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Flavoxate is a anticholinergic agent that is FDA approved for the treatment of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis.. Common adverse reactions include Nausea, vomiting, headache, blurred vision, drowsiness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- 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.
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.
Off-Label Use and Dosage (Adult)
There is limited information regarding Off-Label Guideline-Supported Use of Flavoxate in adult patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Flavoxate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- 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.
Off-Label Use and Dosage (Pediatric)
There is limited information regarding Off-Label Guideline-Supported Use of Flavoxate in pediatric patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Flavoxate in pediatric patients.
- 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.
- Flavoxate HCl should be given cautiously in patients with suspected glaucoma.
Clinical Trials Experience
- The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
- Leukopenia (one case which was reversible upon discontinuation of the drug).
There is limited information regarding Postmarketing Experience of Flavoxate in the drug label.
There is limited information regarding Flavoxate Drug Interactions in the drug label.
Use in Specific Populations
- 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.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Flavoxate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Flavoxate during labor and delivery.
- 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.
- Safety and effectiveness in children below the age of 12 years have not been established.
There is no FDA guidance on the use of Flavoxate with respect to geriatric patients.
There is no FDA guidance on the use of Flavoxate with respect to specific gender populations.
There is no FDA guidance on the use of Flavoxate with respect to specific racial populations.
There is no FDA guidance on the use of Flavoxate in patients with renal impairment.
There is no FDA guidance on the use of Flavoxate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Flavoxate in women of reproductive potentials and males.
There is no FDA guidance one the use of Flavoxate in patients who are immunocompromised.
Administration and Monitoring
There is limited information regarding Monitoring of Flavoxate in the drug label.
There is limited information regarding IV Compatibility of Flavoxate in the drug label.
- The oral LD50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD50 for flavoxate HCl in mice is 1837 mg/kg.
- It is not known whether flavoxate HCl is dialyzable.
|Systematic (IUPAC) name|
|Mol. mass||391.46 g/mol|
Mechanism of Action
- Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.
- Flavoxate HCl tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.
- Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C24H25NO4•HCl. The molecular weight is 427.94. The structural formula appears below:
- Flavoxate HCl is supplied in tablets for oral administration. Each round, white, film-coated Flavoxate HCl tablet is debossed "PAD" and "0115" on one side and plain on the other side and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of colloidal silicon dioxide, ethyl acrylate, hypromellose, lactose monohydrate, magnesium stearate, methyl methacrylate, microcrystalline cellulose, nonoxynol 100 and sodium starch glycolate. Film coating is composed of hypromellose 2910 6cP and polyethylene glycol.
There is limited information regarding Pharmacodynamics of Flavoxate in the drug label.
- 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
- Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate HCl have not been performed.
There is limited information regarding Clinical Studies of Flavoxate in the drug label.
- Flavoxate HCl Tablets, 100 mg, are supplied as round, white, film-coated tablets debossed "PAD" and "0115" on one side and plain on the other side, in bottles of 100.
- 100 mg 100's:
- NDC 0574-0115-01
- Store at 20° to 25°C (68° to 77°F)
Package and Label Display Panel
PRINCIPAL DISPLAY PANEL - 100 MG TABLET BOTTLE
Flavoxate HCl Tablets
Ingredients and Appearance
Patient Counseling Information
- Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.
Precautions with Alcohol
- Alcohol-Flavoxate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Look-Alike Drug Names
There is limited information regarding Flavoxate Look-Alike Drug Names in the drug label.
The contents of this FDA label are provided by the National Library of Medicine.