Flavoxate Hydrochloride
Flavoxate Hydrochloride is an FDA drug label for the active ingredient FLAVOXATE HYDROCHLORIDE manufactured by Epic Pharma, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231227.
- Generic name
- FLAVOXATE HYDROCHLORIDE
- Manufacturer
- Epic Pharma, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 42806-058
- Application
- ANDA076835
- Label effective
- 20231227
Indications & Usage
INDICATIONS 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.
Dosage & Administration
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.
Contraindications
CONTRAINDICATIONS 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.
Warnings
WARNINGS Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
Adverse Reactions
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.