Drug Reference
Flavoxate
Drugs for urinary frequency and incontinence
Rx only
Fact box
- Therapeutic class
- Drugs for urinary frequency and incontinence
- Action class
- Cholinergic Muscarinic Antagonist
- Mechanism
- Cholinergic Muscarinic Antagonists
- Habit forming
- No
- Availability
- Prescription (Rx)
Available as
100 MG · Oral Tablet200 MG · Oral Tablet
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
INDICATIONS AND USAGE Flavoxate HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
How it works
CLINICAL PHARMACOLOGY Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle. In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate HCl was excreted in the urine within 24 hours.
How to use / dosing
DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.
Side effects
ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness. Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and palpitation. Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia. Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation. Renal: Dysuria.
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyUnsafe
Pregnancy: Teratogenic Effects-Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
BreastfeedingCaution
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when flavoxate HCl is administered to a nursing woman.
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
WARNINGS Flavoxate HCl should be given cautiously in patients with suspected glaucoma.
Contraindications
CONTRAINDICATIONS Flavoxate HCl tablets are contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.
Pediatric use
Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Overdose
OVERDOSAGE The oral LD 50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD 50 for flavoxate HCl in mice is 1837 mg/kg. It is not known whether flavoxate HCl is dialyzable.
Current FDA labels (DailyMed)
- FLAVOXATE HYDROCHLORIDE TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]
- FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS US LLC]
- FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]
- FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]
- FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.