Flavoxate Hydrochloride
FDA Drug Information • Also known as: Flavoxate Hydrochloride
- Brand Names
- Flavoxate Hydrochloride
- Dosage Form
- POWDER
- Product Type
- BULK INGREDIENT
Description
DESCRIPTION Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic. Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H -1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C 24 H 25 NO 4
What Is Flavoxate Hydrochloride Used For?
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 and 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.
Side Effects (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.
Warnings and Precautions
WARNINGS Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
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.
Pregnancy and Breastfeeding
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 hydrochloride. 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.
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 hydrochloride is administered to a nursing woman.
Overdosage
OVERDOSAGE The oral LD 50 for flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD 50 for flavoxate hydrochloride in mice is 1837 mg/kg. It is not known whether flavoxate hydrochloride is dialyzable.
How Supplied
HOW SUPPLIED Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ Є58 ” on one side and plain on the other side. They are supplied as follows: NDC 24658-720-01 in bottles of 100 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container. Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Greenvale, NY 11548 Rev. 02-2025-00 MF058REV02/25 OE2582
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.