Brand Name
Flavoxate
View Brand InformationFDA approval date: December 22, 2004
Classification: Cholinergic Muscarinic Antagonist
Form: Tablet
What is Flavoxate?
Flavoxate hydrochloride 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 hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
Approved To Treat
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Brand Information
Flavoxate Hydrochloride (Flavoxate Hydrochloride)
1DESCRIPTION
Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.
Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4
Each tablet for oral administration contains 100 mg flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.
2CLINICAL 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 hydrochloride was excreted in the urine within 24 hours.
3INDICATIONS AND USAGE
Flavoxate hydrochloride 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 hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
4CONTRAINDICATIONS
Flavoxate hydrochloride is 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.
5WARNINGS
Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
6ADVERSE 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.
7OVERDOSAGE
The oral LD
It is not known whether flavoxate hydrochloride is dialyzable.
8HOW SUPPLIED
Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “
NDC 42806-058-01 Bottles of 100
NDC 42806-058-10 Bottles of 1000
Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container.
Distributed by
Epic Pharma, LLC
Laurelton, NY 11413
Rev. 07-2023-00
MF058REV07/23
OE1140
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 100ct
Flavoxate Hydrochloride Tablets, 100 mg 100ct
