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
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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