a b

Specific Populations

Pregnancy

Category B.b

Lactation

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

Pediatric Use

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

Geriatric Use

Possible increased incidence of mental confusion compared with younger adults.b

Common Adverse Effects

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

Interactions for Flavoxate Hydrochloride

No formal drug interaction studies to date.a b

Flavoxate Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Appears to be well absorbed from the GI tract. a

Onset

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

Duration

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

Distribution

Extent

Not known whether flavoxate is distributed into milk.a

Elimination

Elimination Route

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

Special Populations

Not known whether flavoxate is dialyzable.a

Stability

Storage

Oral

Tablets

15–30°C.a b

Actions

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

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

Advice to Patients

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

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

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

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

Preparations

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

* 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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Flavoxate HCl 100MG Tablets (GLOBAL PHARMACEUTICAL CORP): 100/$99.99 or 300/$279.96

Urispas 100MG Tablets (MCNEIL): 28/$51.99 or 84/$145.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Flavoxate. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3600-1.

b. Ortho-McNeil Pharmaceutical, Inc. Urispas (flavoxate hydrochloride) prescribing and patient information. Raritan, NJ; 2004 Aug.

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